NurOwn May Be Given to Early ALS Patients in US Who Finished Phase… – ALS News Today

BrainStorm Cell Therapeutics has opened an expanded access program (EAP) in the U.S. to allow certain amyotrophic lateral sclerosis (ALS) patients to gain access to its investigational cell-based therapy NurOwn.

EAPs, also known as compassionate use programs, are intended to make investigational therapies available outside of a clinical trial to people whose serious or life-threatening conditions have few or no adequate treatments, when the therapys benefits are thought to outweigh potential risks.

Developed in partnership with the U.S. Food and Drug Administration (FDA), the program will allow clinicians to prescribe NurOwn, at no cost, to ALS patients who completed the therapys pivotal, placebo-controlled Phase 3 trial (NCT03280056) and who meet specific eligibility criteria.

Those with less advanced disease as measured by the ALS Functional Rating Scale(ALSFRS-R) will be the first to receive the treatment. This decision was based on the trials top-line data, which showed a superior treatment response in people in earlier stages of ALS.

Detailed, full data are expected to be presented at upcoming scientific conferences, and published in a peer-reviewed scientific journal.

We are pleased to have the opportunity to treat additional patients with NurOwn through this Expanded Access Program, which was strongly advocated for by members of the ALS advocacy community, Chaim Lebovits, BrainStorms CEO, said in a press release.

We recognize the urgency with which people with ALS want and need access to new potential treatments. This EAP is an important next step to providing an immediate option for some patients, Lebovits added.

Fred Fisher, president and CEO of The ALS Associations Golden West Chapter, said that enabling early access, while the data review continues, is an extraordinary gesture of support and compassion for those living with ALS, and reflects an understanding of the ALS communitys urgent need for an effective therapy. The Golden West Chapter represents the largest ALS community in the U.S.

I applaud Brainstorm for taking this important step, and I look forward to learning the results of their full data analysis, Fisher added.

Lebovits emphasized that BrainStorm remains committed to rapidly advancing NurOwn through clinical development and regulatory review in the hope that the greatest number of people living with ALS may benefit. The EAP will not interfere with data or regulatory timelines.

NurOwn involves collecting mesenchymal stem cells(MSCs) from a patientsown bone marrow, and expanding and maturating them into cells that produce high levels of neurotrophic factors molecules that promote nervous tissue growth and survival. MSCs are stem cells that can generate a variety of other cell types.

The mature cells called MSC-NTF cells are then injected into the patients spinal canal to promote and support nerve cell repair. Using a patients own cells minimizes the risk of an immune reaction, as might occur with cells from a donor.

NurOwn has been designated an orphan drug in both the U.S. and European Union, and given to fast track designation in the U.S.; all help to speed its clinical development and review.

Afterpromising Phase 2 resultsin people with fast-progressing ALS, BrainStorm launched a Phase 3 trial to confirm NurOwns benefits in a larger patient population.

The Phase 3 study evaluated the therapys safety and effectiveness in 189 people with rapidly progressing ALS, who wererandomly assigned to a total of three injections of either NurOwn or a placebo, given directly into the spinal canal, every other month.

Patients were recruited at six clinical sites in the U.S.: three in California, two in Massachusetts, and one in Minnesota. NurOwn will be available under the EAP at these six centers.

Top-line data showed that a greater proportion of NurOwn-treated patients (34.7%) had a slower disease progression as assessed with the ALSFRS-R compared with those given a placebo (27.7%).

However, this difference did not reach statistical significance. This was mainly due to unexpectedly good placebo group responses, exceeding those reported in other ALS trials, the company reported.

Also, no significant group differences were observed in ALSFRS-R score mean changes over the seven months of treatment (-5.52 in the NurOwn group vs. -5.88 in the placebo group), meaning that the trial failed to meet both its main and secondary effectiveness goals.

However, greater treatment responses were seen in a pre-specified group of participants with less advanced disease.

In this group, 34.6% of those given NurOwn showed a slower disease progression, compared with 15.6% of those in the placebo group. In addition, the mean decline in the ALSFRS-R total score was 1.77 with NurOwn and 3.78 with a placebo reflecting a 2.01-point improvement with the cell-based therapy.

Differences between these groups were also not statistically significant, but they were considered clinically meaningful. Based on these positive findings, BrainStorm is actively working with the FDA to identify regulatory pathways that may support NurOwn approval as an ALS treatment.

Biomarker analyses also confirmed that NurOwn was driving its intended biological effects. Its use significantly increased the levels of neurotrophic factors, and dropped those of neurodegenerative and neuroinflammatory biomarkers, in patients cerebrospinal fluid a finding not observed among placebo patients. (The cerebrospinal fluid is the liquid that surrounds the brain and spinal cord.)

This expanded access program is an appropriate and welcome next step in following up the exciting results of the Phase 3 study; it is widely anticipated and deeply appreciated by our ALS patients, said Robert Brown, MD, PhD, one of the trials principal investigators.

Brown is also the Leo P. and Theresa M. LaChance chair in medical research, and chair of the neurology department atUniversity of Massachusetts Medical Schooland UMass Memorial Medical Center.

NurOwn will initially be manufactured by the Dana Farber Cancer Institute, assisted by on-site BrainStorm personnel.

BrainStorm also is evaluating NurOwn as a potential therapy for other neurodegenerative diseases, such as multiple sclerosis, Parkinsons disease, Huntingtons disease, as well as for autism spectrum disorder.

Marta Figueiredo holds a BSc in Biology and a MSc in Evolutionary and Developmental Biology from the University of Lisbon, Portugal. She is currently finishing her PhD in Biomedical Sciences at the University of Lisbon, where she focused her research on the role of several signalling pathways in thymus and parathyroid glands embryonic development.

Total Posts: 45

Ins holds a PhD in Biomedical Sciences from the University of Lisbon, Portugal, where she specialized in blood vessel biology, blood stem cells, and cancer. Before that, she studied Cell and Molecular Biology at Universidade Nova de Lisboa and worked as a research fellow at Faculdade de Cincias e Tecnologias and Instituto Gulbenkian de Cincia. Ins currently works as a Managing Science Editor, striving to deliver the latest scientific advances to patient communities in a clear and accurate manner.

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NurOwn May Be Given to Early ALS Patients in US Who Finished Phase... - ALS News Today

Follow the Money: Spatial Omics, CAR-NK Cells, AI-Powered Biology – Bio-IT World

December 21, 2020 | Funding updates around the life sciences including cash for a handheld mass spec device, Series D for oncolytic immunotherapy, a new company launch in allogenic CAR-NK cells, AI-powered cell classification, a 3-D sequencing platform, and more.

$170M: Israeli Digital Health First VC Firm

OTV (formerly Olive Tree Ventures), Israels digital health first venture capital firm, today announced the closing of a fund with a total value of $170M. OTV also announced their new name and the appointment of a new Head of Asia Pacific to spearhead the funds expansion into the regions market. OTV is the only venture capital fund in Israel whose primary focus is digital health, specializing in supporting their portfolio companies reach maturity, refine execution, tackle regulatory hurdles and ensure a global imprint on validated products. Over the course of the past five years, OTV has prioritized investment in digital health companies that develop cutting-edge solutions to todays most pressing healthcare problems. OTVs portfolio includes some of the worlds highest-profile digital health leaders, including TytoCare, Lemonaid Health, Emedgene, Scopio and Donisi Health.

$116M: Handheld, Desktop Mass Spec

908 Devices, which provides mass spectrometry devices for forensic and scientific research, raised the proposed deal size for its upcoming IPO. The Boston, MA-based company now plans to raise $116 million by offering 6.3 million shares at a price range of $18 to $19. The company had previously filed to offer the same number of shares at a range of $15 to $17. At the midpoint of the revised range, 908 Devices will raise 16% more in proceeds than previously anticipated. 908 Devices provides handheld and desktop mass spectrometry devices that are used to interrogate unknown and invisible materials, providing actionable answers to directly address critical problems in life sciences research, bioprocessing, industrial biotech, forensics and adjacent markets. Since its inception, the company has sold more than 1,200 handheld and desktop devices to over 300 customers in 32 countries, including 18 of the top 20 pharmaceutical companies by 2019 revenue, as well as numerous domestic and foreign government agencies and leading academic institutions.

$91M: Series C for Digital, Decentralized Trials

Medable has announced $91 million in Series C funding to accelerate the life sciences industrys shift to digital and decentralized clinical trials. The round was led by Sapphire Ventures, with follow-on investment from existing investors GSR Ventures, PPD, and Streamlined Ventures. The funding brings Medables total capital raised to more than $136 million. Medables flexible and modular software platform enables clinical leaders to shift from clinic-centric to patient-centric research strategies. The platform provides a unified experience for patients and clinicians, enabling recruitment, remote screening, electronic consent, clinical outcomes assessment (eCOA), eSource, telemedicine, and connected devices. Medable has seen rapid eCOA adoption, driving the field forward with enhancements including connected devices and telemedicine. The COVID-19 pandemic has driven demand for remote clinical trial technologies and Medable is enabling complex research protocols to be conducted remotely through its platform. By minimizing the need for in-person site visits, Medable customers have achieved unprecedented results including 3X faster enrollment and over 90% retention rates.

$58M: Series B for Healthcare Ecosystem Platform

H1, a global platform for the healthcare ecosystem, announced today that it has closed a $58 million Series B round of funding. The round was co-led by IVP and Menlo Ventures, which led the Series A round in April 2020. Transformation Capital, Lux Capital, Lead Edge Capital, Novartis dRx and YC also participated. H1 has created the largest healthcare platform to forge connections in the healthcare ecosystem. The H1 team has taken a unique approach to building the platform that combines AI, human powered engineering, third-party data sources, and government partnerships, to create the largest platform of healthcare professionals, currently spanning over 9 million healthcare professions around the globe.

$50M: Series C for Somatic Cancer, Wellness Platform

Congenica has announced the completion of its Series C funding round, raising $50 million. The round was co-led by Tencent and Legal & General and included other new investors Xeraya, Puhua Capital and IDO Investments. Existing investors Parkwalk, Cambridge Innovation Capital and Downing also participated. The funding is aimed at accelerating international market development and driving further expansion of Congenicas product platform into somatic cancer, wellness and through partnerships with pharmaceutical companies. Furthermore, the company will deliver capabilities including the ability to integrate with existing electronic health systems and deliver automated interpretation.

$47M: Series D for Novel Oncolytic Immunotherapies

CG Oncology has closed a $47 million Series D preferred stock financing led by new investor Kissei Pharmaceutical Co., Ltd., with participation from existing investors ORI Healthcare Fund, Camford Capital and Perseverance Capital Management. The financing will support the advancement of CG Oncologys late-stage clinical programs for its lead oncolytic immunotherapy, CG0070, including an ongoing global Phase 3 trial (BOND3) with CG0070 as a monotherapy for the treatment of BCG-unresponsive, Non-Muscle Invasive Bladder Cancer (NMIBC), and a combination Phase 2 study (CORE1) of CG0070 with KEYTRUDA (pembrolizumab) in the same indication. In addition, a Phase 1b study (CORE2) is currently ongoing with CG0070 in combination with OPDIVO (nivolumab) as a neoadjuvant immunotherapy for Muscle-Invasive Bladder Cancer (MIBC) in cisplatin-ineligible patients.

$42M: Series A for Allogeneic CAR-NK Cell Therapies

Catamaran Bio has launched with $42 million in financing. Sofinnova Partners and Lightstone Ventures co-led the Series A round that is part of the launch financing, with participation by founding investor SV Health Investors, as well as Takeda Ventures and Astellas Venture Management. Proceeds will be used to advance the companys two lead chimeric antigen receptor (CAR)-NK cell therapy programs. In addition, funding will expand the companys TAILWIND Platform, an integrated and proprietary suite of technologies for designing, genetically engineering, and manufacturing allogeneic CAR-NK cell therapies.

$34M: Series B for glycoproteomic powered ovarian cancer diagnostic

InterVenn Biosciences has raised $34M in a Series B fundraising. The latest round was led by Anzu Partners with full participation of Genoa Ventures, Amplify Partners, and True Ventures; Xeraya Capital and the Ojjeh Family joined the syndicate as well. Funds will be used to commercialize the companys High-Throughput-Glycoproteomic powered diagnostic for ovarian cancer; to service increasing partnership platform demand; and to accelerate development efforts for the immuno-oncology treatment response and colorectal cancer indications. InterVenn has demonstrated that analysis of protein glycosylation, the most common and most complex form of post-translational protein modification, is a highly effective way of discovering uniquely informative biomarkers. This breakthrough was made possible given the companys development of its AI neural network for high throughput analysis (PiP) and enabling software that powers the proprietary Vista research product for over a dozen different oncology indications.

$24M: Series A for Molecular Cartography

Resolve Biosciences has completed a $24 million Series A financing round and appointed Co-founder Jason T. Gammack as Chief Executive Officer. The Series A financing round was led by PS Capital Management and MasterMind Advisory Services and included participation from Alafi Capital, John Shoffner, and High Tech Grnderfonds. The company will use the proceeds to accelerate product development and drive industry adoption of its Molecular Cartography technology. The company's Molecular Cartography platform is a groundbreaking multi-analyte and highly multiplex spatial analysis technology that enables scientists to resolve the most daunting biological challenges in areas such as oncology, neuroscience, and infectious disease. It produces deep contextual datasets that illuminate molecular interactions at subcellular resolution, while preserving the sample tissue. The initial applications of Resolve's Molecular Cartography platform deliver the highest-resolution view of transcriptomic activity and provide the ability to interrogate hundreds of genes in a single run. Future solutions will add DNA, protein, and metabolomic data layers. Unlike current approaches, Resolve's technology provides the required sensitivity, specificity, and workflow convenience to elucidate the cell's complex transcriptional landscape.

$23M: Series A for Traumatic Brain Injury Test

BRAINBox Solutions announced the initial closing on a $23 million Series A financing to support the clinical development of the company's BRAINBox TBI (Traumatic Brain Injury) Test to aid both in the diagnosis and prognosis of mild TBI (concussion). BioVentures Investors led the financing round and was joined by the Tauber Foundation, the Virginia Tech Carilion Innovation and Seed Funds, Genoa VC, Pharmakon Holdings LLC, Astia Angels and additional qualified investors, including Kevin Love, professional basketball player and mental health advocate. BRAINBox TBI is the first test designed to assist in both the diagnosis and prognosis of concussion. The multi-marker and multi-modality test, which can be used in either point-of-care or clinical laboratory settings, includes a panel of blood biomarkers as well as advanced digital neurocognitive testing in partnership with BrainCheck, Inc. Using proprietary AI algorithms, BRAINBox TBI combines the results of the test components and patient reported outcomes to generate a single, objective score for diagnosis up to 96 hours from the time of injury and a prognosis report for likely injury-related symptoms up to three months post-event.

$23M: Series B for Digital, Computational Pathology Solutions

Proscia has secured $23 million in Series B funding led by Scale Venture Partners, with participation from Hitachi Ventures, the strategic corporate venture capital arm of Hitachi, Ltd., bringing its funding total to $35 million. The company will use the investment to accelerate its global growth and strengthen its position of leadership in transforming cancer research and diagnosis at a time when demand for modernizing pathology is higher than ever. With its Concentriq software platform, Proscia is accelerating the transformation to digital pathology, which centers around high-resolution images of tissue biopsies, as the new standard of care. Concentriq combines enterprise scalability with powerful AI applications to help laboratories, health systems, and life sciences companies unlock new insights, accelerate breakthroughs, and improve patient outcomes.

$21.5M: Series B for Software, Data Products for Biomarker Discovery

Ovation.io has raised $21.5 million in Series B funding led by SignalFire with participation from Madrona Venture Group, Borealis Ventures, StageDotO Ventures and industry veteran David Shaw. Ovations suite of software and data products make it easier for molecular diagnostic labs to bring innovative tests to the patients that need them. Developed by scientists to help laboratories accelerate adoption of molecular diagnostics, Ovation is a turn-key, cloud-based platform with configurable, out-of-the-box workflows for molecular tests and seamless integrations to support the needs of a rapidly growing lab. With this latest round of funding, Ovation will work with its network of participating labs to develop insights that can help life-science companies reduce the time and cost associated with biomarker discovery.

$20M: Series A for AI-Powered Cell Classification

Deepcell has closed its Series A round of financing with $20 million, led by Bow Capital and joined by Andreessen Horowitz, which led its $5 million seed round. The new funding will allow Deepcell to develop its microfluidics-based technology, continue building a cell morphology atlas of more than 400 million cells, and drive a hypothesis-free approach to cell classification and sorting. Spun out of Stanford University in 2017, Deepcell is using deep learning and big data to classify and isolate individual cells from a sample. The technology combines advances in AI, cell capture, and single-cell analysis to sort cells based on detailed visual features, delivering novel insights through an unprecedented view of cell biology. The Deepcell platform maintains cell viability for downstream single-cell analysis and can be used to isolate virtually any type of cell even those occurring at frequencies as low as one in a billion to offer access to rare cells and atypical cell states that will help advance precision medicine research.

$20M: Series B for Spatial Omics

Rebus Biosystems has closed a $20 million Series B financing round, led by Illumina Ventures and joined by Lifecore Partners, Ncore Ventures, Xolon Invest, CTK Investments, Ray Co., Ltd., Seegene Medical Foundation, LabGenomics Co., Ltd., and Timefolio Asset Management. At the heart of the Rebus Biosystems spatial omics solution is the companys patented Synthetic Aperture Optics (SAO) system, which provides the resolution and sensitivity of a 100X oil lens, but with the breadth and depth of a 20X air lens. Data is captured 100 times faster than with other imaging based spatial omics methods that rely on 100x lenses and z-stacking. Speed and ease of use of the system is further improved by integration with custom microfluidics and image processing.

$14.8M: Scaled Up Production of Portable PCR Diagnostic Device

QuantuMDx Group Limited, a UK-based life sciences company, is investing over 11 million to scale up production to mass manufacture its flagship diagnostic device, Q-POC and disposable test cassette. QuantuMDx accelerated development, scale-up and manufacture of Q-POCits rapid point-of-care testing systemearlier this year in response to the COVID-19 pandemic.Q-POC is a portable, PCR device offering rapid, sample-to-answer, molecular diagnostic testing at the point of care, with results in approximately 30 minutes. The Q-POC system comprises a sample collection kit, single-use test cassette and analyzer. The companys first commercial assay for Q-POC will detect SARS-CoV-2, the virus causing COVID- 19, and Flu A & B, providing a powerful rapid PCR diagnostics and surveillance tool for clinicians and public health officials.QuantuMDx has worked with British development partner Cambridge Design Partnership to undertake pilot manufacturing of Q-POCTM, and is now working with Cogent Technology, as the company scales for volume manufacturing.

$14M: Novel Treatment for Ischemic Stroke

BrainsGate has secured $14 million in a new investment round at a pre-money valuation of $147 million. New investor, BNP Joint Capital Fund, and the Impact investment and consulting firm SPERO led the round alongside existing investors, Elron, Medtronic, Agate, Pitango, and Cipio. The new investment is expected to fund BrainsGate through its pre-market approval (PMA) and enable it to achieve volume production readiness and apply for coverage from the Centers for Medicare & Medicaid Services (CMS) for its Ischemic Stroke System (ISS). BrainsGates therapy involves a less than 5 minutes procedure in which a neurostimulator implant is injected into an existing canal. The implant stimulates a nerve center that augments collateral blood flow to improve stroke patients outcomes in a 24-hour window. In May 2020, BrainsGate received marketing approval in Europe (CE marking) of its ISS product. BrainsGates PMA application was filed with the US FDA in February 2020. The company plans to initiate commercialization activities subject to the PMA being approved.

$10.6M: UK Investment Firm for Life Sciences

Intuitive Investments Group, a closed-end investment company focused on the life sciences sector, has raised 7.85 million (before expenses) in its AIM float by placing 39,250,000 new Ordinary Shares at 20p. The net proceeds of the Placing will be used by the Company to invest in fast growing and/or high potential Life Sciences businesses, based predominantly in the UK, wider Europe and the US, chosen from an identified pipeline of investment opportunities. Investments will be focused on diagnostics and healthcare, medical devices, tools and technologies and bio-therapeutics and pharmaceuticals

$7.4M: BARDA Extension For Point-of-Care Infection Diagnostics

Inflammatix has announced a contract extension of $7.4 million from the Biomedical Advanced Research and Development Authority (BARDA) to further develop its point-of-care test and system to diagnose infection by reading the immune system. The contract is part of a BARDA contract worth up to $72 million, if all options are exercised. The new funding will support continued development and commercialization of Inflammatixs sample-to-answer, point-of-care Myrna test system, which is designed to read RNA using machine learning and produce results in under 30 minutes, as well as continued development of the ViraBac EZ test (formerly known as HostDx Fever), which reads gene expression patterns in the immune system to identify whether a suspected infection is bacterial or viral, enabling physicians to quickly and accurately determine when to prescribe antibiotics. The test will use a fingerstick collection and capillary blood sample, and is designed for use in primary care, urgent care and other outpatient clinical settings.

$6.6M: Series A for Robotics, Machine Learning in Biology

Trailhead Biosystems announced its $6.6 million Series A financing. The company has developed a proprietary platform to perform systems-level interrogation of complex biological problems, ranging from the generation of industrially-scalable manufacturing conditions for specialized human cells to combinatorial drug discovery in cancer and anti-viral therapies. Trailhead robotically conducts the largest dimensioned experiments in biology, using machine learning to discover critical process parameters and combinatorial inputs that explain biological responses. Trailhead aims to rapidly develop the capability of creating specialized human cell types at high purity for regenerative medicine and therapeutic purposes at an industrial scale, addressing current industry needs for highly specialized cells used in drug discovery and modeling of human diseases. Through strategic partnerships, the cells provided by the company will be used to address multiple areas of clinical need. The company currently develops products that target type I diabetes, Parkinson's disease, Multiple Sclerosis, Alzheimer's disease, and blood disorders, among others.

$6.1M: 3-D Sequencing Platform

DNA sequencing instigator Single Technologies announced the completion of a heavily oversubscribed 5 million share issue to existing and new shareholders. Among the new investors are Jens von Bahr, Rothesay Ltd, Carl-Henric Svanberg funded Cygnus Montanus Trust, Professor Ulf Landegren and Andreas Ehn. The funds will be used to accelerate development of the companys 3-D sequencing platform. Stockholm Corporate Finance acted as financial advisor. The new funding will enable the company to finalize automating its 3-D sequencing process, make it more robust and improve quality for both Whole Genome Sequencing (WGS) and transcriptomics applications. The ambition is to open the first data sequencing production site in Stockholm by 2022.

$5M: Gates Grant for At-Home COVID-19 Test

Sherlock Biosciences has received a $5 million grant from the Bill & Melinda Gates Foundation to continue to advance INSPECTR, its instrument-free, synthetic biology-based molecular diagnostics platform. In addition to advancing the INSPECTR platform development to be as sensitive as gold-standard PCR tests, the funding will support the development of an over-the-counter disposable product, similar to an at-home pregnancy test, that can be used to detect SARS-CoV-2, the virus that causes COVID-19. Pending approval, the company says they will launch this product in mid-2021. INSPECTR, which stands for Internal Splint-Pairing Expression Cassette Translation Reaction, uses synthetic biology to enable the creation of instrument-free diagnostic tests that can be conducted at home, at room temperature. INSPECTR can be adapted to work on a simple paper strip test or to provide an electrochemical readout that can be read with a mobile phone. It can also be adapted for use in laboratory or point-of-care settings.

$4M: Prostate Health Center at Mount Sinai

Mount Sinai has received a $4 million donation from Lizzie and Jonathan Tisch to support prostate health and the Milton and Carroll Petrie Department of Urology at Mount Sinai. The prostate program will be named The Lizzie and Jonathan Tisch Center for Prostate Health. The medical services provided at the Lizzie and Jonathan Tisch Center for Prostate Center include state-of-the-art prostate cancer screening and imaging technologies, precision urology, focal therapy, targeted biopsies, robotics for prostate cancer surgery, prostate cancer fusion biopsy, and active surveillance. Additionally, prostate cancer experts such as Dr. Tewari; Avinash Reddy, MD; Sujit Nair, PhD; Robert Valenzuela; MD; Michael Palese, MD; and Steven Kaplan, MD, are available to see patients at the newly named Center.

$2.9M: NIH Grant for Human Placental Stem Cells

Human placental stem cells may have the potential to regenerate heart tissue after a heart attack, according to Mount Sinai researchers who have received a $2.9 million grant from the National Institutes of Health to study them. Their findings could lead to new therapies for repairing the heart and other organs. Hina W. Chaudhry, MD, Director of Cardiovascular Regenerative Medicine at the Icahn School of Medicine at Mount Sinai, is the Principal Investigator for this four-year award. Dr. Chaudhry and a team of investigators previously discovered that mouse placental stem cells can help the hearts of mice recover from injury that could otherwise lead to heart failure. They identified a specific type of placental stem cells, called Cdx2 cells, as the most effective in making heart cells regenerate.

$2M: Cryo Solutions for Cell, Gene Therapy

GlycoNet has secured a $2-million USD equity investment for PanTHERA CryoSolutions (PanTHERA), a Canadian biotechnology start-up. The investment came from US-based investor Casdin Capital and bioproduction tools supplier BioLife Solutions Inc. In addition to an up-front investment, subject to closing conditions, BioLife will provide an additional $2 million to support product development over the next 24 months in exchange for exclusive, worldwide marketing and distribution rights to the technology for use in cell and gene therapy applications. The core technology from PanTHERA was created out of an academic research collaboration between the University of Ottawa and the University of Alberta. During cryopreservation of biological materials, the uncontrolled growth of ice causes cell injury and death. PanTHERA's solution is to develop ice recrystallization inhibitors (IRIs) to control the growth of ice and prevent this damage from occurring, ultimately resulting in superior cellular products after thawing.

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Follow the Money: Spatial Omics, CAR-NK Cells, AI-Powered Biology - Bio-IT World

Stem cells in drug development – Nordic Life Science

The high cost and uncertain outcomes of developing new drugs has taken a toll on research over the past several years. Few companies can take the hit of investing hundreds of thousands of dollars in research and testing, only to see dangerous side effects emerge during the final stages, human clinical trials.

The pursuit of more accurate, less costly testing methods has led many companies to stem cells, which can be coaxed into developing into cells of human organs such as the heart and liver and provide a more accurate, less expensive process for testing. Researchers have been able to generate cells in the laboratory that reach the gold standard required by the pharmaceutical industry to test drug safety. Now, drug companies are increasingly adopting stem cells for research, for testing the toxicity of drugs and identifying potential new therapies.

Id say there have been a lot of advances in past five years, but its still in its early days, said Dr. Steven Minger, chief scientist for cellular sciences, GE Healthcare Life Sciences. There is still a concern about how good the cells are and how they will react. Weve gone a long way and have a lot of high-quality data, but pharmaceutical companies still have to decide if this is superior to the method they have been using for 40-50 years.

Standard procedure for decades has been to test new drugs on the organs of animals, such as rabbits. But in many cases, there were no adverse reactions in the animals, so companies proceeded to clinical trials, only to discover then the drug caused side effects on human organs, forcing the company to abandon the drug or launch costly research to find a solution.

Now some new medications are being tested for safety on differentiated cells generated from humanpluripotent cell lines, which are stem cells capable of developingintoanytypeofcellortissueexcept thosethatformaplacentaorembryo. Not only is there an endless supply of them, but they provide a more consistent basis for testing. Human cells are much more predictable and predictable certainly lowers risks, Minger noted. Not to mention saving money; developing a new compound can cost as much as $27 million, he added.

Companies were spending millions of dollars to fail, Minger continued, This [stem cell testing] will make for safer, cheaper, better drugs. The sooner companies are aware of problems with a drug, the easier it is to address them. They can bail fast, bail early or get rid of the toxic compounds as quickly as possible, he said. And just because a drug comes up bad, doesnt mean the drug is bad. It gives you more options early. The fact that you have data early means you have time to do something with it. Later on, you dont what to spend billions to find out the problem.

Cells currently available for use in testing are heart muscle and liver, which are the organs where 80 percent of drug failures occur, Minger added. Drug companies get the cells from firms such as Swedens Takara Bio Europe AB, which produces heart muscle cells and liver cells for drug and biotechnology companies as well as universities. They allow for early testing on human material; you have quality controlled material from the same source, said Kristina Runeberg, site head/senior director, business development, for Takara Bio Europe AB. Heart and liver cells were considered most important and developed first, but she expects neural cells to come next, and researchers also are working on beta cells, which are in the pancreas.

The results from stem cell testing so far are convincing companies and regulatory agencies that this is the new best practice. The U.S. Federal Drug Administration (FDA) is expected to require at least some drugs to undergo stem cell testing as part of the approval process in the not so distant future.

We have huge amounts of data and believe they are superior to animal cells; now through a number of organizations working together with the FDA, there is starting to be a consensus built that stem cells have a huge potential and should be the new standard for how pharmaceutical compounds are assessed on a safety basis, according to Minger.

Future developments include using stem cells to test for long-term chronic toxicity in certain drugs, which requires keeping the same culture for longer periods of time, Runeberg said. Researchers also are working on new ways to identify hazards and test toxicity, added Minger.

There are 220 different cell types, and it is theoretically possible to make them all, Runeberg added. The field has started with the most important ones. In the future, more and more will be developed and more companies will be commercially involved.

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Stem cells in drug development - Nordic Life Science

Global Cell Culture Market by Product, Application, End-user and Region – Forecast to 2025 – PRNewswire

DUBLIN, Dec. 18, 2020 /PRNewswire/ -- The "Global Cell Culture Market by Product (Consumables [Media, Serum, Vessels], Equipment [Bioreactor, Centrifuge, Incubator, Autoclave]), Application (Therapeutic Proteins, Vaccines, Diagnostics, Stem Cells), End-user (Pharma, Biotech) and Region - Forecast to 2025" report has been added to ResearchAndMarkets.com's offering.

The global cell culture market is projected to reach USD 33.1 billion by 2025 from USD 19 billion in 2020, at a CAGR of 11.8% during the forecast period.

The growth of this market is majorly driven by the growing awareness about the benefits of cell culture-based vaccines, increasing demand for monoclonal antibodies (mAbs), funding for cell-based research, growing preference for single-use technologies, and the launch of advanced cell culture products. On the other hand, the high cost of cell biology research and the lack of proper infrastructure for cell-based research activities are the major factors restraining this market's growth.

Based on product, the consumables segment holds the largest market share during the forecast period

Based on product, the cell culture market is segmented into equipment and consumables. The consumables segment accounted for the largest market share in 2019 and is expected to register the highest CAGR during the forecast period. The dominant share and high growth of the consumables segment can be attributed to the repeated purchase of consumables and increased funding for cell-based research.

Based on application, the biopharmaceutical production segment is expected to register the highest CAGR during the forecast period

Based on application, the cell culture market is categorized into biopharmaceutical production, stem cell research, diagnostics, drug screening & development, tissue engineering and regenerative medicine, and other applications. The biopharmaceutical production application segment is expected to register the highest CAGR during the forecast period.The high growth of this segment is attributed to the commercial expansion of major pharmaceutical companies, growing regulatory approvals for the production of cell culture-based vaccines, and the increasing demand for monoclonal antibodies (mAbs).

Pharmaceutical & Biotechnology companies end-user segment is expected to grow at the highest CAGR in the cell culture market during the forecast period

Based on end-users, the cell culture market is segmented into pharmaceutical & biotechnology companies, academic & research institutes, hospitals and diagnostic centers, and cell banks. The pharmaceutical & biotechnology companies segment is expected to witness the highest growth during the forecast period. The growing use of single-use technologies, the increasing number of regulatory approvals for cell culture-based vaccines, and the presence of a large number of pharmaceutical players in this market are some of the factors driving the cell culture market for this end-user segment.

North America is expected to account for the largest share of the cell culture market in 2019

In 2019, North America accounted for the largest share of the cell culture market, followed by Europe, the Asia-Pacific, Latin America, and the Middle East & Africa. The large share of this market segment can be attributed to the growing regulatory approvals for cell culture-based vaccines, technological advancements, and growth in the biotechnology & pharmaceutical industries in the region are the key factors driving the growth of the cell culture market in North America.

Key Topics Covered:

1 Introduction

2 Research Methodology 3 Executive Summary

4 Premium Insights 4.1 Cell Culture: Market Overview 4.2 Asia-Pacific: Cell Culture Market Share, by End-user and Country (2019) 4.3 Cell Culture Market: Geographic Growth Opportunities 4.4 Regional Mix: Cell Culture Market 4.5 Cell Culture Market: Developed Vs. Developing Markets

5 Market Overview 5.1 Introduction 5.2 Market Dynamics 5.2.1 Market Drivers 5.2.1.1 Growing Awareness About the Benefits of Cell Culture-Based Vaccines 5.2.1.2 Increasing Demand for Monoclonal Antibodies 5.2.1.3 Funding for Cell-Based Research 5.2.1.4 Growing Preference for Single-Use Technologies 5.2.1.5 Launch of Advanced Cell Culture Products 5.2.1.6 Growing Focus on Personalized Medicine 5.2.2 Market Restraints 5.2.2.1 High Cost of Cell Biology Research 5.2.2.2 Lack of Infrastructure for Cell-Based Research in Emerging Economies 5.2.3 Market Opportunities 5.2.3.1 Growing Demand for 3D Cell Culture 5.2.3.2 The Growing Risk of Pandemics and Communicable Diseases 5.2.3.3 Emerging Economies 5.3 COVID-19 Impact on the Cell Culture Market 5.4 Value Chain Analysis 5.5 Supply Chain Analysis 5.6 Ecosystem Analysis 5.7 Regulatory Analysis

6 Cell Culture Market, by Product 6.1 Introduction 6.2 Impact of the COVID-19 on the Cell Culture Market 6.3 Consumables 6.3.1 Sera, Media, and Reagents 6.3.1.1 Media 6.3.1.1.1 Serum-Free Media 6.3.1.1.1.1 Lack of Sera Eliminates the Risk of Contamination by Viruses 6.3.1.1.2 Classical Media & Salts 6.3.1.1.2.1 Classical Media is Commonly Used in Virology, Vaccine Production, and Primary Tissue Explant Culture 6.3.1.1.3 Stem Cell Culture Media 6.3.1.1.3.1 Stem Cell Culture Media to Witness the Highest Growth in the APAC Market During the Forecast Period 6.3.1.1.4 Specialty Media 6.3.1.1.4.1 Specialty Media is Suitable for the Growth of Selective Cell Types 6.3.1.2 Reagents 6.3.1.2.1 Growth Factors 6.3.1.2.1.1 Growth Factors are Unique Cell Signaling Molecules That Help in Cell Proliferation & Development 6.3.1.2.2 Supplements 6.3.1.2.2.1 Supplements Such as Amino Acids Play a Key Role in Inducing Cell Growth 6.3.1.2.3 Buffers & Chemicals 6.3.1.2.3.1 Chemical Buffers are Widely Used, But It Can be Toxic at Higher Concentrations 6.3.1.2.4 Cell Dissociation Reagents 6.3.1.2.4.1 Dissociation Reagents Can be Enzymatic or Non-Enzymatic 6.3.1.2.5 Balanced Salt Solutions 6.3.1.2.5.1 Balanced Salt Solutions Find Wide Applications in Life Sciences 6.3.1.2.6 Attachment & Matrix Factors 6.3.1.2.6.1 The Development of Cells is Dependent on Attachment Factors 6.3.1.2.7 Antibiotics/Antimycotics 6.3.1.2.7.1 The Possibility of Contamination Risks Make the Long-Term Use of Antibiotics/Antimycotics Conditional 6.3.1.2.8 Contamination Detection Kits 6.3.1.2.8.1 Contamination Detection Kits Provide Rapid Results 6.3.1.2.9 Cryoprotective Reagents 6.3.1.2.9.1 Cryoprotective Reagents Protect Tissues/Cells from Damage due to Freezing 6.3.1.2.10 Other Cell Culture Reagents 6.3.1.3 Sera 6.3.1.3.1 Fetal Bovine Sera (FBS) 6.3.1.3.1.1 Use of FBS is Now Restricted due to Regulatory Guidelines 6.3.1.3.2 Adult Bovine Sera (ABS) 6.3.1.3.2.1 ABS is a Cost-Effective Alternative to FBS and is Used as a Biochemical Reagent in IVD 6.3.1.3.3 Other Animal Sera 6.3.2 Vessels 6.3.2.1 Roller/Roux Bottles 6.3.2.1.1 Roller Bottles Offer an Economical Means of Cultivating Large Cell Volumes 6.3.2.2 Cell Factory Systems/Cell Stacks 6.3.2.2.1 Cell Stacks Require Special Handling Equipment and Skilled Expertise 6.3.2.3 Multiwell Plates 6.3.2.3.1 Larger Well Formats Allow for Greater Culture Volumes 6.3.2.4 Flasks 6.3.2.4.1 Disposable Flasks are in Greater Demand Among End-users 6.3.2.5 Petri Dishes 6.3.2.5.1 The Wide Usage of Petri Dishes is Attributed to Ease of Use 6.3.3 Bioreactor Accessories 6.4 Equipment 6.4.1 Supporting Equipment 6.4.2 Bioreactors 6.4.3 Storage Equipment

7 Cell Culture Market, by Application 7.1 Introduction 7.2 Impact of the COVID-19 on the Cell Culture Market 7.3 Biopharmaceutical Production 7.3.1 Therapeutic Proteins 7.3.1.1 Growing Applications of Recombinant Proteins to Drive the Growth of this Segment 7.3.2.1 Rising Incidence of Disease Outbreaks to Drive the Market Growth for Vaccine Production 7.4 Diagnostics 7.4.1 The Growing Risk of Viral Infections Drives the Uptake of Cell Culture Products for Diagnostics 7.5 Drug Screening & Development 7.5.1 Increasing Adoption of Cell-Based Assays in R&D Activities to Drive Segment Growth 7.6 Stem Cell Research 7.6.1 Increasing Stem Cell Research Activities & Investments Drive Segment Growth 7.7 Tissue Engineering and Regenerative Medicine 7.7.1 Increasing Funding for Regenerative Medicine Boosts Segment Growth 7.8 Other Applications

8 Cell Culture Market, by End-user 8.1 Introduction 8.2 Impact of the COVID-19 on the Cell Culture End-User Market 8.3 Pharmaceutical & Biotechnology Companies 8.3.1 Growing Regulatory Approvals for Cell-Culture Based Vaccines Drives Segment Growth 8.4 Hospitals and Diagnostic Laboratories 8.4.1 Increasing Applications of Cell Culture for the Diagnosis of Various Diseases to Drive Segment Growth 8.5 Research & Academic Institutes 8.5.1 Increasing Government Funding for Research Projects and the High Prevalence of Cancer to Drive Growth for this End-User Segment 8.6 Cell Banks 8.6.1 Increasing Awareness of Preserving Stem Cells to Drive Segment Growth

9 Cell Culture Market, by Region 9.1 Introduction 9.2 COVID-19 Impact on the Cell Culture Market 9.3 North America 9.5 Asia-Pacific 9.6 Latin America 9.7 Middle East and Africa

10 Competitive Landscape 10.1 Overview 10.2 Competitive Scenario 10.2.1 Partnerships, Agreements, and Collaborations (2020) 10.2.2 Product Launches & Upgrades (2020) 10.2.3 Expansions (2020) 10.2.4 Acquisitions (2019-2020)

11 Company Evaluation Matrix and Company Profiles 11.1 Company Evaluation Matrix Definition & Methodology 11.2 Competitive Leadership Mapping (2019) 11.2.1 Stars 11.2.2 Emerging Leaders 11.2.3 Pervasive Companies 11.2.4 Emerging Companies 11.3 Market Share Analysis, 2019 11.4 Company Profiles 11.4.1 Thermo Fisher Scientific Inc. 11.4.2 Merck KGaA 11.4.3 Becton, Dickinson & Company 11.4.4 Corning Incorporated 11.4.5 Danaher Corporation 11.4.6 Eppendorf AG 11.4.7 Fujifilm Irvine Scientific, Inc. (Acquired by Fujifilm Corporation) 11.4.8 Lonza Group AG 11.4.9 Sartorius AG 11.4.10 Cellgenix GmbH 11.4.11 Miltenyi Biotec 11.4.12 Stemcell Technologies, Inc. 11.4.13 Himedia Laboratories 11.4.14 Invivogen 11.4.15 Infors AG 11.4.16 Promocell 11.4.17 Pan Biotech GmbH 11.4.18 Seracare Life Sciences Incorporation 11.4.19 Caisson Labs 11.4.20 Solida Biotech GmbH

12 Appendix 12.1 Insights from Industry Experts 12.2 Discussion Guide 12.3 Knowledge Store: The Subscription Portal 12.4 Available Customizations

For more information about this report visit https://www.researchandmarkets.com/r/ea1loc

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Global Cell Culture Market by Product, Application, End-user and Region - Forecast to 2025 - PRNewswire

Glycostem and Ghent University sign license agreement on NK cell therapy technology | DNA RNA and Cells | News Channels – PipelineReview.com

Details Category: DNA RNA and Cells Published on Friday, 18 December 2020 13:05 Hits: 509

- New opportunities for the development of NK-antibody combination therapies

- Significant positive effect on production time of Glycostem's lead product oNKord, and future CAR-NK and TCR-NK therapies

OSS, The Netherlands I Dec. 17, 2020 I Glycostem Therapeutics B.V., a leading clinical-stage company focused on the development of therapeutic off-the-shelf Natural Killer (NK) cells, and Ghent University (UGent) have signed a license agreement for an innovative NK cell production technology. Ultimately, this agreement will bring significant benefit to targeted treatment of patients suffering from cancer. The agreement not only opens up new opportunities for development of NK-antibody combination therapies but also has significant positive impact on the production time of Glycostem's lead product oNKord and its second (CAR-NK) and third (TCR-NK) generation therapies viveNKTM.

"This license agreement offers new opportunities for more targeted treatment of cancer patients. By using UGent's technology we are able to increase the expression of CD16 receptors resulting in an increase of the NK-cell's activity and its antibody binding properties. When a patient's immunity is weak, administering NK-cells will boost the patient's immune system and increase the antibody's therapeutic effectiveness," explains Troels Jordansen, CEO at Glycostem.

Glycostem's NK-cell based therapies are manufactured in its in-house GMP licensed facility. "Ghent University's technology has the potential to almost halve the time needed for NK cell progenitor cells to differentiate into fully functional NK-cells. By incorporating this in our processes both our manufacturing time and cost-effectiveness will be affected very positively without negative effect on the potency of the NK cells. This is an important part of paving the way for further upscaling the production of our NK-cells," says Troels Jordansen.

"We are glad to see our research translated to a clinical setting as it is based on many years of fundamental research into NK cell biology," tells Prof. Georges Leclercq, head of the UGent research team and group leader in the Cancer Research Institute Ghent (CRIG). "We hope that with this collaboration, we can positively impact the lives of many patient's affected by difficult to treat cancers."

Dr. Dominic De Groote (UGent Business Development) further explains: "This partnership is the result of continuing efforts by Ghent University and Ghent University Hospital to become a leading academic and clinical center for cell-based therapies. This technology is part of our growing portfolio of oncology and Advanced Therapy Medicinal Products (ATMP) related assets that we are actively developing from the bench to the bedside through our translational platforms."

Taking cellular immunotherapy to the next level

Glycostem is focused on developing first, second and third generation cancer treatments based on NK-cells. This licensing deal will affect Glycostem's full portfolio. After a successful phase I study Glycostem initiated a first-of-its-kind pivotal trial in acute myeloid leukemia (AML) with in-house manufactured nonmodified NK cells (oNKord). Over the coming months, AML patients will receive this form of treatment as part of a phase I-IIa trial. A pivotal phase IIa trial for Multiple Myeloma (MM) patients is expected to start second half of 2021. This makes Glycostem one of the frontrunners in this promising field of cellular immunotherapy.

About Glycostem

Netherlands-based Glycostem Therapeutics BV, a clinical stage biotech company, develops allogeneic cellular immunotherapy to treat several types of cancer. By harnessing the power of stem cell-derived Natural Killer (NK) cells, Glycostem's products are a safe alternative to CAR-T-cells. Glycostem's lead product, oNKord, is manufactured from allogeneic raw material and is available off-the shelf. Thanks to its nine patent families, longstanding technical expertise and resources, as well as 'Orphan Drug Designation', Glycostem has secured a leadership position in the global NK-cell market.

oNKord is produced in a closed system (uNiKTM) in Glycostem's state-of-the-art and GMP (Good Manufacturing Practice) licensed production facility in the Netherlands, from which it can be distributed globally. The production technology includes ex vivo generation of high numbers of NK-cells with a high degree of purity for clinical applications. oNKord successfully passed phase I clinical trial (elderly and frail AML - Acute Myeloid Leukemia - patients), providing solid safety data and strong indication of clinical activity, including response on MRD (Minimal Residual Disease). Results indicate that oNKord may be safely infused in AML patients.

Glycostem is furthermore developing a range of CAR-NK and TCR-NK products in-house and in cooperation with global partners.

Glycostem Therapeutics BV http://www.glycostem.com

Foot note: "oNKord" is a registered trademark of Glycostem in the US and in Europe. Trademark registrations of "viveNK" and "uNiK" are pending.

About Ghent University

Ghent University (UGent) is a major Belgian university located in the heart of Europe. Our organization is dedicated to research and innovation with over 5,500 researchers active in a wide area of life, physical and social sciences. Strong partnerships with the Ghent University Hospital (1000+ beds), VIB, IMEC and global leaders in academia and pharma/biotech industry thrive life science innovation at our university and is part of the thriving Belgian biotech region. Our translational platforms such as CRIG (focus on cancer) and GATE (focus on advanced therapy medicinal products) facilitate to bring science to the patient.

Prof. Georges Leclercq has a longstanding and internationally recognized expertise in differentiation and function of NK cells. The recent focus of his research group is to reveal the role of several transcription factors in the differentiation of human hematopoietic stem cells into mature NK cells, and in the maintenance and function of these mature NK cells. The ultimate aim is to attribute to improved NK-based cancer immunotherapy.

Cancer Research Institute Ghent http://www.crig.ugent.be

SOURCE: Glycostem

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Glycostem and Ghent University sign license agreement on NK cell therapy technology | DNA RNA and Cells | News Channels - PipelineReview.com

EdiGene Expands Management Team by Appointment of Head of US Subsidiary Dr. Bo Zhang and Head of Business Development Dr. Kehua Fan – BioSpace

Dec. 14, 2020 10:00 UTC

BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- EdiGene, Inc., which develops genome editing technologies to accelerate drug discovery and develop novel therapeutics for a broad range of diseases, today announced the appointment of Bo Zhang, Ph.D., as Head of the US Subsidiary, and Kehua Fan, M.D., as Head of Business Development. Both will report to Dr. Dong Wei, CEO of EdiGene.

Our company and R&D portfolio are entering into an exciting phase, as evidenced by the recent close of Series B financing and submission of the first gene editing product IND in China, said Dong Wei, Ph.D.CEO of EdiGene, Translating cutting-edge gene editing technologies into innovative solutions for patients requires deep internal R&D expertise as well as strong external partnerships. We are delighted to have Dr. Zhang and Dr. Fan join us at this significant stage of growth. Their extensive experience and proven track record in advancing innovative therapies, in addition to strong leadership skills, will help us to strengthen our portfolio and accelerate technology translation to help patients in need.

Dr. Zhang has around 20 years of experience in research and drug development in both industry and academia in the US. Prior to joining EdiGene, he was Vice President of KLUS Pharma and focused on cell therapy and new technologies. Before that, he was Director of Development at Cobalt Biomedicine leading CAR-T and other cell/gene therapy programs, and R&D Director at OvaScience developing stem cell-based products. Prior to that, he held various oncology research and development positions at Merrimack Pharmaceuticals and Archemix. Dr. Zhang completed his postdoctoral fellowship at Harvard Medical School/Boston Childrens Hospital. He received his B.S. degree from Henan Normal University, M.S. degree from Chinese Academy of Sciences and Ph.D. from University of New Hampshire.

Dr. Kehua Fan has over 15 years of Business Development, Clinical Development of innovative drugs and other healthcare industry experience with MNCs and biotech companies. Before EdiGene, she served as Head of Strategy and Partnership at Junshi Biosciences, in charge of pipeline development strategy focus on oncology, autoimmune and metabolic diseases along with external partnership. Before that, she held positions in business development, clinical development strategy and operation on various therapeutic areas at Quintiles, GSK, Sanofi and Pfizer. She started her career as a General Surgeon at Zhongshan Hospital of Chongqing. She received a masters degree in Cardiovascular Pharmacology from West China Medical Center of Sichuan University and a bachelors degree in Clinical Medicine from Soochow University.

About EdiGene, Inc EdiGene is a biotechnology company focused on leveraging the cutting-edge genome editing technologies to accelerate drug discovery and develop novel therapeutics for a broad range of genetic diseases and cancer. The company has established its proprietary ex vivo genome-editing platforms for hematopoietic stem cells and T cells, in vivo therapeutic platform based on RNA base editing, and high-throughput genome-editing screening to discover novel targeted therapies. Founded in 2015, EdiGene is headquartered in Beijing, with subsidiaries in Guangzhou, China and Cambridge, Massachusetts, USA. More information can be found at http://www.edigene.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201214005267/en/

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EdiGene Expands Management Team by Appointment of Head of US Subsidiary Dr. Bo Zhang and Head of Business Development Dr. Kehua Fan - BioSpace

Global Primary Antibodies Market To Reflect Impressive Growth Rate by 2028||Leading Players-Thermo F – PharmiWeb.com

Global Primary antibodies MarketIndustry Trends and Forecast to 2028 focuses on the major drivers and limitations for the key players. These research report also provides Comprehensive analysis of the market share, segmentation, revenue forecasts and geographic regions of the market. The Primary antibodies market research report is a professional and in-depth study on the current state of Primary antibodies Industry. Report Carrying 350 pages,60 Figures And220 Tables in it.

This report studies the Primary antibodies market. Management consulting is the practice of assist organizations to improve their development, performance, operating primarily through the analysis of existing organizational problems and the development of plans for improvement. Organizations may draw upon the services of management consultants for a number of reasons, including gaining external (and presumably objective) advice and access to the consultants specialized expertise

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Primary antibodies market is expected to gain market growth in the forecast period of 2021 to 2028. Data Bridge Market Analysis analyses the market for growth in the above forecast timeframe at a CAGR of 7.70%. Increasing levels of investment in research and development activities will further create lucrative opportunities for market growth.

The major players covered in the primary antibodies market report are

Global Primary Antibodies Market Scope and Market Size

Primary antibodies market is segmented on the basis of type, technology, source, research area, application, end user. The growth amongst these segments will help you analyse meagre growth segments in the industries, and provide the users with valuable market overview and market insights to help them in making strategic decisions for identification of core market applications.

Based on type, the primary antibodies market is segmented into monoclonal antibodies, and polyclonal antibodies.

On the basis of technology, the primary antibodies market is segmented into immunohistochemistry, immunofluorescence, western blotting, flow cytometry, immunoprecipitation,ELISA, and other technologies.

Based on source, primary antibodies market is segmented into mouse, rabbit, goat, and other sources.

On the basis of research area, the primary antibodies market is segmented into infectious diseases, immunology,oncology, stem cells, neurobiology, and others.

Based on application, the primary antibodies market is segmented into proteomics, drug development, and genomics.

Primary antibodies market has also been segmented based on the end user into pharmaceutical and biotechnological companies, academic and research institutes, and contract research organizations.

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Primary Antibodies Market Country Level Analysis

Primary antibodies market is analysed and market size insights and trends are provided by country, type, technology, source, research area, application and end user as referenced above.

The countries covered in the primary antibodies market report are U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Saudi Arabia, U.A.E, South Africa, Egypt, Israel, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA), Brazil, Argentina and Rest of South America as part of South America.

The U.S. dominates the North America primary antibodies market due to the growing number of stem cell, biomedical and cancer research along with increasing occurrences of chronic disorders in the region, while Asia-Pacific is expected to grow at the highest growth rate in the forecast period of 2021 to 2028 due to the surging levels of investment on research and development activities in the region.

Strategic Key Insights Of The Primary Antibodies Report: Production Analysis Production of the Patient Handling Equipment is analyzed with respect to different regions, types and applications. Here, price analysis of various Primary antibodies Market key players is also covered. Sales and Revenue Analysis Both, sales and revenue are studied for the different regions of the Primary antibodies Market. Another major aspect, price, which plays an important part in the revenue generation, is also assessed in this section for the various regions. Supply and Consumption In continuation of sales, this section studies supply and consumption for the Primary antibodies Market. This part also sheds light on the gap between supply and consumption. Import and export figures are also given in this part.

Competitors In this section, various Primary antibodies industry leading players are studied with respect to their company profile, product portfolio, capacity, price, cost, and revenue. Analytical Tools The Primary antibodies Market report consists the precisely studied and evaluated information of the key players and their market scope using several analytical tools, including SWOT analysis, Porters five forces analysis, investment return analysis, and feasibility study. These tools have been used to efficiently study the growth of the major industry participants. The 360-degree Primary antibodies overview based on a global and regional level. Market share, value, volume, and production capacity is analyzed on global, regional and country level. And a complete and useful guide for new market aspirants Facilitates decision making in view of noteworthy and gauging information also the drivers and limitations available of the market.

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Drivers:Global Primary Antibodies Market

Increasing levels of investment in research and development activities will further create lucrative opportunities for market growth.

Increasing number of stem cell and neurobiology research, rising academicresearchand industry collaborations, growing availability of the technologically advanced products, increasing focus on the biomarker discovery are some of the major as well as impactful factors which will likely to augment the growth of the primary antibodies market in the projected timeframe of 2021-2028.

On the other hand, increasing number of applications from emerging economies along with rising demand forpersonalized medicinesand protein therapeutics which will further contribute by generating immense opportunities that will led to the growth of the primary antibodies market in the above mentioned projected timeframe.

Customization Available :Global Primary Antibodies Market

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Global Primary Antibodies Market To Reflect Impressive Growth Rate by 2028||Leading Players-Thermo F - PharmiWeb.com

US gets more help in raging battle against COVID-19 as FDA authorizes Moderna vaccine, the second allowed for emergency use – USA TODAY

The FDA has authorized Moderna's COVID-19 vaccine for emergency use in the U.S. The first shots of the vaccine are expected to be given Monday. USA TODAY

CAMBRIDGE, Mass. Americans will soon have access to a second COVID-19 vaccine.

Stephen Hahn, commissioner of the U.S. Food and Drug Administration, granted emergency authorization Fridayto a vaccine made by Moderna,a week after giving similar clearance to one made by Pfizer and its German collaborator, BioNTech.

His is "authorizing" rather than approving the vaccine, because longer-term research is needed to meet the full standards for approval, which officials don't want to wait for during the public health emergency.

The speedy path to authorization was possible because the agencycut through regulatory red tape,Hahnsaid at a Friday night press conference. "We worked quickly based onthe urgency of this global pandemic ... we have not cut corners."

The announcementmakesthe U.S.the first country to authorize two COVID-19 vaccines that demonstrate "clear and compelling efficacy, Dr.Peter Marks director of the Center for Biologics Evaluation and Research at the FDA said during the press conference.Marks said it isanother milestone as we work to end the COVID-19 pandemic.

The move comes a day afterthe U.S. reported its 17 millionth case of COVID-19and an independent advisory committee reviewed data from human trials of Moderna's mRNA-1273 vaccine, deciding its benefits outweighed its risks. The vaccine, according to a trial that included 30,000 volunteers,protected more than94% of recipients from active disease, without causing major safety concerns.

Trucks will begin moving the vaccine this weekend, with the first of 5.9 million already manufactured Moderna shots expected to be given on Monday.

Your vaccine questions, answered:I had COVID, should I still get vaccinated? What are the side effects? What are its 'ingredients?'

In this special edition episode of States of America, experts answer the biggest questions Americans have about the vaccine, side effects, how it's getting to you and more. USA TODAY

It's a triumphant moment for the 10-year-old Cambridge, Massachusetts, biotech companythat until nowhad never brought a product to market.

Now, both its vaccine and the one byPfizer-BioNTecharepoised to change the course of the worst pandemic in a century.

The virus that causes COVID-19 hasswept the world and particularly devastated the United States, which accounts for 4% of the world's populationbut nearly 23%of its COVID-19 cases and 19%of its deaths.

During the current winter surge, anAmerican is reported dead about every 34 seconds from the virus, and 150 are diagnosed every minute.

But it will take time to roll out vaccine across the country and the world, achieving the 70% protection from both vaccination and natural disease that experts say will be needed to stop widespread infections.

In this file photo taken on November 18, 2020 shows a syringe and a bottle reading "Vaccine Covid-19" next to the Moderna biotech company logo.(Photo: JOEL SAGET, AFP via Getty Images)

Moderna, which developed its vaccine in collaboration with government scientists,says it will be able to deliver 20 million doses of its vaccine by the end of December. Another 80 million will be available in the first few months of 2021, under a contract signed in Augustthat brought the U.S. government's direct financial backing of the companyto $2.5 billion.

"It is through the dedicated efforts of our federal scientists and their collaborators at Moderna and in academia, the clinical staff who conducted the vaccine's rigorous clinical trials, and the tens of thousands of study participants who selflessly rolled up their sleeves, that another safe and highly effective vaccine to protect against COVID-19 will soon be rolled out to the American public," Dr. Francis Collins, director of the National Institutes of Health, said Friday.

Just last week, the government closed a deal for a second 100 million doses to be delivered in the second quarter of next year, bringing taxpayers' total investment in mRNA-1273 up to$4.1 billion.

Another candidate vaccine, from Johnson & Johnson, fully enrolled its large-scale humantrial Thursdayand expects to report its first safety and effectiveness data in January.

A fourth, created by AstraZeneca and Oxford University, is a few weeks behind, and a fifth candidate, by vaccine developer Novavax ofGaithersburg, Maryland, is expected to begin its major U.S. trial shortly.

If all or most of these come through, there shouldbe plenty of vaccine by the endof next summer to cover every American who wants one.

"It's just incredible science and human achievement,"said Dr. Steven Joffe, a professor of medical ethics and health policyat the Perelman School of Medicine at the University of Pennsylvania."Not just the science that went into the vaccines, but the organizational effort to pull off those trials it's marvelous."

Although Moderna moved extremely fast, winning authorization just 11 months after beginning work on mRNA-1273, ithas been developing the technology behind its vaccinefor a decade.

The company was founded in 2010 on the banks of the Charles River, a short walkfrom the Massachusetts Institute of Technology, where one of its founders was a faculty member,and another a graduate and board member.

That MIT gradand board of trustees member, venture capitalist Noubar Afeyan,said he was intrigued at the time by the idea of making drugs inside the human body.

Messenger RNA, which the body uses to translate the DNA code into the proteins that do all the body's work, seemed like the right tool to address a whole host of medical problems, he said.

Operation Warp Speed has helped Moderna move faster in vaccine development.(Photo: JOSEPH PREZIOSO/AFP via Getty Images)

Afeyan saidhe likes to start companies with big ideas that seem like science fictionand then "take the fiction out" by finding the science to make it real.

Moderna was initially namedLS18 to indicate it was the 18th life sciences company Afeyan had started. (He's lost track of whether his latest company is LS79 or LS80, he said.) The idea was seeded by a stem cell scientist at nearby Harvard University, Derrick Rossi, who was trying to commercialize his research using the body's most versatile cells to make medicines.

Afeyan said it was a provocative concept. But by May of the following year, when the company was officially launched as Moderna, they had dropped the idea of using stem cells, which Afeyan said were too unstable in the body, and focused instead on messenger RNA (hence the name ModeRNA).

Messenger or mRNA is the body's own delivery system, taking "messages" from the DNA code in the cell's nucleus to a protein manufacturing center.

Where's the COVID-19 vaccine? Who's been vaccinated?Here's how we'll know.

These proteins direct every activity of life, so figuringout how to make them on demand could help people who suffer severe diseases because their bodies make faulty proteinsas with sickle cell disease, cystic fibrosis and myriad rare diseases. Such proteins could alsoprime the immune system to target cancer cells, or infectious diseases.

Afeyan and his collaborators wanted to tackle this whole range of medical challenges.

But first, they needed a CEO to run the company.

Afeyan said he had been negotiating with a French entrepreneur who was, like him, a biomedical engineer. ButStphane Bancel wasn't sure he wanted to leave a stable job as CEO of an established diagnostics company for the risk of a startup with a never-before-tried idea.

Bancel was walking home across the Longfellow Bridge from Cambridge to Boston one winter night, when Afeyan called and turned on the hard sell.

Afeyan said he would never have a bigger idea to offer Bancel. If this becomes the next Genentech, "you're going to hate yourself" for not being involved, Afeyan told him, referring to the South San Francisco company that launched the entire biotechnology industry with its birth in 1976.

Later that year, Bancel signed on to run Modernaand continues to lead the company, which has now made several founders and its CEO into billionaires.

Moderna IPO(Photo: Flagship Pioneering)

The earliest seeds of Moderna

There werea few key scientific advances that led mRNA to where it is today.

Onecame from another Moderna co-founder, Robert Langer, a professor at MIT and a serial entrepreneur.

Early in his career, Langer, who had recently earned his doctorate in chemical engineering from MIT, was struggling to find a job. He didn't want to work in the oil industry, though he'd gotten 20 job offers, including fourfrom Exxon alone.

After months of searching, Dr. Judah Folkman, a passionate doctor at what is now called Boston Children's Hospital finally took a chance on him. Folkman believed he could cure cancer by cutting off the blood supply to tumorsbut he couldn't figure out how to slowly release drugs to work effectively.

Nevermind the political messenger: When it comes to COVID-19 guidance, trust the message, experts say

Langer spent years developinga way to encapsulatenucleic acids the same building blocks as in mRNA vaccines into tiny particles that could make their way into cells.

"At first people didn't think it was possible," Langer said. He published a 1976 paper showing it could be donebut still, it was a slog to get people to believe in its potential.

"After that paper came out, I must have had 10 years of people rejecting grants" to support the work, he said. (His work with Folkman provided the underlying science for the drug Avastin, which earned $7 billion in sales in 2019 and is used to treat many types of cancer as well as wet age-related macular degeneration, the leading cause of blindness in older adults.)

Langer and others made additional improvements over the years, includingadding polyethylene glycol to the surface of particles, which enabled them to survive in the body for longer. That's one of the key ingredients of Moderna and Pfizer-BioNTech's vaccines.

A subject receives a shot in the first-stage safety trial of a potential vaccine by Moderna for COVID-19 at the Kaiser Permanente Washington Health Research Institute in Seattle on March 16.(Photo: Ted S. Warren, AP)

In 2010, when Langer was one of the world's best knownbioengineers and a leader in the field of drug delivery, Rossi came to see him with a scientific insight he hoped would be the basis for starting a company. Langer introduced him to Afeyan, and the idea for LS18was born.

By the following year,Rossi moved on and the core group includedLanger, Afeyan, Dr. Kenneth Chien, a prominent cardiologist and researcher, andTimothy Springer, an immunologist at Harvard Medical School.

The four met once a week tobrainstorm, while a handful of scientists at Afeyan's Flagship Pioneering advanced their ideas in the lab.

Moderna's first real home wasan underwhelming office half basement, half ground floor just a few blocks away.

The vision from its earliest days, Langer said, was to build a "platform" that could be used as the basis for drugs, vaccinesand even tissue engineering another field he had helped pioneer.

Some Americans aren't in a rush to get a COVID-19 vaccine: Experts understand, but say there's no need to wait.

For several years, Moderna has been collaboratingon vaccine development withscientists at the National Institute of Allergy and Infectious Diseases, the agency led by Dr. Anthony Fauci.

By the end of 2018 when Moderna went public,it was the biggest initial public offering ever for a biotech company, though shares fell 19% that first day as investors worried it was overpriced.

A year later the company was testing 20 different mRNA's in humans five or six times more research programs than the typical biotech.

That was enough, said Nina Deka, a senior research analyst at ROBO Global, for her fund to decide to make Moderna one of the 85 companies included in its portfolio of health care technology and innovation stocks.

Moderna had recently announced plans to develop a COVID-19 vaccine when ROBO Global decided to invest.

"Not because of what they did this year, but what they've done since the start of the company," Deka said.

With two mRNA vaccines under development, ROBO Global expected that even if Moderna's vaccine didn't succeed, the technology would advance, buoying everyone in the industry.

"It's not just vaccines. It's also cancer. It's also orphan drugs" for rare diseases, she said.

The company had just built a brand new production facility in the Boston suburb of Norwood, and it was using advanced artificial intelligence to direct its research, which ROBO Global appreciated,Deka said.

Plus, it was breaking speed records with its candidate COVID-19 vaccine.

"The next question is," Deka said,"if they can do this quickly, what else can they do?"

Contact Karen Weintraub at kweintraub@usatoday.com

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

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Diamyd Medical and Critical Path Institute announce data sharing collaboration to develop advanced drug development tools in type 1 diabetes -…

STOCKHOLM, Dec. 16, 2020 /PRNewswire/ -- Diamyd Medical and the Critical Path Institute (C-Path) are proud to announce their collaboration to significantly improve the scientific community's insight into type 1 diabetes (T1D) through Diamyd Medical's contribution of fully anonymized data from a European Phase III trial to the Trial Outcome Measures Initiative (TOMI) T1D integrated database.

The Phase III trial evaluated the use of the diabetes vaccine Diamyd, an antigen-specific immunotherapy based on the auto-antigen GAD (glutamic acid decarboxylase), to induce immunological tolerance and stop the autoimmune destruction of insulin producing cells. The Data Contribution Agreement between Diamyd Medical and C-Path will allow for this unique set of fully anonymized clinical trial data to be integrated into an ever-growing list of committed trial data sets within the TOMI-T1D project.

TOMI-T1D is an international partnership between academia, the pharmaceutical industry and nonprofit organizations. It is funded by the world's leading charities dedicated to diabetes research, JDRF, and Diabetes UK, guided by both organizations' strong commitment to facilitate deep interrogation of consolidated community-wide trial data as a means to accelerate clinical research and therapeutic development for T1D. TOMI-T1D aims to create a clinical trial simulation tool (CTST) with large and diverse clinical datasets from the T1D community. The project also seeks to engage the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to identify opportunities for regulatory endorsement of such drug development tools.

The Diamyd Medical data includes relevant information about disease progression, drug effects and clinical trial design. Contribution of these robust data sets from industry led trials is critical to TOMI-T1D's work in developing innovative and quantitative tools that can facilitate clinical development efforts and be endorsed by regulators for future use by the pharmaceutical industry to optimize the design of future clinical trials.

"Progress towards the establishment of approved therapies for people with T1D is critically reliant on participation from our partners in industry with their data", said Simi Ahmed and Elizabeth Robertson, on behalf of the charity partnership.

"This is indeed a right step in that direction", said Colin Dayan, lead PI at Cardiff University.

"We are thrilled that Diamyd Medical is taking a leading role and championing precompetitive collaborations advancing type 1 diabetes regulatory science solutions", said Inish O'Doherty Executive Director at C-Path. "Their data will help in the construction and evaluation of a clinical trial simulation tool to assist in the development of novel therapies for type 1 diabetes patients".

"We are very honored to be part of this important collaboration -involving key stakeholders within the type 1 diabetes landscape, said Ulf Hannelius, President & CEO of Diamyd Medical. "As we are moving into an era of precision medicine in type 1 diabetes, we can expect to see significant therapeutic advances, and access to high quality data will be integral to maximizing these efforts".

To learn more about the TOMI-T1D project visit: https://c-path.org/programs/tomi-t1d/

About Critical Path Institute

Critical Path Institute (C-Path) is an independent, nonprofit organization established in 2005 as a public and private partnership. C-Path's mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, accelerating the path to a healthier world. An international leader in forming collaborations, C-Path has established numerous global consortia that currently include more than 1,600 scientists from government and regulatory agencies, academia, patient organizations, disease foundations, and dozens of pharmaceutical and biotech companies. C-Path US is headquartered in Tucson, Arizona and C-Path, Ltd. EU is headquartered in Dublin, Ireland, with additional staff in multiple other locations. For more information, visit c-path.org and c-path.eu.

About JDRF

JDRF's mission is to accelerate life-changing breakthroughs to cure, prevent, and treat T1D and its complications. To accomplish this, JDRF has invested more than $2.5 billion in research funding since our inception. We are an organization built on a grassroots model of people connecting in their local communities, collaborating regionally for efficiency and broader fundraising impact and uniting on a national stage to pool resources, passion and energy. We collaborate with academic institutions, policymakers and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. Our staff and volunteers throughout the United States and our five international affiliates are dedicated to advocacy, community engagement and our vision of a world without T1D. For more information, please visit jdrf.org or follow us on Twitter: @JDRF

About Diabetes UK

1. Diabetes UK's aim is creating a world where diabetes can do no harm. Diabetes is the most devastating and fastest growing health crisis of our time, affecting more people than any other serious health condition in the UK - more than dementia and cancer combined. There is currently no known cure for any type of diabetes. With the right treatment, knowledge and support people living with diabetes can lead a long, full and healthy life. For more information about diabetes and the charity's work, visit http://www.diabetes.org.uk

2. Diabetes is a condition where there is too much glucose in the blood because the body cannot use it properly. If not managed well, both type 1 and type 2 diabetes can lead to devastating complications. Diabetes is one of the leading causes of preventable sight loss in people of working age in the UK and is a major cause of lower limb amputation, kidney failure and stroke.

3. People with type 1 diabetes cannot produce insulin. About 10 per cent of people with diabetes have type 1. No one knows exactly what causes it, but it's not to do with being overweight and it isn't currently preventable. It's the most common type of diabetes in children and young adults, starting suddenly and getting worse quickly. Type 1 diabetes is treated by daily insulin doses - taken either by injections or via an insulin pump. It is also recommended to follow a healthy diet and take regular physical activity.

4. People with type 2 diabetes don't produce enough insulin or the insulin they produce doesn't work properly (known as insulin resistance). Around 90 per cent of people with diabetes have type 2. They might get type 2 diabetes because of their family history, age and ethnic background puts them at increased risk. They are also more likely to get type 2 diabetes if they are overweight. It starts gradually, usually later in life, and it can be years before they realise they have it. Type 2 diabetes is treated with a healthy diet and increased physical activity. In addition, tablets and/or insulin can be required.

For more information on reporting on diabetes, download our journalists' guide: Diabetes in the News: A Guide for Journalists on Reporting on Diabetes (PDF, 3MB).

About Diamyd Medical

Diamyd Medical develops therapies for type 1 diabetes. The diabetes vaccine Diamyd is an antigen-specific immunotherapy for the preservation of endogenous insulin production. Significant results have been shown in a genetically predefined patient group in a large-scale metastudy as well as in the Company's European Phase IIb trial DIAGNODE-2, where the diabetes vaccine is administered directly into a lymph node in children and young adults with newly diagnosed type 1 diabetes. A new facility for vaccine manufacturing is being set up in Ume for the manufacture of recombinant GAD65, the active ingredient in the therapeutic diabetes vaccine Diamyd. Diamyd Medical also develops the GABA-based investigational drug Remygen as a therapy for regeneration of endogenous insulin production and to improve hormonal response to hypoglycaemia. An investigator-initiated Remygen trial in patients living with type 1 diabetes for more than five years is ongoing at Uppsala University Hospital. Diamyd Medical is one of the major shareholders in the stem cell company NextCell Pharma AB.

Diamyd Medical's B-share is traded on Nasdaq First North Growth Market under the ticker DMYD B. FNCA Sweden AB is the Company's Certified Adviser; phone: +46 8-528 00 399, e-mail: info@fnca.se

CONTACT:

For further information, please contact:

Ulf Hannelius, President and CEO

Phone: +46 736 35 42 41

E-mail: ulf.hannelius@diamyd.com

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/diamyd-medical-ab/r/diamyd-medical-and-critical-path-institute-announce-data-sharing-collaboration-to-develop-advanced-d,c3255392

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SOURCE Diamyd Medical AB

Company Codes: Frankfurt:DMN, ISIN:SE0005162880, Munich:DMN, Stockholm:DMYD, Stockholm:DMYD-B.ST

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Diamyd Medical and Critical Path Institute announce data sharing collaboration to develop advanced drug development tools in type 1 diabetes -...

Skandalaris LEAP winners announced | WashU Fuse | Washington University in St. Louis – Washington University in St. Louis Newsroom

Its been a busy and exciting time for our friends at Skandalaris Center: This week they announced winners of both the Skandalaris Venture Competition (SVC) and Fall 2020 LEAP Cycle.

The Skandalaris Centers Fall 2020 LEAP Cycle has ended and a new set of translational research projects have been funded. LEAP is an asset-development program and gap fund designed to provide intellectual and financial capital to WashU-affiliated translational projects.

A panel of industry experts and community partners evaluated 22 projects based on three criteria:

Seven teams were selected to receive LEAP funds and accelerate their projects towards partnering and launching:

AIR Seal allows for quick, easy ventilation of COVID-19 patients through a laryngeal mask airway (LMA) that is dynamically sealed to block viral aerosol transmission.

TEAM:Vivian Lee, graduate student, Doctor of Medicine, School of Medicine Mohamed Zayed, vascular surgeon/assistant professor of surgery, School of Medicine Chase Hartquist, undergraduate/graduate student, Mechanical Engineering, McKelvey School of Engineering Halle Lowe, undergraduate/graduate student, Mechanical Engineering, McKelvey School of Engineering Vinay Chandrasekaran, undergraduate student, Computer Science, McKelvey School of Engineering

The first single-use, disposable device capable of performing continuous bedside pressure-monitoring, preventing pressure-ulcer development/progression, and reducing hospital liability and spend related to pressure-ulcer care.

TEAM: Justin Sacks, Shoenberg Professor; chief of Division of Plastic and Reconstructive Surgery, School of Medicine

EnhanceAR-Seq lets the clinician personalize prostate cancer treatment through a blood-based liquid biopsy to improve patient survival.

TEAM: Aadel Chaudhuri, assistant professor of Radiation Oncology, School of Medicine Christopher Maher, associate professor, Oncology Division, Stem Cell Biology, School of Medicine Russell Pachynski, assistant professor, Oncology Division, Molecular Oncology, School of Medicine

FLAAM is a new approach to 3D printing metals that is capable of fabricating novel components composed of many highly-desired materials not accessible in existing 3D printing processes, including ultra-high temperature materials, materials with locally tailored properties, and entirely new metal alloys.

TEAM:Richard Axelbaum, Stifel and Quinette Jens Professor of Environmental Engineering Science, McKelvey School of Engineering Phillip Irace, PhD candidate, McKelvey School of Engineering Kathy Flores, professor, Mechanical Engineering & Material Science, McKelvey School of Engineering Daniel Miracle, senior scientist, Aire Force Research Lab

A sensitive, radiological imaging tool (RadioCF-PET) to detect kidney damage in its earliest stages to improve and facilitate personalized therapies to prevent or slow the development of kidney disease.

TEAM:Edwin Baldelomar, postdoctoral research fellow, Institute of Clinical Translational Sciences (ICTS) Kevin Bennett, associate professor of Radiology, School of Medicine Jennifer Charlton, pediatric nephrologist & associate professor, University of Virginia

Aims to license the first safe and effective virus that specifically targets cancer stem cells, the most treatment-resistant cells in brain tumors.

TEAM: Milan Chheda, assistant professor of Medicine and Neurology, School of Medicine Michael Diamond, The Herbert S. Gasser Professor, Departments of Medicine, Molecular Microbiology, Pathology & Immunology, School of Medicine

The LEAP program is helpful beyond the funding. We benefited from the process of writing the proposal, incorporating market research, andmost importantlyclearly defining what needs to be done to forge a successful licensing partnership.

SonoBiopsy provides molecular diagnoses of brain diseases without surgery.

TEAM: Hong Chen, assistant professor, Biomedical Engineering, McKelvey School of Engineering Chris Pacia, graduate student, PhD, Biomedical Engineering, McKelvey School of Engineering Lu Xu, graduate student, PhD, Biomedical Engineering, McKelvey School of Engineering

LEAP is supported by Washington University in St. Louis Institute of Clinical and Translational Sciences, Siteman Cancer Center, Skandalaris Center for Interdisciplinary Innovation and Entrepreneurship, Center for Drug Discovery, and Office of Technology Management.

Learn more about LEAP.

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Skandalaris LEAP winners announced | WashU Fuse | Washington University in St. Louis - Washington University in St. Louis Newsroom