Global CAR-T Pipeline Insight Report 2020: Overview, Landscape, Therapeutic Assessment, Current Treatment Scenario and Emerging Therapies -…

December 30, 2020 04:38 ET | Source: Research and Markets

Dublin, Dec. 30, 2020 (GLOBE NEWSWIRE) -- The "CAR-T - Pipeline Insight, 2020" drug pipelines has been added to ResearchAndMarkets.com's offering.

The "CAR-T - Pipeline Insight, 2020," report provides comprehensive insights about 250+ companies and 250+ pipeline drugs in CAR-T pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

CAR-T: Overview

CAR-T is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion. CAR T-cell therapy is used to treat certain blood cancers, and it is being studied in the treatment of other types of cancer. Also called chimeric antigen receptor T-cell therapy.

Potential Mechanisms of CAR-T Cell-Mediated Toxicity

Significant progress has been made in the field of cancer immunotherapy, and CAR-T cells have shown outstanding efficacy in clinical trials. As with all technologies, CAR-T technologies also need to go through a long process of development, and CAR-T cell therapy has related acute and chronic toxicities that have become a roadblock on the developmental path. If these setbacks are not overcome, it will be difficult to make a more significant breakthrough.

Cytokine Release Syndrome

Cytokine release syndrome (CRS) is the most common toxic side effect in CAR-T cell therapy. CRS is a systemic inflammatory response caused by the significant increase in cytokines accompanied by the rapid in vivo activation and proliferation of CAR-T cells, usually occurring within a few days after the first infusion. CRS is a clinical condition with mild symptoms of fever, fatigue, headache, rash, joint pain, and myalgia. Severe CRS cases are characterized by tachycardia, hypotension, and high fever. Mild to moderate CRS is usually self-limiting and can be managed through close observation and supportive care. Severe CRS must be treated with tocilizumab or steroids alone for intensive treatment.

Advances in Research of CAR-T Cell Therapy for Solid Tumors

Although early CAR-T cell trials of solid tumors did not show the same success as observed in leukemia trials, a better understanding of the multiple barriers seen in solid tumors could promote the design of clinical trials for CAR-T cells. In this early stage of clinical development, CAR-T cells offer much hope. The ability of genetic manipulation techniques to modify CAR-T cells provides almost unlimited opportunities for other changes and improvements, thus providing a strong desire for future success.

Global Landscape of CAR-T Cell Therapy

At present, CAR-T cells are widely used in cellular immunotherapy for various tumors. According to statistics, more than 300 clinical trials of CAR-T cell therapies have been approved by many national drug regulatory agencies, including the FDA of the United States. Statistical data from these clinical trials show that although the effects of various clinical trials vary due to the use of different sources and the preparation techniques of CARs and T cells, as well as differences in pretreatment and combinations of drugs, overall, CAR-T cells are effective in treating tumors with an effective rate of 30% to 70% or even more than 90%. For example, the complete remission rate for r/r ALL treated with the Novartis drug CTL0l9, which the FDA has approved, is 93%. Perhaps CAR-T cell therapy will ultimately remedy the fate of human cancer.

CAR-T Emerging Drugs Chapters

This segment of the CAR-T report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

CAR-T: Therapeutic Assessment

This segment of the report provides insights about the different CAR-T drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in CAR-T

There are approx. 250+ key companies which are developing the therapies for CAR-T. The companies which have their CAR-T drug candidates in the most advanced stage, i.e. phase III include, Janssen Research & Development, ViiV Healthcare, Sorrento Therapeutics, Celgene, Novartis, Abbott etc.

Report Highlights

Current Treatment Scenario and Emerging Therapies:

Key Players

Key Products

For more information about this drug pipelines report visit https://www.researchandmarkets.com/r/c6ze76

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Global CAR-T Pipeline Insight Report 2020: Overview, Landscape, Therapeutic Assessment, Current Treatment Scenario and Emerging Therapies -...

Versiti Blood Centers and Noodles & Company Serve Up Thanks to Blood Donors – PRNewswire

MILWAUKEE, Dec. 30, 2020 /PRNewswire/ -- Versiti Blood Centers and premier partner Noodles & Company are dishing out discounts for life-saving donations during National Blood Donor Month this January.

Since 2016, Noodles & Company has supported Versiti's mission by aligning as a community partner and donating over $1.3 million in discounts and coupons to blood donors. Throughout January 2020, all attempting blood donors will receive a coupon redeemable for $4 off their order when they donate at a Versiti donor center or select community blood drive.

January is National Blood Donor Month, which highlights the critical need for blood during winter when donations often decline. Donors of all blood types are needed, but especially O negative blood donors who carry the universal blood type given to people in emergency situations.

To schedule an appointment, visit versiti.org.

About Versiti Blood Centers Versiti is a not-for-profit organization headquartered in Milwaukee that specializes in blood services, esoteric diagnostic testing, organ, tissue and stem cell donation, medical services and leading-edge research. Founded in 1947, Versiti is the primary provider of blood products and services for more than 250 hospitals in five midwestern states: Illinois, Indiana, Michigan, Ohio and Wisconsin. Versiti collects more than 602,000 units of blood each year at 35 permanent donation sites and more than 12,000 community blood drives. For more, visit versiti.org.

SOURCE Versiti, Inc.

https://www.versiti.org

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Versiti Blood Centers and Noodles & Company Serve Up Thanks to Blood Donors - PRNewswire

The Top 10 FDA Oncology Drug Approvals of 2020 – Curetoday.com

While 2020 had its share of negative healthcare headlines, the Food and Drug Administration (FDA) continued to push through approvals on a large number of oncology therapies throughout the year, from acute myeloid leukemia (AML) to breast cancer and beyond.

Heres a look back at 2020s top 10 most popular FDA drug approvals in the oncology space, as determined by CURE readers.

In August, the FDA approved the expansion of Kyprolis (carfilzomib) in combination to with Darzalex (daratumumab) plus dexamethasone in once- and twice-weekly dosing regimens for the treatment of patients with relapsed or refractory multiple myeloma who have received a maximum of three prior lines of therapy.

After granting it an accelerated approval in 2018, the Food and Drug Administration fully approved Venclexta (venetoclax) in combination with Vidaza (azacytidine), Dacogen (decitabine) or low dose cytarabine (LDAC) in newly diagnosed patients with AML aged 75 years or older in October.

The combination of Monjuvi (tafasitamab-cxix) and Revlimid (lenalidomide), approved in August, fills an unmet need for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are also unable to undergo autologous stem cell transplant, said Dr. Gilles Salles.

The targeted drug Qinlock (ripretinib), which interferes with the activity of proteins that drive gastrointestinal stromal tumor (GIST), was approved by the FDA in May for patients with advanced disease that has progressed despite treatment with other kinase inhibitors.

The FDAs approval of Braftovi (encorafenib) and Erbitux (cetuximab) with or without Mektovi (binimetinib) for adults with metastatic colorectal cancer (CRC) with a BRAF V600E mutation is a welcomed approval, according to Dr. Richard Goldberg, because patients with this mutation have a poorer than average prognosis and more limited treatment options than other colorectal cancer patients. Having an effective, rationally designed regimen for them that attacks multiple points in the pathway that drives their tumor was sorely needed, said Goldberg.

In May, the FDA approved Retevmo (selpercatinib), the first of its kind, to treat non-small cell lung cancer (NSCLC), medullary thyroid cancer and other types of thyroid cancers with rearranged during transfection, or RET, alterations. The kinase inhibitor blocks a type of enzyme and helps prevent cancer cells from growing.

The FDA approved and granted priority review in September to Gavreto (pralsetinib) for the treatment of patients with metastatic, RET fusion-positive NSCLC. The FDA approval of Gavreto for RET fusion-positive non-small cell lung cancer is an important step towards our goal of providing an effective treatment option for every person diagnosed with lung cancer, no matter how rare or hard-to-treat their type of disease, said Dr. Levi Garraway, Genentechs chief medical officer and head of Global Product Development, in a statement.

The Food and Drug Administrations May approval of the first antibody-drug conjugate to treat patients with pretreated metastatic triple-negative breast cancer was a major milestone, according to Dr. Aditya Bardia, a breast medical oncologist at Massachusetts General Hospital Cancer Center.

This approval in April was big news for patients with a variety of adult cancers. The important social distancing measures for COVID-19 have created a number of challenges for people with cancer, including keeping to planned treatment schedules, Dr. Roy Baynes, senior vice president, head of global clinical development and chief medical officer at Merck Research Laboratories, said in a press release. Todays approval of an every-six-weeks dosing schedule for Keytruda gives doctors an option to reduce how often patients are at the clinic for their treatment.

Our most popular approval coverage for the combination of Nerlynx and Xeloda in February comes off the heels of the phase 3 NALA trial that looked at the efficacy of Nerlynx in combination with Xeloda, which found a significant improvement in patients progression free survival (the time from treatment to disease progression or worsening) compared to Tykerb (lapatinib) in combination with Xeloda.

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The Top 10 FDA Oncology Drug Approvals of 2020 - Curetoday.com

Numerous Indian American STEM Researchers Named Fellows of American Association for the Advancement of Sciences – India West

The American Association for the Advancement of Sciences recently announced its group of 2020 AAAS Fellows, which included several Indian Americans and South Asian Americans.

Nearly 500 AAAS members earned the lifetime distinction, according to the associations news release.

AAAS Fellowsare elected each year by their peers serving on theCouncil of AAAS, the organizations member-run governing body. The title recognizes important contributions to STEM disciplines, including pioneering research, leadership within a given field, teaching and mentoring, fostering collaborations and advancing public understanding of science, the release said.

Among the Fellows were ShailajaK.Mani of theBaylor College of Medicinefor distinguished contributions to molecular and cellular neuroscience focused on molecular transcriptional regulation of steroid hormone receptors, signal transduction pathways and role of the microbiome; K. RajaReddyof Mississippi State Universityfor distinguished contributions to the field environmental plant physiology and agricultural systems modeling and applications; and SureshK.Alahariof Louisiana State University Health Sciences Center School of Medicine for distinguished contributions in cancer research and teaching, with a focus on signal transduction.

Additionally, SwathiArurof The University of Texas MD Anderson Cancer Center for discovery of Dicer1 phosphorylation by RAS/ERK signaling in Caenorhabditis elegans and implications for human fertility and cancer metastasis;

HitenD.Madhaniof U.C. San Francisco for distinguished contributions to the fields of molecular biology and genetics, particularly for developing fungal systems to uncover mechanisms of chromatin modifications and RNA splicing; TuliMukhopadhyayof Indiana University for distinguished contributions to the field of virology, particularly in structure and assembly of arthropod-borne viruses; RamaNatarajanof the City of Hope National Medical Center for distinguished contributions to the field of diabetes and its vascular complications, particularly for studies showing the roles of epigenetics and non-coding RNAs; and P. HemachandraReddyof Texas Tech University Health Sciences Center For pioneering contributions to the fields of Alzheimer's disease and mitochondrial neurobiology, particularly in discovering key role of mitochondria in neurodegenerative diseases and their treatment, were among the newly elected members

Additional members elected included RohitBhargavaof the University of Illinois at Urbana-Champaignfor pioneering contributions to chemical imaging, including infrared spectroscopic imaging theory, development of instrumentation, and its applications to realize all-digital cancer pathology; VishvaDixitof Genentech Inc.for pioneering studies defining the biochemical framework illuminating many of the key components of the cell death pathway; PrashantK.Jain of theUniversity of Illinois at Urbana-Champaign for distinguished contributions to the field of nanomaterial chemistry leading to atomistic understanding of artificial photosynthesis, multielectron transfer, catalysis and phase transitions; ManishChhowallaof the University of Cambridge (United Kingdom) for distinguished contributions to the field of two-dimensional materials, particularly using phase engineering to study their electronic, electrocatalytic and energy storage properties; VistaspM.Karbhariof TheUniversity of Texas at Arlington for distinguished contributions to the field of composites in civil infrastructure particularly in low-cost processing, durability and damage tolerance, rehabilitation and multi-threat mitigation; and SanjayKumarof U.C. Berkeley for distinguished contributions to the field of bioengineering, particularly the development of biomaterial and single-cell technologies to investigate mechanobiological signaling in health and disease.

SudipK.Mazumderof the University of Illinois at Chicago,for distinguished contributions to the field of multi-scale control and analysis of power-electronic systems; UdayB.Palof Boston University,for pioneering work providing novel materials-based solutions in the field of green engineering as applied to energy conversion and primary production of materials; HrideshRajanof Iowa State University,for distinguished contributions to data driven science, particularly to modularity and modular reasoning in computer software and the development of the Boa language and infrastructure; SureshK.Bhargavaof RMIT University (Australia),for an exceptional contribution to the fields of industrial chemistry and technology, particularly for molecular engineering, catalysis and nanotechnology bringing innovative solutions to the industries; MunindarP.Singhof North Carolina State University, for distinguished contributions to the field of computer science, particularly to foundations of multiagent systems and their applications in service-oriented computing, sociotechnical systems and governance; AnujSrivastavaof Florida State University,for distinguished contributions to the field of statistical pattern recognition, particularly for development of differential geometric approaches to statistical shape analysis; and SenduraiManiof The University of Texas MD Anderson Cancer Center,for demonstrating that cancer can make its own cancer stem cells and promote plasticity, resulting in metastasis and chemoresistance by activating latent embryonic epithelial-mesenchymal transition, were among the newly elected members.

Also named were D.NageshwarReddyof the Asian Institute of Gastroenterology (India),for pioneering work in gastroenterology, particularly advances in therapeutic pancreatic biliary endoscopy and innovations in transgastric endoscopic surgery; and for service to international gastroenterology societies; Debomoy (Deb)K.Lahiriof Indiana University, for distinguished contributions to the field of molecular and translational neuroscience, particularly roles of epigenetics and microRNA on neuronal physiology and eventually treating human neurodegenerative diseases; NiraoM.Shahof Stanford University,for exceptional contributions to the field of behavioral neuroscience, particularly the dissection of neural circuits and transcriptomics controlling social behaviors.

Also named Fellows were M.N.V.RaviKumarof Texas A&M University,for distinguished contributions to the field of drug delivery, particularly the next-generation polyesters and non-competitive targeting strategies are of profound significance to the human health; and BulbulChakrabortyof Brandeis University, for important theoretical contributions to diverse areas of condensed matter physics, particularly disordered systems including frustrated magnets and granular materials.

TalatShahnazRahmanUniversity of Central Florida, for distinguished contributions to computational and theoretical nanoscience, in predictions of chemical, vibrational, and structural properties of low-dimensional systems, together with diversity in STEM; NandiniTrivediof The Ohio State University,for her contributions to the theoretical understanding of quantum matter, characterized by innovative use of quantum Monte Carlo techniques and close experimental collaborations; RamananLaxminarayanof the Center for Disease Dynamics, Economics & Policy/Princeton University,for distinguished contributions to the field of economic epidemiology, with particular reference to the spread and control of antimicrobial resistance; and SudiptoBanerjeeof UCLA,for innovative contributions to Bayesian methodology with focus on spatially indexed information, for high-impact applications, for educational and mentoring excellence, professional service and academic administration were named.

A virtual induction ceremony for the 489 newly elected Fellows will take place on Feb. 13, 2021, the Saturday following the AAAS Annual Meeting.

The honorees will receive official certificates and rosette pins in gold and blue, colors symbolizing science and engineering, by mail.

The tradition of electing AAAS Fellows began in 1874. Since then, the recognition has gone to thousands of distinguished scientists, such as inventor Thomas Edison, elected in 1878, sociologist W. E. B. Du Bois (1905), anthropologist Margaret Mead (1934), computer scientist Grace Hopper (1963), physicist Steven Chu (2000), and astronaut Ellen Ochoa (2012). The 2020 group contains members of each ofAAASs 24 sections, the release notes.

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Numerous Indian American STEM Researchers Named Fellows of American Association for the Advancement of Sciences - India West

Gut microbiota: How does it interact with the brain? – Medical News Today

Through studies in mice, researchers find evidence that having a healthful balance of gut microorganisms is important for good health.

Researchers from the Institut Pasteur, French National Center for Scientific Research (CNRS), and Inserm have found evidence that gut microbiota also plays a role in mood regulation and brain function.

Gut microbiota is the community of bacteria, fungi, and viruses that live in the digestive tract.

These findings in mice suggest that changes to gut bacterial communities may lead or contribute to depression. If humans have a similar mechanism, doctors might be able to use bacteria strains to treat mood disorders, such as depression.

A group of 16 researchers from several prominent French research institutions conducted the study, which appears in Nature Communications.

Studies have found that some people with depression experience dysbiosis, which is an imbalance or change in their intestinal microbiota.

Research conducted on rodents also shows that gut dysbiosis has associations with neurological changes linked with depression, such as:

Animal studies also show that gut microbiota helps regulate anxiety. It may also influence the development of neurological conditions caused by circuit dysfunctions, such as Parkinsons disease, Alzheimers disease, depression, and obsessive-compulsive disorder.

Researchers think this is because gut bacteria release metabolites, tiny bits of food broken down by digestion that influence brain function. Metabolites may impact mood regulation by acting on the endocannabinoid system.

The endocannabinoid system is a complex cell-signaling system consisting of lipid (fat)-based neurotransmitters and their receptors.

It is found throughout the body and plays a role in important aspects of health, such as immune and nervous system function and cellular communication in the nervous system. It also regulates emotions, moods, and stress responses by activation of the systems main receptor, CB1.

Previous research supports the idea that restoring gut microbial health may help treat depression. In animal studies, prebiotic treatment influenced emotional behavior. In human studies, prebiotic supplementation also improved mood in people with depression.

But despite educated theories, researchers still do not know precisely how gut bacteria impact brain function.

Researchers in the recent study set out to find the mechanisms linking gut microbiota and mood disorders. A team of researchers from some of these same French institutions published a report earlier this year, which found that stress-induced changes in gut microbiota reduced the efficacy of the antidepressant fluoxetine in mice.

In the study, researchers submitted genetically identical mice to unpredictable chronic mild stress (UCMS), a mouse model of stress-induced depression, for 8 weeks.

This treatment caused the mice to develop depressive-like behaviors, such as reduced eating, grooming, weight loss, and hippocampal neurogenesis. The hippocampus is responsible for learning and memory and is heavily affected by several psychiatric and neurological conditions.

Researchers then transplanted fecal samples containing gut microbiota from control and UCMS-exposed mice into healthy mice. To serve as a control, mice that received fecal transplants were germ-free mice or received treatment with antibiotics for 6 days.

After 8 weeks, mice that received transplants from UCMS mice developed depression-like symptoms. The mice also experienced a reduction in the number of new brain stem cells and neurons in their hippocampus.

These findings show that transferring gut microbiota from stress-induced depressive mice to healthy mice induced depression-like behaviors.

Surprisingly, simply transferring the microbiota from an animal with mood disorders to an animal in good health was enough to bring about biochemical changes and confer depressive-like behaviors in the latter.

Pierre-Marie Lledo, head of the Perception and Memory Unit at the Institut Pasteur (CNRS/Institut Pasteur), joint last author of the study

To figure out how this occurred, researchers explored the possibility that UCMS-exposed microbiota may trigger depression by altering metabolism. They found that mice with UCMS microbiota had significantly reduced levels of certain fatty acids in their blood and brain.

The reduced fatty acids included monoacylglycerols (MAG), diacylglycerols (DAG), polyunsaturated fatty acid (PUFA), and linoleic acid. monoacylglycerols (MAG), diacylglycerols (DAG), polyunsaturated fatty acid (PUFA), and linoleic acid. Variations of two of these fatty acids, DAD and PUFA, are converted into endocannabinoids (eCB).

The researchers speculate that gut dysbiosis may cause these changes in fatty acid levels. Studies link the dysregulation of the endocannabinoid system and its central receptor, CB1, with depression in both UCMS-model mice and humans.

In the study, the researchers found that mice with UCMS microbiota had greatly reduced levels of eCBs in their hippocampus and blood. They also found that mice with UCMS microbiota had reduced levels of Lactobacillus bacteria.

The researchers were able to reduce the depressive impact of the UCMS microbiota by enhancing CB1 levels and giving the mice a strain of Lactobacillus bacteria orally.

These findings suggest that chronic stress, diet, and the gut microbiota contribute to the development of depression-like behaviors via the endocannabinoid system.

This discovery shows the role played by the gut microbiota in normal brain function, says Grard Eberl, Head of the Microenvironment and Immunity Unit (Institut Pasteur/Inserm) and joint last author of the study.

More specifically, imbalances in the gut bacterial community that reduce fatty acid levels vital to the endocannabinoid system and brain function seem to encourage the development of depression-like behaviors.

These findings mean certain bacteria could act as a natural antidepressant, treating mood disorders by restoring gut microbial health. And this is promising news, considering the slew of potential adverse side effects and relatively low efficacy rate of most current antidepressants.

To confirm their results, the researchers will need to test their findings in humans. The researchers say that new research will also need to explore whether changes to the gut microbiota impact other brain targets of the endocannabinoid system in the same way.

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Gut microbiota: How does it interact with the brain? - Medical News Today

Four years after devastating spinal injury, former St. Paul’s football player reunites with caregivers – NOLA.com

Michael Doherty was just 17 when he lost the ability to walk, but the former St. Paul's studenthasn't lost his determination to regain the mobility taken from him when he suffered a spinal cord injury during a 2016 football game at the Covington school.

Now a junior at LSU, Doherty is quick to say that he's gained something in the years since his injurythe realization that nothing should be taken for granted and a deep gratitude for those who've helped him, including doctors, nurses and therapists, as well as family and friends.

During a recent visit to Lakeview Regional Medical Center, the 21-year-old said thank you in person to some of the staff members who cared for him when he arrived at the Covington areahospital's emergency department on that fateful November night, a stay that stretched to 17 days.

Michael Doherty, center, heads to his truck after visiting with the medical team at Lakeview Regional Medical Center near Covington that helped him during surgery and recovery following a spinal injury he suffered while playing high school football in November 2016. Doherty uses a wheelchair to get around but he and his doctors hope he'll be able to walk again in the future. (Photo by Chris Granger | The Times-Picayune | The New Orleans Advocate)

"He could hardly raise his arms," said Holly Leonhard, then a critical care nurse and now a nurse practitioner, as she marveled at her former patient's progress.

This time, Doherty arrived at the hospital on his own steam, driving a modified truck that uses hand controls and a platform that slides out so he can maneuver his wheelchair without assistance.

Many people on his team of caregivers 27 in all had not seen him since he left the hospital four years ago. But they hadn't forgotten his determination to recover, something that they say was evident from the outset.

Sharon Resmondo, who was a night nurse then, choked up a bit as she recalled those days.

"The beginning was very hard," she said. "But he rallied every day."

"I have children his age," critical care nurse Melanie Norris added. "It was his resolve: he was going to get through it. Your heart went out to him. He hasn't proven us wrong yet."

Hospital staffers remember lighter moments, too, particularly the unending stream of visitors, mostly his classmates, and their gentle bending of the rules to allow them to be there for their friend. His hospital room was rearranged to bring in a big-screen TV, and some friends even slept over.

Nurse Practitioner Sharon Resmondo, center, holds up her phone so that other medical staff who couldn't see Michael Doherty in person could visit with him in a video chat on Wednesday, December 9, 2020 at Lakeview Regional Medical Center near Covington. Doherty wanted to thank the medical staff that helped him during surgery and in his recovery following a spinal injury suffered during a high school football game in November 2016. (Photo by Chris Granger | The Times-Picayune | The New Orleans Advocate)

Dr. Marco Hidalgo, medical director of the hospital's trauma program, said there was a train of people bringing food just for the visitors.

"I kept asking, 'Don't these kids have to go to school?' There was never a day when there were not at least a dozen," Hidalgo said. "He had more visitors in a day than the whole hospital has now."

Because of COVID-19, he pointed out, such attention isn't possible.

Doherty, at the time a junior defensive back, was injured in what appeared to be a routine play in a November 2016 playoff game against Archbishop Shaw. But after the play, Doherty couldn't pick himself up.

Michael Doherty, center, is surrounded by some of the medical team that helped him during surgery and recovery at Lakeview Regional Medical Center near Covington back in November 2016 following a spinal injury he suffered at a high school football game. On Wednesday, December 9, 2020, Doherty drove to the hospital using a modified truck to thank the staff. (Photo by Chris Granger | The Times-Picayune | The New Orleans Advocate)

Dr. Justin Owen, a neurosurgeon, got the phone call from the football field that night about an injured player who couldn't feel his legs. While those on the scene were focused on his thoracic spine, Owen said he was much more concerned about his neck, and that is where his spinal cord was compressed, at the C5-6 vertebrae. Doctors were also worried about a possible clot in one of the arteries that supplies blood to the brain.

Owen and the others operated on Doherty deep into the next morning and the plan was to transfer him to New Orleans afterward. But Owen said the south shore hospital "got cold feet." So Lakeview reevaluated him and kept a very close eye on him, he said.

His caregivers agree that the presence of so many people was a key to Doherty's recovery, which wouldn't have been possible if he had been moved. "The fact that he was closer meant that family and friends could be there," Hidalgo said.

Doherty left Lakeview Regional to go the Shepherd Center in Atlanta, where he worked hard at rehabilitation, returning to St. Paul's in March of 2017 to finish his junior year. He has returned to the Shepherd Center since, and also works on his own.

He has some feeling in his legs and has regained enough arm movement to handle a cellphone, cups and the all-important hand controls for his truck.

"It gives me a lot of independence," he said. "I had to rely on other people for rides."

Michael Doherty visits with the medical team that helped him during surgery and recovery at Lakeview Regional Medical Center near Covington on Wednesday, December 9, 2020. In November 2016, Doherty suffered a spinal injury during a high school football game. (Photo by Chris Granger | The Times-Picayune | The New Orleans Advocate)

As for school, he jokingly told Owen, "It's fun, but the school part sucks." He's looking forward to life after college, when he hopes to have a career in sports administration.

His love of football hasn't diminished, and his on-campus job is working in the player personnel office for the LSU football program, which handles recruitment.

"It was a great year last year, then 2020 came," Doherty said with a smile.

But his biggest goal remains to walk again. Owen and Hidalgo believe he will.

"You're going to walk again, I know it's going to happen," Hidalgo told Doherty. The reason, he said, is Doherty's spirit. "I really would not tell that to a lot of patients."

The steering wheel on the modified truck that Michael Doherty drives. Doherty recently visited with the team at Lakeview Regional Medical Center near Covington that helped him during surgery and recovery following a spinal injury he suffered while playing high school football in November 2016. Doherty uses a wheelchair to get around but he and his doctors hope he'll be able to walk again in the future. (Photo by Chris Granger | The Times-Picayune | The New Orleans Advocate)

Owen pointed to advances in research, including stem cell therapy and robotics, and Doherty's youth. Statistically, those most likely to succeed are often athletes, he said, because they understand the demands that must be met to do something like winning a two-minute race.

For Doherty, the race is more of a marathon, but one he intends to win.

He found himself in a reflective mood after watching a football game at his alma mater before Thanksgiving, prompting him to make a rare post on social media. "Four years ago, I played my last football game and my life was forever changed," he wrote. "I miss playing football, and I wish I could play one more game."

But he also stressed the positives in his life. "I want to thank every doctor, nurse and therapist that has helped me along the way," he wrote. "I appreciate everything you had done for me. This journey will not stop until I reach my final goal of walking again."

"I wouldn't be where I am today without them."

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Four years after devastating spinal injury, former St. Paul's football player reunites with caregivers - NOLA.com

New Combination Therapy Tested By Children’s May Offer Hope For Leukemia Patients – WVXU

Cancer cells pose an uncanny ability to make new cells and dodge drugs, "somewhat like would-be robbers hacking the bank's alarm code," one doctor explains. But researchers at Cincinnati Children's Hospital Medical Center have figured out how cancer cells rewire themselves and, in turn, how to possibly overcome drug resistance.

This drug resistance may explain why some acute myeloid leukemia (AML) and other cancer patients suffer fatal relapses despite many improvements in leukemia outcomes over the years, according to a Children's news release.

"Overcoming resistance to therapy remains a holy grail of leukemia treatment," says Yi Zheng, Ph.D., director, experimental hematology and cancer biology at Cincinnati Children's. Zheng and his colleagues have now discovered a way to boost the effectiveness ofmTOR inhibitors, which prohibit unwanted cell proliferation.

"While the latest study is based on mouse models, building upon the findingspublished Dec. 21, 2020, in PNASeventually could improve outcomes for people with AML, and possibly other forms of cancer," a release says.

What Happens When Treatments Target mTOR?

"Using a novel mouse model, we have learned that deleting the mTOR gene prompts blood stem cells to multiply rapidly to open other pathways to continue producing new blood cells," says Zheng, the study's senior author. "We also found that leukemia cells use a similar response to continue multiplying despite mTOR-inhibiting treatments."

He says attacking mTOR essentially sets off alarms among hemopoietic stem cells (HSCs), which act like blood cell factories deep in bone marrow. Then the cells themselves produce a flood of new, re-wired blood cells. These re-wired stem cells, treated with mTOR inhibitors, can begin multiplying, rendering mTOR inhibitor drugs useless.

The co-authors say mTOR treatment resistance can be counteracted by inhibiting activity of the MNK, CDK9 or c-Myc genes. So-called BET inhibitors can act against c-Myc activity. Other inhibitors that are in clinical trials can act against CDK9.

Next Steps

Scientists at Cincinnati Childrens have already launched some of the research needed to prepare the combination therapies for in vivo test leading to human clinical trials, the news release says. That process will take time, but since mTOR inhibitors have been widely tested in clinical trials, investigators have a head start on exploring combination therapies.

Longer term, the findings may extend beyond AML, Zheng says, because mTOR has been a recognized target in most human cancers, including solid tumors like brain tumors.

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New Combination Therapy Tested By Children's May Offer Hope For Leukemia Patients - WVXU

Real-time observation helpful in Stem cell for vascular diseases: Study – Hindustan Times

A study has found out that Stem cell treatment for vascular diseases can be predicted through real time observation.(ANI)

A recent study has found out that Stem cell treatment for vascular diseases can be predicted through real-time observation.

In the study which was published in the journal Biomaterials, therapeutic efficacy prediction was done using initial distribution images of stem cells that differentiate to endothelial cells. It can be applied to research in the field of stem cell treatments for blood vessel regeneration.

In recent years, the number of high-risk groups for ischemic diseases such as critical limb ischemia where tissues of the toe may decay is increasing due to an increase in the number of people with obesity, diabetes, and hypertension which are triggered by changes in dietary habits, smoking and consumption of alcohol. A number of studies are actively conducted on endothelial progenitor cells (hEPCs), which are stem cells that contribute to the blood vessel regeneration in the ischemic tissues, to treat such ischemia diseases.

Vascular hEPCs migrate to regions requiring angiogenesis, such as ischemic regions, and then differentiate into endothelial cells of blood vessels or release growth factors that help the formation of blood vessels to induce regeneration of the damaged blood vessels. Hence, these cells can be developed into stem cell therapy for diseases related to blood vessels including ischemic diseases.

However, when the hEPCs with outstanding blood vessel regeneration capability are used as stem cell therapy in ischemic diseases, the therapeutic treatment efficacy may differ depending on various variables such as survival of the transplanted cells and migration to the treatment region. Accordingly, treatments for ischemic diseases are remaining in the clinical stage without being commercialized due to the limitations in accurately observing and predicting the therapeutic efficacy.

The Korea Institute of Science and Technology (KIST) recently announced that the collaborative research team led by Dr. Kwangmeyung Kim from Center for Theragnosis and Sung-Hwan Moon from Stem Cell Research Institute, T&R Biofab Co. Ltd developed a method that can predict the therapeutic efficacy based on the distribution of the initial transplantation of hEPCs by tracking the initial distribution and migration of the transplanted cells using fluorescence romographic images.

The KIST research team first enabled observing fluorescence signals through fluorescence molecular tomography by binding fluorescent dyes to the surface of hEPCs. Subsequently, the team transplanted the cells into the hind limb of mouse with severe limb ischemia and tracked them through images for 28 days to evaluate the cell movement in the body; then, tracked and observed the regeneration process of the blood flow through laser scanning microscope (Laser Doppler imaging). As a result, it was revealed that the hEPCs migrate to the damaged tissues where the ischemic disease is found.

Additionally, the shapes of cell clusters were observed to be injected into two different shapes as a result of analyzing the images of hEPCs during the initial transplantation of cell therapy treatment. The two shapes were condensed round shape and spread shape. When the therapeutic efficacy was observed by classifying the experimental groups into these two shapes, it was found that the initial condensed round shape cells migrated better and showed superior therapeutic efficacy in the experimental groups. Based on these findings, the research team predicted that the treatment efficacy will be superior when the treatment cells are formed into a condensed round shape during the initial treatment.

Our developed technology, which can quickly and accurately monitor the initial transplantation forms and changes of stem cell therapy, will enable predicting the efficacy of the transplanted hEPCs in the early stages of ischemic disease treatments, and we expect it to be used in the development of stem cell therapy treatments for ischemic diseases in the future, said Dr. Kwangmeyung Kim at KIST, who led the research.

(This story has been published from a wire agency feed without modifications to the text. Only the headline has been changed.)

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Real-time observation helpful in Stem cell for vascular diseases: Study - Hindustan Times

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