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Stempeutics partners with Global Consortium of cell therapy companies – Express Healthcare

Seeking European Commission Funding to Fight Against Corona

Stempeutics Research, a group company of Manipal Education and Medical Group (MEMG), recently announced that it has partnered with Global Consortium of cell therapy companies seeking European Commission Funding to Fight Against Corona! (FAC!). Under this partnership, Stempeutics will export its stem cell product Stempeucel (subject to regulatory approvals) for treating critically ill COVID-19 patients with lung disease. First the product will be clinically tested and upon successful outcomes, it intends to export the product on a regular basis. In this connection it is signing up an alliance with Educell, Slovenia.

Currently, no specific drugs or vaccines are available to cure the patients with COVID-19 infection. Mortality in COVID-19 infected patients with the inflammatory lung condition ARDS (Acute Respiratory Distress Syndrome)is reported to approach 50 per cent, and is associated with older age, co-morbidities such as diabetes, cardiovascular disease, COPD (chronic obstructive pulmonary disease), higher disease severity, and elevated markers of inflammation. Current therapeutic interventions (with the exception of ventilators / respirators which are in very short supply) do not appear to be improving in-hospital survival. Hence, there is a large unmet need for a safe and effective treatment for COVID-19 infected patients, especially in severe cases. A promising new therapy for the ARDS, the terminal stage of COVID-19, using MSCs can quickly (2-4 days) reduce inflammation of the lung tissue, and allow patients to more quickly come off of the ventilatory support and hopefully fully recover with less significant lung damage.

Stempeucel is an allogeneic, off the shelf, pooled mesenchymal stromal cells having anti- inflammatory and immune-modulatory properties which prevents the over activation of the immune system. Stempeucel product exhibits a wide range of potent therapeutic properties. The product exhibits potent immunomodulatory and anti-inflammatory properties which could help in reducing the inflammation caused due to the cytokine storm elicited by the bodys immune cells in response to SARS-CoV-2 (COVID-19) related infection in the lungs. Also, the growth factor, Angiopoietin-1 (Ang-1) is effective in reducing alveolar epithelium permeability in the lung. Hence it is envisaged, Stempeucel will reduce the fatal symptoms of COVID 19 induced pneumonia and its progression to ARDS.

Commenting on this initiative, Dr Miomir Knezevic, Leader, Global Consortium and Founder, Educell said, We are happy to partner with Stempeutics since its product Stempeucel is already designated as an ATMP [1] in Europe and also Stempeucel technology has been patented in many countries in Europe. Stempeutics manufacturing process is scalable and the product is affordable which are key to meet the demands of COVID-19 patients.

BN Manohar, CEO, Stempeutics said, From the clinical data using Stempeucel in different clinical trials in other indications it may be postulated that Stempeucel has the potential capability for treating COVID-19 infection. Together with the safety profile observed from DCGI approved clinical trials involving more than 350 patients injected with Stempeucel by different routes of injection, this therapy may help in mitigating the lung tissue damaging effects of COVID-19 infection.

Dr Stephen Minger, Scientific Advisor, Global Consortium and ex Global Director of R&D, Cell Technologies GE Healthcare added, The most severely affected CV-2 infected patients will often go on to develop ARDS which necessitates assisted ventilation to preserve breathing and lung function. Moreover, many ARDS patients will also experience an acute but severe life-threatening inflammatory response (cytokine storm) which can result in long-term damage to lung tissue and lung function. Treating ARDS patients with allogeneic expanded bone marrow derived MSCs could alleviate and ameliorate lung inflammation and compromised lung function and significantly reduce the time required for patients to be ventilated.

Dr Raviraja NS, Sr Director, Business Development and Innovation, Stempeutics, said, Given the severe shortage of ventilators in the world, and the high mortality rate of patients who develop ARDS (approx. 50 per cent), the clinical use of MSCs in COVID-19 ADRS patients could drastically impact on the healthcare burden currently occurring due to very large patient numbers, limited equipment and overworked medical personnel.

Reference:

[1] ATMP is Advanced Therapy Medicinal Product regulated by EU Act December 7, 2007.

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Stempeutics partners with Global Consortium of cell therapy companies - Express Healthcare

CYTOVIA Therapeutics and MACROMOLTEK to Develop Dual-Acting Natural Killer Immunotherapy Against SARS CoV2 (COVID-19) – BioSpace

NEW YORK and AUSTIN, Texas, April 07, 2020 (GLOBE NEWSWIRE) -- Cytovia, Inc. (Acquired By Maxim Pharmaceuticals) (Cytovia), an emerging biopharmaceutical company developing Natural Killer (NK) immunotherapies for cancer and infectious diseases, announced today that it is expanding its programs to help urgently address the current SAR CoV2 (COVID-19) crisis.

Natural Killer cells are a first line of defense not only against tumor cells but also against severe acute infectious diseases. Using a bi-functional approach has the potential to minimize virus escape from the immune response thereby inhibiting the intensification of the inflammation leading to Acute Respiratory Syndrome (ARS). The activation of NK cells through the NKp46 receptor aims to destroy the virus-infected cells while the other arm can either block the entry of the virus into epithelial cells or neutralize circulating viruses.

Dr Daniel Teper, co-founder, Chairman and CEO of Cytovia said: Our goal is to bring the best candidate to clinical trials by the end of the year 2020 and make it available to patients in 2021. As we become more prepared for potential next waves of the pandemic, physicians will need therapeutic options to strengthen the immune response and prevent rapid worsening of the disease. We expect that our novel approach might also be applied in the future to other severe acute infectious diseases, an area that still has significant unmet medical needs. Partnering with Macromoltek will fast-track this process.

Dr Monica Berrondo, co-founder and CEO of Macromoltek added: Our computational approach to antibody design allows to fast track the development of optimal therapeutic candidates in weeks rather than months. In the fight against SARS CoV2, time is of the essence. We are delighted to be part of a multi-disciplinary team passionate about winning the race against the virus with novel therapeutic solutions.

Cytovia will lead a highly coordinated team of scientific collaborators in order to achieve aggressive timelines for its COVID-19 therapeutic program. Cytovia will leverage its own proprietary bi-functional technology, developed by co-founder Dr Kadouche, NK activating antibodies licensed last month from Yissum, the technology transfer company of the Hebrew University of Jerusalem, and novel antibodies neutralizing or blocking SARS CoV2, designed by Macromoltek, a computational antibody discovery company. The selected bi-functional antibodies will further benefit from the Fast to Clinic approach implemented by STC Biologics, a Boston, MA based antibody development and manufacturing company.

About Cytovia TherapeuticsCytovia aims to accelerate patient access to transformational immunotherapies, addressing several of the most challenging unmet medical needs in cancer and severe acute infectious diseases. Cytovia focuses on Natural Killer (NK) cell biology and applies precision medicine tools to develop the right therapy for the right patient at the right stage of the disease. Cytovia has secured access to multiple advanced technologies, including an induced pluripotent stem cell (iPSC) platform for NK cell therapy, gene editing of Chimeric Antigen Receptors (CAR) to enhance targeting of NK cells, and NK engager multi-functional antibodies. Cytovia partners with the University of California San Francisco (UCSF), the New York Stem Cell Foundation (NYSCF) and the Hebrew University of Jerusalem. Learn more at http://www.cytoviatx.com.

About MacromoltekMacromoltek, a computationalde novodrug design company, rapidly producesaccurate and credible antibody designs. They have built a proprietary platform that enables design against difficult targets inaccessible by traditional methods. A Y Combinator cohort company, they are already designing antibodies for several large biopharmas and smaller biotechs. https://www.macromoltek.com

Media and Investor Contacts

Cytovia TherapeuticsSophie Badr(Media)sophiebadre21@gmail.com929.317.1565

Anna Baran Djokovic (Investors)Anna@cytoviatx.com

MacromoltekLisa Hendricksonlhendrickson@sparkcity.co917.912.9424

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CYTOVIA Therapeutics and MACROMOLTEK to Develop Dual-Acting Natural Killer Immunotherapy Against SARS CoV2 (COVID-19) - BioSpace

3 drug candidates authorized to treat COVID-19 patients – Korea Biomedical Review

The government said it has approved three investigational drugs to treat a limited number of more than 10 patients infected with the new coronavirus (COVID-19) so far.

The Ministry of Food and Drug Safety regulator gave the latest nod to GemVax & Kaels GV1001, an experimental drug for Alzheimers disease. On Friday, the regulator allowed Kyungpook National University Chilgok Hospital to use GV1001 to treat two COVID-19 patients.

On March 30, GemVax & Kael announced that it applied for a patent on GV1001 to be used as COVID-19 treatment. GV1001 is a peptide derived from human telomerase reverse transcriptase, an enzyme that maintains the length of telomeres at the ends of human chromosomes. The agent demonstrated the effect of preventing the cytokine storm caused by COVID-19 in preclinical studies, the company said.

As GV1001 has not only anticancer effects, but various other effects such as anti-inflammation, anti-oxidation and cellular protective effects, the drug might work against COVID-19, too, the company said.

The regulator grants approval for investigational medicines for therapeutic purposes for individual patients on the condition that there is no other treatment option, and the patient suffers from a life-threatening disease. The authorities have given such nod to three drug candidates, including GV1001, to be used for more than 10 COVID-19 patients.

A second approval went to ImmuneMeds experimental drug, hzVSF (humanized virus suppressing factor), to be used for seven patients in Seoul National University Hospital (SNUH), Yeungnam University Medical Center, Chungnam National University Hospital, and Severance Hospital. Pharmicell also obtained the nod for Cellgram-AKI, a stem cell therapy, for the treatment of up to 24 COVID-19 patients.

As the government gave the latest nod for COVID-19 treatment only for compassionate use, the approval does not mean that the three investigational drugs proved efficacy and safety.

The hospitals using the three experimental treatments do not control the drug administration or establish a control group because they do not intend to evaluate the candidates efficacy and safety.

Seeking approval for therapeutic purposes for individual patients requires only a specialists opinion and a medical certificate. In that case, the attending doctor is responsible for the use of the investigational drug.

same@docdocdoc.co.kr

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3 drug candidates authorized to treat COVID-19 patients - Korea Biomedical Review

Surgeon offers innovative treatments – Brunswick News

From a young age, David M. Sedory, MD was focused on making his dream of becoming a doctor into a reality. And he set his course to do just that.

Using an ROTC scholarship, he attended Washington University in St. Louis, Mo., where he completed his undergraduate work. Sedory went on to Case Western Reserve University School of Medicine in Cleveland, Ohio.

I owed the military some time, so when I completed medical school I matched into the orthopedic residency at Brooke Army Medical Center in San Antonio, Texas. I was there for five years, he said.

In 2010, Sedory was stationed at Fort Stewart in Savannah and was deployed to Afghanistan in 2011. He finished out his military career at Hunter Airfield as team surgeon for the Army Rangers, while simultaneously working with Optim Orthopedics, which has a clinic in Brunswick.

Taking care of soldiers, their families and some of the wounded coming back from overseas was an incredible honor, he commented. When youre caring for soldiers in combat, you really have to have a team approach and I have tried to apply some of those philosophies and lessons to my current job with Optim.

Once his military time ended, Sedory transitioned into full-time work as a surgeon with Optim Orthopedics. Today, he specializes in sports medicine, focusing on areas often prone to injury.

I do shoulder, hip, and knee reconstruction. A lot of high-end cartilage repair, as well as joint replacements, he said.

Sedory has long been a noted expert in arthroscopic surgery, especially of the hip. This is a minimally invasive procedure that can treat a number of ailments, including impingement, labral tears, and tendon tears. He has lectured at national meetings and is an instructor at courses for other surgeons trying to learn these techniques.

Hip arthroscopy is mainly aimed at younger, active patients with the majority being between the ages of late teens to early 50s. They have a hip that is causing them pain from a labral tear, impingement or cartilage damage but its not broken down to the point of arthritis or needing a full hip replacement, he explained.

I also treat a lot of older patients with tendon tears around their hips that are causing a lot of pain and function issues. Many of them have been getting the run around for years and have been told that they have bursitis. Often times the underlying problem is actually a tear, much like a rotator cuff tear in the shoulder.

The knee, too, can also present similar deterioration or damage. And, like the hip, new modalities can offer a great deal of relief. Sedory has taken a great interest in cartilage reconstruction and transplantation, which can be used in either the knee or hip. This procedure is also offered to younger patients who have had some previous issues but do not qualify for a full knee replacement.

Ideal candidates for cartilage reconstruction surgery are between the ages of 18 and 50, Sedory commented.

There are a variety of methods for cartilage repair. These include stem cell or biological injections; debridement; microfracture; and implantation of juvenile cartilage to regenerate new cartilage.

Dr. Sedory noted that the cartilage can even be taken from ones own body, regrown in a lab, then implanted during a second surgery. This is known as MACI (matrix-induced autologous cartilage implantation). Cartilage can also be obtained from a healthy tissue donor and implanted in the leg.

These are often combined with other procedures such as ligament reconstruction, meniscus transplantation (replaces the shock absorber in the knee), or osteotomy to correct malalignment, Sedory said.

It is kind of like having the tires on your car wear out from bad alignment; you cant just slap on new tires, you have to fix the underlying stability or alignment problem as well to get the best outcome.

Once the procedure has been completed, most patients go on to spend four to six weeks on crutches followed by several months of physical therapy.

Dr. Sedory treats patients in Savannah and the surrounding area. He is currently expanding his practice in Brunswick. The Optim clinic is located at 1111 Glynco Parkway, off Spur 25, and adjacent to Applecare.

I mostly am seeing hip reconstruction patients. Either for an anterior hip replacement or hip arthroscopy, he said.

But a big part of my practice in Savannah is complex knee reconstruction and cartilage repair. I want patients to know that those are options available to them as well.

To make an appointment with Dr. Sedory, call 912-644-5300 or find out more at optimorthopedics.com

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Surgeon offers innovative treatments - Brunswick News

Health Tech: Dallas-based American Heart Association Awards $14M in Research Grants for Heart, Brain, and COVID-19 Innovation – dallasinnovates.com

Dallas-based American Heart Association (AHA) awarded more than $14 million in scientific research grants for health technology solutions focused on heart and brain health, including special projects related to COVID-19, last week. The grants went to four multidisciplinary teams around the country to create the AHAs 10th Strategically Focused Research Network. The newest network centers on Health Technologies and Innovation.

Consumer adoption of healthcare technology on digital mediums like tablets, smartphones, and wearable devices offer a unique outlet to find new solutions to improve health outcomes, American Heart Association president Robert A. Harrington said in a statement.

The AHA peer review team moved forward with its selection of the centers for its latest strategically focused research network when the COVID-19 pandemic in the U.S. broke. The nonprofit science-based organization knows the times are challenging as it works towards its mission of a culture of health.

It felt this was an incredible opportunity for us to provide additional support in harnessing new innovations to tackle the challenges that are crippling the nation, and frankly the globe, Harrington said.

Grantees that will create the 10th network are research teams at Cincinnati Childrens Hospital, The Johns Hopkins University, Stanford University School of Medicine and the University of Michigan. Each team will receive $2.5 million each for their individual projects aimed at reducing health care disparities, empowering people to better manage their health and wellness, and enhancing patient/provider connectivity, the AHA said.

Collectively the teams will also receive $4 million to work on at least one highly impactful project and form a national Health Technology Research Collaborative, it said. The Collaborative may ultimately serve as an American Heart Association research think tank to assist with identifying, creating, testing and bringing to scale future innovative health technologies.

In addition, each research team also can apply for supplemental research grants of up to $200,000 for rapid action projects to develop technology solutions to address the COVID-19 pandemic, the AHA said. Those projects might provide aid for health care systems, doctors or care providers, first responders, patients or consumers.

These supplemental grants are part of the AHAs $2.5 million commitment to research efforts to better understand this unique coronavirus and its interaction with the bodys cardiovascular and cerebrovascular systems.

The peer review committee has assembled an exceptional network to move this work forward and I want to recognize the dedication and commitment of that panel of many renowned experts, Harrington said. The Association uses an intense, multi-stage review process in selecting the centers for our focused research networks and were very appreciative of the committee members who lend their time and expertise to this critical process.

The AHA program brings together basic, clinical, and population researchers with engineers, IT developers, policy leaders, health care clinicians and patients. That lets the teams improve existing technology, and also identify new and innovative ways to put technology to work in addressing heart and brain health, American Heart Association volunteer James A. Weyhenmeyer, Ph.D. said.

Weyhenmeyer is vice president for research and economic development at Auburn University and chair of the Associations peer review team for the selection of the new grant recipients. Its especially important that all of these projects be focused with an equity-first lens to ensure our most vulnerable populations are being served, he noted.

The AHA is currently funding seven Strategically Focused Research Networks (SFRN) with focuses on Go Red For Women, Heart Failure, Obesity, Children, Vascular Disease, Atrial Fibrillation, and Arrhythmias & Sudden Cardiac Death. Three of AHAs networksPrevention, Hypertension, and Disparitieshave been completed. Locally, the University of Texas Southwestern was a grantee in the completed Prevention SFRN.

With the launch of its newest network, the American Heart Association has invested more than $190 million to establish 12 SFRNs since the program was launched in 2010-2011. The idea behind the science networks is the collaboration of scientists to focus research to address key strategic issues that were identified by the AHAs Board of Directors, in areas such as hypertension, womens health, heart failure, obesity, children, vascular disease, atrial fibrillation, sudden cardiac death, and type 2 diabetes. Each established network centers around the understanding, prevention, diagnosis and treatment of a key research topic. Four to six research centers make up each network, AHA said, which brings together investigators with expertise.

More networks can be expected in 2020 and beyond, AHA said.

The latest projects funded by the $14.5 million in grants commenced on April 1. Here they are, per the AHA:

Active Detection and Decentralized Dynamic Registry to Improve Uptake of Rheumatic Heart Disease Secondary Prevention (ADD-RHD) at Cincinnati Childrens HospitalLed by Andrea Beaton, M.D., a pediatric cardiologist at Cincinnati Childrens Hospital, this team will address the global health issue of rheumatic heart disease which affects more than 40 million people, most living in poor countries or poor areas in wealthier countries. The team will concentrate on getting more people living with rheumatic heart disease into guideline-based care using technology to find more people with rheumatic heart disease, keep them in care and generate the investment case to scale up national rheumatic heart disease action plans in low-income countries. Additionally, theyll be looking for early career doctors and scientists who want to help people get better care using technology and educate this next generation in solutions developed to improve global health in the future. The team consists of a collaborative with the Rheumatic Heart Disease Research Collaborative in Uganda (RRCU) including the Uganda Heart Institute, Childrens National Medical Center and the University of Washington in Seattle; the Cincinnati Childrens Digital Experience and Bioinformatics Centers; Northern Kentucky Universitys Biostatistics Department, Health Innovation Center and Health Sciences Institute; REACH (a global technical organization in rheumatic heart disease) and an industry partnership with Caption Health. While the project and solutions will be made for people living in developing countries, the team hopes to learn a lot about how to help people have better health in the United States.

Center for Mobile Technologies to Achieve Equity in Cardiovascular Health at The Johns Hopkins University in BaltimoreLed by cardiologist Seth Martin, M.D., M.H.S., and neurologist David Newman-Toker, M.D., Ph.D., this teams mission is to leverage mobile and wearable technologies to empower patients and clinicians, enhance the quality of care, increase value and improve the diagnosis and management of heart diseases and stroke. Early and accurate diagnoses are essential to ensure the appropriate delivery of guideline-recommended management to engage patients and their caregivers to achieve the best patient outcomes possible. The collaborative project will span the patient experience from diagnosis to management to improve patient care throughout the patient journey. Specifically, the team will develop and test a smartphone application for stroke diagnosis, following their experience with a goggle-based eye-tracking technology in the Armstrong Institute Center for Diagnostic Excellence. On the management side, the team will work on a virtual cardiovascular rehab that builds on their Corrie Health platform to empower patients in guideline-based prevention. Patients and their families from demographically diverse backgrounds will join as partners in the technology advancement process.

Center for Heart Health Technology (H2T): Innovation to Implementation at Stanford University Led by Mintu Turakhia, M.D. M.A.S., Executive Director of Stanfords Center for Digital Health, associate professor of medicine and a cardiac electrophysiologist at the VA Palo Alto Health Care System, the H2T Centers mission is to rapidly develop technologies that address unmet needs for heart health, evaluate them quickly and then implement these solutions at scale. The team will address the issue of high blood pressure, which affects more than 115 million Americans and costs the U.S. health care system more than $22 billion each year. The team will develop a clinician- and patient-facing digital health system for semi-automated management and evidence-based titration of blood pressure medications. The app will be tested in a randomized trial conducted in Northern California and New Jersey in people of different races, educations, and backgrounds and in a population of gig economy workers (rideshare drivers), who can be at increased risk of heart disease.

Wearables In Reducing Risk and Enhancing Daily Lifestyle (WIRED-L) at the University of MichiganLed by Brahmajee Nallamothu, M.D., M.P.H., a professor in the Division of Cardiovascular Diseases at the University of Michigan, this team plans to establish the Wearables In Reducing risk and Enhancing Daily Lifestyle (WIRED-L) Center dedicated to building and testing mobile health (mHealth) apps that leverage wearables like smartwatches to improve physical activity and nutrition in hypertensive patients. The apps will use just-in-time-adaptive digital interventions to deliver notifications to participants when they are most likely to be responsive using contextual information obtained from their devices. WIRED-L will enroll diverse communities that include African Americans and older adults rarely included in mHealth studies, to better close the digital divide between rich and poor. Additionally, WIRED-L will train a diverse and inclusive set of future leaders in mHealth through a highly integrated program that focuses on the key and complementary areas of clinical trials, data science, and health equity research.

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Hubert Zajicek wants to tap the strong innovation community in North Texas to share know-how, combat shortages, and come up with new solutions during the COVID-19 pandemic.

The Plano-based remote patient monitoring startup is now offering providers a no-cost solution for low-risk patients or those with mild symptoms simply by answering a series of questions.

The collaboration will allow physicians to virtually diagnose medical conditions, heightening safety for everyone.

A professor at the University of North Texas Health Science Center is collaborating with an international team to test whether stem cells can combat COVID-19 pneumonia.

Due to the effects of COVID-19, Southlake-based SmartCounseling is working to reduce costs for mental health services. The company's new platform also allows licensed professionals to expand their services online quickly.

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Health Tech: Dallas-based American Heart Association Awards $14M in Research Grants for Heart, Brain, and COVID-19 Innovation - dallasinnovates.com

Metrion Biosciences and International Scientific Consortium Publish Data and New Recommendations for in Vitro Risk Assessment of the Cardiac Safety of…

Part of the US FDAs Comprehensive in vitro Proarrythmia Assay (CiPA) Initiative

Metrion Biosciences Limited (Metrion), the specialist ion channel CRO and drug discovery company, today announced it has contributed to two new peer-reviewed papers under the U.S. Food and Drug Administrations (FDA) CiPA (Comprehensive in vitro Proarrhythmia Assay) initiative. The papers, in Nature Scientific Reports1 and Toxicology and Applied Pharmacology2, focus on application of improved cardiac safety testing protocols and recommendations for best practice for the drug discovery industry.

The CiPA Initiative (www.cipaproject.org), which began in July 2013 following a workshop at the US FDA, has the objective to revise and enhance the regulatory framework assessing cardiac safety of new chemical entities. Under current guidelines, new therapeutics undergo initial assessment of proarrhythmic risk by measuring activity against the hERG cardiac ion channel, before progressing to studies in preclinical animal models and ultimately, a Thorough QT interval study in the clinic. The CiPA initiative aims to extend the use of advances in early electrophysiology-based cardiac ion channel screening, in silico predictive modelling, and human induced pluripotent stem cell derived cardiomyocytes to improve the accuracy and reduce the cost of predicting the cardiac liability of new drug candidates. Metrions research forms part of the first stage of the proposed harmonisation work, to provide clarity on how to standardise cardiac ion channel assays to ensure they deliver consistent data for in silico models of clinical cardiac arrythmia risk.

The first paper1, published in Nature Scientific Reports on 27th March 2020 by an international group of authors drawn from 20 different commercial and academic laboratories, including Metrion Biosciences, was coordinated by the Health and Environmental Sciences Institute (HESI). It reviews data from a multi-year, multi-site collaboration across industry, academia and the FDA regulatory agency to optimize experimental protocols and reduce experimental variability and bias. The goal of the study was to guide the development of best practices for the use of automated patch clamp technologies in early cardiac safety screening. High quality in vitro cardiac ion channel data is required for accurate and reliable characterisation of the risk of delayed repolarisation and proarrhythmia in the human heart and to guide subsequent clinical studies and regulatory submissions.

The second paper2, to be published formally in Toxicology and Applied Pharmacology paper on 1st May 2020 but currently available online, uses automated patch clamp data from the CiPA consortium to address the lack of statistical quantification of variability, which hinders the use of primary hERG potency data to predict cardiac arrhythmia. The consortium establishes a more systematic approach to estimate hERG block potency and safety margins.

Dr Marc Rogers, CSO, Metrion Biosciences, said: "The Metrion team has been a participant in the international CiPA Initiative since inception and we are now pleased to be able to announce the publication of our data from this global collaborative scientific effort. We believe these projects will make a significant contribution to the eventual revision of cardiac safety testing guidelines by the FDA and other international regulatory agencies. They also contribute to deepening our knowledge of the underlying causes of proarrhythmia, which will help prevent early attrition of potentially promising drugs."

Contributing organisations to the Nature Scientific Reports CiPA study include: Charles River Laboratories; Bayer AG; Sophion Bioscience A/S; Nanion Technologies; GlaxoSmithKline PLC; Pfizer; Sanofi R&D; Astra Zeneca; BSYS GmbH; Bristol-Myers Squibb Company; Eurofins Discovery; Merck; Metrion Biosciences Ltd.; Natural and Medical Science Institute at the University of Tbingen; Northwestern Feinberg School of Medicine, Chicago; Roche Innovation Center Basel; Novoheart; Health and Environmental Sciences Institute, Washington, DC; AbbVie.

Contributing organisations to the Toxicology and Applied Pharmacology hERG study include: Center for Drug Evaluation and Research, Food and Drug Administration; Eli Lilly and Company; AstraZeneca; CiPA LAB; NMI-TT GmbH; Sophion Bioscience A/S; B'SYS GmbH; The Ion Channel Company; F. Hoffmann-La Roche AG; Eurofins Discovery; Bristol-Myers Squibb; Merck & Co., Inc; Metrion Biosciences Ltd.; Nanion Technologies; Charles River Laboratories; Bayer AG; University of Nottingham; Universit de Lille.

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Metrion Biosciences and International Scientific Consortium Publish Data and New Recommendations for in Vitro Risk Assessment of the Cardiac Safety of...

BioIVT Opens New Blood Donor Center to Support Boston-area Research into COVID-19 Therapies, Vaccines and Diagnostics – Salamanca Press

WESTBURY, N.Y., April 6, 2020 /PRNewswire/ --BioIVT, a leading provider of research models and services for drug and diagnostic development, today announced the opening of its new blood donor center on the Tufts University campus in Medford, MA to support academic and pharmaceutical researchers involved in COVID-19, cell and gene therapy research.

"BioIVT wants to play a leading role in supporting COVID-19 research efforts and blood donations are a vital resource for the research and development of new therapies, vaccines, and diagnostics. We have many years' experience developing blood products, including blood-derived immune cells for cell and gene therapy research, and we want to make that expertise count," said BioIVT CEO Jeff Gatz. "Researchers recognize and appreciate BioIVT's rapid response and commitment to high quality, fresh blood products and this new donor center will allow us to offer those attributes and services to additional US clients."

BioIVT's new Boston blood donor center is its seventh. The company has similar facilities located in California, Tennessee and Pennsylvania to serve US clients and in London, UK for EU-based clients.

"While the initial focus at our Boston donor center will be on delivering fresh blood, leukopaks and buffy coats within hours of collection, we plan to add more capabilities and donors over time," said Jeff Widdoss, Vice President of Donor Center Operations at BioIVT.

Leukopaks, which contain concentrated white blood cells, are used to help identify promising new drug candidates, assess toxicity levels, and conduct stem cell and gene therapy research. They are particularly useful for researchers who need to obtain large numbers of leukocytes from a single donor.

BioIVT blood products can be supplied with specific clinical data, such as the donor age, ethnicity, gender, BMI and smoking status. Its leukopaks are also human leukocyte antigen (HLA), FC receptor and cytomegalovirus typed. HLA typing is used to match patients and donors for bone marrow or cord blood transplants. FC receptors play an important role in antibody-dependent immune responses.

COVID-19-related Precautions Blood donor centers are considered essential businesses and will remain open during the COVID-19 quarantine. BioIVT is taking additional safety measures to protect both blood donors and its staff during this difficult time. It has instituted several social distancing measures, including increasing the space between chairs in the waiting room and between donor beds, and limiting the entrance of non-essential personnel. The screening rooms are disinfected between donors and all areas of the center continue to be cleaned at regular intervals.

As soon as each blood donor signs their informed consent form, their temperature is taken. If they have a fever, their appointment is postponed, and they are referred to their physician. Any donor who develops COVID-19 symptoms after donating blood is required to inform the center immediately.

All BioIVT blood collections are conducted under institutional review board (IRB) oversight and according to US Food and Drug Administration (FDA) regulations and American Association of Blood Banks (AABB) guidelines.

Those who would like to donate blood at BioIVT's new Boston-area donor center should call 1-833-GO-4-CURE or visit http://www.biospecialty.com to make an appointment.

Further information about the products available from BioIVT's new donor center can be found at https://info.bioivt.com/ma-donor-ctr-req.

About BioIVTBioIVT is a leading global provider of research models and value-added research services for drug discovery and development. We specialize in control and disease-state biospecimens including human and animal tissues, cell products, blood and other biofluids. Our unmatched portfolio of clinical specimens directly supports precision medicine research and the effort to improve patient outcomes by coupling comprehensive clinical data with donor samples. Our PHASEZERO Research Services team works collaboratively with clients to provide target and biomarker validation, phenotypic assays to characterize novel therapeutics, clinical assay development and in vitro hepatic modeling solutions. And as the premier supplier of hepatic products, including hepatocytes and subcellular fractions, BioIVT enables scientists to better understand the pharmacokinetics and drug metabolism of newly-discovered compounds and their effects on disease processes. By combining our technical expertise, exceptional customer service, and unparalleled access to biological specimens, BioIVT serves the research community as a trusted partner in elevating science. For more information, please visit http://www.bioivt.com or follow the company on Twitter @BioIVT.

BioIVT Contact: Courtney Noah, SVP, Marketing & Client Services, 516-483-1196Media Contact: Lisa Osborne, Rana Healthcare Solutions, 206-992-5245, lisa@ranahealth.com

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BioIVT Opens New Blood Donor Center to Support Boston-area Research into COVID-19 Therapies, Vaccines and Diagnostics - Salamanca Press

Rafarma Establishes Advisory Board, Appoints First Member and Will Acquire Additional Patents and Intellectual Property – GlobeNewswire

Ljubljana, Slovenia, April 06, 2020 (GLOBE NEWSWIRE) -- RAFARMA PHARMACEUTICALS INC. OTC:(RAFA) - In establishing its Advisory Board, Rafarma Pharmaceuticals announces the appointment of its first board member, Vladislav N. Laskavy, PhD., who will begin advising the company and assisting with the development of multiple treatment options as the company rolls out detox spas throughout Thailand and Europe. Dr. Laskavy is a well-known research scientist and has worked on numerous research projects studying Cancer, Autoimmune Deficiency, Viral Diseases, AIDS and many other diseases and treatments. Rafarma will also enter into non-dilutive agreements with Dr. Laskavy to acquire all of his intellectual property and patents, including multiple United States, Australian and other International patents which include patents for cancer treatment and stem cell therapy.

The addition of Dr. Laskavy enables Rafarma to add multiple treatment options to the companys current Medicinal Marijuana treatment protocols. Rafarma CEO Vladimir Dolgolenko stated: We feel the addition of Dr. Vladislav Laskavy to our advisory board will assist us in providing truly unique treatment options at our cutting-edge detox spas. We have an aggressive growth plan to implement our detox spas all throughout Thailand and Europe. With the current research from our Thailand partners and the new addition of Dr. Laskavy, we feel we will be able to provide an amazing health experience to our customers and patients.

One of the new products Rafarma plans to roll out in its spas will be XR. XR belongs to a new class of immunomodulating drugs that contribute to the activation of an antigen-specific immune response, the development of which eliminates the infectious agent. More details and specifications for use of this drug will be released as the company moves forward. Rafarma is also excited to implement its own stem cell activation therapy using Dr. Laskavys patented techniques throughout the spas. All of the acquisitions will take place under agreements that will not cause dilution to the current holdings of the existing shareholders of Rafarma.

Dr. Laskavy stated: I am very excited to be a part of the Rafarma Pharmaceuticals team and I look forward to the progress we can make treating those in need of help. Rafarma expects the addition of Dr. Laskavy and his expertise to greatly enhance its current medical marijuana treatment offerings as well as other ground-breaking treatments to help people live healthier and stronger lives.

Forward-Looking Statements: This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934. Except for historical matters contained herein, statements made in this press release are forward-looking statements. Without limiting the generality of the foregoing, words such as may, will, to, plan, expect, believe, anticipate, intend, could, would, estimate, or continue, or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements. Forward-looking statements involve known and unknown risk, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Also, forward-looking statements represent our managements beliefs and assumptions only as of the date hereof. Additional information regarding the factors that may cause actual results to differ materially from these forward-looking statements is available in the Company's filings with OTC Markets. Except as required by law, we assume no obligation to update these forward-looking statements publicly or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

For more information contact:RAFARMA(307) 429-2029

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Rafarma Establishes Advisory Board, Appoints First Member and Will Acquire Additional Patents and Intellectual Property - GlobeNewswire

Stem Cell And Platelet Rich Plasma (PRP) Alopecia Therapies Market Size, Growth Analysis, Opportunities, Trends, Developments and Forecast to 2026 -…

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The report provides an excellent overview of the key Stem Cell And Platelet Rich Plasma (PRP) Alopecia Therapies market segments, focusing on their CAGR, market size, market share and potential for future growth. The Stem Cell And Platelet Rich Plasma (PRP) Alopecia Therapies market is mainly divided by product type, application and region. Each segment in these categories is the subject of in-depth research to familiarize yourself with its growth prospects and key trends. The segment analysis is very important to identify the most important growth pockets of a global market. The report provides specific information on market growth and demand for various products and applications so that players can focus on profitable sectors of the Stem Cell And Platelet Rich Plasma (PRP) Alopecia Therapies market.

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Table of Content

1 Introduction of Stem Cell And Platelet Rich Plasma (PRP) Alopecia Therapies Market1.1 Overview of the Market1.2 Scope of Report1.3 Assumptions

2 Executive Summary

3 Research Methodology of Verified Market Research3.1 Data Mining3.2 Validation3.3 Primary Interviews3.4 List of Data Sources

4 Stem Cell And Platelet Rich Plasma (PRP) Alopecia Therapies Market Outlook4.1 Overview4.2 Market Dynamics4.2.1 Drivers4.2.2 Restraints4.2.3 Opportunities4.3 Porters Five Force Model4.4 Value Chain Analysis

5 Stem Cell And Platelet Rich Plasma (PRP) Alopecia Therapies Market, By Deployment Model5.1 Overview

6 Stem Cell And Platelet Rich Plasma (PRP) Alopecia Therapies Market, By Solution6.1 Overview

7 Stem Cell And Platelet Rich Plasma (PRP) Alopecia Therapies Market, By Vertical7.1 Overview

8 Stem Cell And Platelet Rich Plasma (PRP) Alopecia Therapies Market, By Geography8.1 Overview8.2 North America8.2.1 U.S.8.2.2 Canada8.2.3 Mexico8.3 Europe8.3.1 Germany8.3.2 U.K.8.3.3 France8.3.4 Rest of Europe8.4 Asia Pacific8.4.1 China8.4.2 Japan8.4.3 India8.4.4 Rest of Asia Pacific8.5 Rest of the World8.5.1 Latin America8.5.2 Middle East

9 Stem Cell And Platelet Rich Plasma (PRP) Alopecia Therapies Market Competitive Landscape9.1 Overview9.2 Company Market Ranking9.3 Key Development Strategies

10 Company Profiles10.1.1 Overview10.1.2 Financial Performance10.1.3 Product Outlook10.1.4 Key Developments

11 Appendix11.1 Related Research

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Fate Inks $100M Deal With Janssen for Stem Cell-Derived Cancer Therapies – Xconomy

XconomySan Diego

Fate Therapeutics has signed an agreement with Janssen Biotech to develop new cancer cell therapies that are derived from stem cells and landed $100 million up front as part of the global collaboration deal.

The San Diego-based biotech has built a pipeline of experimental cell therapies that use induced pluripotent stem cells (iPSCs) to create chimeric antigen receptor (CAR) T-cell and CAR natural killer (NK) cell treatments. Fate (NASDAQ: FATE) has used iPSCs to make clonal cell lines that it likens to the cell lines used to create make monoclonal antibodies and other drugs.

Sourcing material for cell therapies this way is meant to reduce the manufacturing challenges associated with currently available cell therapy products. The two FDA-approved cell therapies, CAR-Ts, use a patients own living cells. Off-the-shelf versions in development, which use cells from healthy donors, face similar obstacles when it comes to cost-effective mass production, including variability between batches.

Janssen will provide Fate with proprietary antigen-binding domains for up to four targets associated with antigens that are overexpressed on tumors. Fate will use them to research and develop new preclinical iPSC-derived cell therapy candidates, both CAR-T-cell and CAR NK cell product candidates. Janssen will reimburse Fate for that R&D work.

Once a candidate is submitted to the FDA for permission to move into the clinic, Janssen will have the option to exclusively license it.

SVB Leerink analyst Daina Graybosch, in a research note, called the deal a major validation of Fates regenerative medicine platforms. The agreement also removes near-term cash concerns for Fate at a time when clinical research across the biotech industry is being delayed by COVID-19 disruptions, she wrote.

Under the deal terms, Fate gets $50 million in cash and $50 million from a sale of newly issued shares of its stock to Janssen parent company Johnson & Johnson (NYSE: JNJ) at $31 per share, a 47 percent premium over Fates closing price Thursday of $21.07 apiece.

The deal makes Fate eligible for payments of up to $1.8 billion tied to development and regulatory milestones and up to $1.2 billion if candidates are commercialized, plus royalties. The company also retains the option to co-commercialize each collaboration candidate in the US.

Fates stock price popped about 9 percent on the news Friday, reaching nearly $23 per share as of market close.

Previous collaborations Fate has struck include a 2018 deal with Japans Ono Pharmaceutical for joint development and commercialization of two off-the-shelf iPSC-derived CAR-Ts, and a four-year deal to help Juno Therapeutics (now part of Bristol Myers Squibb) find small molecules to enhance its T-cell immunotherapies, an agreement that concluded last year.

Fate, which launched in 2007, has four of its own iPSC-derived cell therapies in Phase 1 testing: two targeting blood cancers and two designed to treat advanced solid tumors.

The company also has three iPSC programs in preclinical testing, and two in research. Two of the preclinical programs are on track to be submitted to the FDA for its OK to move into the clinic in the second quarter of this year, Fate said.

In addition, the biotech has developed off-the-shelf cell therapies not derived from iPSCs that use NK cells from healthy donors modified to improve their biological properties and therapeutic function, but according to the companys latest annual report, it doesnt plan to further develop those therapies.

Since its initial public offering in 2013, the company has raised about $363 million across three stock sales, the most recent in September 2019.

Image: iStock/seb_ra

Sarah de Crescenzo is an Xconomy editor based in San Diego. You can reach her at sdecrescenzo@xconomy.com.

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Fate Inks $100M Deal With Janssen for Stem Cell-Derived Cancer Therapies - Xconomy