Canadian Company STEMCELL Technologies Is an Essential Industry Partner for COVID-19 Research and Vaccine Development – Business Wire

VANCOUVER, British Columbia--(BUSINESS WIRE)--Products made by Vancouvers STEMCELL Technologies are now being used in over 30 COVID-19 studies worldwide. These studies are focusing on areas ranging from diagnostics and treatments to vaccine development and future prevention. STEMCELL is playing a crucial role in COVID-19 research by providing cutting-edge laboratory tools and reagents as well as through close collaborations with scientists. This will ultimately accelerate the pace of discovery and hopefully lead to a rapid resolution to the global pandemic.

At STEMCELL, we have a team of world-class scientists who have dedicated their careers to developing superior cell culture and cell isolation systems required to study devastating diseases, said Dr. Allen Eaves, STEMCELLs Founder, President, and CEO. It is always incredibly rewarding to see their hard work and expertise put to use. Every day were learning about new ways our customers are using our products to research solutions for the COVID-19 pandemic, and were actively working to support these researchers in any way we can.

STEMCELL is the global industry expert in developing systems for culturing human organoids, which are three-dimensional clusters of cells that closely resemble the biology of human organs. STEMCELL has partnered with an international team including Dr. Josef Penninger at the University of British Columbia, along with Nuria Montserrat in Spain, Drs. Haibo Zhang and Art Slutsky from Toronto, and Ali Mirazimis infectious biology team in Sweden. The group used STEMCELLs organoid systems in a study that examined how SARS-CoV-2 infects patients. Their findings, recently published in the top scientific journal Cell, provide insight into a potential treatment capable of stopping early infection of the novel coronavirus.

Human organoids enable us to better understand the pathology of this disease and to rapidly reach a therapeutic breakthrough. This work stems from an amazing collaboration among academic researchers and companies, including Dr. Ryan Conders gastrointestinal group at STEMCELL Technologies, who have all been working tirelessly day and night for weeks, said Dr. Penninger.

Life science researchers and clinical labs also depend on STEMCELLs specialized cell isolation tools and instruments to extract the white blood cells responsible for immune responses from blood samples. Dr. James Crowe at the Vanderbilt Vaccine Center in Nashville, Tennessee is using a custom version of STEMCELLs EasySep system to isolate specific immune cells from the blood of COVID-19 survivors. Their goal is to rapidly develop antibody treatments and vaccines. This research group has used the same system to identify potential treatments for other viruses, including Ebola, chikungunya, HIV, dengue, norovirus, and respiratory syncytial virus.

STEMCELL listened to us when we came to them asking for custom tools to isolate the specific immune cells were working with from COVID-19 patients, said Dr. Crowe. We were able to integrate the new products and protocols into our research. In turn, we hand information about these products back to STEMCELL so that they can make it available to other labs. Its been a productive collaboration.

STEMCELL recently reported that researchers at Chinas Centre for Disease Control (CDC) successfully used STEMCELLs lung cell culture product, PneumaCultTM, to grow human lung airway cells and quickly obtain the viruss gene sequence, drastically shortening the path to vaccine development. Additionally, an international team including long-time STEMCELL collaborator Dr. Franois Jean at the University of British Columbia, an expert in antiviral drug discovery and emerging human viruses, is using STEMCELLs lung tissue culture system in a recently-funded study to develop and evaluate candidate therapeutics for COVID-19.

Solving medical challenges requires experts in science and medicine to work together with efficiency and accuracy, says Dr. Eaves. STEMCELL is proud to be a crucial component of this network by providing innovative tools, services, and expertise needed by our colleagues in research labs and clinical settings globally.

In addition to supporting rapid and groundbreaking developments for COVID-19 research, STEMCELLs products have been used successfully to study many other devastating viruses. This includes the use of PneumaCult to study respiratory viruses such as various coronaviruses, parvovirus, rhinovirus, respiratory syncytial virus, and influenza. Scientists have also successfully modeled microcephaly caused by Zika virus and cytomegalovirus using STEMCELLs BrainPhys and other products for neuroscience research. Similarly, STEMCELLs IntestiCult was used to study viruses targeting the intestinal system, including enteric coronavirus and norovirus. Finally, STEMCELLs EasySep reagents and RoboSep instrument have been central to studies of the immune response to viruses including HIV, Ebola, and dengue viruses.

About STEMCELL Technologies

STEMCELL Technologies is Canadas largest biotechnology company, with over 1,500 employees and year-on-year growth of approximately 20% for the last 26 years. Based in Vancouver, STEMCELL supports life sciences research around the world with more than 2,500 specialized reagents, tools, and services. STEMCELL offers high-quality cell culture media, cell separation technologies, instruments, accessory products, and educational resources that are used by scientists advancing the stem cell, immunology, cancer, regenerative medicine, microbiology, and cellular therapy fields. Find more information at http://www.stemcell.com.

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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.

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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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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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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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YOUR HEALTH: Something fishy to help improve eyesight – WQAD.com

Macular degeneration is the leading cause of vision loss for adults over the age of 60

NASHVILLE, Tenn Age-related loss of eyesight affects 11 million people in the United States and that number is expected to nearly double by 2050.

But tiny zebrafish may help improve that outlook.

ish might be tiny, but they come with some supersized powers.

"Zebrafish, unlike mammals, are able to regenerate parts of their retina if they become injured," explained David Calkins, director of the Vanderbilt University Vision Research Center.

Researchers from Vanderbilt University Medical Centerare studying how this characteristic of zebrafish can help humans dealing with age-related vision loss due to damage to the retina.

"The cells that make up the retina between the fish and the human eye are very, very similar," said James Patton, a Vanderbilt Biological Sciences professor.

Except for one cell called MG for Muller Glia.

In a zebrafish, when that cell is damaged it will activate and then regenerate.

"So the fish will go from blind to about two-and-a-half weeks later, total regain of eyesight," Patton added.

Humans have the same Muller Glia cell but are incapable of regeneration like the zebrafish.

But Patton said he is trying to find out if suppressing a certain type of micro-RNA in humans could activate Muller Glia the same way it does in zebrafish.

There is a treatment where stem cells are injected into the back of the eye to see if those stem cells will integrate into the retina and then replace lost cell types.

A stem cell that's already a resident cell in the retina is used to replace all the rest of the lost cells

This is similar to the method that the Muller Glia cell naturally does in the zebrafish.

Right now, theeconomic burden for eye disordersand vision loss sits at $35 billion.

"If there were ways to keep people seeing and overcome degenerative disorders, that would have a huge economic impact, not to mention quality of life," said Patton.

Before human testing, they will have to test on smaller mammals, such as mice and see if they can suppress a particular mirco-RNA that regulates the Muller Glia cell.

If this story has impacted your life or prompted you or someone you know to seek or change treatments, please let us know by contacting Jim Mertens atjim.mertens@wqad.comor Marjorie Bekaert Thomas atmthomas@ivanhoe.com.

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YOUR HEALTH: Something fishy to help improve eyesight - WQAD.com

First Two Patients Enrolled in Randomized Phase 2, COVID-19 Trial with Leronlimab; Five More Severely Ill COVID-19 Patients Treated Under Emergency…

VANCOUVER, Washington, April 06, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that the first two COVID-19 patients have been treated with leronlimab under the Companys Phase 2 randomized clinical trial, which is for patients with mild-to-moderate indications. The Company anticipates that enrollment of more patients will accelerate this week at multiple clinical sites.

In addition, the Companys investigational new drug, leronlimab, has now been administered to 15 severely ill COVID-19 patients at four hospitals, 10 patients treated at a leading medical center in the New York City area and five patients at three other hospitals, all under an emergency investigational new drug (EIND), which were granted by the U.S. Food and Drug Administration (FDA) for each individual patient.

CytoDyn also anticipates initiating its other COVID-19 trial this week. This trial is a Phase 2b/3 for severely ill COVID-19 patients and is for 342 patients, double-blinded with a 2:1 ratio (drug to placebo ratio). Patients enrolled in this trial are expected to be administered leronlimab for two weeks, with the primary endpoint being the mortality rate at 14 days. The Company will perform an interim analysis on the data from 50 patients following two weeks of leronlimab therapy.

Bruce Patterson, M.D., Chief Executive Officer and founder of IncellDx, a diagnostic partner and advisor to CytoDyn, commented, We are encouraged by the positive results demonstrated with leronlimab in the New York patients. Our team is working hard to distribute leronlimab to multiple clinical sites to initiate therapy in patients with severe COVID-19 disease. While every patient is experiencing different comorbidities, we are seeing similar clinical responses, which we believe is a reflection of leronlimabs mechanism of action.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, said, Our partnership with the New York medical team and now other hospitals has been exemplary. We are collaborating in every aspect to deliver leronlimab to patients in order to provide proof of concept as soon as possible. The outstanding coordination among the physicians, the hospital administrators, the FDA, and our team, will hopefully help mitigate the deleterious effects from this pandemic should we prove leronlimab as a solution. The lead physician in New York is a true medical hero, who deserves to be recognized for his contribution to humanity in the pandemic of COVID-19. We are very hopeful of sending the day three and day seven results of the first ten EIND patients to the FDA by the end of this week.

About Coronavirus Disease 2019SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

About Leronlimab (PRO 140) The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

About CytoDyn CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in April of 2020 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at http://www.cytodyn.com.

Forward-Looking Statements This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. The Companys forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Companys cash position, (ii) the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv) the Companys ability to enter into partnership or licensing arrangements with third parties, (v) the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Companys ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Companys clinical trials, (viii) the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTSInvestors: Dave Gentry, CEO RedChip Companies Office: 1.800.RED.CHIP (733.2447) Cell: 407.491.4498 dave@redchip.com

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First Two Patients Enrolled in Randomized Phase 2, COVID-19 Trial with Leronlimab; Five More Severely Ill COVID-19 Patients Treated Under Emergency...

Yiviva Announces Dosing of First Patient in Phase 2b Study of First-Line YIV-906 Plus Sorafenib Combination Therapy in the Treatment of Hepatocellular…

- First-in-class oncology therapeutic candidate YIV-906 applies an integrative systems biology approach -- Global study to evaluate efficacy, safety, and quality of life in patients with hepatitis B-positive hepatocellular carcinoma -

NEW YORK and SHANGHAI, China, April 06, 2020 (GLOBE NEWSWIRE) -- Yiviva today announced that the first patient has been dosed in a Phase 2b study of YIV-906 in combination with sorafenib in the treatment of patients with hepatitis B-positive hepatocellular carcinoma (HCC). YIV-906 is a novel, proprietary therapeutic candidate based on molecular profiling of extracts identified from use in traditional botanical medicine. YIV-906 has demonstrated that it can potentiate the anti-tumor activity of sorafenib, enhance innate and adaptive immune function in the tumor microenvironment, protect cells of the gastrointestinal tract by reducing inflammation mediated by IL-6, NF-kappaB, COX2, iNOS, and accelerate regeneration of damaged gastrointestinal tissue by promoting progenitor and stem cell growth via the Wnt signaling pathway.

Patients and providers are eager to have evidence-based systemic treatment options for cancer, such as YIV-906, commented Edward Chu, M.D., Chief of the Division of Hematology and Oncology, Deputy Director at the UPMC Hillman Cancer Center, University of Pittsburgh School of Medicine and senior advisor to Yiviva. YIV-906 applies a novel systems biology approach that has been shown in preclinical and preliminary clinical studies to enhance immune function in the tumor microenvironment and protect gastrointestinal tissue. Observations of the effects of YIV-906 in proof of concept clinical studies provide a compelling rationale for conducting this large global study in the first-line treatment setting. In addition, patients with hepatitis B-positive HCC represent a population with particularly limited treatment options where the YIV-906 approach could have a particularly significant impact on care.

The development of YIV-906 is a state-of-the-art approach using modern science, bioinformatics, and current GMP manufacturing to develop a precisely engineered botanical medicine, commented Yun Yen, M.D., Ph.D., Co-Global PI Coordinator of the YIV-906 study and former President of Taipei Medical University. The components of YIV-906 have been selected for their expected effects across multiple targets when administered as a complex mixture in combination. Given the major need for better treatments for patients with liver cancer, and the safety and efficacy profile of YIV-906 as seen to date, we look forward to the results of this global study. This could lead to new therapeutic strategies to treat cancer patients holistically.

The randomized, placebo-controlled Phase 2b study of YIV-906 is evaluating efficacy, safety, and quality of life in patients with hepatitis B-positive HCC. The clinical study is designed to enroll approximately 125 patients at 20 sites in the U.S., mainland China, Hong Kong, and Taiwan, including Memorial Sloan Kettering Cancer Center, Taipei Medical University, Queen Mary Hospital in Hong Kong and the China National Cancer Center in Beijing. Patients will be randomized 2:1 to either the study arm (YIV-906 plus sorafenib) or control arm (placebo plus sorafenib). The primary endpoint of the study is an evaluation of progression free survival. Secondary endpoints include safety and quality of life assessments and additional measures of clinical efficacy, including time to progression, overall survival, objective response rate and disease control rate. Change of quality of life will be assessed according to HCC18 and EORTC QLQ-C30 assessments. Additional information is available at https://clinicaltrials.gov/ct2/show/NCT04000737.

About YIV-906

YIV-906 (also PHY906 or KD018) is a therapeutic candidate comprised of a proprietary cGMP botanical extract of four herbs inspired by a traditional Chinese medicine formulation used for over a millennium. YIV-906 has the potential to be developed as a platform oncology therapeutic when administered in combination with chemotherapy, immunotherapy and radiation therapies, in multiple cancer indications. YIV-906 has been shown to enhance immune function in the tumor microenvironment (by polarizing M1 macrophages and activating T cells), protect the gastrointestinal tract (by inhibiting inflammation via IL-6, NF-kappa-B, COX2, and iNOS pathways) and promote intestinal tissue repair (by increasing activity and expression of components of the Wnt signaling pathway). YIV-906 has been observed to enhance the anti-tumor activity of sorafenib in preclinical models of hepatocellular carcinoma and has shown promise in preliminary clinical studies in liver, pancreatic, colorectal and rectal cancers. YIV-906 has been granted Orphan Drug designations from the U.S. Food and Drug Administration (FDA) for development of YIV-906 in the treatment of hepatocellular carcinoma and pancreatic cancer. Yiviva holds worldwide intellectual property for YIV-906 including 32 patents related to methods of use, manufacturing and quality control. YIV-906 is being developed for approval under the U.S. FDA Botanical Drug regulatory pathway.

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About Yiviva

Yiviva is a clinical stage biotechnology company developing multi-target botanical therapeutics using a systems biology approach, focused on cancer, inflammatory and chronic diseases. The Yiviva STAR (signal transduction, activity and response) discovery platform accelerates the identification of botanical therapeutics that influence immune function, inflammatory responses, cell growth and metabolic functions and hormone activity. Yiviva applies patented, mechanism-based quality control linked to biological activity to satisfy established regulatory requirements for complex products. The company was launched with Yale University as a co-founder and co-founders include Yung-Chi Cheng, Ph.D., with teams in New York, New Haven, Connecticut and Shanghai. For further information, please visit https://yiviva.com.

Contact:Tel: +1 646-883-3906Email: hello@yiviva.com

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Yiviva Announces Dosing of First Patient in Phase 2b Study of First-Line YIV-906 Plus Sorafenib Combination Therapy in the Treatment of Hepatocellular...

Coronavirus Business Tracker: How The Private Sector Is Fighting The COVID-19 Pandemic – Forbes

Alain Mrieux, founder of BioMrieux.

Latest update: April 6, 2020, at 5:46 pm ET.

Businesses around the world are shifting into overdrive to help battle the coronavirus, providing everything from rubber gloves and ventilators to diagnostic tools and, hopefully soon, vaccines. While the pandemic continues to wreak havoc, large corporations and small businesses are developing creative solutions to halt the spread of the virus.

Just as automakers famously shifted to make tanks and planes during World War II, todays global giants LVMH, Ford and GE to name a few are retooling their production lines to help make everything from hand sanitizers to respirators. On the medical front, there are more than three dozen COVID-19 vaccines under development, a smart move considering that two out of every three vaccines for infectious diseases fail, according to a study by the Massachusetts Institute of Technology.

Forbes will continue to update this list of private companies and how they are stepping up to fight the COVID-19 pandemic:

Testing:

Abbott Laboratories: Abbott Park, Illinois healthcare firm obtained emergency FDA authorization for its 5-minute coronavirus testing kit on March 27, with plans to start manufacturing 50,000 kits a day.

Alphabet: Through its healthcare arm Verily, Googles parent company launched a website where users can find nearby testing sites in four California counties.

Jeff Bezos.

Amazon: Jeff Bezos retail behemoth invested $20 million in the Amazon Web Services Diagnostic Initiative, which aims to speed up delivery of COVID-19 tests to the market.

BioMrieux: French biotech company, founded by billionaire Alain Mrieux,received emergency FDA approval for its subsidiarys new testing kit, which cuts testing times for the virus down to 45 minutes.

Carbon: California-based 3D printing unicorn backed by Russian tech investor Yuri Milner will soon be distributing testing swabs and face shields to hospitals in the Bay Area.

Cellex: North Carolina biopharma firms antibody-based test for COVID-19 received emergency approval from the FDA.

Cepheid: Sunnyvale, California molecular diagnostics company gained emergency FDA authorization for its new 45-minute COVID-19 testing kit.

Copan Diagnostics: Family-owned company located at the heart of Italys hard-hit Lombardy region makes diagnostic swabs for testing, airlifting 500,000 swabs to the U.S.

DiaSorin: Italian biotech company owned by billionaire Gustavo Denegri obtained emergency authorization from the FDA for its new 60-minute testing kit for COVID-19.

Ipsum Diagnostics: Sandy Springs, Georgia diagnostic company gained emergency FDA authorization for its COVID-19 testing kit.

Mammoth Biosciences: South San Francisco-based biotech startup, founded by three 30 Under 30 alums, prototyped a rapid test by using the gene-editing tool Crispr to detect the disease.

Mesa Biotech: San Diego biotech business obtained FDA approval for its new 30-minute testing kit for COVID-19.

Puritan Medical Products: Maine-based diagnostic maker, one of the worlds largest makers of diagnostic swabs along with Italys Copan Diagnostics, is reportedly increasing production to make one million COVID-19 testing swabs a week.

QIAGEN: Hilden, Germany-based molecular diagnostics firm received emergency approval from the FDA for its new COVID-19 testing kit.

Siemens Healthineers: The German conglomerates healthcare unit received FDA clearance for its blood gas analyzer, which helps doctors monitor the conditions of critical COVID-19 patients in ICUs.

Treatments:

AbbVie: North Chicago-based, publicly traded pharma firm is collaborating with authorities in the EU, the U.S. and China on experimental use of its HIV drug lopinavir/ritonavir to treat COVID-19.

AIM Immunotech: Florida-based pharmaceutical company announced on March 9 it would begin experimental testing of its chronic fatigue syndrome drug rintatolimod as a treatment for COVID-19 in Japan, at the National Institute of Infectious Diseases and the University of Tokyo.

AlloVir: Houston-based cell and gene therapy company is collaborating with Baylor College of Medicine to discover and develop T-cell therapies to fight COVID-19.

Amgen: Thousand Oaks, California biotech outfit is working with Seattle-based Adaptive Technologies to develop antibody-based treatments for COVID-19.

Apeiron Biologics: Vienna-based biotech firm announced it would begin a trial of its immunotherapy treatment on 200 COVID-19 patients in Austria, Germany and Denmark.

Applied Therapeutics: New York-based biopharma outfit is conducting trials of its lung inflammation and cardiomyopathy drug, AT-001, on COVID-19 patients at several hospitals in New York City, including Mount Sinai.

Ascletis: Hangzhou, China pharmaceutical company announced results of clinical trials of its antiviral drug danoprevir on COVID-19 patients in China; the small-scale study found that danoprevir combined with ritonavir is safe and well tolerated in all patients.

Celltrion: South Korean healthcare firm is developing an antiviral treatment for COVID-19, with plans to start human trials in July; the company is also developing rapid self-testing kits that would provide results within fifteen to twenty minutes, expected by the summer.

Celularity: New Jersey-based therapeutics startup obtained FDA clearance to begin trials of a potential stem cell treatment against COVID-19.

Cocrystal Pharma: Bothell, Washington pharma outfit is developing antivirals to treat COVID-19 using patents it recently acquired from the Kansas State University Research Foundation.

CytoDyn: Vancouver, Washington biotech firm announced preliminary results from three days of testing its antiviral drug leronlimab on COVID-19 patients in New York; the company stated in a press release that test results from the first four patients suggests immunological benefit within three days following treatment with leronlimab.

Eli Lilly: Indianapolis pharma company is partnering with Vancouver-based biotech outfit AbCellera to develop antibody-based treatments for COVID-19.

Emergent BioSolutions: Maryland drugmaker is developing treatments derived from the antibodies found in the blood of people who tested positive for the disease.

EUSA Pharma: British pharmaceutical firm initiated trials of its siltuximab antibody treatment on COVID-19 patients at the Papa Giovanni XXIII hospital in Bergamo, Italy; the company released initial data on April 1 showing that one third of patients experienced clinical improvement with reduced need for oxygen support and a further 43% saw their disease stabilise.

Fujifilm: Tokyo-based conglomerates pharmaceutical arm, Fujifilm Toyama Chemical, recently started phase 3 clinical trials of its flu drug favipiravir on COVID-19 patients in Japan and is accelerating production.

Gilead: The Californian biotech giant initiated clinical trials in March for its antiviral drug remdesivir on patients in the U.S.

Grifols: Spanish pharmaceutical company is working with the FDA and the U.S. Department of Health and Human Services to develop a COVID-19 treatment using the blood plasma of former patients.

Harbour BioMed: Cambridge, Massachusetts biomedical firm announced a collaboration with New Yorks Mount Sinai Health System to develop new human antibodies to treat COVID-19.

Humanigen: Burlingame, California pharma company received emergency FDA approval for compassionate use of its antibody lenzilumab in COVID-19 patients.

I-Mab Biopharma: Shanghai-based biopharma outfit announced it would begin clinical trials of its TJM2 antibody treatment on COVID-19 patients in the United States, with plans to expand to other countries affected by the pandemic.

Innovation Pharmaceuticals: Wakefield, Massachusetts biopharma firm is researching the use of its drug brilacidin part of a category of investigational new drugs called defensin mimetics, which could have antimicrobial effects as both a treatment and a vaccine for COVID-19, in separate efforts with a major U.S. university and with the Department of Health and Human Services.

ISR Immune System Regulation: Swedish immunotherapy firms subsidiary, ISR HBV, is conducting toxicological studies to determine whether its Immunolid ISR50 treatment could be used against COVID-19.

Kamada: Israeli pharmaceutical company is working on an antibody-based treatment for COVID-19 using the blood plasma of patients who recovered from the disease.

Merck KGaA: Darmstadt, Germany-based pharma multinational donated a supply of its multiple sclerosis drug interferon beta-1a to the French National Institute of Health and Medical Research in Paris for clinical trials on COVID-19 patients. The companys North American life sciences arm, MilliporeSigma, is supplying several vaccine efforts with reagents and other essential raw products for vaccine development.

Mesoblast: Australian medical firm is working with authorities in the U.S., Australia, China and Europe to evaluate the use of its remestemcel-L drug to treat COVID-19.

Mylan: Pennsylvania-based pharmaceutical firm restarted production of hydroxychloroquine, a drug used to fight lupus, malaria and arthritis, at its West Virginia factory; the drug is being tested as a treatment for COVID-19 in human trials in New York.

Partner Therapeutics: Lexington, Massachusetts biotech startup began clinical trials of its bone marrow stimulant drug sargramostim on COVID-19 patients at University Hospital Ghent in Belgium.

PharmaMar: Spanish drugmaker is preparing to start clinical trials of its multiple myeloma drug plitidepsin to treat COVID-19 patients at several hospitals in Spain.

Pluristem Therapeutics: Haifa, Israel-based medical company is developing a cell-based therapy to treat COVID-19, announcing on March 30 it had dosed three Israeli patients under a compassionate use program, with plans to enroll more.

Leonard Schleifer.

Regeneron Pharmaceuticals: Westchester, New York biotech outfit, run by billionaires Leonard Schleifer and George Yancopoulos, is conducting clinical trials of its rheumatoid arthritis drug sarilumab, developed with French firm Sanofi, on patients in New York.

Roche: Swiss pharma titan, part-owned by billionaire Maja Oeri, is testing its arthritis drug tocilizumab to treat patients in China and received FDA approval to begin U.S. trials.

Roivant Sciences: Swiss pharma company is working with U.S. authorities to begin trials of its antibody treatment, gimsilumab, on COVID-19 patients.

Synairgen: Southampton, UK-based drugmaker began clinical trials of its SNG001 treatment on COVID-19 patients on March 31.

Takeda: Japanese medical firm is working on hyperimmune therapy using blood plasma from previously infected patients.

Teva Pharmaceuticals: Pharma multinational is ramping up production of hydroxychloroquine, which is being tested as a treatment for COVID-19 in human trials in New York.

Vir Biotechnology: The San Francisco-based firm is collaborating with Biogen and Chinese medical firm WuXi Biologics to manufacture antibodies that could treat the virus; on April 6, British pharma giant GlaxoSmithKline purchased a stake in the company for $250 million, with the goal of collaborating on treatments for COVID-19.

Vaccines:

AJ Vaccines: Danish vaccine developer is working on a COVID-19 vaccine that could hit the market in 2021.

Altimmune: The company is developing a novel intranasal vaccine for the coronavirus, making it one of three firms based in Gaithersburg, Maryland along with Emergent Biosolutions and Novavax thats working on treatments and vaccines for COVID-19.

Arcturus Therapeutics: San Diego-based vaccine maker is developing a COVID-19 vaccine with researchers at the Duke-National University of Singapore medical school in Singapore.

Biocad: Russian drug developer is researching a COVID-19 vaccine, with animal trials scheduled for late April.

Thomas and Andreas Struengmann.

BioNTech: German biotech firm backed by billionaire twins Thomas and Andreas Struengmann is working to develop a coronavirus vaccine in partnership with Pfizer and Fosun Pharma, chaired by billionaire Guo Guangchang.

CanSino Biologics: Tianjin, China-based pharma company isstarting clinical trials for its COVID-19 vaccine, using the vaccine technology deployed to develop the Ebola vaccine.

Codagenix: Melville, New York biotech firm is teaming up with the Serum Institute of India to develop a live-attenuated COVID-19 vaccine, which uses a live but weakened form of the virus.

Dietmar Hopp.

CureVac: German firm, funded by billionaire Dietmar Hopp and the Bill and Melinda Gates Foundation, received $87 million from the European Commission to scale up development of its coronavirus vaccine.

Dyadic: Jupiter, Florida company is collaborating with the Israel Institute for Biological Research on both treatment and a vaccine against COVID-19, using the firms gene expression platform.

Dynavax: Emeryville, California vaccine maker is working with the Coalition for Epidemic Preparedness Innovations (CEPI) and the University of Queensland to develop a COVID-19 vaccine.

EpiVax: Providence-based immunology firm is working with the University of Georgia and Miramar, Florida biotech outfit Generex on separate COVID-19 vaccine efforts.

ExpreS2ion: Danish biotech company received a grant of nearly $1 million from the European Union to develop a vaccine for COVID-19.

GeoVax: Atlanta-based medical company is collaborating with Wuhan-based BioVax to jointly produce a COVID-19 vaccine.

GlaxoSmithKline: British pharma titan is partnering with CEPI and Chengdu, China-based Clover Pharmaceuticals to use its pandemic vaccine adjuvant platform which boosts the immune response in patients receiving a shot to speed up development of COVID-19 vaccines; on April 6, the company purchased a stake in San Francisco-based Vir Biotechnology for $250 million, with the goal of collaborating on treatments for COVID-19.

Greffex: Houston-based genetic engineering firm is preparing to begin animal trials for its COVID-19 vaccine.

Heat Biologics: North Carolina biopharma company is developing a COVID-19 vaccine with the University of Miami.

iBio: Newark, Delaware biotech upstart is collaborating with Beijing-based CC-Pharming on the rapid development of a COVID-19 vaccine.

Inovio: Plymouth Meeting, Pennsylvania biotech business is the second company to start human trials of a COVID-19 vaccine, announcing on April 6 it would begin testing in Philadelphia and Kansas City; the company also received $11.9 million in funding from the Department of Defense to rapidly produce the vaccine.

Johnson & Johnson: The companys pharma unit, Janssen, will start manufacturing its vaccine developed with the Department of Health and Human Services this month, with human trials set to begin by September and a public rollout hoped for early 2021. The company and the federal government are investing more than $1 billion in the vaccine effort.

Medicago: Quebec City-based biotech company received more than $7 million from the Canadian and Quebec governments to fund development of its COVID-19 vaccine.

Moderna: Massachusetts biotech company, led by billionaire CEO Stphane Bancel, was the first tobegin human trials of its vaccine on March 16 in Seattle and could deploy it to health workers for emergency use by the fall.

Novavax: Maryland-based vaccine maker received $4 million in funding from CEPI to accelerate development of its vaccine candidates, with clinical trials expected in the late spring.

Sanofi: French medical firm is working with the federal government and Massachusetts-based Translate Bio to expedite its coronavirus vaccine, using technology previously used to develop one for SARS.

SK Group: South Korean conglomerates pharmaceutical arm, SK Bioscience, is conducting animal trials of its COVID-19 vaccine.

Sorrento Therapeutics: San Diego-based biotech firm is teaming up with Cambridge, MA gene therapy company SmartPharm Therapeutics to develop a gene-encoded COVID-19 vaccine; its also working with Chinese drugmaker Mabpharm on a fusion protein treatment for the disease.

Takis Biotech: Italian startup with just 25 employees is developing a vaccine with Stony Brook-based Applied DNA Sciences, with plans to begin human trials before the end of the year.

Themis Bioscience: Austrian biotech firm is part of a group, with the Institut Pasteur and the University of Pittsburgh, which received $4.9 million in initial funding from CEPI to build a COVID-19 vaccine modeled on the vaccine for measles.

Tonix Pharmaceuticals: New York-based pharma outfit is researching a potential COVID-19 vaccine based on the virus that causes horsepox.

Vaxart: San Francisco vaccine manufacturer Vaxart is working with Emergent Biosolutions to develop and manufacture an oral vaccine that can be taken as a tablet.

Vaxil: Israeli biotech startup began preclinical trials for its COVID-19 vaccine candidate.

VBI Vaccines: Massachusetts-based vaccine developer is collaborating with the National Research Council of Canada on a pan-coronavirus vaccine, which would target COVID-19 as well as SARS and Middle East respiratory syndrome, or MERS.

Protective Equipment And Sanitizer:

Anheuser-Busch InBev: The worlds largest beer company is making more than one million bottles of hand sanitizer from surplus alcohol at its breweries around the world.

Aria Designs: North Carolina furniture manufacturer received financing from CIT Group to procure millions of N95 surgical masks with its international suppliers.

Giorgio Armani.

Armani: Billionaire Giorgio Armanis luxury fashion brand converted all production at its Italian factories to manufacture single-use medical overalls on March 26.

Bacardi: The Bermuda-based spirits giant converted production at nine production facilities in Mexico, France, England, Italy, Scotland, Puerto Rico and the continental U.S. to make hand sanitizer.

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Coronavirus Business Tracker: How The Private Sector Is Fighting The COVID-19 Pandemic - Forbes

Treatment with CytoDyn’s Leronlimab Indicates Significant Trend Toward Immunological Restoration in Severely Ill COVID-19 Patients – Associated Press

VANCOUVER, Washington, April 02, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that the three-day effect of leronlimab in eight severely ill COVID-19 patients demonstrated a significant improvement in several important immunologic bio-markers. Patient test data reveals improvement in cytokines, IL-6, and a trend toward the normalization of the CD4/CD8 ratio.

The Companys investigational new drug, leronlimab, has been administered to 10 severely ill patients with COVID-19 at a leading medical center in the New York City area under an emergency IND recently granted by the FDA. The Company recently initiated enrollment in a Phase 2 trial for leronlimab treatment of COVID-19 patients with mild-to-moderate indications and under the same IND, is now proceeding with its second COVID-19 clinical, a Phase 2b/3 trial for the treatment of critically ill patients.

Bruce Patterson, M.D., Chief Executive Officer and founder of IncellDx, a diagnostic partner and advisor to CytoDyn, commented, We are very pleased with our most recent laboratory data for patients treated with leronlimab for COVID-19 infection. We continue to see increases in the profoundly decreased CD8 T-lymphocyte percentages by Day 3, normalization of CD4/CD8 ratios, and resolving cytokine production including reduced IL-6 correlating with patient improvement. The current data suggests a trend toward the restoration of immune function and mitigation of the cytokine storm. This is consistent with prior laboratory results in the first four patients treated for COVID-19 with leronlimab.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, said, As leronlimab continues to provide hope for many patients, our management team is focused to ensure we can distribute the drug across the country in a timely fashion. These results, although anecdotal, appear to be very promising. We are now initiating enrollment for two clinical trials, first trial is a Phase 2 for mild-to-moderate and second trial is a Phase 2b/3 for a severely ill population.

About Coronavirus Disease 2019SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

About Leronlimab (PRO 140) The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

About CytoDyn CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in April of 2020 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at http://www.cytodyn.com.

Forward-Looking Statements This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. The Companys forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Companys cash position, (ii) the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv) the Companys ability to enter into partnership or licensing arrangements with third parties, (v) the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Companys ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Companys clinical trials, (viii) the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTSInvestors: Dave Gentry, CEO RedChip Companies Office: 1.800.RED.CHIP (733.2447) Cell: 407.491.4498 dave@redchip.com

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Treatment with CytoDyn's Leronlimab Indicates Significant Trend Toward Immunological Restoration in Severely Ill COVID-19 Patients - Associated Press