Biopharma Update on the Novel Coronavirus: April 7
News information is not all-inclusive. Please check back for updates.
Infusion Pumps: The FDA issued guidance to help expand the availability of infusion pumps and accessories for health care professionals. This policy is intended to remain in effect only for the duration of the COVID-19 pandemic.
Diagnostics Update: The FDA has worked with more than 270 test developers who plan to submit EUA requests to detect COVID-19. Also, 28 EUAs have been issued. The FDA has been notified that more than 145 laboratories have begun testing under the policies set forth in its COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.
Former FDA Commissioner Scott Gottlieb indicated that COVID-19 will continue to disrupt daily life in the fall of this year unless an effective treatment is found. He is not the only one to warn of the likelihood of a seasonal return of COVID-19, but believes the same urgency being seen in vaccine development needs to apply to treatments.
Mesa Biotech will ship 10,000 of its Accula SARS-CoV-2 molecular rapid point of care diagnostic tests this week. The test provides diagnostic results in 30 minutes.
Psomagen is developing a COVID-19 diagnostic using its Mango imaging technology. Mango was originally developed to sensitively detect RNA molecules, which can help improve viral screening.
Testing Therapies, Antivirals and Vaccines
Inovio Pharmaceuticals will initiate a Phase I trial for INO-4800, its DNA vaccine candidate designed to prevent COVID-19 infection. The company will begin dosing healthy volunteers this week. The Phase 1 study of INO-4800 will enroll up to 40 healthy adult volunteers. Preclinical data have shown promising immune response results across multiple animal models. Additional preclinical trials, including challenge studies, will continue in parallel with the Phase 1 clinical trial.
Ridgeback Biotherapeutics, a company owned by Emory University, will begin clinical testing of a COVID-19 treatment. The company received clearance from the FDA to begin clinical trials of EIDD-2801, a highly potent ribonucleoside analog designed to prevent the replication of SARS-CoV-2, the virus that causes COVID-19.
Karyopharm Therapeutics will begin a clinical trial assessing low dose oral Xpovio (selinexor ), a multiple myeloma drug, in hospitalized patients with severe COVID-19. Xpovio is an oral, selective inhibitor of nuclear export (SINE) compound which blocks the cellular protein XPO1. In addition to its roles in cancer, XPO1 also facilitates the transport of several viral proteins from the nucleus of the host cell to the cytoplasm, and it amplifies the activities of pro-inflammatory transcription factors. SINE compounds have recently been identified as having the potential to interfere with key host protein interactions with SARS-CoV-2, the virus that causes COVID-19. SINE XPO1 inhibitors have demonstrated activity against over 20 different viruses, including the RNA viruses, influenza, respiratory syncytial virus (RSV) and other common causes of respiratory infection.
Leading Biosciences has developed a potential approach to treat COVID-19 patients suffering from acute respiratory distress syndrome (ARDS) and multiple organ dysfunction syndrome (MODS) using its investigational drug LB1148. Currently under development to treat organ dysfunction and reverse lethal complications of organ dysfunction associated with septic shock and major surgery, LB1148 is a novel oral liquid formulation designed to inhibit digestive enzyme activity and preserve gut integrity during intestinal distress. The company believes the mechanism of action of LB1148 may limit the viral load in patients with COVID-19 as the SARS-CoV-2 virus uses the ACE2 receptor, which is highly expressed in the lung and GI tract to infect epithelial cells of these organs. Recent work has shown that protease inhibitors may block the enzymatic activity required for COVID-19 infection through the ACE2 receptor.
The United States leads the world in biotech innovation, but does it also lead the world in the development of COVID-19 diagnostics, vaccines and therapeutics? Based upon the number of clinical trials listed with ClinicalTrials.gov, the answer, so far, is “no.” But, if the number of potential solutions in development are considered, “no” may become “yes.”
Alexion Pharmaceuticals is to launch a Phase II trial of Soliris in COVID-19, after a 10-patient proof-of-concept trial, which began 10 days ago.
Cytovia Therapeutics and Macromoltek are developing a dual-acting natural killer immunotherapy against COVID-19.
AstraZeneca and GlaxoSmithKline are collaborating with the University of Cambridge to develop high-throughput screening technology for COVID-19 testing. One of the primary goals is to find alternatives to the reagents currently used in testing that are in short supply.
London, UK-based Wellcome Trust, a research-charity, is working to raise $8 billion to battle COVID-19. The initiative is called the COVID-Zero, and the goal is to raise the funds by the end of April. It would be used to fill in the gaps seen in funding for vaccines, treatments and diagnostic testing.
CytoDyn is collaborating with the UK’s Department of Health to provide emergency access to leronlimab, the company’s investigational drug for COVID-19. They are working to set up clinical trial sites in the UK. The FDA recently cleared CytoDyn to launch a Phase IIb/III trial of the drug in severe and critically ill COVID-19 patients.
Other Industry News
While the world is working to slow the COVID-1 pandemic by social isolation and quarantine, numerous companies globally are working to develop a vaccine against the virus. Despite some overly optimistic pronouncements by some politicians, the most likely timelines—at best—for a viable vaccine against SARS-CoV-2, the coronavirus causing COVID-1, are 12 to 18 months. And that’s if everything goes right.
Disgraced pharma executive Martin Shkreli is pleading to be temporarily let out of prison in order to join in the fight against COVID-19, the disease that has swept across the globe infecting more than 1.3 million people across the globe.
A CDC report confirms initial reports from China that COVID-19 is less severe in pediatric patients than adults. The report shows that children with the disease are less likely than adults to experience fever, cough or shortness of breath. The CDC findings were based on an analysis of 2,572 known juvenile cases of COVID-19 that were part of a batch of 149,760 laboratory-confirmed COVID-19 cases.
Cancer Research U.K. reported that many laboratories and researchers who typically aim their talents at cancer treatments have repurposed their lives and careers to halt the progression of COVID-19. The groups have donated equipment and reagents to national COVID-19 testing and have set up their own testing hubs across the U.K. But, as a result of this repurposing and the impact of social distancing requirements for safety, Cancer Research U.K. is predicting a financial toll on its work. The organization funds about 50% of all cancer research in the United Kingdom. As a result, the group is reducing its funding by 5% to 10% and also reducing infrastructure funding by 20%.
The BIO International Convention, like numerous other conferences and conventions, is moving to a virtual format for its June 8-12 convention, which they are dubbing BIO Digital 2020. They are offering a variety of offerings—it is, after all, one of the largest industry gatherings in the world—including Virtual BIO One-on-One Partnering, Online Education, and On-Demand Company Presentations.
The Organization notes: “Nothing Stops Innovation. We’ll get beyond this health crisis together. Developing treatments and solutions to the world’s most urgent challenges and complicated problems is what we do.”