Biopharma Update on the Novel Coronavirus: April 6

News information is not all-inclusive. Please check back for updates.

FDA Actions

Coordination of National Effort to Develop Blood-Related Therapies: The FDA is leading a national effort to facilitate the development of two investigational blood-derived therapies. “Under President Trump’s leadership, the FDA is launching a new national effort to bring blood-related therapies for COVID-19 to market as fast as possible,” said HHS Secretary Alex Azar.

Respirators Approved Under Standards Used in Other Countries: The FDA posted information regarding respirators approved in other countries and if they can be used during the COVID-19 pandemic an its answer is yes.

New Animal Drug Development: The FDA issued guidance for sponsors conducting ongoing trials to support new animal drug development.

Diagnostics Update: The FDA has worked with more than 240 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 125 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.

Diagnostics

Eurofins: The Eurofins’ U.S. Clinical Diagnostics network will launch on April 6, an Antibody Test for hospital workers, first responders and patients. Testing will occur at Boston Heart Diagnostics, a Eurofins subsidiary.

Ortho Clinical Diagnostics: Ortho Clinical Diagnostics announced it will be launching a COVID-19 antibody test - the VITROS® Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack. Testing kits will be available in a few weeks.

Testing Therapies, Antivirals and Vaccines

Takeda and CSL Behring formed a new alliance, joined by Biotest, BPL, LFB and Octapharm to develop a potential plasma-serviced therapy for treating COVID-19. The alliance begins immediately.

GlaxoSmithKline: Following close on the heels of its vaccine development agreement with China’s Xiamen Innovax Biotech Co., Ltd., GlaxoSmithKline and Vir Biotechnology forged a research and development deal to develop treatments for COVID-19.

Hope Biosciences: Hope Biosciences announced the FDA has approved a Phase II clinical trial evaluating its autologous, adipose-derived mesenchymal stem cells to provide immune support against COVID-19.

Israel-based RedHill Biopharma dosed a COVID-19 patient with its proprietary investigational new drug, opaganib (Yeliva) under compassionate use in Israel. Additional patients are expected to be dosed in the coming days, the company said. Opaganib is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with anticancer, anti-viral and anti-inflammatory activities.

The U.S. Food and Drug Administration accepted Inovio Pharmaceuticals’ Investigational New Drug application for INO-4800, its DNA vaccine candidate designed to prevent COVID-19 infection, paving the way for Phase 1 clinical testing of INO-4800 in healthy volunteers beginning this week. The first dosing is planned for today. Preclinical results for the vaccine have been consistent with Innovio’s Phase I vaccine study for Middle East Respiratory Syndrome, also caused by a coronavirus, in which Inovio’s DNA vaccine was well tolerated and induced high levels of antibody responses in 95% of patients.

OncoSec Medical Inc. and Providence Cancer Institute teamed up on a Phase I vaccine candidate for COVID-19. The candidate, CORVax12, is designed to act as a prophylactic vaccine to prevent COVID-19. CORVax12 consists of OncoSec’s existing product candidate, TAVO (interleukin-12 plasmid), in combination with an immunogenic component of the SARS-CoV-2 virus recently developed by researchers at NIH’s National Institute of Allergy and Infectious Diseases and licensed to OncoSec on a non-exclusive basis.

Mateon Therapeutics delivered the requisite testing results to Golden Mountain Partners (GMP) confirming the applicability and potential use of OT-101, a TGF-beta antisense drug candidate, for COVID-19. It showed potent activity against both COVID-19 and SARS with a robust safety index of greater than 500.

CytoDyn announced that the first two COVID-19 patients have been treated with leronlimab under its Phase II clinical trial. It expects enrollment to accelerate this week. The drug has also been administered to 15 severely ill COVID-19 patients at four hospitals under emergency investigational new drug (EIND) approval.

OncoSec Medical announced that Providence Cancer Institute is beginning a first-in-human Phase I trial of OncoSec’s novel DNA-encodable investigational vaccine, CORVax12, to prevent COVID-19.

Izana Bioscience initiated a two-center compassionate use trial of namilumab (IZN-101) for patients with rapidly worsening COVID-19 in cooperation with the Humanitas Research Hospital and Humanitas University. It will take place in Bergamo and Milan, Italy. Namilumab is the company’s Phase III-ready monoclonal antibody against granulocyte-macrophage colony stimulating factor (GM-CSF) in development for rheumatoid arthritis and ankylosing spondylitis.

Akers Biosciences, Inc. and Prema Biotech obtained clones of all three coronavirus antigens, Spike (S), Envelope (E), and Membrane (M) that have been selected for their vaccine candidate. The clone development process has four primary steps including first, the design and synthesis of the genes; second, the selection of the right host; third, the insertion of the gene into the host; and fourth, the verification that the clone has the right gene, and all characteristics are correct.

Company Actions

Gilead Sciences: One of the promising experimental drugs being tested to treat COVID-19, the disease caused by the novel coronavirus SARS-Cov2-, is Gilead Sciences’ remdesivir. The company had decided to accelerate its production of the drug based on overwhelming demand and doesn’t plan to charge.

Pfizer: Pfizer and The Pfizer Foundation announced that it will commit $40 million in medical and charitable cash grants to help fight the COVID-19 pandemic in the U.S. and around the world.

Moderna, Inc. Chief Executive Officer Stephane Bancel has become a billionaire due to the company’s surging stock. Company stock has spiked nearly 5% as it continues to advance its mRNA vaccine treatment against COVID-19. Bancel owns approximately 9% of Moderna stock, according to Coinspeaker.

Other Industry News

The Trump administration invoked the Defense Production Act to force Texas and Colorado-based medical suppliers to sell their products to the federal government first, ahead of states, hospitals or foreign countries. This was for $137 million in medical supplies. The two companies are Colorado-based Marathon Medical Corp. and Texas-based Retractable Technologies, which makes retractable needles. The administration has also used the DPA “against” 3M for N95 masks.

Nufabrx has partnered with Bossong Medical and Manufacturing Solutions Center to produce a new line of reusable copper medical masks called TheraMasks. They are powered by CuTEC copper, a naturally antibacterial material.

BIG NEWS!

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.”