Biopharma Update on the Novel Coronavirus: April 8

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

FDA Actions

Serological Tests: Serological tests can help with the COVID-19 fight by helping health care professionals identify individuals who have overcome an infection. To date, the FDA has authorized one EUA for a serological test that is intended for use by clinical laboratories.

Ophthalmic Assessment: The FDA issued guidance for remote ophthalmic assessment and monitoring devices. This can help facilitate patient care while reducing contact and exposure to COVID-19.

Extracorporeal Membrane Oxygenation (ECMO) and Cardiopulmonary Bypass Devices: The FDA issued guidance to help expand the availability of devices used in ECMO therapy. 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, 30 EUAs have been issued. The FDA has been notified that more than 150 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

Abbott Laboratories’ five-minute rapid coronavirus testing kit is being widely-used at the White House. The point-of-care test, approved last month under Emergency Use Authorization, is being used to test visitors to the White House. All visitors meeting with President Donald Trump, Vice President Mike Pence or other staff members are required to take the test before meetings, the Washington Post reported.

PharmaCyte Biotech struck a licensing agreement with Hong Kong-based Hai Kang Life Corporation Limited for technology to develop COVID-19 diagnostic kits.

Tauriga Sciences and Aegea Biotechnologies partner to develop a rapid, multiplexed COVID-19 test. It will be PCR-based and measure the virus from nasal or other swabs using Aegea’s patented and clinically validated technologies, including Selector Technology. It can be run on most PCR-based instrument platforms.

Testing Therapies, Antivirals and Vaccines

CSL Behring/SAB Biotherapeutics: CSL Behring and SAB Biotherapeutics announced their partnership to fight COVID-19 with rapid development of SAB-185. SAB-185 is a COVID-19 therapeutic candidate and is currently on track for clinical evaluation by early summer.

George Yancopoulos, Regeneron Pharmaceuticals‘s chief scientific officer, told CBS that the industry, and world at large, will know within a few weeks of testing whether or not the company’s purified antibody treatment will work for COVID-19 patients. He said the company is eying early summer for the start of controlled testing and if successful, they “could be treating hundreds of thousands, if not millions of people.”

Italian plasma company Kedrion Biopharma has begun development of a plasma-derived therapy for treating the COVID-19 virus that could make it available to patients in as little as three to six months.

New Jersey-based Bellerophon Therapeutics submitted an Investigational New Drug Application to the FDA to study the INOpulse inhaled nitric oxide system (iNO) for the treatment of patients infected with COVID-19. INOpulse is the only therapy to deliver targeted nitric oxide by autonomously adjusting to the patient’s breathing pattern to ensure accurate and consistent drug delivery into the airways, the company said. The IND submission follows an agreement by the FDA to allow treatment with INOpulse for COVID-19 patients under an emergency expanded access program. To date, three COVID-19 patients have completed treatment with INOpulse, with several additional patients currently on the INOpulse therapy.

EpiVax and GAIA Vaccine Foundation (GVF) partnered to crowd-source funds for a project to accelerate a COVID-19 vaccine candidate (EPV-CoV19) into clinical trials in six months. They have also pledged to make a free license available to developing countries who qualify, in the context of the partnership. EPV-COV19 is a peptide-based, epitope-driven vaccine that can be quickly and safely manufactured in most countries.

The World Health Organization lists more than 40 research projects to develop a coronavirus vaccine, with two already in the clinic. They include: Moderna; Inovio Pharmaceuticals; CanSino Biological; Johnson & Johnson; Sanofi; Pfizer and BioNTech; CureVac; University of Queensland; ExpreS2ion Biotechnologies; GlaxoSmithKline and Vir Biotechnology; numerous others.

Cytel Inc. has launched an open-access global COVID-19 Clinical Trial Tracker to help facilitate greater collaboration between researchers, policymakers, clinicians, journalists, philanthropists, and other critical stakeholders who need to understand the complex dynamics of the global response to finding a solution to the COVID-19 outbreak.

Company Actions

Insulin makers Eli Lilly and Sanofi are offering different programs to provide low-cost insulin products to patients during the COVID-19 pandemic. The companies have options for those who have insurance, as well as for patients who do not have insurance.

AstraZeneca described its internal and partnering efforts to battle COVID-19, the disease caused by the novel coronavirus SARS-CoV-2.

M Squared Associates (M2): M2 is providing pro bono consulting to innovators and developers who may not be registered medical device manufacturers, but could help address shortages of supplies needed for diagnosis, treatment and prevention of COVID-19.

SynDaver Labs, a Tampa-based biotech, will begin to manufacture respirator masks that are in short supply in the pandemic. Additionally, the company will offer 3-D printing plans for free to those who want to use it. Their initial focus is on fulfilling orders for masks for law enforcement agencies and emergency service providers in Florida.

SwiftScale Biologics, a biomanufacturing company spun out of Cornell University, is hoping to quickly translate an antibody therapy against COVID-19 using glycoengineered bacteria. It believes it can scale up production 10 times faster than conventional methods. Centivax is planning to launch a Phase I/II trial in late July, with SwiftScale building capacity to produce 100,000 doses a month for 10 months if the trial is a success.

Predictive Technology Group received orders of 1 million units of its Assurance AB COVID-19 IgM/IgG Rapid Antibody Test from its distribution partner, Wellgistics.

Catalyst Pharmaceuticals partners with First Responders Children’s Foundation to support the COVID-19 Emergency Response Fund.

OraSure Technologies received $710,310 in funds from the federal government’s Biomedical Advanced Research and Development Authority (BARDA) to develop its at-home COVID-19 test that would use spit samples. The kit would be similar to at-home pregnancy tests.

Other Industry News

The fastest way to get a safe, effective vaccine for COVID-19 to physicians and patients is to build upon an existing vaccine with an already-established manufacturing and supply chain…or to revolutionize the manufacturing process.

Why some people get sick and Die from COVID-19 and others don’t, might be in the genes. COVID-19, the disease caused by the novel coronavirus SARS-CoV-2, affects different people differently. As has been broadly noted, about 85% of cases are mild, while others can become fatally ill. Although the fatality rate is highest in the elderly and immunocompromised, it also can kill the relatively young and healthy. Which is a somewhat unexpected aspect of the disease. As the pandemic progresses, researchers are attacking the virus from every angle and also learning more and more about how and why the virus affects who it does.

Medidata, now owned by Dassault Systemes, issued a report on how clinical trials are being hammered globally by the COVID-19 pandemic. They noted that from 4,599 clinical studies and 182,321 study sites, the year-on-year difference between March 2019 and March 2020 across all reported countries and targeted disease areas showed enrollment had dropped 65% on average. The hardest hit was the UK, down 80.1%, and the U.S. down 66.7%. Endocrine disorders were the hardest hit, down 80%, with cardiovascular, central nervous system and dermatology down around mid- to high-60%.

Certara Corporation launched the COVID-19 Pharmacology Resource Center to advance therapeutics for COVID-19. The center is an online resource that unites experts across the globe in accelerating efforts in the fight against COVID-19 by providing pharmacology simulation tools and a forum for scientific exchange. The center, funded by the Bill & Melinda Gates Foundation, is designed to aid scientists in determining the optimal dose of therapeutics that are being evaluated in COVID-19 clinical studies, such as hydroxychloroquine and lopinavir/ritonavir.

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.”