Biopharma Update on the Novel Coronavirus: May 4

CV Update_ May 4

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FDA Actions

Remdesivir: The FDA issued an EUA for remdesivir. The EUA allows for remdesivir to be distributed in the U.S. to treat suspected or laboratory-confirmed COVID-19 patients who are hospitalized with severe disease.

Convalescent Plasma: The FDA updated guidance on convalescent plasma to provide clarification for investigators on how to submit investigational applications for COVID-19.

EUA: The FDA issued an EUA to Fresenius Medical Care for emergency use of the multiFiltrate PRO System and multiBic/multiPlus Solutions which is a type of dialysis therapy used to filter and clean the blood when the kidneys are damaged or are not functioning normally.

Diagnostics Update: The FDA has worked with more than 380 test developers who plan to submit EUA requests to detect COVID-19. Also, 54 individual EUAs have been issued. In addition, 23 authorized tests have been added to the EUA letter of authorization for high complexity molecular-based laboratory developed tests (LDTs). The FDA has been notified that more than 235 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.



The U.S. Food and Drug Administration (FDA) green-lit Roche’s new Elecsys Anti-SARS-CoV-2 antibody test that will help determine whether or not people have been infected by the novel coronavirus that has swept across the globe and developed antibodies to the disease.

The Dark Report produced a lengthy article on how clinical diagnostic labs are on the brink of financial collapse as cash flow crashed from lack of lab testing in the early part of the pandemic, which can cause potential issues for scaling up for COVID-19 testing. The Dark Report, which focuses on the clinical diagnostic industry, found that U.S. clinical labs saw a drop of routine specimens between 50% and 60% in March, with the industry losing $800 to $900 million weekly.


Testing Therapies, Antivirals and Vaccines

President Trump’s Operation Warp Speed has a goal of making 100 million doses of a vaccine against COVID-19 available by November, 200 million by December and 300 million by January 2021. This aggressive and perhaps overly optimistic target has winnowed a possible 93 vaccine programs to 14 top candidates, which they expect will be further narrowed to six or eight.

As researchers and physicians try to identify ways to effectively treat and prevent COVID-19, the disease caused by the novel coronavirus SARS-CoV-2, some are studying whether high-dose intravenous immunoglobulin (IVIg) could work. IVIg is a common blood plasma product that is used to treat other immune disorders.

Eli Lilly and Junshi Biosciences announced they have entered into a partnership to develop therapeutic antibodies for the potential prevention and treatment of COVID-19. Junshi has engineered multiple neutralizing antibodies and the lead candidate has the potential to enter clinical testing in the second quarter of 2020.

Combioxin SA received positive feedback from the FDA on its pre-IND application for use of CAL02 in COVID-19 patients at high risk of secondary bacterial infections. Secondary bacterial infections have been observed in a substantial number of critically ill COVID-19 patients and represent a leading cause of death. Co-infections also extend further the duration of intensive care management.

Vir Biotechnology and Alnylam Pharmaceuticals selected a development candidate for VIR-2703, an investigational RNAi therapeutic targeting the SARS-CoV-2 genome. The companies plan to meet with the FDA and other regulatory authorities to discuss a potential accelerated path for filing an Investigational New Drug application near the end of the year. The companies plan to advance VIR-2703 as an inhalational formulation for the potential treatment and/or prevention of COVID-19.

CytoDyn reported that it expects to complete enrollment for its 75-patient, Phase II trial of leronlimab for COVID-19. The FDA has approved 54 emergency INDs for leronlimab treatment of COVID-19, and the company has requested compassionate use authorization from the FDA for COVID-19 patients not eligible for participation in two ongoing U.S. clinical trials.


Company Actions

As reported by The Hill, the CEO of Gilead Sciences, Daniel O’Day, said that remdesivir will be sent to those COVID-19 patients most in need this week.

Arcturus Therapeutics and Catalent partnered to support the manufacture of Archturus’s COVID-19 mRNA vaccine candidate (LUNAR-COV19). The project uses Archturus’s self-transcribing and replicating mRNA (STARR) technology and its LUNAR lipid-mediated delivery to produce low dose, potentially single shot COVID-19 vaccine. They will use Catalent’s drug manufacturing facility in Madison, Wisconsin, to support human clinical trials, and if successful, commercialization of the vaccine.


Other Industry News

Biotech Professionals Express Fears…and Hope, During Pandemic: While the biopharmaceutical industry is working frantically to develop the tests, vaccines and therapeutics to combat COVID-19, the people doing the work are pushing their fears to one side. But, when asked, they admit to concerns. Not surprisingly, they mirror the fears shared by much of the world.

BioSig Technologies submitted an article to an online peer-reviewed journal that highlights pre-clinical data regarding the combination of Gilead Sciences’ remdesivir and merimepodib, a broad-spectrum antiviral candidate, as a potential combination treatment for COVID-19. In in vitro studies, the combination treatment reduced the virus to undetectable levels in humans.

Ireland’s Alkermes plc announced it is accepting applications for its newly-established COVID-19 Relief Fund, a special edition of the company's signature Alkermes Inspiration Grants program. The company will provide up to $500,000 in grants to assist nonprofit organizations in their work to address COVID-19-related needs for people living with addiction, serious mental illness, or cancer. The application period runs through May 20.

As reported by the Wall Street Journal, the Trump administration made assertions that the coronavirus originated in a Wuhan lab. On Sunday, U.S. Secretary of State Mike Pompeo said he has seen, “enormous evidence” that COVID-19 came from a lab.

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