Biopharma Update on the Novel Coronavirus: April 20

CV Update_April 20

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FDA Actions

Public-Private Partnership: The FDA, the National Institutes of Health (NIH), the Foundation for the NIH and others have entered into a public-private partnership to accelerate the development of COVID-19 vaccine and treatment options. This partnership is called the Accelerating COVID-19 Therapeutics Interventions and Vaccines (ACTIV).

Temporary Injection: The FDA and FTC previously issued a warning letter to Genesis II Church of Health and Healing to stop distributing products that claimed to treat COVID-19. In response to the warning letter, Genesis made clear that they had no intention of taking corrective action. Therefore, a federal court has issued a temporary injunction against Genesis and four individuals associated with the entity.

Warning Letter: The FDA and FTC issued a warning letter to Nova Botanix LTD DBA CanaBD for selling fraudulent COVID-19 products and claiming to prevent or treat COVID-19.

Further Expansion of COVID-19 Testing Options: The FDA announced that spun synthetic swabs with samples from the front of the nose, could be used to test patients for COVID-19.

EUA for Extracorporeal Blood Purification (EBP): The FDA issued a EUA for EBP to ExThera Medical Corporation’s Seraph 100 Microbind Affinity Blood Filter to treat patients with confirmed COVID-19. Additional requirements for use are that the patients need to be over the age of 18, admitted to the ICU and confirmed or imminent respiratory failure.

Diagnostics Update: The FDA has worked with more than 320 test developers who plan to submit EUA requests to detect COVID-19. Also, 39 EUAs have been issued. The FDA has been notified that more than 190 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

U.K.-based Mologic will begin manufacturing its laboratory diagnostic test for COVID-19. The laboratory-based ELISA diagnostic test is expected to produce up to 46,000 results per day, potentially contributing a significant portion of the UK government’s planned 100,000 tests per day.

Vela Diagnostics has been awarded a $225,000 contract by the Biomedical Advanced Research and Development Authority (BARDA) to develop manual and automated tests to detect SARS-CoV-2, the virus that causes COVID-19. The ViroKey SARS-CoV-2 RT-PCR Test is a probe-based reverse transcription PCR test that detects the virus by targeting conserved regions of the SARS-CoV-2 genome.

 

Testing Therapies, Antivirals and Vaccines

Novartis: Swiss pharma giant Novartis will launch a Phase III trial assessing hydroxychloroquine for the treatment of hospitalized patients with COVID-19 disease. The trial will be conducted at more than a dozen sites across the United States.

SOM Biotech. SOM Biotech announced the in vitro validation of three COVID-19 drug candidates. The candidates inhibit the main protease of SARS-CoV-2 and clinical studies can be initiated immediately.

Cyclacel Pharmaceuticals, Inc. entered into an agreement with the University of Edinburgh to study fadraciclib (CYC065) and seliciclib (CYC202 or R-roscovitine), clinical-stage CDK2/9 inhibitors, as potential early treatments for the inflammatory response observed in patients with COVID-19 disease. Previously published research from The University of Edinburgh and other investigators have found that CDK inhibitors, including seliciclib, help resolve undesirable inflammation by promoting apoptosis of inflammatory neutrophils.

Karyopharm Therapeutics announced the dosing of the first patient in a randomized Phase II clinical study evaluating low dose oral Xpovio (selinexor) in hospitalized patients with severe COVID-19. Selinexor is an oral selective inhibitor of nuclear export (SINE) compound which blocks the cellular protein XPO1 which is involved in both the replication of SARS-CoV-2, the virus that causes COVID-19, and in the inflammatory response to the virus.

Moleculin Biotech: Moleculin announced it has entered into an agreement with ImQuest BioSciences. The agreement will expand in vitro and in vivo testing of Moleculin’s COVID-19 lead candidate, WP1122.

 

Company Actions

Wavelength Pharmaceuticals significantly expanded its production of active pharmaceutical ingredients (APIs) for drugs needed to manage respiratory critical care patients. The company indicates the demand for these products, including Midazolam, Cisatracurium, and Rocuronium have “skyrocketed as a result of the global coronavirus pandemic.”

 

Other Industry News

Traditional vaccine development and regulatory policies are changing in response to the current pandemic. Some of those approaches may become more common, expanding into other, non-pandemic-related areas in the future, according to experts speaking at a briefing hosted by The Commonwealth Fund and the Alliance for Health Policy on April 17.

The global healthcare sector has been subjected to an array of cyberattacks as it deals with the COVID-19 pandemic.  Among those agencies being attacked by hackers are the World Health Organization and the Department of Health and Human Services.

Psychologists and child life specialists at St. Jude Children's Research Hospital have developed a suite of tools available in multiple for utilization by parents and caregivers to help children better understand the current COVID-19 pandemic. The tools include a coloring book developed for children ages 5-9 and an activity book aimed at children ages 10-13.

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