Biopharma Update on the Novel Coronavirus: May 26

CV Update_May 26

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FDA Actions

Warning Letters: The FDA and FTC issued warning letters to Apollo Holding LLC and North Coast Biologics LLC for selling fraudulent COVID-19 products.

FAQs on Testing for COVID-19: The FDA updated questions and answers about at-home self-collection and what tests should no longer be distributed for COVID-19.

Diagnostics Update: The FDA has worked with more than 400 test developers who have submitted or plan to submit EUA requests to detect COVID-19. Also, 109 individual EUAs have been issued, which includes 96 molecular tests, 12 antibody tests and 1 antigen test.



With funding from CARB-X, HelixBind is developing a system that will assess COVID-19 patients for secondary bacterial infections, such as the kind seen among COVID patients in Wuhan, China. The HelixBind system includes a test menu targeting the large majority of bacterial and fungal microorganisms associated with sepsis. The platform provides results in about three hours. HelixBind’s test will enable clinicians to rapidly identify secondary infections in all patients, including those already on antimicrobials, and to track patient progress over time.

Todos Medical signed a cross-distribution agreement with L1 Systems, a wholly-owned subsidiary of Medigus, for the distribution of COVID-19 related products, including ventilators. Todos is making available to L1 its comprehensive suite of testing solutions, including best-in-class RNA extraction tools, RNA extraction reagents, qPCR reagents, Digital PCR reagents and US-validated SARS-CoV-2 rapid point-of-care antibody test kits.


Testing Therapies, Antivirals and Vaccines

Questions over the efficacy and safety of hydroxychloroquine continue to be raised following the World Health Organization’s decision to temporarily halt a study of the malaria drug as a potential treatment for COVID-19.

Two weeks after announcing it received $388 million from the Coalition for Epidemic Preparedness Innovations (CEPI) to advance its COVID-19 vaccine candidate, Novavax has enrolled and dosed its first patients in a Phase I/II study.

Merck has largely stayed out of the COVID-19 battle, but exploded into it with three major deals and collaborations today.

A preliminary report published in the New England Journal of Medicine found that Gilead’s remdesivir helps those COVID-19 patients on supplemental oxygen.

Algernon Pharmaceuticals submitted a New Drug Application to the FDA for a Phase IIb/III study of its re-purposed drug NP-120 (Ifenprodil) as a potential therapeutic treatment for patients with COVID-19. Ifenprodil is an NMDA receptor antagonist. The company believes NP-120 can reduce the infiltration of neutrophils and T-cells into the lungs where they can release glutamate and cytokines respectively. The latter can result in the highly problematic cytokine storm that contributes to the loss of lung function and ultimately death as has been reported in COVID-19 infected patients. 

Beyond Air received approval from Health Canada for use of its LungFit system for a study in hospitalized COVID-19 patients with severe ARDS. Part 1 will assess safety at 80 parts per million NO, and then, Part 2 will assess the safety and efficacy of 150 ppm NO.

Datatrak International inked a new partnership with Renibus Therapeutics for a COVID-19 clinical trial. Datatrak is a software-as-a-service (SaaS) and cloud-based technology company. Renibus has been fast-tracked by the FDA to launch a Phase II trial of RBT-9 in COVID-19 patients at high-risk of deteriorating health due to age or comorbid conditions.

China-based Junshi Biosciences announced the publication of research results from the Company’s efforts to generate therapeutic COVID-19 neutralizing antibodies. The company identified two specific human monoclonal antibodies isolated from a recovered COVID-19 patient, CA1 and CB6. While both antibodies demonstrated substantial neutralization activity in vitro against SARS-CoV-2, CB6 exhibited superior neutralizing activities, the company said. Junshi and partner Eli Lilly and Company intend to file an IND and initiate clinical trials in the U.S. and China in the second quarter of 2020.

BioAegis Therapeutics Inc. announced that the National Institute of Health (NIH) Clinical Center is measuring patient gelsolin levels as part of the NIAID Strategic Plan for COVID-19 Research. BioAegis’ lead product, recombinant human plasma gelsolin (rhu-pGSN), is based on this highly abundant circulating human protein. Gelsolin is a human protein that is abundant in healthy individuals and is a master regulator of inflammation. In the case of severe injury or infection, the body’s supply of gelsolin becomes depleted, which can lead to an overexuberant inflammatory response, organ damage and death, as seen in COVID-19.

Company Actions

Capricor Therapeutics is participating in the Maxim Group’s COVID-19 virtual conference on May 27. They will be on a panel called “Cell therapy for ARDS – When Remdesivir is not enough.”


Other Industry News

As reported by Bloomberg, Shi Zhengli, the deputy director of the Wuhan Institute of Virology, said viruses being discovered now are “just the tip of the iceberg” and scientists and governments need to be transparent and cooperative to fight epidemics.

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