Biopharma Update on the Novel Coronavirus: June 26

CV Update_June 26

News information is not all-inclusive and updates will now be published on Mondays, Wednesdays and Fridays. 


FDA Actions

Partnering with the European Union and Global Regulators: The FDA explains how it has long partnered with global organizations to leverage expertise and experience, and now as well for the response with the COVID-19 pandemic.

EUAs for Ventilators and Ventilator Accessories: The FDA’s list of EUAs has been updated adding the AustinP51 (resuscitator) to Appendix B of the ventilator EUA.

Diagnostics Update: To-date the FDA has authorized150 individual EUAs, which include 126 molecular tests, 23 antibody tests and 1 antigen test.


Testing Therapies, Antivirals and Vaccines

Vaxart, Inc. announced its oral COVID-19 vaccine was selected by Operation Warp Speed to participate in a non-human primate challenge study. The study will evaluate the efficacy of the oral COVID-19 vaccine.

Theravance Biopharma announced the first COVID-19 patient has been dosed in a Phase II study of TD-0903 which is a lung-selective, nebulized Janus kinase inhibitor (JAKi) testing to be used as a potential treatment for lung injury in COVID-19 patients.

EMD Serono announced the FDA has cleared its IND for M5049 in the treatment of patients with COVID-19. The company will initiate a Phase II clinical trial studying the safety and efficacy of M5049.

Extract from the medicinal plant Artemisia annua, may be a new potential treatment for COVID-19. Researchers at the Max Planck Institute of Colloids and Interfaces in collaboration with virologists at Freie Universität Berlin have shown the plan is active against SARS-CoV-2.

St. Andrews University is partnering with start-up ILC Therapeutics working to move into clinical trials of a therapeutic drug, Alfacyte, as a potential treatment for COVID-19.

NeuroRx and Relief Therapeutics were awarded FDA Fast Track Designation to investigate RLF-100 (Aviptadil) for acute lung injury/acute respiratory distress syn drome from COVID-19. RLF-100 is a synthetic form of human Vasoactive Intestinal Peptide (VIP) that reduces inflammation in the lungs and protects the alveolar type II cells.

Canada-based Entos Pharmaceuticals announced the selection of two lead candidates for a pan-coronavirus Fusogenix DNA vaccine (Covigenix) from its prototyping program launched at the onset of the global COVID-19 pandemic. The selection of two lead candidates is based on strong preclinical results demonstrating high immunogenicity, high levels of SARS-CoV-2 neutralizing antibodies, and the potential for no antibody-dependent enhancement. The two lead Covigenix candidates showed robust preclinical in vivo results, achieving all vaccine profile targets, including potency, ADE safety assessment, high immunogenicity, and efficacy.


Company Actions

With Moderna on the precipice of launching its Phase III trial of 30,000 people for its COVID-19 vaccine, mRNA-1273, it is ramping up manufacturing capabilities. The company announced it had partnered with Catalent, which specializes in advanced delivery and manufacturing solutions for drugs.

Vaxart, Inc. announced it signed a Memorandum of Understanding with Attwill Medical Solutions Sterilflow, LP (AMS) with intent to establish AMS as a resource lyophilization development and large scale manufacturing including tableting and enteric coating for Vaxart’s oral COVID-19 vaccine.

Inovio received a $71 million contract from the U.S. Department of Defense. Funding will support the scale-up of its intradermal DNA delivery device CELLECTRA® 3PSP to deliver INOVIO's COVID-19 vaccine. Inovio is planning to initiate a Phase II/III efficacy study this summer.


Other Industry News

Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones including COVID-19 immunity.

In the journal Blood, researchers reported the novel coronavirus significantly changes platelet gene expression and function. Proteins from the virus cause blood platelets to become hyperreactive which can lead to more clots.

Researchers are finding that antibodies are not the only evidence that an individual has recovered from a COVID-19 infection. "Our results indicate that epidemiological data relying only on the detection of SARS-CoV-2 antibodies may lead to a substantial underestimation of prior exposure to the virus." (The paper has not yet been peer viewed.)

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