Biopharma Update on the Novel Coronavirus: June 8

FDA Actions
Reissued EUAs: The FDA reissued EUAs revising which types of respirators can be decontaminated for reuse.
Availability and Capability of Non-Invasive Monitoring Devices: The FDA issued new guidance that expands the availability and capability of non-invasive monitoring devices. This guidance replaces March 20, 2020 guidance.

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, 124 individual EUAs have been issued, which includes 106 molecular tests, 17 antibody tests and 1 antigen test.

Genomics company Phosphorous, based in New York, announced I received Emergency Use Authorization from the FDA for its COVID-19 saliva test that features at-home sample collection. This is only the second at-home unsupervised saliva test approved so far by the FDA.

Testing Therapies, Antivirals and Vaccines

An oncology drug could prove to be effective against COVID-19. Researchers with The U.S. Oncology Network discovered AstraZeneca’sCalquence (acalabrutinib) benefited a small number of patients who have severe infections of the novel coronavirus.

Junshi Biosciences announced that the first healthy volunteer has been dosed in the Phase I clinical study of JS016 in China. JS016 is the first SARS-CoV-2 neutralizing antibody to enter clinical trials in China. Junshi and Eli Lilly and Company are collaborating to co-develop JS016 globally.

RELIEF Therapeutics and NeuroRx have expanded their Phase II/III clinical trial of RLF-100 for COVID-19 to include patients receiving high flow oxygen and noninvasive ventilation (CPCP), in addition to patients on ventilators. RLF-100 (Aviptadil) is a formulation of synthetic human Vasoactive Intestinal Peptide (VIP).

Coronavirus Illustration

Ashvattha Therapeutics, a biotech company located in the Bay area, is developing its drug, OP-101, an anti-inflammatory drug with the potential to help fatal inflammatory events associated with coronavirus infections. The company is entering Phase II clinical trials with the hope to have interim analysis done at the end of September.
Applied DNA Sciences provided an update in the development of a linear-DNA form of COVID-19 vaccine candidates with partner Takis Biotech. The first injections of plasmid-based DNA vaccine candidates produced neutralizing antibodies in test animals. Linear DNA versions of the candidates began dose-response trials and results are expected to be published in June 2020.

Company Actions

Sherlock Biosciences and Integrated DNA Technologies (IDT) entered a strategic partnership to manufacture CRISPR SARS-CoV-2 diagnostic and research products. Sherlock recently received EUA from the FDA for its SARS-C0V-2 test kit. It is the first CRISPR-based diagnostic test to receive EUA for COVID-19.

SiO2 Materials Science signed a $143 million deal with the DoD’s Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND) in partnership with BARDA to accelerate production scale-up of the company’s primary packaging platform for storing COVID-19 vaccines and therapeutics. The company’s materials science is a combination of a plastic container with a microscopic thin, undetectable to the naked eye, pure glass coating for biologic drugs and vaccines.

Other Industry News

To achieve population-level COVID-19 vaccinations, first rebuild trust. Poll after poll shows that many Americans – 30% to 50% – are unwilling to be vaccinated against COVID-19 once a vaccine becomes available. Meanwhile, officials are banking on widespread vaccination to allow society to return to normal, without masks or social distancing. We can’t return to normal without population-level vaccinations, though.

A paper published in Cell Systems shows researchers have identified 27 proteins in the blood of COVID-19 patients that could potentially be used to treat the disease and help to decide which type of treatment to use, as reported by ScienceDaily.

In a research letter in JAMA Network Open, a blood test used to find hypercoagulability accurate may predict clotting risk in patients with severe COVID-19.
Louis J. Ignarro, Nobel Prize-winning researcher and UCLA Distinguished Professor Emeritus pointed to a recent study by Ackermann et al. in the New England Journal of Medicine, “Pulmonary Vascular Endothelialitis, Thrombosis, and Angiogenesis in COVID-19” supports the use of nitric oxide as a treatment for COVID-19. Essentially, he said, “this study shows that the coronavirus causes destruction of the capacity of blood vessels in the lungs to produce nitric oxide (NO).”


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