Biopharma Update on the Novel Coronavirus: August 3
News information is not all-inclusive and updates will now be published on Mondays, Wednesdays and Fridays.
Serology Tests: The FDA authorized the first two COVID-19 serology tests, from Siemens, that display an estimated quantity of antibodies present in the blood.
Warning Letter: The FDA issued a warning letter to Vapore, LLC, dba Mypurmist, for selling fraudulent COVID-19 related products.
Diagnostics Update: To-date the FDA has authorized 194 individual EUAs, which include 159 molecular tests, 33 antibody tests and 2 antigen tests.
Dark Daily outlines the various ways that COVID-19 laboratory testing has been perpetrated, with early cases showing up in March. Some of it is in Medicare billing data, while others involve fraudulent or unapproved antibody tests. Others have used the tests to collect consumers’ personal information.
According to an Oxford University study with 9,000 healthcare workers, antibody tests may not work for people who had a mild infection.
The National Institutes of Health awarded seven companies working on new coronavirus diagnostic technology, $249 million in grants. The recipients include Fluidigm, Ginkgo Bioworks, Helix Opco, Mammoth Biosciences Inc., Mesa Biotech, Quidel Corp. and Talis Biomedical.
Testing Therapies, Antivirals and Vaccines
Eli Lilly announced it is moving into a late-stage, Phase III clinical trial for an antibody COVID-19 treatment. Recruitment will come from residents and staff at long-term care facilities in partnership with the National Institute of Allergy and Infectious Diseases (NIAID).
Members of the COVID R&D Alliance, including AbbVie, Amgen and Takeda Pharmaceutical, enrolled the first patients in the I-SPY COVID Trial. The trial will evaluate the efficacy of cenicriviroc, a chemokine dual-receptor antagonist, Otezla (apremilast), a PDE4 inhibitor, and Firazyr (icatibant injection), a bradykinin B2 receptor antagonist in severely ill, hospitalized COVID-19 patients who require high-flow oxygen.
AbCellera's LY-CoV555, a neutralizing antibody that is being co-developed by Eli Lilly as a potential treatment and prophylaxis for COVID-19, has progressed to Phase III clinical trials. The study will include up to 2,400 participants and assess the ability of LY-CoV555 to prevent infection of long-term care residents and facility staff who have been exposed to SARS-CoV-2.
A recent study in EBioMedicine, a Lancet publication, showed study patients who succumbed to COVID-19 had neutrophil extracellular traps (NETs) in the blood vessels of the lungs. NETs are sticky webs composed of DNA that are expelled from neutrophils outside the cell into the extracellular space and are the immune system's first line of defense against infection. However, NETs are also associated with several diseases and have been demonstrated to cause blood clotting and severe immune responses. In response, Neutrolis, a Cambridge, Mass. biotech announced the development of first-in-class therapies that target neutrophils in COVID-19. The lead candidate, NTR-441, is an engineered analog of the natural NET-destroying enzyme DNASE1L3—the world’s first investigational drug that can be systemically delivered to accurately target NETs.
Other Industry News
With billions of doses of COVID-19 expected to be available by year’s end and a global population of 7.8 billion, public health officials are scrambling to deliver the vaccines in ways that are equitable and effective. The challenge is about more than having a vaccine, and more than delivering it, public health experts at Johns Hopkins Medical School explained during a media briefing last Wednesday.
Russia is planning to mass vaccinate against COVID-19 in October. Russia reported that COVID-19 vaccine clinical trials were complete and claimed test results showed an immune response in all participants with no side effects.