Biopharma Update on the Novel Coronavirus: August 12
News information is not all-inclusive and updates will now be published on Mondays, Wednesdays and Fridays.
FDA Actions
Warning Letter: The FDA issued a warning letter to H-Lab Life for selling fraudulent COVID-19 products.
Warning Letter: The FDA issued a warning letter to Soluciones Cosmeticas, SA de CV for Bersih hand sanitizers that tested positive for methanol contamination.
A U.S. Florida District Court has granted motions for default judgment and entered permanent injunctions against defendants at Genesis III Church of Health and Healing for selling unapproved or misbranded COVID-19 products such as Mineral Miracle Solutions (MMS).
New Webpage with FAQs: The FDA posted a new webpage, Registration and Listing of Medical Devices During the COVID-19 Pandemic. The webpage answers questions about procedures and requirements with the registration of facilities and the listing of devices.
EUAs: The FDA issued EUAs for the following.
- GWU SARS-CoV-2 RT-PCR Test (George Washington University Public Health Laboratory)
- Solaris Multiplex SARS-CoV-2 Assay (Solaris Diagnostics)
- Alpha Genomix TaqPath SARS-CoV-2 Combo Assay (Alpha Genomix Laboratories)
Diagnostics Update: To-date the FDA has authorized 210 individual EUAs, which include 171 molecular tests, 37 antibody tests and 2 antigen tests.
Diagnostics
LabCorp announced details of a no-charge antibody testing program in response to federal health authorities’ request to increase donations of COVID-19 blood plasma. For the next three months, LabCorp will perform the high-affinity antibody test at no charge to patients who receive blood tests as part of a medically necessary exam.
Testing Therapies, Antivirals and Vaccines
The government of Russia has approved a vaccine for COVID-19, marking the first preventative treatment for the novel coronavirus. Despite the approval announcement, there is wide skepticism over how effective the Russian vaccine could be due to its early approval.
In April, researchers from the Vlaams Institute for Biotechnology in Ghent and the University of Texas at Austin identified antibodies in the blood of llamas that they thought could neutralize SARS-CoV-2, the virus that causes COVID-19. There had been earlier work as well on the use of llama antibodies as a potential universal flu vaccine. Now, researchers at the University of California, San Francisco (UCSF), have taken the concept a step further and synthesized a molecule inspired by llama antibodies called nanobodies.
Veru Inc. is developing a dual anti-inflammatory/antiviral medication to combat severe COVID-19 infections. Originally designed to disrupt cell signaling in a variety of cancers, the compound uses that same mechanism of action to dampen the cytokine storm that leads to severe acute respiratory distress syndrome (SARDS) in the most serious cases of COVID-19.
As published in a report on Wednesday in the journal Nature, Pfizer and BioNTech’s experimental COVID-19 vaccine continues to show promising results in early phase trials. The interim report indicates the RNA vaccine induces a “robust” immune response in healthy adult and shows an acceptable safety profile.
Romark announced it has started a Phase III clinical trial of an experimental new drug candidate NT-300 as a treatment for COVID-19.
Company Actions/Announcements
Three companies have made agreements with Mexico to start Phase III clinical trials of COVID-19 vaccines. The vaccines are being developed by Janssen Pharmaceuticals (owned by J&J), Cansino Biologics and Walvax Biotechnology Co Ltd.
Moderna has a deal with the Trump administration for 100 million doses, about $1.5 billion, for it’s experimental coronavirus vaccine. The government is paying about $15 per dose and patients will receive the vaccine for free.
SAB Biotherapeutics dosed the first patient in its Phase I study evaluating the safety of SAB-185, a therapeutic candidate for COVID-19, in healthy volunteers. SAB-185, a highly potent polyclonal antibody therapeutic, could potentially treat ill patients and provide protective antibodies that could have significant value to protect the military, front-line responders, mission-critical staff, and high-risk populations against COVID-19.
Zyter announced the availability of its Zyter COVID-19 Suite, made up of four integrated digital screening, thermal engineering, contact tracing and monitoring tools. They are also available as stand-alone solutions.
Emmes provided the data and statistical analysis support for the Phase I trial of Moderna’s mRNA-1273, its COVID-19 vaccine. Emmes is a leading contract research organization (CRO).
University of California, Riverside researchers utilized machine learning to identify hundreds of new potential drugs to treat COVID-19. The program used small numbers of previously known ligands for 65 human proteins known to intact with SARS-CoV-2 proteins, then screened more than 10 million commercially available small molecules, and identified the best-in-class hits for 65 human proteins.
Other Industry News
On Tuesday, the US Health and Human Services Secretary, Alex Azar, responded to an announcement that Russia approved the world’s first COVID-19 vaccine. Azar stated, "The point is not to be first with the vaccine. The point is to have a vaccine that is safe and effective for the American people and the people of the world.” Azar said he hopes to have a vaccine approved by December.
As reported by CNN, researchers are working on COVID-19 mysteries and why the experience is so different from one individual to the next. One answer may be looking at people who had a variety of previous vaccinations.
A study out of The Hebrew University of Jerusalem and Ben Gurion University of the Negev found that countries with higher levels of vaccination against tuberculosis using Bacille Calmete-Guerin vaccine (BCG) had better outcomes for COVID-19 patients. They analyzed 55 countries. BCG has been used for about 100 years. The vaccine appears to prime the immune system against viral infections and has also been studied as an immunotherapy for early-stage bladder cancer.