Biopharma Update on the Novel Coronavirus: May 8

CV Update_May 8

News information is not all-inclusive. Please check back for updates.

FDA Actions

Fraudulent Medical Products: The FDA provided an update on its efforts to help fight concerning actions by companies that are taking advantage of consumers during the COVID-19 pandemic.

Warning Letters: The FDA and FTC issued warning letters to Alive By Nature, Inc. and GlutaGenic for selling fraudulent COVID-19 products.

Test Report: The FDA shared data from an independent validation study performed at the Frederick National Laboratory for Cancer Research. The data were used to support a EUA request. The test report provides new details on the serology testing that is being performed by the National Cancer Institute.

EUA: The FDA issued a EUA to Sherlock BioSciences, Inc.’s Sherlock CRISPR SARS-CoV-2 Kit. The test is first of its kind in the use of CRISPR technology for an infectious disease test.

EUA Reissued: The FDA reissued a EUA for non-NIOSH-approved respirators manufactured in China.

Risk of Misinterpreting Hydrogen Peroxide Indicator Colors for Vapor Sterilization: The FDA issued a letter to health care providers to address the potential to misinterpret the indicators used to validate the sterilization of medical devices. There is currently no standard indicator color to indicate a sterilized device.

Diagnostics Update: The FDA has worked with more than 385 test developers who plan to submit EUA requests to detect COVID-19. Also, 63 individual EUAs have been issued. In addition, 25 authorized tests have been added to the EUA letter of authorization for high complexity molecular-based laboratory developed tests (LDTs). The FDA has been notified that more than 245 laboratories have begun testing under the policies set forth in its COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.

Diagnostics

Rutgers’ RUCDR Infinite Biologics received an amended emergency use authorization from the FDA late Thursday for the first SARS-CoV-2 coronavirus test that will allow people to collect their own saliva at home and send to a lab for results.

Testing Therapies, Antivirals and Vaccines

San Diego-based Sorrento Therapeutics is teaming up with New York City-based Mount Sinai Health System to develop an antibody cocktail called COVI-SHIELD to treat COVID-19.

A new research paper argues that repurposing older drugs to treat COVID-19 patients will be faster than developing an effective vaccine.  The researchers said it will be important to use drugs that target parts of the cells the virus typically attaches to. More specifically, the researchers pointed to the key cellular proteins the virus binds to, TMPRSS2 and ACE2.    

Certara and Australia’s DMTC (formerly the Defence Materials Technology Centre) Ltd. entered into a research collaboration to evaluate the preventative use of chloroquine in health care workers at risk of infection from the novel coronavirus strain that causes COVID-19.  Certara will support the DMTC-led clinical trial by analyzing study data to develop mathematical models to understand the viral time course and factors impacting drug exposure and prophylactic response in health care workers.

RedHill Biopharma received the go-ahead from the FDA for its Phase IIa trial of Yeliva (opaganib) in moderate-to-severe COVID-19. A total of 139 patients have been dosed to date in the completed Phase I and Phase II trials of the drug in cancer. This Phase IIa will enroll up to 40 patients. The drug is a proprietary, first-in-class, oral spingosine kinase-2 (SK2) selective inhibitor with anticancer, anti-inflammatory and anti-viral activities.

Arcturus Therapeutics released new supportive preclinical data from its adaptive cellular (CD8+ cells) and balanced (Th1/Th2) immune response data from its LUNAR-COV19 vaccine program. The therapy showed a strong antibody response with 100% virus neutralization at a very low vaccine dose.

Beroni Group, in collaboration with Tianjin University in China, discovered 24 types of nanobodies that can be used to detect and treat COVID-19. They screened a library of more than one billion nanobody sequences and identified 24 that can bind to the key proteins of coronavirus with high affinity and specificity. They now expect to run animal experiments and clinical trials with possible results in the next 12 to 18 months.

Novant Health initiated a Phase IIb/III clinical trial of CytoDyn’s leronlimab for severely and critically ill COVID-19 patients. Leronlimb is a CCR5 antagonist developed for multiple therapeutic indications, primarily in cancer, but in earlier studies has shown effectiveness in treating COVID-19.

Company Actions

As reported by CNBC, if Moderna’s coronavirus proves to work, the supply will be limited. Moderna’s CEO, Stephane Bancel will work with the U.S. government to determine who will get the first doses. According to Bancel, the company won’t immediately have enough for everyone.

To date, 10 plasma companies globally have joined the CoVIg-19 Plasma Alliance, founded to accelerate the development of a plasma-derived hyperimmune globulin therapy against COVID-19. The founding companies include Biotest, BPL, CSL Behring, LFB, Octapharma and Takeda, but has since added ADMA Biologics, BioPharma Plasma, GC Pharma and Sanquin. The Alliance is also collaborating with the U.S. National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH) to evaluate the safety, tolerability and efficacy of the hyperimmune therapy in adults with COVID-19. The trial is expected to launch this summer.

As reported by the San Francisco Business Times, the Gladstone Institutes is launching a new research unit focused on COVID-19. Dr. Melanie Ott, will lead the Gladstone Institute of Virology and will target COVID-19 and new therapies against future infectious diseases.

Other Industry News

A study from the Keck School of Medicine at USC suggests that temporarily suppressing the immune system during the early stages of COVID-19 can avoid severe symptoms. This is related to research showing an interaction between the body’s two primary lines of defense may be overstimulating the patients’ immune system. The research was published in the Journal of Medical Virology.

The impact of summer weather is not enough to stop the transmission of COVID-19, according to a new study from the MIT Sloan School of Management. The research, by Hazhir Rahmandad, an Associate Professor of System Dynamics at the school, and colleagues from Harvard, UConn, and Virginia Tech find warmer temperatures may offer partial relief in some regions, but not enough to curtail the risk.

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