Biopharma Update on the Novel Coronavirus: June 24
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 North Isle Wellness Center for selling fraudulent COVID-19 products.
FDA Partnership: The FDA is collaborating with the Critical Path Institute (C-Path) and the National Institutes of Health’s National Center for Advanced Translational Sciences (NCATS) on the CDRC External Link Disclaimer. The CDRC (CURE Drug Repurposing Collaboratory), will be a forum for clinical practice data to inform potential new uses of existing drugs in areas of high unmet medical needs.
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, 145 individual EUAs have been issued, which include 122 molecular tests, 22 antibody tests and 1 antigen test.
Diagnostics
Fluidigm Corporation announced that Integrated Genetics Lab Services (iGLS), which is using Fluidigm’s microfluidics technology and reagents in a COVID-19 testing workflow designed to run on the Fluidigm Biomark HD system, was chosen by Spanish health authorities to expand SARS-CoV-2 screening.
Testing Therapies, Antivirals and Vaccines
Shares of Fulcrum Therapeutics are up more than 14% in premarket trading after the company announced it will begin the Phase LOSVID III study to assess losmapimod as a potential treatment of COVID-19.
New information released Tuesday by GlobalData showed that there are now more than 718 pipeline drugs associated with COVID-19. In addition, 70% of these products are in the discovery or preclinical stages.
The World Health Organization (WHO) has updated its draft landscape of COVID-19 vaccine candidates. Thirteen candidates are currently in clinical evaluation and 129 are in preclinical evaluation.
A trial with pigs with AstraZeneca’s COVID-19 vaccine candidate found that two doses of the shot produced a strong immune response than a single dose as reported by Reuters.
Genexine has moved forward with GX-19, its DNA vaccine targeting COVID-19. The company has started enrolling for a Phase I/II clinical trial and is the first domestic vaccine trial to be approved by South Korea.
RedHill Biopharma announced results from treating the first severe COVID-19 patients with its Yeliva (opaganib). The data, published in medRxiv, was encouraging, demonstrating substantial benefit to patients in terms of clinical outcomes and inflammatory markers.
Company Actions
Sanofi Pasteur, the vaccines business unit of Paris-based Sanofi, and Lexington, Massachusetts-based Translate Bio announced the expansion of an existing collaboration to develop mRNA vaccines for infectious diseases. The deal will give Sanofi about a 7.2% stake in Translate Bio in addition to the broad rights to vaccines. Sanofi expects its mRNA COVID-19 vaccine candidate to enter the clinic by the end of the year, and if everything goes well, it could be up for regulatory approval in the second half of 2021.
As reported by Forbes, Avicanna Inc has been awarded a Mitacs grant to work on a cannabinoid-based therapy for lung inflammation associated with COVID-19. The company is expanding its research collaboration with Dr. Christine Allen’s Research Group.
Repertoire Immune Medicines announced it has received funding from the COVID-19 High Performance Computing (HPC) Consortium. The funding will help support COVID-19 research programs. Repertoire will leverage the cloud computing resources of Amazon Web Service to simulate and predict the complex immunological interactions across patient populations that lead to the clearance of SARS-CoV-2.
NeuroRx, Inc. announced the FDA awarded Fast Track Designation for the investigation of RLF-100 (Aviptadil) for the treatment of acute lung injury/acute respiratory distress syndrome associated with COVID-19. RLF-100 is a synthetic form of human Vasoactive Intestinal Peptide (VIP) which reduces inflammation in the lungs and protects the alveolar type II cells that are believed to be an entry route for the SARS-CoV-2 to invade the lungs.
Nascent BioSciences appointed Navpaul Singh as chief medical consultant in charge of research into the company’s drug, pritumumab, for viral infections, including COVID-19.
IBM Watson Health selected Oncotelic, a wholly-owned subsidiary of Mateon Therapeutics, and iBio, access to its IBM Clinical Development (ICD) platform free of charge for a clinical trial of their drugs in COVID-19. In the case of Oncotelic, it is for Mateon’s lead drug candidate, OT-101. For iBio, it’s for use in for two COVID-19 vaccine candidates, IBIO-200 and IBIO-201, which are being studied in preclinical tests at Texas A&M University System Laboratories.
Other Industry News
Speaking before Congress on Tuesday, Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Disease and a member of the government’s COVID-19 response team, urged people to adopt strategies that involve wearing a mask in public, maintaining social distance and avoiding large gatherings of people.
COVID-19-related testimonies will continue in Congress today, with representatives from the Biotechnology Innovation Organization (BIO) expected to address the current pandemic as well as key priorities that will need to be in place in order to effectively respond to the next global viral threat.
As reported by Reuters, Japan’s ability to flatten the cure of COVID-19 cases has led to a shortage of patients to enroll in clinical trials. Approximately 54 COVID-19 clinical trials have been launched in Japan, but most are still in the patient recruitment phase.
Draper announced the release of a scientific article in bioRxiy that describes the potential use of organ-on-a-chip for COVID-19 and the seasonal flu.