Biopharma Update on the Novel Coronavirus: March 30
News information is not all-inclusive. Please check back for updates.
Mitigation of Supply Interruptions of Food and Medical Products: The FDA is working to make sure Americans have access to safe food and medical products. This includes addressing shortages of respirators, mitigation strategies for personal protective equipment, open to importing PPE and other devices, reached to 1,000+ device manufacturing sites worldwide focusing on essential devices, working with textile manufacturers about how to repurpose their product lines to make masks, encouraging manufacturers and healthcare facilities to report any supply disruptions and providing maximum regulatory flexibility as needed.
Food and Drug Administration (FDA) is approving for use during the COVID-19 pandemic under Emergency Use Authorization (EUA) will turn out to be ineffective or substandard. Now, the agency issued an EUA for hydroxychloroquine and chloroquine, long-used malaria drugs to treat the illness caused by the novel coronavirus.
Batelle received FDA waiver for its decontamination technology that can clean compatible N95 respirator chambers for safe reuse up to 20 times.
Abbott: Abbott’s new point-of-care test for the novel coronavirus that causes COVID-19 was approved by the U.S. Food and Drug Administration (FDA) under Emergency Use Authorization (EUA). This test detects coronavirus in as little as 5 minutes.
Jennifer Doudna, best known for discovering CRISPR gene editing, has launched a la in the San Francisco Bay Area to run COVID-19 tests. It is planned to process more than 1,000 patient samples daily with a 24-hour turnaround. The lab will be at the University of California, Berkeley’s Innovative Genomics Institute, where Doudna is the executive director.
Testing Therapies, Antivirals and Vaccines
GigaGen: GigaGen is developing a recombinant polyclonal antibody therapy (rCIG) to treat COVID-19. First uses are envisioned as treatments for severely ill coronavirus patients and individuals at high risk of contracting the disease, including healthcare professionals.
Johnson & Johnson: J&J has identified a lead vaccine candidate for COVID-19 and anticipates clinical trials in September with potential safety and efficacy results by the end of the year. If the results are positive, the company will seek Emergency Use Authorization to provide 1 billion doses to fight the global pandemic.
Cobra Bio: Cobra Bio Secures $3.3 Million to Develop DNA Vaccine Against COVID-19. The U.K. company is working with a consortium of European groups to fight the pandemic. The vaccine candidate is expected to enter human trials in 2021.
Physician-scientist Dr. Steven Quay, MD, PhD, announced a new combination treatment that has the potential to improve pulmonary function and reduce or eliminate mechanical ventilation in patients with the coronavirus infection. The treatment uses two drugs previously approved by the FDA for other conditions.
Bellerophon Therapeutics, which recently received expanded emergency authorization, treated the first patient with COVID-19 at the University of Miami School of Medicine with its INOpulse inhaled nitric oxide system (iNO).
CytoDyn has now treated 10 patients with leronlimab under an Emergency Investigational New Drug (EIND) by the FDA.
Altimmune is launching a collaboration with the University of Alabama at Birmingham (UAB) to develop its single-dose, intranasal COVID-19 vaccine, named AdCOVID.
Following the FDA’s emergency use authorization approval of hydroxychloroquine as a treatment for COVID-19, Novartis Chief Executive Officer Vas Narasimhan called the drug the “biggest hope” against COVID-19. Hydroxychloroquine, a treatment for malaria, lupus and arthritis, is manufactured by Sandoz, the generic subsidiary of Novartis. The Swiss pharma giant has pledged to donate 130 million doses and is supporting clinical trials assessing the drug against the pandemic, Reuters said. In addition to hydroxychloroquine, Novartis is also testing its cancer drug Jakavi, multiple sclerosis drug Gilenya and fever drug Ilaris as treatment options for complications related to COVID-19.
Regeneron and Sanofi expanded their clinical trial of rheumatoid arthritis drug Kevzara against COVID-19 in multiple countries that have been impacted by the pandemic. The companies launched a Phase II/III trial in Italy, Spain, Germany, France, Japan, Canada and Russia. The trial will recruit hospitalized patients from several countries who are severely or critically ill with COVID-19 infection. The companies launched a U.S. trial earlier this month to assess the IL-6 inhibitor against the disease. It’s believed that Kevzara may play a role in driving the inflammatory immune response that causes acute respiratory distress syndrome observed in patients with severe COVID-19 infection. The role of IL-6 is supported by preliminary data from a single-arm study in China using another IL-6 receptor antibody.
LabShares: Massachusetts-based LabShares announced that it is offering free bench space for the scientific community-at-large for researchers working on diagnostic, therapeutics and other biomedical projects addressing the global COVID-19 crisis.
Predictive Technology Group and Jiangsu Dablood Pharmaceutical responded to misinformation about their Assurance AB COVID-19 IgM/IgG Rapid Antibody Test published by Hindenburg Research. Hindenburg claimed that Dablood was not approved by the Chinese government to offer COVID-19 tests.
MediWound has temporarily suspended the initial of additional clinical sites and new patient enrollment in its U.S. EscharEx Phase II trial for venous leg ulcers. Existing sites will continue to manage randomized patients currently being treated, as well as enhanced safety measures, including remote site monitoring, virtual tools and digital communications. The NexoBrid expanded access (NEXT) program continues to enroll patients. The patient follow-up in the pivotal U.S. Phase III DETECT study of NexoBrid continues.
Medtronic is publicly sharing its ventilator design specifications for the Puritan Bennett 560 (PB 560) to help speed global production.
The Allergan Foundation, a charitable organization committed to providing a lasting and positive impact in the communities in which Allergan, Inc. employees live and work. Donated $2 million to organizations responding to the COVID-19 pandemic. Brent Saunders, chairman of the foundation, said the goal of the grants is to “put much needed financial help in the hands of organizations who support vulnerable people in need of food, housing and mental health services as quickly as possible.” Organizations that will receive a portion of the grant money include New York Community Trust NYC COVID-19 Response & Impact Fund; Community Food Bank of New Jersey; Orange County, California United Way; Central Texas Food Bank; and Freestore Foodbank of Cincinnati, Ohio.
Other Industry News
On Friday, March 27, President Trump invoked the Defense Production Act to force General Motors to manufacture ventilators to address the COVID-19 crisis.