Biopharma Update on the Novel Coronavirus: April 28
News information is not all-inclusive. Please check back for updates.
Diagnostics Update: The FDA has worked with more than 380 test developers who plan to submit EUA requests to detect COVID-19. Also, 49 individual EUAs have been issued. In addition, 21 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 225 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.
EUA for Face Masks: The FDA updated and re-issued a EUA for face masks. The FDA clarified that face masks, including cloth coverings, that are authorized by the EUA are only authorized for the general public and health care personnel as source control. The masks are not authorized to be PPE.
LabCorp will offer antibody tests for COVID-19 with no upfront out-of-pocket costs to people who receive an order for a test through a doctor or healthcare provider.
As reported by CNBC, Quest Diagnostics announced the launch of direct-to-consumer coronavirus antibody tests. Individuals will be able to order a coronavirus antibody test online and costs $119. The results are available within one to two days after a blood sample is taken.
Todos Medical announced positive data from its Colloidal Gold point-of-care 2 to 10 minute fingerprick blood antibody test kits. The study was of 71 patients with susepected COV ID-19 infection admitted to a hospital.
IDTechEx released a market research report on the COVID-19 diagnostics test market, benchmarking more than 100 commercial devices across several types of technologies. Companies cited include Roche, Bio-Rad, ThermoFisher Scientific, PerkinElmer, GE Healthcare, Quest Diagnostics, Mammoth Biosciences and numerous others.
Testing Therapies, Antivirals and Vaccines
There are more than 70 groups worldwide rushing to develop a vaccine against COVID-19, including Moderna, Johnson & Johnson, Pfizer and BioNTech, Novavax and many others. One of the groups that appears to be ahead of the race isn’t a commercial biopharma company, but Oxford University’s Jenner Institute. Their primary focus is vaccine development and they had already tested a vaccine for an earlier coronavirus last year, showing it was not harmful to humans.
Quotient Sciences announced a collaboration with CytoAgents, Inc. to accelerate the development of CytoAgents lead COVID-19 drug candidate, GP1681, into Phase I and Phase II clinical trials in 2020.
Spain’s PharmaMar S.A. received clearance from the Spanish Medicines and Healthcare Products Agency to begin a clinical trial in hospitalized COVID-19 patients with Aplidin (plitidepsin). Plitidepsin acts by blocking the protein eEF1A, present in human cells, which is used by SARS-CoV-2 to reproduce and infect other cells. By means of this inhibition, the expectation is that reproduction of the virus inside the cell is prevented, making this propagation to the rest of the cells unviable.
Days after Regeneron and Sanofi reported their IL-6 inhibitor Kevzara may not be as effective as hoped against COVID-19 patients, a study from France suggests a similar drug, Roche’s Actemra, is showing promise in preventing extreme inflammation in critically ill COVID-19 patients. While the results of the study have yet to be published, researchers told the French newswire AFP that Actemra is providing a clear clinical benefit to patients. Following the announcement from Regeneron and Sanofi, the companies amended their study of the medication to include only hospitalized patients who are “critical” to receive the highest dose of Kevzara.
Cambridge, Mass.-based Moderna, Inc. is ready to begin Phase II of its mRNA vaccine for COVID-19. The company submitted an Investigational New Drug Application to the FDA to begin mid-stage studies of mRNA-1273. Moderna said it received initial feedback from the FDA on the design of the planned Phase II study, which is expected to begin in the second quarter of 2020. A Phase III study could begin in the fall of 2020.
Innate Pharma dosed its first patient in a Phase II study of its anti-C5aR antibody, avdoralimab, in COVID-19 patients with severe pneumonia. The primary endpoint of the study is to improve the proportion of COVID-19 patients with severe pneumonia who no longer need to be hospitalized, and to reduce the need for and duration of mechanical ventilation in patients with COVID-19 pneumonia complicated by acute respiratory distress syndrome.
Neurocrine Biosciences received U.S. FDA approval for its add-on Parkinson’s disease treatment on Monday. As reported by Reuters, the launch, however, will be delayed due to disruptions caused by COVID-19.
Numerous major global biopharma companies reported their quarterly earnings. Typically, the COVID-19 pandemic has affected the companies, although not necessarily in a straightforward way. Many of the companies reported increased sales for the quarter as customers increased stockpiles and inventory in preparation for the pandemic, while other forms of sales and clinical trials were negatively impacted. Here’s a look.
Other Industry News
Researchers are unloading their arsenals at COVID-19. In addition to remdesivir, one analyst sees two other options as potential solutions for the virus -- synthetic antibodies and the use of UV light. The UV light is not seen as a treatment for people, but studies have shown that it is effective at eliminating bacterial pathogens on surfaces, as well as in aerosol form. Synthetic antibodies, while still in preclinical testing, are showing promise in preventing COVID-19 from attaching to cell walls.
Two different surveys provide a mixed view regarding the hopes a COVID-19 vaccine will be available by the end of 2020. A BioSpace survey of biopharma professionals reveals a dim outlook from industry insiders, as 65% had little hope a vaccine will be available this year. GlobalData readers though were optimistic, with 80% being confident a vaccine will be available. GlobalData analysts though were less optimistic, with their viewpoints more inline with the BioSpace survey.
As the COVID-19 pandemic continues, a new report shows cancer screenings have plunged during the coronavirus outbreak. Lung cancer patients are facing delays for biopsies, lung cancer surgery, treatment infusions, radiation therapy, clinical trials and lung cancer screening due to COVID-19. Jacob Sands, an oncologist with the American Lung Association, said the delays are creating enormous stress for lung cancer patients, as well as other cancer patients. As the pandemic continues, Dr. Sands recommends that patients be prepared to reschedule appointments and treatments, and encourages them to stay in close contact with their healthcare provider about their treatment plan.
As more joint collaborations are announced by companies and organizations joining the battle against COVID-19, the legal website Law360 issued a reminder of key points for the entities to consider as they sign the agreements, including ownership expectations and provisions for commercialization and licensing.