Biopharma Update on the Novel Coronavirus: July 17
News information is not all-inclusive and updates will now be published on Mondays, Wednesdays and Fridays.
COVID-19 Industry Hotline: On Friday, July 17, the FDA will its COVID-19 Industry Hotline. The FDA will be providing support through this directory, Contacts for Medical Devices During the COVID-19 Pandemic.
Diagnostics Update: To-date the FDA has authorized 182 individual EUAs, which include 151 molecular tests, 29 antibody tests and 2 antigen tests.
As reported by Reuters, Australian researchers have created a test that can determine if someone is infected with COVID-19 and if they have been infected in the past. The test uses blood samples and takes about 20 minutes to obtain the results.
As reported by the Wall Street Journal, Abbott has seen a surge in revenue in its U.S. diagnostics business due to demand for its COVID-19 testing.
Testing Therapies, Antivirals and Vaccines
Phase I data from the COVID-19 vaccine under development by AstraZeneca and Oxford University’s Jenner Institute is showing a robust defense against the novel coronavirus that has infected more than 13 million people across the globe. The data is showing the COVID-19 vaccine generates antibodies and T-cells against the virus.
As reported on CNBC, Johnson & Johnson said next week the company will start a Phase I clinical trial of 1,000 participants for its COVID-19 vaccine candidate Ad26.COV2-S. J&J expects to start a Phase III clinical trial in late September.
An open letter to the director of the National Institutes of Health, signed by more than 100 scientists is calling for the use of “human challenge trials”. The scientists think this will “greatly accelerate” the development of a COVID-19 vaccine.
Fab’entech launched a program to develop an immunotherapy against COVID-19. The program is based on the French company’s polyclonal immunotherapy technology program that enables targeted recognition of a virus or toxin and its specific neutralization. Polyclonal antibodies, compared to monoclonal antibodies, can target different parts of the antigen of interest.
NeuroRx, in partnership with Relief Therapeutics, announced the independent Data Monitoring Committee had reviews the findings in the first 30 patients in its trial of Aviptadil (RLF-100) in patients with Critical COVID-19 with respiratory failure. The committee recommended the primary endpoint changed to “alive and free of respiratory failure at 7-10 days.” The primary endpoint was previously mortality at 28 days. The change is driven by the general decrease in mortality with advances in treatment for Critical COVID-19 and by early observations in the clinical trial.
As reported by Reuters, Sinopharm begun Phase III clinical trials of its COVID-19 vaccine. The trial is being conducted in Abu Dhabi using up to 15,000 volunteers.
BioAegis Therapeutics announced it received regulatory clearance from The Spanish Agency for Medicines and Health Products (AEMPS) for a Phase II clinical trial of recombinant human plasma gelsolin (rhu-pGSN) in hospitalized patients with severe COVID-19 pneumonia.
Australian-based biotech Recce Pharmaceuticals signed a collaboration with Path BioAnalytics Inc., a precision medicine company based in Durham, N.C., to investigate the potential of two of Recce’s drug candidates to be effective against SARS-CoV-2 infection, the virus that causes COVID-19. This study will evaluate RECCE 327, the company’s lead candidate, and newly formulated RECCE 529 as a preventative and mitigating treatment.
Algernon Pharmaceuticals will initiate Phase IIb/III studies of NP-120 (Ifenprodil) for COVID-19 at Westchester Research Center at Westchester General Hospital in Miami. Ifenprodil is an NMDA receptor antagonist specifically targeting the NMDA-type subunit 2B.
PhaseBio Pharmaceuticals, Inc. dosed the first patient in its Phase II VANGARD study evaluating PB1046 as a treatment for hospitalized COVID-19 patients who are at high risk for rapid clinical deterioration and acute respiratory distress syndrome. PB1046 is a novel, once-weekly, subcutaneously-injected VIP receptor agonist that targets VPAC receptors in the cardiovascular, pulmonary and immune systems.
CalciMedica announced Thursday that its experimental drug, Auxora™, shows early promise in helping COVID-19 patients stay off ventilators and recover sooner.
Celltrion Group launched its Phase I trial of a potential antiviral antibody treatment for COVID-19. It will enroll 32 healthy volunteers who have not been diagnosed with COVID-19. It is expected to be completed by the third quarter. It is also set to run a further in-human Phase I trial of the antiviral candidate in mild COVID-19 patients across Europe.
Novartis pledged to provide COVID-19 drugs, including antibiotics, steroids and diarrhea pills to 79 low-income countries at no profit.
Adagio Therapeutics launched with $50 million to advance its portfolio of coronavirus antibodies as both therapeutics and prophylactics on the fight against SARS-CoV-2.
As reported by Reuters, the European Union is in talks for the advance purchase of possible COVID-19 vaccines from Moderna, Sanofi and Johnson & Johnson, BioNTech and CureVac.
Other Industry News
The US, UK and Canada have accused Russia of trying to steal COVID-19 vaccine information from researchers and are alerting scientists and pharma companies to be aware of any suspicious activity.
The Trump Administration stripped COVID-19 hospitalization data from the Centers for Disease Control and Prevention (CDC). In a letter to governors, the Trump Administration recommended using the National Guard or another contracted agency to manage and control reporting COVID-19 data at the state level. David C. Harvey, the Executive Director of the National Coalition of STD Directors (NCSD), issued a statement that echoes those of many other public health experts: “As COVID-19 rates worsen, we need strong, coordinated federal response to COVID-19i more than ever. This move by the Administration will threaten the quality of data needed to respond quickly and accurately to the pandemic.”