Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 22, 2020.
News information is not all-inclusive. Please check back for updates.
FDA Actions
First Test for Patient At-Home Sample Collection: On Tuesday, the FDA authorized the first diagnostic at-home sample collection test for COVID-19. The EUA was re-issued to LabCorp COVID-19 RT-PCR Test.
EUA for Decontaminating Compatible N95 or N95 equivalent Respirators: The FDA issued a EUA for use of the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer.
ANDA for Albuterol Sulfate Inhalation Solution: The FDA recognizes the increasing demand for albuterol products during the COVID-19 pandemic and approved an Abbreviated New Drug Application (ANDA) for Albuterol Sulfate Inhalation Solution 0.021% and 0.042% for the relief of bronchospasm in patients 2 to 12 years of age with asthma.
Diagnostics Update: The FDA has worked with more than 350 test developers who plan to submit EUA requests to detect COVID-19. Also, 42 individual EUAs have been issued. In addition, 17 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 210 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
Researchers at Switzerland-based Empa, ETH Zurich and Zurich University Hospital have developed a sensor that has the potential to identify SARS-CoV-2, the novel coronavirus that causes COVID-19, in the air. The work is led by Jing Wang at Empa, who usually works on measuring and analyzing airborne pollutants.
Avacta Group: Avacta announced that it has successfully generated multiple Affimer reagents that bind the SARS-COV-2 viral antigen. This is part of its collaboration with Cytiva to develop an Affimer-based rapid test for COVID-19.
LabCorp announced it will expand serological testing for SARS-CoV-2, the virus that causes COVID-19, to more hospitals and healthcare organizations. The company has built up the capacity to perform over 50,000 serological tests per day and complete those tests within an average of one to three days from the time the specimen is picked up, assuming adequate supplies. The company is preparing to make the tests more broadly available over the coming weeks for ordering by hospitals and health systems, organizations, and physicians.
In the rush to get tests for COVID-19 and antibodies to the disease onto the market, there’s growing evidence some of them aren’t particularly good. Roche’s chief executive officer Severin Schwan recently said that a lot of the antibody blood tests are a “disaster. These tests are not worth anything, or have very little use. Some of these companies, I tell you, this is ethically very questionable to get out with this stuff.” He based his statements on test kits Roche had evaluated in developing its own tests, although he declined to identify which ones were a disaster, although he did say the ones he referred to were not from established testing companies.
Testing Therapies, Antivirals and Vaccines
BioNTech/Pfizer: Both companies announced a Phase ½ clinical trial for BioNTech’s BNT162 vaccine program to prevent COVID-19 infection has been approved to start in Germany. This is the first clinical trial of a COVID-19 vaccine candidate to start in Germany. Trials for BNT162 are expected to start in the US upon regulatory approval.
San Diego-based aTyr Pharma Inc. is moving its COVID-19 therapy ATYR1923 into Phase II. The mid-stage trial will assess the drug candidate in COVID-19 patients with severe respiratory complications. ATYR1923 has been shown pre-clinically to downregulate T-cell responses, which dampens the inflammatory cytokine and chemokine signaling that has been implicated in these severe COVID-19 cases. ATYR1923 has also been shown to improve lung function, as well as to reduce inflammation and fibrosis, in multiple animal models of immune-mediated acute lung injury, the company said.
Nascent Biotech has initiated tests to assess the possibility that its lead assets, the monoclonal antibody Pritumumab (PTB) could be used to treat COVID-19. The antibody recognizes the cell-surface vimentin, which is implicated in the entry of SARS-CoV-2 into the cells it infects.
China’s clinical trial of HIV drug Kaletra, marketed by AbbVie, and influenza drug Arbidol showed that they have no effect on mild to moderately severe COVID-19. It was a small trial of 86 patients, 34 receiving Kaletra (lopinavir/ritonavir) and 35 receiving Arbidol (umifenovir), while 17 patients received only supportive and oxygen if needed. Arbidol is a drug manufactured in Russia by Pharmstandard.
A study of malaria drug hydroxychloroquine showed no benefit in COVID-19 patients in an analysis of use across veteran’s hospitals. According to an Associated Press report, there were more deaths among the patients given hydroxychloroquine versus standard of care. The study was not considered rigorous nor has it been peer-reviewed. The study looked at medical records of 368 COVID-19 patients who were treated with hydroxychloroquine. Some of the patients were treated in combination with the antibiotic azithromycin.
Company Actions
CytoSMART Technologies: CytoSMART plans to donate 100 mini live-cell imaging systems to researchers in high containment labs worldwide and feels labs working to fight COVID-19 will benefit. Laboratories are welcome to apply for Lux2 live-cell imager here.
France-based Pharnext SA forged an agreement with the University Hospital Institute (UHI) Méditérranée Infection to research potential drug candidates for COVID-19. The joint activities will focus on rapidly testing in vitro a number of already approved drugs that were previously identified by Pharnext as potential candidates for fighting COVID-19 using its PLEOTHERAPY AI platform.
Q BioMed and its partner Mannin Research tied up with Canada-based Cyclica to create novel therapies for the treatment of life-threatening complications caused by COVID-19 and other viral infections. The goal is to conduct human trials this year. The partnership will pair Mannin’s Tie2 based small molecule platform with Cyclica’s AI platform to accelerate the development of a potential drug. The potential candidate will target the Angiopoietin-Tie2 signaling pathway in order to treat vascular leakage associated with pulmonary edema, addressing the respiratory infection caused by viruses such as COVID-19.
Other Industry News
After leading a flurry of collaborations with multiple companies to hasten the development of vaccine candidates and treatments for COVID-19, Rick Bright, the director of BARDA has abruptly departed his post for another position in the government.
Could antibodies found in the blood of llamas, the doe-eyed South American pack animal, hold a key to developing a vaccine for COVID-19? A team of researchers from Belgium believes so.
