COVID-19 update: Remdesivir readout in weeks; hospital-use diagnostic under development; antibodies advancing
Initial signals from two ongoing trials in China of Gilead’s remdesivir to treat COVID-19 should be available in a few weeks, Marie-Paule Kieny said at a WHO press conference Wednesday. Assistant Director-General Kieny co-chaired the Feb. 11-12 Global Research and Innovation Forum dedicated to mobilizing responses to the COVID-19 outbreak.
The pair of placebo-controlled trials, which are being coordinated by the China-Japan Friendship Hospital in Beijing, are evaluating remdesivir to treat COVID-19 (2019-nCoV) infection. According to ClinicalTrials.gov, a trial to treat mild to moderate infection, which is not yet recruiting, will enroll 308 patients; a trial to treat severe infection has begun recruitment and plans to enroll 452 patients.
Speaking after the forum, WHO Director General Tedros Adhanom Ghebreyesus said the organization has a “master plan for coordinating clinical trials and ensuring they are done coherently and consistently.”
Also on Wednesday, BrightGene Bio-medical technology Co. Ltd. (Shanghai:688166) said it has synthesized the API for remdesivir and is mass producing the investigational drug.
In a statement released by the Shanghai exchange, BrightGene noted that testing has not been completed on remdesivir. The company stated that if remdesivir makes it to the market, “BrightGene will need authorization from the patent holder Gilead to market” its version of the therapy.
BrightGene said that if it received permission to bring a remdesivir product to the market, it would donate the drug for use during the outbreak.
Gilead Sciences Inc. (NASDAQ:GILD) did not respond to inquires about BrightGene’s statements. Gilead CEO Daniel O’Day said last week the company “will not get into a patent dispute” (see “O’Day on Remdesivir”)
Developing and deploying diagnostics that can be used at hospitals, clinics and physicians’ offices will be critical to containing and treating COVID-19 (2019-nCoV), Luciana Borio, VP In-Q-Tel and former National Security Council director of medical and biodefense preparedness policy, told the Senate Homeland Security Committee Wednesday.
Qiagen N.V. (NYSE:QGEN; Xetra:QIA) Wednesday confirmed to BioCentury reports that it is developing a molecular assay to detect COVID-19 that could be used in hospitals and clinics.
The company will seek FDA Emergency Use Access to market a version of its QIAstat-Dx respiratory panel to test for the presence of COVID-19. The panel is run on the FDA-cleared QIAstat-Dx syndromic testing system, which is widely deployed at hospitals and clinics.
The Qiagen test could be ready by the end of February, the company said.
Cepheid announced Tuesday that it is developing an automated point-of-care molecular test for the qualitative detection of COVID-19. The test will be designed using Cepheid’s GeneXpert systems and “is expected to deliver point-of-care results in about 30 minutes,” the company said.
Cepheid, a unit of Danaher Corp., said it will submit the test for clearance through FDA’s Emergency Use Authorization pathway and expects to make the test available globally. The company did not say when its COVID-19 test will be available.
Antibodies and vaccines
At least four companies have launched programs to discover and develop mAbs that could treat and potentially provide protection against COVID-19 (see “A Dozen Vaccine Programs Under Way”).
Vir Biotechnology Inc. (NASDAQ:VIR) said Wednesday it has identified two antibodies that bind to SARS-CoV-2, which causes COVID-19. The antibodies “were originally found because they bind and neutralize the original SARS-CoV. The antibodies target the SARS-CoV-2 spike protein in the region that the virus uses to enter cells through the cellular receptor ACE2.”
“We are in the process of assessing neutralization with a pseudo-virus,” said Vir CEO George Scangos in a statement. He added that the company is “working with international partners to assess the capacity of these antibodies to neutralize the live virus, SARS-CoV-2.”
Also targeting the spike protein is Moderna Inc. (NASDAQ:MRNA). On Monday, the biotech said its mRNA-based COVID-19 vaccine is ready for Phase I testing (see “Moderna Raises $500M, Readies Coronavirus Vaccine for Clinical Testing”).
AbCellera Biologics Inc., which is working under a contract from the Defense Advanced Research Projects Agency (DARPA), told BioCentury Wednesday that it “has been gathering reagents and testing our platform on a sample from a recovered SARS patient while we wait for an incoming sample from a recovered COVID-19 patient.”
“AbCellera’s approach is to do discovery directly from a donor sample from a patient that has recovered from COVID-19 to find potent SARS-CoV-2 neutralizing antibodies,” the company said. It expects to a receive a sample “very soon” and to begin discovery work using its Pandemic Prevention Platform (see “DARPA-funded AbCellera to Pursue mAbs to treat Coronavirus Outbreak”).
Johnson & Johnson (NYSE:JNJ) announced Tuesday that it has expanded its collaboration with BARDA to expedite its investigational coronavirus vaccine program.
“BARDA will provide funding to support accelerated development of a vaccine candidate into Phase I clinical studies, with options for additional funding to progress a promising candidate,” J&J said in a statement. In parallel, Janssen Pharmaceuticals, a unit of J&J, “will work to upscale the production and manufacturing capacities required to meet public health needs.”
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