March 23 COVID-19 roundup: Gilead looks to expand access to remdesivir, antiviral gains Orphan designation; plus N.Y.’s chloroquine trial, Celltrion and more
As Gilead begins shifting its individual compassionate use authorizations for COVID-19 candidate remdesivir to broader expanded access programs, the antiviral was granted Orphan Drug designation Monday. The day also saw several companies begin work on antibody-based therapeutics and coronavirus testing kits.
Gilead Sciences Inc. (NASDAQ:GILD), which has provided emergency access to remdesivir for several hundred patients, said an increase in compassionate use requests “flooded an emergency treatment access system that was set up for very limited access to investigational medicines and never intended for use in response to a pandemic.”
The company said instead of accepting further individual compassionate use requests for remdesivir, it is working with worldwide regulatory authorities to launch expanded access programs for the COVID-19 therapeutic. This approach, the company said, will accelerate access and enable the collection of data.
Gilead did not respond to questions regarding how the shift will affect the number of patients who receive remdesivir.
FDA also granted the antiviral Orphan Drug designation Monday, which would give remdesivir seven years of exclusivity if approved. A product can qualify for the designation if it is intended to treat a condition that affects 200,000 or fewer Americans. According to CDC, over 33,000 people have tested positive in the U.S.; however, that number could soon exceed 200,000.
A second Orphan pathway allows manufacturers to seek the designation if they demonstrate that there is no “reasonable expectation” that sales revenue would exceed development and distribution costs. This pathway has been the source of recent controversy (see “Senate Bill Introduced to Close Orphan Drug ‘Loophole’”)
Chloroquine trial set to begin
The other experimental COVID-19 treatment in the national spotlight, chloroquine, will begin clinical testing in New York starting Tuesday, New York Gov. Andrew Cuomo said Sunday. The trial will also evaluate chloroquine’s more tolerable derivative, hydroxychloroquine, and the antibiotic azithromycin.
The state has acquired 750,000 doses of chloroquine, 70,000 doses of hydroxychloroquine and 10,000 doses of azithromycin.
While chloroquine and hydroxychloroquine have both been shown to block SARS-CoV-2 replication in cell culture, so far data in COVID-19 patients are scant, and data from randomized controlled clinical studies of the drugs have yet to emerge (see “Industry to Boost Supply of Chloroquine”).
Celltrion Healthcare Co. Ltd. (KOSDAQ:091990) is developing COVID-19 products on multiple fronts.
The South Korean biotech is screening antibodies from the blood of recovered patients to find those that are most effective at neutralizing SARS-CoV-2. It expects to begin clinical testing of an antiviral based on neutralizing antibodies in 3Q20.
The company is also developing a “super antibody” that can neutralize several kinds of coronavirus related strains, including SARS, to enable “further protection against unforeseen or unexpected mutations” and to prepare for “potential future pandemic situations.”
Celltrion expects to launch this summer a spike protein-based self-testing diagnostic kit, which can show results in 15-20 minutes. Once the kit gains CE mark, it will be available in Europe; Celltrion also plans to apply for device authorization from FDA.
Fellow Asian biopharma Shanghai Junshi Biosciences Co. Ltd. (HKEX:1877) has partnered with the Institute of Microbiology of the Chinese Academy of Sciences to develop an antibody-based COVID-19 therapy.
Junshi said in vitro and in vivo studies of multiple strains of neutralizing antibodies have demonstrated their blocking activity. The company is conducting toxicology studies ahead of submitting an IND with Chinese and other regulatory agencies.
Celltrion and Junshi join a growing list of companies developing antibody-based COVID-19 therapeutics (see “A Growing List of New Vaccines and Therapies in Development”).
Florida-based CDMO Ology Bioservices Inc. won a $14 million contract from the Department of Defense to develop and manufacture, along with the Vanderbilt University Medical Center, a mAb to treat COVID-19 and prevent SARS-CoV-2 infection.
Technologies and companies funded by the DoD’s Defense Research Advanced Projects Agency are at the forefront of the response to the COVID-19 pandemic. AbCellera Biologics Inc. is using technology created in response to a DARPA challenge to develop its antibody therapy; Vir Biotechnology Inc. (NASDAQ:VIR) is deploying antibody discovery technology that can be traced to a company that received part of its funding from DARPA (see “DARPA’s Gambles Might Have Created the Best Hopes for Stopping COVID-19”).
Verily, Microsoft, IBM initiatives
Also Monday, Verily Life Sciences LLC provided an update one week into its online COVID-19 screening portal.
Launched initially in two counties in the San Francisco Bay Area to direct people with COVID-19 symptoms to drive-through testing sites, Verily said it has tested over 1,200 people. The company now plans to open two additional testing sites, one in Riverside County and one in Sacramento County, which it expects will allow it to “serve thousands more.”
The online portal, which is hosted on Verily’s Baseline platform, aims to automate test ordering systems to get people tested more quickly (see “Bumpy Ride for Debut of Verily’s COVID-19 Screening Platform”).
The tests are produced by Thermo Fisher Scientific Inc. (NYSE:TMO) and Becton Dickinson and Co. (NYSE:BDX). The PWNHealth physician network approves individuals for testing; healthcare providers from Hawthorne Effect and Elligo perform the on-site tests, which are then processed by Quest Diagnostics Inc. (NYSE:DGX).
Also taking a tech-driven approach to the pandemic is Microsoft Corp. (NASDAQ:MSFT), which expanded its partnership with Adaptive Biotechnologies Corp. (NASDAQ:ADPT) to map population-wide immune responses to COVID-19.
“Finding the relevant immune response signature may advance solutions to diagnose, treat and prevent the disease,” the partners said. The companies initially partnered in 2018 to create a T cell receptor-antigen map to translate the genetics of the adaptive immune system.
To generate the immune response data, Adaptive will open enrollment in April to collect de-identified blood samples from individuals diagnosed with or recovered from COVID-19 using a mobile phlebotomy service provided by Laboratory Corp. of America Holdings (NYSE:LH). Covance Inc. will manage the virtual clinical trial Immune cell receptors from blood samples will be sequenced by Illumina Inc. (NASDAQ:ILMN) and mapped to SARS-CoV-2 specific antigens confirmed by Adaptive.
IBM Corp. (NYSE:IBM) also launched the COVID-19 High Performance Computing Consortium Monday to bring online 16 systems to allow researchers to run calculations in epidemiology, bioinformatics, and molecular modeling.
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