Biopharma Update on the Novel Coronavirus: June 12
News information is not all-inclusive and updates will now be published on Mondays, Wednesdays and Fridays.
FDA Actions
EUA for First COVID-10 Next-Generation Sequence Technology Test: This week the FDA issued a EUA to Illumina, Inc. for the Illumina COVIDSeq Test for the qualitative detection of SARS-CoV-2 RNA from respiratory specimens.
Warning Letter: The FDA issued a warning letter to www.outoftheboxremedies.com for selling products with misleading claims that they can mitigate, prevent, treat, diagnose or cure COVID-19.
Diagnostics Update: The FDA has worked with more than 400 test developers who have submitted or plan to submit EUA requests to detect COVID-19. Also, 135 individual EUAs have been issued, which include 114 molecular tests, 20 antibody tests and 1 antigen test.
Cue Health received EMU for its rapid, portable, point-of-care COVID-19 test. It is a molecular test for the RNA of SARS-CoV-2 that can provide results in 25 minutes from a nasal swab sample.
30 Members of Congress sent a letter to Alex Azar, Secretary of the Department of Health and Human Services (HHS) requesting that funds from the Paycheck Protection Program and Health Care Enhancement Act be sent directly to clinical laboratories that have invested heavily in COVID-19 testing capacity. They note that although the labs are eligible for the existing funds, there is nothing specifically earmarked for laboratories that have invested heavily in in scaling up their clinical testing capabilities during the pandemic.
Testing Therapies, Antivirals and Vaccines
The amount of scientific information unearthed about SARS-CoV-2, the virus that causes COVID-19, in only six months is unprecedented. The speed is remarkable, although much of it will still need to be confirmed over time with more careful study. Still, each day presents new data with a glimmer of hope. Here’s a look at some recent findings.
On Monday, Eli Lilly and Company announced that its partner Junshi Biosciences had dosed the first healthy volunteer in a clinical trial of a neutralizing antibody against COVID-19. The company is testing a second antibody to test and is conducting preclinical studies of a third antibody. In an interview with Reuters, the company’s Chief Scientific Officer Daniel Skovronsky said the third antibody could possibly begin human trials in the new few weeks.
Cambridge, Massachusetts-based Moderna announced it had finalized the Phase III clinical trial structure for its COVID-19 vaccine, mRNA-1273.
Regeneron announced on Thursday that it has started the first clinical trial of an investigational dual antibody cocktail, REGN-COV2 for the prevention and treatment of COVID-19. The investigational drug was designed to help protect against viral escape.
U.K.-based Stabiltech Biopharma, which is developing next-generation vaccines, partnered with New Zealand’s BioCell Corporation to manufacture its oral coronavirus vaccine, OraPro-COVID-19. Human trials for Stabilitech’s potential breakthrough vaccine are scheduled for August of this year.
As reported by The Japan Times, Daiichi Sankyo Co. said its goal is to launch a clinical study of a genetic vaccine for COVID-19 around March 2021.
CytoDyn hit its 75 patient enrollment target for its Phase II trial of leronlimab for mild to moderate COVID-19. Leronlimab is a humanized IgG4 monoclonal antibody that blocks CCR5 and was first developed for HIV.
Company Actions
Emergent BioSolutions announced it has partnered with AstraZeneca to support the manufacturing of COVID-19 candidate, AZD1222. The agreement is valued at approximately $87 million.
Adaptive Biotechnologies Corp. and Microsoft Corp. on Thursday launched ImmuneCODE, a real-time database, generated from thousands of COVID-19 blood samples from patients around the globe.
As reported by Reuters, PeptiDream Inc said it will be collaborating with Merck to develop COVID-19 therapies.
Other Industry News
Decentralized clinical trials gained a foothold in the pharmaceutical industry amidst the COVID-19 pandemic and will continue to be used once the pandemic ends, according to panelists at BIO 2020, speaking Thursday in a virtual session.
When COVID-19 hit, the disease forced biotech companies to alter the way business was conducted and changed the way research could be conducted onsite from the implementation of social distancing rules. While standard operating procedures may have faced an adjustment, the global pandemic has not altered the plans for some companies to expand their physical footprint in the United States and elsewhere.
In the early days of the COVID-19 pandemic, most drug companies issued statements assuring the public and investors that they were making efforts to secure their supply chains in order to ensure supplies of essential medications. Nonetheless, a USA Today report found that from January through May, 28 generic drugs in 405 dosages made the U.S. Food and Drug Administration (FDA)’s list of drugs in shortage.
The Global Virus Network published an article in the journal Science suggesting the stimulation of innate immunity by live attenuated vaccines in general, and oral poliovirus vaccine (OPV) in particular, could provide temporary protection against COVID-19. OPV is a live attenuated vaccine that was safely used in the United States from 1963-2000.
PRA Health Sciences announced the enhancement of its commercial Health Harmony COVID-19 Monitoring Program with the integration of the Microsoft Healthcare Bot service. Users of PRA’s Health Harmony digital platform who enroll in their organization’s COVID-19 Monitoring Program can use the AI-based chatbot, which can recognize and respond to COVID-19-related questions, to enhance their own COVID-19 care. For organizations that have implemented the Monitoring Program, it allows them to understand the patient flow and to monitor, educate, and individualize care.