Bio Roundup: Coronavirus Diagnostics, Therapeutics, Vaccines & More

Xconomy National — 

The past week brought a sea change in many of our daily lives as the impact of the continued spread of the novel coronavirus altered how we work and play as communities around the world attempt to slow its spread.

Xconomy, as always, is focused on the stories coming out of the life sciences community. Major developments on the COVID-19 front took place this week as research into and development of potential therapeutics and vaccines proceeded. Meanwhile, a lack of access to diagnostic tests left many communities struggling to determine who has contracted the illness.

On Monday, trials of an experimental coronavirus vaccine developed by Moderna and the National Institutes of Health began in Seattle with the first healthy patients dosed; by midweek, the World Health Organization said 10 countries had agreed to participate in its large international study of potential treatments, dubbed the SOLIDARITY trial; by Friday, 40 million California residents, with some exemptions, were under orders to stay at home.

And that’s only a smidgen of what’s taken place in the past few days. Given the firehose of news, we’ve decided to devote our Friday roundup to items about the ongoing pandemic to help you keep track of developments in the time of COVID. Without further ado, let’s round it all up.

TALK, TRIALS OF THERAPEUTICS

—President Donald Trump on Thursday drew attention to the Gilead Sciences (NASDAQ: GILD) drug candidate remdesivir, which is being evaluated in five clinical trials as a potential COVID-19 therapy, and an old drug also being considered a potential treatment: hydroxychloroquine, an antimalarial. Reports of the possible benefit of using the antivirals used to treat and prevent malaria, as well as reduce inflammation in patients with certain autoimmune diseases, to ameliorate COVID-19 infections prompted Israeli generics giant Teva Pharmaceutical (NYSE: TEVA) to promise 6 million tablets of the investigational treatment to hospitals, and Bayer said to give 3 million doses of its malaria drug, chloroquine phosphate (Resochin), to the US government.

—Roche’s South San Francisco-based subsidiary Genentech said it was in talks with the FDA to start a Phase 3 trial of its rheumatoid arthritis drug tocilizumab (Actemra) in hospitalized patients with severe pneumonia associated with COVID-19. The drug blocks the receptor for an inflammatory protein called IL-6. Genentech said it would start enrollment in April and aim to evaluate 330 patients globally.

—Regeneron Pharmaceuticals (NASDAQ: REGN) and Sanofi started a Phase 2/3 trial evaluating sarilumab (Kevzara), an arthritis drug the companies developed together, in patients hospitalized with severe COVID-19 infection. Like tocilizumab, sarilumab blocks the IL-6 receptor, which the companies said may play a role in driving the dangerous inflammatory overreaction that damages the lungs of coronavirus patients with severe infections. Up to 400 patients are slated to be enrolled.

VARIETY OF VACCINES

—Cambridge, MA-based clinical-stage biotech Moderna (NASDAQ: MRNA) said the first patient in an National Institutes of Health study of its Phase 1 study received the first of two doses of its experimental messenger RNA vaccine (mRNA) vaccine, mRNA-1273, against SARS-CoV-2, the novel coronavirus. The 45 patients slated to be enrolled in the trial will receive a second dose of the vaccine in about a month, then be followed for a year to determine if the vaccine is able to spur an immune response and whether it is safe.

—New York-based pharma giant Pfizer (NYSE: PFE) and Germany’s BioNTech announced plans to jointly advance a BioNTech mRNA-based vaccine candidate, BNT162, to prevent COVID-19 infection. The companies said the collaboration, intended to speed work on the BNT162 program, builds on their 2018 R&D agreement around furthering mRNA-based vaccines for the prevention of influenza. The coronavirus vaccine candidate is anticipated to enter clinical testing by the end of April.

—German biotech CureVac batted off rumors that Donald Trump had sought to acquire its potential mRNA vaccine candidate for exclusive US use after its now former-CEO visited the White House. “COVID-19 is an international virus and should be fought on an international basis,” Franz-Werner Haas, Deputy CEO, said during a press conference. CureVac has received funding from the Coalition for Epidemic Preparedness Innovations (CEPI) to support trials of the candidate and a European Commission grant is set to support manufacturing efforts.

—CEPI (again) said it would invest $4.9 million in Institut Pasteur-led consortium to develop a vaccine candidate against COVID-19. Including the new award, CEPI has invested $29.2 million in COVID-19 vaccine R&D to date, backing teh prementioned Curevac, Inovio Pharmaceuticals (NASDAQ: INO), Moderna, Novavax (NASDAQ: NVAX), the University of Hong Kong, the University of Oxford, and the University of Queensland.

TRYING TIMES FOR TESTING

—The Centers for Disease Control on Friday reported more than 10,000 cases of COVID-19 in the US, but experts say the true number is much higher since testing has been so limited. The CDC is tracking 150 coronavirus deaths to date. Companies are working furiously to get emergency authorization from the FDA to sell their tests. This week Hologic (NASDAQ: HOLX), LabCorp (NYSE: LH), Quidel (NASDAQ: QDEL), Quest (NYSE: DGX), Abbott (NYSE: ABT), DiaSorin Molecular, and GenMark Diagnostics (NASDAQ: GNMK) received emergency authorization from the FDA, and more announced they had submitted their tests for review. Roche and Thermo Fisher (NYSE: TMO) led the way last week, receiving the first agency nods under its emergency guidelines for such tests.

—Concerns about the availability of the chemicals, or reagents, needed to run the tests rose. SVBLeerink analyst Puneet Souda wrote in a research note that while discussions with those on the front lines provided optimism as to the likelihood of more testing capacity and instruments coming online, “we remain cautious about the reagent capacity needed for these instruments,” and called rationing of reagents “a likely near-term scenario over the next few weeks” until manufacturers can ramp up production. Last week the UC San Diego Health system said it had decided to develop and validate its own test, but said its capacity is limited to about 20 tests daily because of the limited supply of reagents.

—Indianapolis-based Eli Lilly (NYSE: LLY) said scientists in its research labs would analyze patient samples taken in Indiana healthcare facilities, including nursing homes and emergency rooms, in an effort to expand the state’s ability to conduct coronavirus testing. Lilly also said it was piloting drive-through testing that could help get patients tested outside of healthcare facilities.

—Verily, the life science spinout of Google (NASDAQ: GOOGL) parent company Alphabet, launched an online tool it described as a pilot to screen people who live in the San Francisco Bay Area and want to be tested for coronavirus.

PEOPLE ON THE MOVE

Morphic Therapeutic (NASDAQ: MORF) named Peter Linde its chief medical officer…Thrive Earlier Detection appointed Matt Franklin as its chief commercial officer…and Curevac named Franz-Werner Haas as deputy CEO following newly appointed CEO Ingmar Hoerr’s sudden leave-taking days after succeeding Daniel Menichella as chief executive. Curevac attributed Hoerr’s absence to medical reasons unrelated to coronavirus.

Image: iStock/Michael Vi