With the coronavirus largely controlled in China, two early clinical trials of Gilead’s remdesivir there were stopped due to lack of patients. A trio of manufacturing sites by Lupin, Dr. Reddy’s and Biocon have re-emerged from previous FDA Form 483s to win clearance. After seeing preliminary safety results, China’s CanSino Bio has moved its recombinant COVID-19 vaccine into phase 2, the first in the world to make this clinical advancement. And more.
1. Gilead shares slip as a 2nd remdesivir COVID-19 trial halted in China
Two Chinese studies would have provided the earliest clinical evidence of whether Gilead Sciences’ remdesivir works in COVID-19. But now both studies have stopped due to a lack of eligible patients as the outbreak has been controlled in the country. Outside of China, Gilead shared limited data that the antiviral improved clinical outcomes in 68% of 53 severe patients in a compassionate use program. Leaked early results from the University of Chicago also suggest the drug might work, but the evidence is anecdotal, analysts warned.
2. FDA clears wave of foreign manufacturing plants as COVID-19 concerns continue to grow
The FDA has recently cleared manufacturing sites from Lupin, Dr. Reddy’s and Biocon. Lupin’s oral solid dose plant in Nagpur, India, got the go-ahead after it was knocked with a Form 483 in January. Dr. Reddy’s API facility in Telanga, India, also recovered from a previous citation with three observations. And Biocon’s insulin plant finally put a Form 483 behind it in an FDA decision of voluntary action indicated.
3. China’s CanSino Bio advances COVID-19 vaccine into phase 2 on preliminary safety data
China’s CanSino Bio and its collaborators at the Academy of Military Medical Sciences’ Institute of Biotechnology have become the world’s first to advance a COVID-19 vaccine into phase 2 testing, just three weeks after unveiling a phase 1 study. Now, investigators plan to test the adenovirus type 5 vector-based recombinant vaccine in 500 healthy adults in Wuhan, China.
4. Samsung scores $362M deal to help Vir scale up COVID-19 antibody production
After signing agreements with WuXi Biologics and Biogen to help manufacture COVID-19 antibodies, Vir Biotechnology has inked a $362 million deal with Samsung BioLogics to boost production. The Korean CDMO will start as early as October with its first run and potentially begin commercial manufacturing in 2021 if the treatment proves effective.
5. Celltrion plans July COVID-19 trial, advances ‘super antibody’
Meanwhile, Korean drug developer Celltrion is planning to start testing its own COVID-19 antibody treatment in humans in July. The company is considering whether it can improve on its lead candidate by combining different antibodies into a cocktail. It also hopes to develop a “super antibody” capable of neutralizing other coronaviruses.
6. BeiGene’s PD-1 tislelizumab hits goal in 1st-line lung cancer, cuing Keytruda rivalry (release)
BeiGene said a Chinese phase 3 examining its PD-1 tislelizumab in combination with chemo in front-line non-squamous non-small cell lung cancer has hit its primary endpoint of delaying disease progression at interim analysis. The news follows a similar win the Chinese biotech touted in first-line squamous non-small cell lung cancer. Right now, Merck & Co.’s Keytruda is the only PD-1/L1 with a front-line NSCLC nod in China.
7. India, hoping to challenge Chinese dominance, plans API production push: report
The COVID-19 pandemic has raised concerns over the global pharma supply chain. Now, the Indian government is planning to invest $1.3 billion to increase domestic production of APIs to counteract a perceived over-reliance on Chinese imports, Bloomberg reported. India has identified 53 materials as priorities.
8. J&J, Takeda call off $400M bloodstopper patch deal, after FTC, EU scowls
Takeda’s deleveraging plan has taken a hit. The $400 million deal to sell its TachoSil surgical patch to Johnson & Johnson’s Ethicon has been ditched after the Federal Trade Commission raised anti-competitive concerns. The antitrust watchdog noted J&J’s Evarrest and TachoSil are the only two fibrin sealant patches in the U.S. to stop bleeding during surgery.
9. Fujifilm speeds production of potential COVID-19 therapy Avigan
Amid hopes that its influenza med Avigan could be a possible COVID-19 therapy, Japanese pharma Fujifilm is expanding production. The company’s planning to make 100,000 courses available by July—3.5 times the supply in March—and reach 300,000 courses by September.
10. Dynavax, Sinovac the latest to ally on a COVID-19 vaccine
China’s Sinovac has inked a deal to combine its inactivated coronavirus vaccine candidate with Dynavax’s vaccine adjuvant. Chinese drug regulators recently allowed Sinovac’s shot and another inactivated version by state-owned Sinopharm’s Wuhan Institute of Biological Products to move into clinical trials.
11. Aslan’s Dupixent rival test put on hold amid COVID-19, but delays shouldn’t hit readout
Because of the spread of the novel coronavirus, Singapore’s Aslan Pharma has halted patient recruitment to an atopic dermatitis clinical trial of ASLAN004, an anti-IL-13Rα1 antibody it licensed from CSL that could challenge Sanofi and Regeneron’s blockbuster Dupixent.