Covid-19 roundup: Bristol Myers suspends clinical trials, grounds salesforce; Vir ushers antibody candidates to human testing

The global nature of the Covid-19 pandemic is manifesting more profoundly every day. With Spain’s death toll now surpassing China’s and India on full lockdown, the number of confirmed cases around the world has exceeded 436,000 while recoveries edged close to 112,000.

While the outbreak derails R&D at another pharma giant, several drugmakers have some encouraging updates on both experimental and repurposed molecules. Philanthropic campaigns in anticipation of the economic fallout continue. An Australian biotech is taking extreme measures to hunker down. There’s also an alternative epidemiology model emerging out of the UK, stirring up more discussion regarding the true extent of the infections in the country.

→ Cell therapy trials at Bristol Myers Squibb are grinding to a halt as the pharma giant temporarily suspends all screening, enrollment and apheresis. As for its other clinical trials, no new sites will be activated until April 13, 2020, although existing sites can continue to recruit new patients — contrasting with Eli Lilly’s strategy to pause enrollment for most studies.

Bristol Myers emphasized that the new policies, designed to ensure safety of patients, staff and investigators, do not impact the ongoing BLA activities for ide-cel (bb2121) or liso-cel (JCAR017). The timely approval of these two CAR-T therapies are imperative for Celgene stockholders to claim the $9 CVR tucked into the $74 billion acquisition. The FDA is supposed to hand down its decision on the third component of the CVR, ozanimod, today.

These measures come on top of a mandatory work-from-home policy for anyone in Bristol Myers’ global workforce who can and restrictions on business travel, as well as a “remote engagement model” being adopted by its field-based salesforce.

George Scangos says his team at Vir Biotechnology has come up with two antibody candidates that could be ready for clinical trials in 3 to 5 months — soon after Regeneron is scheduled to begin testing its own cocktail in humans. To save time, the company said, the lead drug has already been transferred to manufacturing partners at WuXi Biologics and Biogen.

The lead drug binds to a “highly conserved” epitope that’s shared with SARS-CoV-1, the current coronavirus’ much deadlier cousin. Vir has identified additional antibodies that bind to different sites and might be used in combination. A search for new candidates from survivors of Covid-19 is also ongoing.

→ The FDA has given Gilead a big boost in its efforts to develop remdesivir — the potential Covid-19 treatment that has gotten so popular that it had to freeze and rework its compassionate program — by granting the antiviral orphan drug designation. Even though the coronavirus infection does currently qualify as a rare disease as, at under 50,000 cases, it affects fewer than 200,000 people, the move has attracted widespread ridicule and condemnation. Some have expressed concerns that this could have implications for patents and eventually pricing of the drug. Data from two clinical studies of remdesivir involving severe and moderate patients, respectively, are expected in April.

→ Preliminary clinical data from 11 patients support repurposing its hep C drug to treat mild and moderate cases of pneumonia caused by SARS-CoV-2 infection, Ascletis said. “Our report demonstrated that danoprevir boosted by ritonavir can suppress viral replication in less than one week and effectively reduce GGO and patch-shape areas,” the company’s researchers, led by CEO Jinzi Wu, wrote in a preprint paper published on medRxiv. “Viral nucleic acids in nasal swabs turned negative at a median of 2 days and the absorption occurred at a median of 3 days after the initiation of danoprevir/ritonavir treatment.” And after 4 to 12 days of treatment, all the patients (who had a moderate form of Covid-19) were discharged from the hospital.

While the biotech emphasizes the importance of preventing mild to moderate cases from turning severe, it’s unclear how significant the improvement is compared to supportive care — the current standard. Ascletis markets danoprevir as Ganovo in China while ritonavir is often used in HIV/AIDS regimens.

→ Like a host of biopharma players, Takeda wants to support its local community in Massachusetts in offering relief to those who are hit by the coronavirus outbreak. The Japanese company, which has a massive R&D presence in Cambridge, MA, is donating $6.25 million to the American Red Cross, the City of Cambridge Mayor’s Disaster Relief Fund and the Town of Lexington’s Emergency Assistance Fund.

→ Worldwide lockdowns aimed at slowing the spread of Covid-19 are taking a toll on the manufacturer of a pill for travelers’ diarrhea. In response to the expected loss in revenue from its sole commercial product — which is sold as a drug in Australia and as a dietary supplement in the US — Immuron said it’s adopting radical cost-cutting and deferring R&D activities to preserve cash. Its New York-based CEO Gary Jacob has also resigned, returning control to Melbourne, where COO Jerry Kanellos will pick up the reins.

→ One day after Boris Johnson’s administration drastically dialed up the UK’s response to the Covid-19 outbreak, a group of Oxford researchers proposed that their original unofficial strategy of herd immunity may not be so off after all. According to their model, as much as half of the UK population could be infected already. They are beginning large-scale antibody testing to determine the accuracy of the theory.

Meanwhile Neil Ferguson — the Imperial College London professor who led the worrisome analysis widely credited with pushing the government into action — is saying that with the new policies and a surge in NHS capacity, he is “reasonably confident” that the UK will be within capacity on a national level.

Moderna is looking to break more records with the lightning-fast development of its mRNA vaccine against SARS-CoV-2, as CEO Stéphane Bancel outlines a short path to emergency use approval that could get its vaccine to the frontline as early as this fall. (Endpoints link)

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