Today, a brief rundown of news involving Bristol Myers Squibb and the U.S. Department of the Treasury, as well as updates from Gilead Sciences and Zymeworks that you may have missed.
A trial participant who received an experimental autoimmune cell therapy from Bristol Myers Squibb died 44 days later, the company said Friday. Following an infusion with “zola-cel” in a multiple sclerosis study, the trial participant experienced what Bristol Myers described as “late onset ... motor symptoms” that couldn’t be quelled by steroids and other drugs. The volunteer later developed septic pneumonia and died shortly afterward. Bristol Myers said no other deaths have been observed in that study or any other autoimmune disease trial of zola-cel. It also touted findings suggesting the therapy’s potential to “reset” the immune system in people with MS. Still, the company as well as Novartis previously paused multiple autoimmune cell therapy studies due to safety concerns. The latest disclosure “adds to the safety overhang” surrounding cellular medicines that, like zola-cel, are rapidly manufactured, wrote William Blair analyst Matt Phipps.
The Treasury Department proposed new rules that could complicate U.S. investment in China’s fast-rising biotechnology sector. The draft regulations unveiled Thursday would add biotech to a list of technologies subject to greater federal scrutiny under the “COINS Act.” U.S. investors, for instance, would have to tell the government about certain transactions and would be barred from pursuing others. Yet cross-border drug licensing deals involving China-originated drugs — which have skyrocketed over the last few years — may not be meaningfully affected, according to multiple reports. The Treasury is seeking public comments before finalizing the rules.
Gilead Sciences on Thursday agreed to pay nearly $1.3 billion in cash to acquire an experimental immune disease drug from Shanghai, China-based PepStar Therapeutics. The deal hands Gilead rights to an oral medicine aimed at “IL-23R,” the target of popular treatments like Skyrizi, Tremfya and the recently approved Icotyde. Like Icotyde, PepStar’s treatment HCXT-2001 is a macrocyclic peptide, a kind of intermediate-sized drug with the strengths of small molecules as well as antibodies. HCXT-2001 has an extended half-life, though, which could give it a “differentiated approach,” the company said. The therapy is currently in Phase 1 testing.
Roche has licensed from Zymeworks full rights to a dual-acting antibody drug for lung cancer. The deal announced Friday is centered on a treatment called ZW209, a T cell engager directed at the cancer protein DLL3. Zymeworks and Roche will collaborate on a Phase 1a study, with the Swiss pharmaceutical giant taking over global development afterward. Roche is paying Zymeworks $55 million up front, another $40 million upon the start of a Phase 1b trial and could add a further $718 million should the treatment hit certain development and sales targets.
