cancer
Sources: ImmunityBio's Soon-Shiong mischaracterized FDA talks on bladder cancer drug
The FDA last year refused to consider an application from ImmunityBio — the biotech chaired by billionaire physician Patrick Soon-Shiong — to expand the use of its bladder cancer drug Anktiva. Regulators cited inconclusive clinical data and a filing that ran afoul of regulatory guidelines, STAT’s Adam Feuerstein writes in his weekly Biotech Scorecard newsletter, citing people with knowledge of the FDA’s actions.
Soon-Shiong later mischaracterized a face-to-face meeting with regulators, these people said, while publicly blaming the FDA for derailing the effort.
The standoff comes as the Soon-Shiong company seeks to broaden Anktiva beyond its April 2024 approval for high-risk carcinoma in situ into the much larger papillary bladder cancer market. The move is aimed at fending off Johnson & Johnson’s rival drug Inlexzo, approved last October for the same type of bladder cancer.
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autoimmune disease
Lilly, Repertoire strike $2 billion autoimmune alliance
Eli Lilly has signed a broad collaboration with Flagship-backed Repertoire Immune Medicines to develop a new class of “tolerizing” therapies for autoimmune disease, a deal worth up to $1.93 billion, including $85 million upfront, milestones, and tiered royalties.
The agreement, Repertoire’s third in autoimmune disease and its largest to date, will apply the company’s DECODE platform across multiple indications with the aim of resetting the immune system to stop attacking healthy tissue without broadly suppressing immunity.
The platform-style deal follows earlier autoimmune partnerships with Bristol Myers Squibb and Genentech and underscores growing pharma interest in precision approaches that promise durable remission rather than chronic immune suppression.