Genetic Clues Reveal Cell Therapy Toxicity Risks; Summit Faces Key FDA Decision
This week, PharmaVoice highlights three major developments: a new study based on Yescarta clinical trial data identifies genes associated with cytokine toxicity, offering clues for designing safer CAR-T therapies; Summit's bispecific antibody ivonescimab has about a 67% probability of FDA approval on the Kalshi prediction market; additionally, Curium is reportedly in advanced talks to acquire Lantheus for approximately $7 billion.

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New genetic clues behind cell therapy toxicity
CAR-T cell therapy is a boon for patients with certain types of blood cancer, but these treatments come with challenges, with dangerous side effects being particularly prominent. A new study reveals that genes may play a key role in toxicity risk.
Researchers used clinical trial data from Kite Pharma's approved CAR-T therapy Yescarta toidentifyspecific genes associated with enhanced production of inflammatory cytokines—cytokine release being a common side effect of these therapies. The study also identified genes that may have a protective effect against toxicity, opening potential pathways for designing safer treatments.
Meanwhile, off-the-shelf CAR-T therapies are moving from the clinical stage toward the market, with lower production costs and complexity than approved autologous products. However, these therapies may not directly compete with autologous options. This week we exploredthe role off-the-shelf therapies might play in the CAR-T landscape。
Prediction market gives odds on Summit's cancer drug
Summit Therapeutics'highly anticipatedbispecific cancer drug ivonescimab—what are the chances of FDA approval? According to Kalshi'sprediction marketdata, the probability is about 67%.
This online betting company expanded its business from elections and sports to clinical trial results this month, launching markets tied to thefate of more than a dozen drugs in late-stage developmentBut Kalshi's foray into drug development has not been without opposition.
This week, we delved into the arguments for and againstonline betting on prediction markets in pharma R&D。
Radiopharmaceutical deal rumors surface
Market rumors suggest that two competitors in the radiopharmaceutical space may soon tie the knot.
According to Bloombergreported this weekciting internal sources, Curium is in advanced talks to acquire Lantheus Holdings. If the deal goes through, the merger of these radiopharmaceutical therapy and diagnostics companies could ultimately be valued at around $7 billion.
If finalized, the deal would join a recent string of transactions in the field—with large pharma companies being particularly active in this area in recent years. This week we looked atRegeneron's search for radiopharmaceutical deals, and why Telix Pharmaceuticals ultimately came into its sights.