Three deaths halt Novartis CAR T-cell trials in autoimmune diseases

Novartis and Alteogen signed an agreement for global rights to develop subcutaneous versions of Novartis products using Alteogen's ALT-B4 enzyme. The deal includes option fees, milestone payments, and royalties, with a potential value of up to $3.22bn. Alteogen's CEO highlighted Novartis' evaluation of ALT-B4 across multiple modalities. This is Alteogen's fourth such agreement in 2024.

Novartis has licensed Alteogen's ALT-B4 drug delivery tech for up to $3.2bn. The tech allows subcutaneous delivery of drugs normally given intravenously. Alteogen's CEO highlights the platform's commercial value. GSK and AstraZeneca have also licensed the tech for up to $265m and $1.35bn, respectively.

Alteogen, a South Korea-based biotech company, has signed a $3.223 billion deal with Novartis for the development and commercialization of subcutaneous products using its Hybrozyme™ technology. The agreement involves multiple options for Novartis to obtain exclusive rights to develop and commercialize subcutaneous formulations for its products using Alteogen's ALT-B4. Alteogen could receive up to $3.223 million in milestone payments and royalties if all options are exercised and milestones are a

Novartis (NYSE: NVS) paused eight clinical trials of its experimental CAR-T therapy rap-cel after three patient deaths due to severe immune reactions. The trials involve autoimmune and neurological diseases, while cancer studies remain unaffected. Analysts expect limited financial impact, with estimated peak sales of $440 million. The company is reviewing the cases with regulators and independent safety boards.

Novartis and Bristol Myers Squibb paused autoimmune CAR-T trials due to safety concerns. Novartis halted eight studies of Rap-cel after three fatal cases, while BMS paused Zola-cel trials due to reversible inflammatory events. Novartis also entered a $3.223B deal with Alteogen for subcutaneous biologics. RedHill acquired Rebyota and Clenpiq from Ferring for $12M upfront. Experts argue for real-world insights in obesity care strategy.

Novartis and Bristol Myers Squibb have paused trials of their CAR-T cell therapies for autoimmune disorders due to safety concerns. Novartis reported fatal outcomes in three trials of Rap-cel, while Bristol Myers noted reversible inflammatory events in Zola-cel trials. Both companies are reviewing data and engaging with regulators. Analysts suggest faster manufacturing processes may be linked to the issues, affecting multiple biotech companies' stocks.