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A Cellectis Trial Death Points To Challenges Ahead For CAR-T

 
• By Jessica Merrill

Excitement over the emerging cancer immunotherapy approach has been super-charged in recent weeks, but Cellectis said it will put two trials on hold after a patient death, a problem seen with similar products.

Stop barrier

Cellectis SA is one of the companies that has benefited from investor enthusiasm over chimeric antigen receptor T cell (CAR-T) therapy in the last week, but its clinical-stage development program has been hit with a reality check. The company announced Sept. 4 that FDA placed a clinical hold on two Phase I studies testing its lead CAR-T candidate UCART 123 after a patient death was reported in one of the trials.

"Cellectis is working closely with the investigators and the FDA in order to resume the trials with an amended protocol...

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Actithera Raises $75m To Enter Competitive FAP-Targeting Radioligand Field

 
• By Andrew McConaghie

While companies such as Eli Lilly and Roche have faced setbacks to their fibroblast activation protein-targeting oncology therapies, Actithera believes its radiopharmaceuticals platform will prove more successful.

Stock Watch: US CAR-T And Vaccine Actions: Net Negative For Access

 
• By Andy Smith

Relaxing CAR-T restrictions may not be an access panacea because of patient fragility and lack of payer incentive. Conversely, the ACIP’s recent recommendation on Thiomersal-containing flu vaccines is probably the thin edge of a more restrictive wedge.

Cogent Peaks With Bezaclastinib SUMMIT Results

 
• By Alaric DeArment

The biotech announced positive topline results from the Phase II SUMMIT study in non-advanced systemic mastocytosis, with data for advanced SM and GIST expected later this year.