Celladon aims to reverse the downhill spiral of cardiomyocyte damage in heart failure. Its first product is a form of gene therapy, delivered by a recombinant adeno-associated viral vector, designed to augment SERCA2a-mediated calcium transport in HF patients. The SERCA2a pathway is pivotal in controlling the heart's pumping ability, and numerous studies have correlated heart failure progression with declines in SERCA2a levels.
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The biotech believes its logic-gated cell therapies can get round the need for ‘clean targets’ which limit CAR-Ts and ADCs.
In first confirmatory randomized controlled trial of any CAR-T therapy in solid tumors, CARsgen’s Claudin 18.2-targeting satri-cel reduced risk of death or disease progression by 63% in Chinese patients with gastric/gastroesophageal junction cancer.
Vaccine and accelerated approvals are expected to face greater scrutiny under new CBER leader Vinay Prasad, but he has promised “no light switch change” to policy, giving some reassurance to companies whose share prices have been battered.
The biotech said it will have a type A meeting with the agency to resubmit for the cell therapy’s approval in EBV+ PTLD.
Vaccine and accelerated approvals are expected to face greater scrutiny under new CBER leader Vinay Prasad, but he has promised “no light switch change” to policy, giving some reassurance to companies whose share prices have been battered.
The biotech said it will have a type A meeting with the agency to resubmit for the cell therapy’s approval in EBV+ PTLD.
While CAR-NKs have pivoted towards autoimmune disease, the Norwegian biotech believes its unique platform can deliver in oncology
