Nexcella, Inc.  a clinical-stage biopharmaceutical company trailblazing cell therapies in AL Amyloidosis and autoimmune disease, today announced that the California Institute for Regenerative Medicine (CIRM) has awarded Nexcella an $8 million CLIN2 grant award to support clinical development of its chimeric antigen receptor T cell (CAR-T) therapy NXC-201 for the treatment of relapsed/refractory AL Amyloidosis.

“AL amyloidosis is an unmet medical need, and current approved therapies for this rare disease are mostly not well tolerated and have not led to sustained remissions,” said Dr. Abla Creasey, PhD, Vice President of Therapeutics Development at CIRM. “This one-time therapy would be an innovative treatment for patients with AL Amyloidosis, and the preliminary data are encouraging.”

“We are grateful for the recognition from CIRM of the importance of NXC-201 in relapsed/refractory AL Amyloidosis, for which there are no FDA approved drugs today,” said Ilya Rachman, M.D., Ph.D., Executive Chairman of Nexcella. Gabriel Morris, President of Nexcella, added, “We are excited to join California’s thriving CIRM biotechnology innovation ecosystem as we proceed on-plan with NEXICART-2.”

The NEXICART-2 U.S. study is intended to evaluate the safety and efficacy of NXC-201 in relapsed/refractory AL Amyloidosis patients with adequate cardiac function who have not been exposed to prior BCMA-targeted therapy. The study builds on positive data from the initial ex-U.S. study, NEXICART-1, presented at the 27^th Annual Meeting of The American Society of Gene and Cell Therapy (ASGCT 2024) which showed a 92% overall response rate in relapsed/refractory AL Amyloidosis patients (12/13). The best responder experienced a 28.0 month duration of response (as reported May 10, 2024, with ongoing follow-up).