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Novel cell therapy granted FDA approval for use as investigational new drug

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Nexcella cell therapy

Nexcella has announced FDA approval of IND application for a novel cell therapy, paving the way for its first US patient dosing.

The US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for a new cell therapy drug. that aims  (formerly HBI0101).

The drug, called BCMA CAR-T NXC-201, is developed by Nexcella, a clinical-stage biopharmaceutical company which develops novel cell therapies for oncology and other indications.

With this clearance, NEXICART-2 (NCT06097832) is to expand studies of NXC-201 in relapsed/refractory AL Amyloidosis to the United States. Depending on its tolerability, there is the potential for expansion into autoimmune indications such as systemic lupus erythematosus (SLE), myasthenia gravis (MG) and multiple sclerosis (MS).

“Building on encouraging NXC-201 clinical data to date, we are thrilled that multiple leading U.S. sites are currently planning to enrol patients in the coming months,” said Ilya Rachman, MD PhD, executive chairman of Nexcella. “No approved treatment options currently exist for relapsed/refractory AL Amyloidosis patients.”

72 patients have been dosed – nine in AL Amyloidosis, 63 in multiple myeloma – with NXC-201.  Relapsed/refractory AL Amyloidosis dose escalation levels demonstrated a 100 per cent overall response rate amongst the nine patients.  For multiple myeloma, results demonstrated a 95 per cent overall response rate.

“We credit our world-class cell-therapy expert team in achieving this IND clearance in line with our previously communicated timelines,” said Gabriel Morris, president of Nexcella. “NXC-201’s favourable tolerability profile, including overcoming neurotoxicity, potentially enables expansion beyond AL Amyloidosis into autoimmune indications.”

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