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Nexcella's Regulatory Plans for NXC-201 Take Shape Amid Positive Multiple Myeloma Readout

NEW YORK – Nexcella on Monday said it is planning to submit a biologics license application (BLA) to the US Food and Drug Administration seeking approval for its autologous BCMA-targeted cell therapy NXC-201 in multiple myeloma after a positive update from a Phase Ib/II trial.

The Los Angeles-based company reported at the International Myeloma Society Annual Meeting in Athens last week that 90 percent of the 50 relapsed or refractory multiple myeloma patients who received the recommended Phase II dose in the trial responded to NXC-201, with more than half, or 58 percent, having a complete response. Among those who had not received prior BCMA-targeted treatment, 95 percent responded to the cell therapy.

Nexcella said it plans to submit a BLA seeking approval for NXC-201 once 100 multiple myeloma patients have been treated in the Phase Ib/II trial.

NXC-201 has also shown a favorable safety profile in clinical trials, which could provide an opportunity to administer the CAR T-cell therapy in the outpatient setting, the company said.

"We feel these overall response rate data are compelling as 72 percent was the overall response rate reported for [Bristol Myers Squibb's Abecma (idecabtagene vicleucel)] from its pivotal 100-patient KarMMa trial in relapsed or refractory multiple myeloma," Polina Stepensky, a principal study investigator and director of Hadassah Medical Organization's department of bone marrow transplantation and immunotherapy for adults and children, said in a statement. "Additionally, we believe NXC-201 has demonstrated promise in the rapidly growing segment of BCMA-exposed relapsed or refractory multiple myeloma patients who are frequently excluded from CAR-T clinical trials."

Last year, Nexcella, a subsidiary of Immix Biopharma, licensed NXC-201 from Hadassah Medical Organization in Israel. The firm is also developing NXC-201 as a treatment for primary amyloidosis, a bone marrow disorder.