Nexcella Completes 2nd NXC-201 Engineering Batch at its U.S. CAR-T Manufacturing Site
News provided byNexcella, Inc.
Sep 19, 2023, 9:15 AM ET
- Successful completion supports expansion of its ongoing NEXICART-1 (NCT04720313) NXC-201 CAR-T clinical trial to the U.S.
- Plan for NXC-201 to expand into earlier lines of therapy, and beyond the 5% of U.S. hospitals that offer CAR-T today
LOS ANGELES, Sept. 19, 2023 (GLOBE NEWSWIRE) -- Nexcella, Inc. (“Nexcella”, “Company”, “We” or “Us”), a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, today announced the successful completion of its 2nd CAR-T NXC-201 engineering batch at its U.S. manufacturing site. This represents an important step forward in the planned U.S. expansion of the Company’s ongoing Phase 1b/2a NEXICART-1 (NCT04720313) study of its novel BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201.
“The completion of our 2nd U.S. engineering batch is a key step towards expanding our NXC-201 clinical trial to the United States,” said Ilya Rachman, M.D. PhD Executive Chairman of Nexcella. “Not only is NXC-201 the first CAR-T in AL amyloidosis, in addition we believe NXC-201’s observed zero neurotoxicity and favorable tolerability profile across 58 patients to-date could enable expansion into earlier lines of therapy and out-patient NXC-201 dosing.”
“Today, CAR-T cell therapies generate greater than $3 billion of annualized sales, even though due to side effects, they are dosed in only 5% of U.S. hospitals,” said Gabriel Morris, President of Nexcella. “We believe NXC-201 will overcome the neurotoxicity and side effect barrier to expand CAR-Ts into to the remaining 95% of the market.”
About Nexcella, Inc.
Nexcella, Inc., is a Los Angeles, California based clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications. Our lead candidate, next generation BCMA-targeted CAR-T NXC-201 for relapsed/refractory multiple myeloma and relapsed/refractory AL amyloidosis, has produced 92% and 100% response rates in each indication, respectively, as of February 9, 2023, across 58 patients. We believe NXC-201 has potential to be the world’s first outpatient CAR-T. Our N-GENIUS platform allows us to discover, develop, and manufacture cutting-edge cell therapies for patients in need. To learn more about Nexcella, Inc. visit us at www.nexcella.com
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