Nexcella, Inc. (“Nexcella”, “Company”, “We” or “Us”) today announced the successful completion of its 3rd engineering batch of BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201 at its U.S. manufacturing site.
- Successful completion supports expansion of its ongoing NEXICART-1 (NCT04720313) NXC-201 CAR-T clinical trial to the U.S.
- NXC-201 is manufactured at our state-of-the-art cellular immunotherapy manufacturing facility in California
LOS ANGELES, Oct. 16, 2023 (GLOBE NEWSWIRE) -- Nexcella, Inc. (“Nexcella”, “Company”, “We” or “Us”) today announced the successful completion of its 3rd engineering batch of BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201 at its U.S. manufacturing site.
NXC-201 will be manufactured for each individual patient using the patient’s own T cells at our state-of-the-art cellular immunotherapy manufacturing facility in California.
“We believe the completion of our 3rd U.S. engineering batch represents an important threshold to demonstrate our U.S. manufacturing capability for NXC-201 IND submission in the United States,” said Ilya Rachman, M.D. PhD, Executive Chairman of Nexcella. “NXC-201’s 100% observed overall response rate across 9 relapsed/refractory AL Amyloidosis patients, where NXC-201 has received orphan drug designation from the FDA, makes this an important milestone in bringing NXC-201 to U.S. patients.”
“Today, CAR-T cell therapies generate greater than $3 billion of annualized sales, even though due to neurotoxicity and side effects, they are dosed in only 5% of U.S. hospitals,” said Gabriel Morris, President of Nexcella. “NXC-201 has been dosed in a large number of patients across released/refractory AL amyloidosis and relapsed/refractory multiple myeloma. We believe NXC-201 could offer hope to those on waiting lists for CAR-T cell therapies, and potentially become the first out-patient CAR-T expanding into to the remaining 95% of U.S. hospitals.”
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 95% and 100% response rates in each indication, respectively, as of July 17, 2023, across 72 patients. NXC-201 has been awarded Orphan Drug Designation (ODD) by the FDA in both multiple myeloma and AL Amyloidosis. 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
Forward Looking Statements
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Contacts:
Mike Moyer
LifeSci Advisors
mmoyer@lifesciadvisors.com
Company Contact:
irteam@nexcella.com
