- 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) -- Immix Biopharma, Inc. (“ImmixBio”, “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, Chief Executive Officer of Immix Biopharma. “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, Chief Financial Officer, Immix Biopharma. “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 Immix Biopharma, Inc.
Immix Biopharma, Inc. (“ImmixBio”) (Nasdaq: IMMX) is a clinical-stage biopharmaceutical company pioneering personalized therapies for oncology and immunology. Our lead CAR-T cell therapy asset, NXC-201, is being developed for relapsed/refractory AL Amyloidosis and relapsed/refractory multiple myeloma. Across 72 patients, response rates of 95% and 100% have been observed from the Phase 1b/2a NEXICART-1 (NCT04720313) study in patients with multiple myeloma and AL amyloidosis, respectively (July 17, 2023). NXC-201 has the potential to be the world’s first out-patient CAR-T. NXC-201 has been awarded Orphan Drug Designation (ODD) by the FDA in both multiple myeloma and AL Amyloidosis. Our lead Tissue Specific Therapeutic (TSTx) asset, IMX-110, is in Phase 1b/2a clinical trials as a monotherapy and IMMINENT-01 (NCT05840835) combination clinical trial with BeiGene’s anti-PD-1 antibody tislelizumab. IMX-110 has been awarded ODD and Rare Pediatric Disease Designation (RPDD) by the FDA. Learn more at www.immixbio.com .
About Nexcella, Inc.
Nexcella, Inc., a subsidiary of Immix Biopharma, Inc. (NASDAQ:IMMX), 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
This press release contains “forward-looking statements.” Forward-looking statements reflect our current view about future events. When used in this press release, the words “anticipate,” “believe,” “estimate,” “expect,” “future,” “intend,” “plan,” or the negative of these terms and similar expressions, as they relate to us or our management, identify forward-looking statements. Such statements, include, but are not limited to, statements contained in this press release relating to our business strategy, our future operating results, continuing development of our product candidates, including development timelines, timing of FDA submissions and expected endpoints, long-term visions and strategies, evaluations and judgements and beliefs regarding potential efficacy and safety of our product candidates, future clinical development of our product candidates, including any implication that results or observations in initial data, data observed to date, or earlier clinical trials will be representative of results or observations in later data or clinical trials, the expected timing of such results and the potential market size and benefits for our product candidates. Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated by the forward-looking statements. They are neither statements of historical fact nor guarantees of assurance of future performance. We caution you, therefore, against relying on any of these forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, without limitation, our ability to raise capital to fund continuing operations; our ability to protect our intellectual property rights; the impact of any infringement actions or other litigation brought against us; competition from other providers and products; our ability to develop and commercialize products and services; changes in government regulation; our ability to complete capital raising transactions; that our product candidates may not realize the anticipated responses discussed in this release or that their development may suffer delays that materially and adversely affects future commercial viability; that the market for our product candidates may not grow at the rates anticipated or at all; and other factors relating to our industry, our operations and results of operations. Actual results may differ significantly from those anticipated, believed, estimated, expected, intended or planned, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Immix Biopharma’s Annual Report on Form 10-K for the year ended December 31, 2022, and other periodic reports subsequently filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and we specifically disclaim any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We cannot guarantee future results, levels of activity, performance or achievements.
Contacts:
Mike Moyer
LifeSci Advisors
mmoyer@lifesciadvisors.com
Company Contact:
irteam@immixbio.com
