- 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) — Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us”), a clinical-stage biopharmaceutical company pioneering personalized therapies for oncology and immunology, 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 Chief Executive Officer of Immix Biopharma. “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, Chief Financial Officer, Immix Biopharma. “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., 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 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
About Immix Biopharma, Inc.
Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is a clinical-stage biopharmaceutical company pioneering personalized therapies for oncology and immunology including CAR-T cell therapies and Tissue Specific Therapeutics (TSTx). Our lead CAR-T cell therapy asset, NXC-201, is being developed for relapsed/refractory AL Amyloidosis and relapsed/refractory multiple myeloma. Initial response rates of 92% and 100% have been observed from the Phase 1b/2a NEXICART-1 (NCT04720313) study in patients with multiple myeloma and AL amyloidosis (February 9, 2023). NXC-201 is being developed by ImmixBio’s subsidiary Nexcella, Inc and has the potential to be the world’s first out-patient CAR-T. Our lead Tissue Specific Therapeutic (TSTx) asset, IMX-110, is in Phase 1b/2a clinical trials as a monotherapy and in the IMMINENT-01 combination clinical trial with BeiGene’s anti-PD-1 antibody tislelizumab (NCT05840835). IMX-110 has been awarded Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) by the FDA. Learn more at www.immixbio.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 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 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.
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