Immix Biopharma Subsidiary Nexcella Completes 2nd NXC-201 Engineering Batch at its U.S. CAR-T Manufacturing Site

Rhea-AI Summary

Immix Biopharma successfully completes 2nd CAR-T NXC-201 engineering batch, supporting expansion of NEXICART-1 clinical trial to the US. Plans to expand into earlier lines of therapy and beyond 5% of US hospitals that offer CAR-T. NXC-201 shows zero neurotoxicity and favorable tolerability profile. CAR-T therapies generate over $3 billion in annual sales, NXC-201 aims to overcome side effects and expand into the remaining 95% of the market.

Positive

• Successful completion of engineering batch supports expansion of clinical trial
• NXC-201 shows zero neurotoxicity and favorable tolerability profile
• Potential to expand into earlier lines of therapy and increase market share

Negative

• None.

• 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 2^nd 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 2^nd 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
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Contacts:
Mike Moyer
LifeSci Advisors
mmoyer@lifesciadvisors.com

Company Contact:
irteam@immixbio.com