• Now dosing at dose expansion level of 450 million NXC-201 CAR+T cells. First cohort at 150 million CAR+T cells already successfully completed
• Each of these two doses have produced complete responses in prior clinical studies
• Lead site Memorial Sloan Kettering Cancer Center (MSKCC); 4 disclosed clinical sites so far
• NXC-201 is the only one-time CAR-T treatment option being studied for relapsed/refractory AL Amyloidosis in U.S. clinical trials
• AL Amyloidosis, a disorder of plasma cells that leads to progressive damage to the heart, kidney and liver, affects approximately 33,000 patients in the U.S.

LOS ANGELES, CA, Oct. 02, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us”, “IMMX”) (Nasdaq: IMMX), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and select immune-mediated diseases, today announced advances in the NEXICART-2 clinical study of its CAR-T NXC-201 for relapsed/refractory AL Amyloidosis, a plasma cell disorder that leads to progressive damage to the heart, kidney and liver, which currently affects approximately 33,000 patients in the U.S. Immix Biopharma’s sterically-optimized CAR-T NXC-201 is the only one-time CAR-T treatment option being studied for relapsed/refractory AL Amyloidosis in U.S. clinical trials.

“We are pleased to report that the NEXICART-2 study is making excellent progress. We are now one step closer to providing a new treatment option for patients with relapsed/refractory AL Amyloidosis, where no FDA drugs are approved today,” said Ilya Rachman, M.D., Ph.D., Chief Executive Officer of Immix Biopharma. “Robust enrollment reflects the enthusiasm of clinical investigators for CAR-T NXC-201.”

“Positive data from our ex-US study of NXC-201, the largest CAR-T clinical study in relapsed/refractory AL Amyloidosis to-date, showed a 92% overall response rate (12/13) and a 28.0 month duration of response (best responder), presented at ASGCT 2024,” said Gabriel Morris, Chief Financial Officer of Immix Biopharma. “We credit the resolute efforts of our investigators, sites, and team as we continue on track for interim and final read-outs.”

The NEXICART-2 study is intended to evaluate the safety and efficacy of NXC-201 in relapsed/refractory AL Amyloidosis patients with adequate cardiac function who have not been exposed to prior BCMA-targeted therapy. Advancement to the second dosing cohort of three patients at 450 million CAR-T cells will dose one patient with NXC-201 every 28-days, subsequently enabling multiple patients to be dosed per month in NEXICART-2.

Each of the NEXICART-2 dose levels have produced complete responses in relapsed/refractory AL Amyloidosis patients in the ex-U.S. NEXICART-1 study presented at ASGCT 2024.

NXC-201 is the only CAR-T therapy currently in development in AL Amyloidosis, mentioned in a review article entitled “Systemic Light Chain Amyloidosis” published in June, 2024 New England Journal of Medicine.

About NEXICART-2

NEXICART-2 (NCT06097832) is an open-label, single-arm, multi-site U.S. Phase 1b/2 dose expansion clinical trial of CAR-T NXC-201 in relapsed/refractory AL Amyloidosis. NEXICART-2 is expected to enroll 40 patients with adequate cardiac function who have not been exposed to prior BCMA-targeted therapy. The study is designed with a standard 6 patient safety run-in to evaluate two doses (three patients each at 150 million CAR+T cells and 450 million CAR+T cells), with dose expansion at 450 million CAR+T cells following. During dose expansion, multiple patients are allowed to be dosed per month. The NXC-201 dosing levels being evaluated in NEXICART-2 study have been evaluated in the NEXICART-1 study and have produced complete responses in relapsed/refractory AL Amyloidosis patients. The study aims to evaluate the safety and efficacy of NXC-201 in this patient population. Primary endpoints are complete response rate and overall response rate, according to consensus recommendations (Palladini et al. 2012).

About NXC-201

NXC-201 is a sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy. Initial NXC-201 clinical data in relapsed/refractory AL Amyloidosis from Phase 1b/2 ex-U.S. study NEXICART-1 has demonstrated a high overall and complete response rate, as well as no neurotoxicity of any kind and short duration of cytokine release syndrome, presented at the American Society of Hematology (ASH) and the American Society of Gene and Cell Therapy (ASGCT) annual meetings.

NXC-201 is being studied in a comprehensive clinical development program for the treatment of patients with relapsed/refractory AL amyloidosis, with the potential to expand into select immune mediated diseases. The NXC-201 NEXICART-2 U.S. clinical trial builds on an existing robust clinical dataset. NXC-201 has been awarded Orphan Drug Designation (ODD) in the US by the FDA and in the EU by the EMA in AL Amyloidosis.

About AL Amyloidosis

AL amyloidosis is caused by abnormal plasma cells in the bone marrow, which produce misfolded amyloid proteins that build-up in the heart, kidney, liver, and other organs. This build-up causes progressive and widespread damage to multiple organs, including heart failure, and leads to high mortality rates.

The U.S. observed prevalence of relapsed/refractory AL Amyloidosis is estimated to be growing at 12% per year according to Staron, et al Blood Cancer Journal, to approximately 33,277 patients in 2024.

The Amyloidosis market was $3.6 billion in 2017, and is expected to reach $6 billion in 2025, according to Grand View Research.

About Immix Biopharma, Inc.

Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and select immune-mediated diseases. Our lead candidate is sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201. NXC-201 is being evaluated in the U.S. Phase 1b/2 trial NEXICART-2 (NCT06097832) as well as the ex-U.S. study NEXICART-1 (NCT04720313). NXC-201 has demonstrated a high overall and complete response rate, as well as no neurotoxicity of any kind and short duration of cytokine release syndrome, presented at the American Society of Hematology (ASH) and the American Society of Gene and Cell Therapy (ASGCT) annual meetings. NXC-201 has been awarded Orphan Drug Designation (ODD) in the U.S. by the FDA and in the EU by the EMA in AL Amyloidosis. Learn more at www.immixbio.com and www.BeProactiveInAL.com.

Forward Looking Statements

This press release contains forward-looking statements regarding Immix Biopharma, Inc., including the potential benefits of our product candidate CAR-T NXC-201. Forward-looking statements include, but are not limited to, our plans, objectives, expectations and intentions and other statements that contain words such as “expects”, “contemplates”, “anticipates”, “plans”, “intends”, “believes”, “estimates”, “potential”, and variations of such words or similar expressions that convey the uncertainty of future events or outcomes, or that do not relate to historical matters. Those forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially. Among those factors are: (i) the risk that the further data from the ongoing Phase 1b/2a clinical trials for CAR-T NXC-201 will not be favorably consistent with the initial data initial data readouts, (ii) the risk that the Company may not be able to advance to registration-enabling studies for CAR-T NXC-201 or other product candidates, (iii) that success in early phases of pre-clinical and clinicals trials do not ensure later clinical trials will be successful; (iv) that no drug product developed by the Company has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (v) the risk that the Company may not be able to obtain additional working capital with which to continue the clinical trials for CAR-T NXC-201, or advance to the initiation of registration-enabling studies, for such product candidates as and when needed and (vii) those other risks disclosed in the section “Risk Factors” included in the Company’s Annual Report on Form 10-K filed with the SEC on March 29, 2024 and other periodic reports subsequently filed with the Securities and Exchange Commission. Immix Biopharma cautions readers not to place undue reliance on any forward-looking statements. Immix Biopharma does not undertake, and specifically disclaims, any obligation to update or revise such statements to reflect new circumstances or unanticipated events as they occur, except as required by law.

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