Immix Biopharma expands clinical sites in the US for NEXICART-2 study in relapsed/refractory AL amyloidosis

• New locations expand patient access and registration options

• Added clinical trial sites include Cleveland Clinic, UC Davis and Sutter Health

• Lead site Memorial Sloan Kettering Cancer Center (MSKCC)

• Data from a clinical trial outside the US presented at ASGCT 2024 showed an overall response rate of 92%

LOS ANGELES, CA, Aug. 28, 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 immune-mediated diseases, today announced the addition of three additional clinical trial sites for its U.S. NEXICART-2 clinical trial in relapsed/refractory AL amyloidosis. The newly added sites include some of the world's leading programs in AL amyloidosis. New sites expand opportunities for patient access to CAR-T NXC-201 in the U.S. MSKCC remains the lead clinical site.

The NEXICART-2 study is designed to evaluate the safety and efficacy of CAR-T NXC-201 in patients with relapsed/refractory AL amyloidosis with adequate cardiac function who have not been previously exposed to BCMA-targeted therapy. The study builds on positive data from the first study outside the US, NEXICART-1, presented at the 27th Annual Meeting of the American Heart Association (AHA).^th American Society of Gene and Cell Therapy Annual Meeting (ASGCT 2024) showing an overall response rate of 92% in patients with relapsed/refractory AL amyloidosis (12/13). The patient with the best response had a duration of response of 28.0 months (reported May 10, 2024).

“As part of our mission to advance treatment options for patients with relapsed/refractory AL amyloidosis, we are proud to expand our presence nationally in the NEXICART-2 clinical trial with the addition of these world-class sites and exceptional principal investigators,” said Ilya Rachman, MD, Ph.D., Chief Executive Officer of Immix Biopharma. Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, “In collaboration with our outstanding team and partners, these additional sites support the upcoming interim and final results of NEXICART-2.”

NXC-201 is the only CAR-T therapy currently in use to treat AL amyloidosis. review Article justified “Systemic light chain amyloidosis” published in June 2024 New England Journal of Medicine.

About NEXICART-2
NEXICART-2 (NCT06097832) is a US Phase 1b/2, open-label, single-arm, multicenter, dose expansion study of CAR-T NXC-201 in relapsed/refractory AL amyloidosis. NEXICART-2 is planned to enroll 40 patients with adequate cardiac function who have not been previously exposed to BCMA-targeted therapy. The study is designed as a standard safety run with 6 patients to test two doses (three patients each with 150 million CAR+T cells and 450 million CAR+T cells), with the possibility of further escalation to 800 million CAR+T cells (all 3 dose levels were tested in the NEXICART-1 study and resulted in complete responses in patients with relapsed/refractory AL amyloidosis). The objective of the study is 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 NEXICART-1
NEXICART-1 (NCT04720313) is an open-label, non-US Phase 1b/2 clinical trial of NXC-201 (formerly HBI0101) in patients with relapsed/refractory multiple myeloma and relapsed/refractory AL amyloidosis (including AL amyloidosis patients with compromised cardiac function and including AL amyloidosis patients who have previously received BCMA-targeted therapy). The primary objective of the trial is to characterize the safety and efficacy and to confirm the recommended Phase 2 dose (RP2D) of NXC-201 (which has already been confirmed). Clinical results from NEXICART-1, most recently from ASGCT 2024, are available at https://immixbio.com/pipeline/#publications.

About NXC-201
NXC-201 is a sterically optimized BCMA-targeted chimeric antigen receptor T cell therapy (CAR-T). Initial data from the Phase 1b/2 NEXICART-1 study outside the US have shown no neurotoxicity in AL amyloidosis.

NXC-201 is being investigated in a comprehensive clinical development program for the treatment of patients with relapsed/refractory AL amyloidosis and may also potentially be expanded to immune-mediated diseases. The US clinical trial of NXC-201 NEXICART-2 (NCT06097832) is based on a robust clinical dataset. NXC-201 has been granted Orphan Drug Designation (ODD) for AL amyloidosis by the US FDA and in the EU by the EMA.

About AL Amyloidosis
AL amyloidosis is caused by abnormal plasma cells in the bone marrow that produce misfolded amyloid proteins that accumulate in the heart, kidneys, liver, and other organs. This accumulation causes progressive and widespread damage to multiple organs, including heart failure, and results in high mortality rates.

According to Staron et al. (Blood Cancer Journal), the observed prevalence of relapsed/refractory AL amyloidosis in the United States is estimated to increase by 12% per year and will amount to approximately 33,277 patients in 2024.

According to Grand View Research, the amyloidosis market was valued at $3.6 billion in 2017 and is expected to reach $6 billion by 2025.

About Immix Biopharma, Inc.
Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is a clinical-stage biopharmaceutical company developing cell therapies for AL amyloidosis and immune-mediated diseases. Our lead candidate is the sterically optimized BCMA-targeted chimeric antigen receptor T-cell therapy (CAR-T), NXC-201. NXC-201 is being evaluated in the US Phase 1b/2 NEXICART-2 trial (NCT06097832) and the non-US NEXICART-1 trial (NCT04720313). NXC-201 has demonstrated no neurotoxicity in AL amyloidosis and short-duration cytokine release syndrome (CRS), supporting expansion to immune-mediated diseases. NXC-201 has been granted Orphan Drug Designation (ODD) for AL amyloidosis by the US FDA and in the EU by the EMA. For more information, see www.immixbio.com And www.BeProactiveInAL.com.

Forward-looking statements
This press release contains forward-looking statements concerning Immix Biopharma, Inc., its results of operations, prospects, future business plans and operations and the matters discussed above, including, but not limited to, the receipt, timing of receipt, finalization of terms and allocation of funds related to the grant discussed above and the potential benefits of our product candidate CAR-T NXC-201. These statements involve risks and uncertainties and actual results may differ materially from any future results expressed or implied by the forward-looking statements. Forward-looking statements also 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 express the uncertainty of future events or results or that do not relate to historical matters. These forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially. These factors include: (i) the risk that additional data from ongoing Phase 1b/2 clinical trials for CAR-T NXC-201 will not be in positive agreement with the initial data, (ii) the risk that the Company will not be able to advance to registrational trials for CAR-T NXC-201 or other product candidates, (iii) that success in early stage preclinical and clinical trials does not guarantee success in later clinical trials; (iv) that no drug product developed by the Company has received pre-market approval from the FDA or has otherwise been incorporated into a commercial drug product, (v) the risk that the Company may not be able to raise additional working capital to continue clinical trials for CAR-T NXC-201 or to proceed with pivotal studies for such product candidates, if required, and (vii) those other risks set forth in the “Risk Factors” section of 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, which reports are available at www.sec.gov. Immix Biopharma cautions that the foregoing list of important factors is not exhaustive. Immix Biopharma cautions readers not to place undue reliance on forward-looking statements. Immix Biopharma undertakes no obligation, and expressly disclaims any obligation, to update or revise any such statements to reflect new circumstances or unanticipated events as they arise, except as required by law. If we update one or more forward-looking statements, this should not be construed as an update to that or any other forward-looking statements.

Contacts
Michael Moyer
LifeSci Consultant
[email protected]

Company contact
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