Immix Biopharma Announces Class-Leading Safety Profile, Allowing Potential Future Indication Expansion
Rhea-AI Summary
Immix Biopharma (NASDAQ:IMMX) announced promising safety data for its CAR-T therapy NXC-201, highlighting the absence of neurotoxicity in low-volume disease cases. The company is advancing its NEXICART-2 clinical trial towards a Biologics License Application (BLA) for treating relapsed/refractory AL Amyloidosis.
The therapy's favorable safety profile positions NXC-201 for potential expansion into other immune-mediated and serious diseases. Interim results were presented at ASCO 2025 by Dr. Heather Landau of Memorial Sloan Kettering Cancer Center, with the company maintaining focus on BLA submission for FDA approval.
Positive
- Zero neurotoxicity of any grade observed in low-volume disease cases
- Potential for indication expansion beyond AL Amyloidosis
- Progress towards first approved CAR-T cell therapy for orphan indication AL Amyloidosis
Negative
- Clinical trial still ongoing with only interim results available
- Limited data focused only on low-volume disease cases
News Market Reaction – IMMX
On the day this news was published, IMMX declined 2.21%, reflecting a moderate negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
– Absence of neurotoxicity of any grade in low-volume disease to-date –
– On track for first Biologics License Application (BLA) approved cell therapy in orphan indication relapsed/refractory AL Amyloidosis –
– Potential future indication expansion planned –
LOS ANGELES, July 11, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” or ”IMMX”), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases, today announced a class-leading safety profile for sterically-optimized CAR-T NXC-201, including absence of neurotoxicity of any grade in low-volume disease to-date, laying a foundation for potential future indication expansion.
“We are singularly focused on completing NEXICART-2 for BLA submission, where we are accelerating progress. Separately and subsequently, for potential future expansion directions, we believe NXC-201 will be able to address a range of immune-mediated and other serious diseases,” said Ilya Rachman, M.D., Ph.D., Chief Executive Officer of Immix Biopharma. Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, “Our near-term efforts are laser- focused on our path to NEXICART-2 BLA submission for FDA approval.”
NEXICART-2 interim results, including safety results, were presented at the American Society for Clinical Oncology (ASCO 2025) by Heather Landau, MD of Memorial Sloan Kettering Cancer Center can be accessed on the Company’s website under publications (ASCO Post article and video, MSKCC article, Cleveland Clinic article). A webcast of the Company’s Key Opinion Leader (KOL) event to discuss the NXC-201 ASCO 2025 interim results, including safety results, can be accessed here.
About Immix Biopharma, Inc.
Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases. Our lead candidate is sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201 with a “digital filter” that filters out non-specific activation. NXC-201 is being evaluated in the U.S. multi-center study for relapsed/refractory AL Amyloidosis NEXICART-2 (NCT06097832), with a registrational design. Interim results were presented at ASCO 2025 in an oral presentation by Heather Landau, M.D. of Memorial Sloan Kettering Cancer Center. NXC-201 has been awarded Regenerative Medicine Advanced Therapy (RMAT) by the US FDA and Orphan Drug Designation (ODD) by FDA and in the EU by the EMA. Learn more at www.immixbio.com and www.BeProactiveInAL.com.
About AL Amyloidosis
AL amyloidosis is caused by abnormal plasma cells in the bone marrow, which produce misfolded amyloid proteins that circulate in the blood, then build-up in the heart, kidney, liver, and other organs. This build-up causes progressive and widespread organ damage, including heart and renal failure, leading to high mortality rates.
The U.S. observed prevalence of relapsed/refractory AL Amyloidosis is estimated to be growing at
The Amyloidosis market was
Forward Looking Statements
This press release contains forward-looking statements regarding Immix Biopharma, Inc., its results of operations, prospects, future business plans and operations and the matters discussed above, including, but not limited to, the potential benefits of our product candidate CAR-T NXC-201 and the timing and results related clinical trials. 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 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 1/2 clinical trials for CAR-T NXC-201 will not be favorably consistent with the data readouts to date, (ii) the risk that the Company may not be able to continue the NEXICART-2 multi-site U.S. Phase 1/2 clinical trial; (iii) the risk that the Company may not be able to advance to registration-enabling studies for CAR-T NXC-201 or other product candidates, (iv) that success in early phases of pre-clinical and clinicals trials do not ensure later clinical trials will be successful; (v) that no drug product developed by the Company has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (vi) 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 25, 2025 and other periodic reports subsequently filed with the Securities and Exchange Commission. These reports are available at www.sec.gov. Immix Biopharma cautions that the foregoing list of important factors is not complete. 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. If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements.
Contacts
Mike Moyer
LifeSci Advisors
mmoyer@lifesciadvisors.com
Company Contact
irteam@immixbio.com
FAQ
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