Immix Biopharma Announces Positive Results for NXC-201 at ASCO Oral Presentation, Enabling Pathway to Best-in-Class Therapy for relapsed/refractory AL Amyloidosis
- 71% complete response rate (5/7 patients) significantly exceeds current treatment outcomes (<10% CR)
- No relapses recorded to date in any patients
- Remaining 2 patients achieved bone marrow MRD negativity, suggesting potential future CRs
- Favorable safety profile with no neurotoxicity and only low-grade cytokine release syndrome
- FDA RMAT designation already received, potentially accelerating approval pathway
- Small patient sample size (only 7 patients) in current data set
- Early-stage trial (Phase 1/2) with interim results only
Insights
Immix's NXC-201 cell therapy shows remarkable 71% complete response rate in relapsed/refractory AL Amyloidosis, vastly outperforming current treatments.
Immix Biopharma's ASCO abstract results for NXC-201 represent a potential breakthrough in treating relapsed/refractory AL Amyloidosis, a rare and often fatal protein deposition disease. The reported 71% complete response (CR) rate (5/7 patients) dramatically exceeds the typical <10% CR rates with current therapies, highlighting significant efficacy in heavily pre-treated patients (median 4 prior therapies).
The cell therapy demonstrated impressive response quality beyond the high CR rate: the remaining two patients achieved bone marrow minimal residual disease (MRD) negativity at a sensitivity of 10-6, suggesting they may convert to complete responses in upcoming assessments. All patients showed normalization of pathological disease markers, with downstream improvements in cardiac and renal function following response.
From a safety perspective, the data is equally compelling: no neurotoxicity was observed – notable since neurotoxicity is a common concern with CAR-T therapies. Only low-grade cytokine release syndrome occurred, lasting less than 24 hours, with no safety signals identified. The absence of relapses to date further strengthens NXC-201's clinical profile.
The FDA RMAT (Regenerative Medicine Advanced Therapy) designation mentioned in the release provides regulatory validation and potentially expedited review pathways. This designation is reserved for cell therapies showing preliminary evidence of addressing unmet needs in serious conditions.
What makes these results particularly meaningful is the challenging patient population: individuals with relapsed/refractory disease who have exhausted multiple prior treatment options. The data suggests NXC-201 could transform the treatment paradigm for a disease with limited effective options currently available.
Immix Biopharma today reported ASCO abstract results from its U.S. multi-center NEXICART-2 Phase 1/2 clinical trial of NXC-201 demonstrating strong efficacy and favorable safety.
– NXC-201 demonstrated a complete response (CR) rate of
– No relapses recorded to-date; no safety signals identified –
– Updated results with a later data cutoff, including endpoint analysis, will be presented at ASCO by lead investigator Heather Landau, MD, of Memorial Sloan Kettering Cancer Center –
– KOL event to discuss significance Tuesday, June 3, 2025 3:00pm ET after ASCO presentation: https://lifescievents.com/event/immix-asco –
LOS ANGELES, CA, May 22, 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 publication of cell therapy NXC-201 Abstract #7508, selected for oral presentation at the 2025 American Society of Clinical Oncology Annual Meeting (ASCO 2025) being held in Chicago, Illinois. The abstract summarizes positive results from the U.S. multi-site NEXICART-2 trial evaluating NXC-201 in relapsed/refractory AL Amyloidosis with a data cutoff of January 28, 2025.
On June 3, 2025 Heather Landau, MD of Memorial Sloan-Kettering Cancer Center in New York will present further updated results at ASCO oral presentation in Chicago, IL. A Key Opinion Leader (KOL) event to discuss the significance will be held Tuesday, June 3, 2025 3:00pm ET with live Q&A (register here to participate).
“We are beyond thrilled with the strength of these results. I believe these results could transform the paradigm of relapsed/refractory AL Amyloidosis treatment,” said Ilya Rachman, MD, PhD, Chief Executive Officer of Immix Biopharma. Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, “Recent NXC-201 FDA RMAT designation and ASCO interim readout demonstrate our progress toward completion of NEXICART-2 enrollment and BLA submission.”
Immix’s Phase 1/2 NEXICART-2 clinical trial is a U.S. multi-site, single-arm study to evaluate the efficacy and safety of NXC-201 in patients who are refractory to, or relapse on treatment for relapsed/refractory AL Amyloidosis.
ASCO Abstract Results
Prior to NXC-201 treatment, the median lines of therapy was 4 (range: 2-9). All patients had baseline relapsed/refractory AL Amyloidosis organ involvement. After NXC-201 treatment, all patients normalized pathological disease markers. Complete responses (CRs) were observed in
Current treatments typically result in a lower than
Updated NXC-201 results with a later data cutoff, including endpoint analysis, will be presented on June 3, 2025 by lead investigator Heather Landau, MD, of Memorial Sloan Kettering Cancer Center:
Upcoming ASCO Presentation
| Title | “Safety and efficacy data from NEXICART-2, the first US trial of CAR-T in R/R light chain (AL) amyloidosis, NXC-201” |
| Presentation Date/Time |
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KOL Event to Discuss NXC-201 ASCO Clinical Data Presentation
A Key Opinion Leader (KOL) event with lead investigator Heather Landau, MD, of Memorial Sloan Kettering Cancer Center, Shahzad Raza, MD of Cleveland Clinic and Jeffrey Zonder, MD of Karmanos Cancer Center will be held subsequently Tuesday, June 3, 2025 at 3:00 pm ET to discuss these results. Register here: https://lifescievents.com/event/immix-asco.
About NEXICART-2
NEXICART-2 (NCT06097832) is an ongoing single-arm multi-site U.S. Phase 1/2 clinical trial of sterically-optimized CAR-T NXC-201 in relapsed/refractory AL Amyloidosis. NEXICART-2 is expected to enroll 40 patients with preserved heart function (excluding patients with pre-existing heart failure) who have not been exposed to prior BCMA-targeted therapy. The primary endpoint of the Phase 1 portion is safety. The primary endpoint of the Phase 2 portion is efficacy.
About NXC-201
NXC-201 is a sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy with a “digital filter” that filters out non-specific activation. Initial data from ex-U.S. study NEXICART-1 has demonstrated high complete response rates in relapsed/refractory AL Amyloidosis. U.S. Phase 1/2 study NEXICART-2 is ongoing. NXC-201 has been awarded Regenerative Medicine Advanced Therapy (RMAT) by the FDA, and Orphan Drug Designation (ODD) 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, 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
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. NXC-201 is being evaluated in the U.S. multi-center study NEXICART-2 (NCT06097832). NXC-201 has demonstrated no neurotoxicity in AL Amyloidosis, supporting expansion into other serious diseases. 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.
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
What are the key results from IMMX's NXC-201 trial for AL Amyloidosis?
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