Immix Biopharma Surpasses 50% Enrollment Milestone in NEXICART-2 Clinical Trial for AL Amyloidosis, Paving the Way for FDA BLA Submission

Immix Biopharma surpassed 50% enrollment in NEXICART-2 trial for CAR-T therapy targeting relapsed/refractory AL Amyloidosis.

Quiver AI Summary

Immix Biopharma, Inc. announced that it has surpassed the 50% enrollment milestone in its NEXICART-2 clinical trial for its CAR-T cell therapy NXC-201, aimed at treating relapsed/refractory AL Amyloidosis, an orphan indication lacking FDA-approved treatments. The company is moving forward with plans to submit a Biologics License Application (BLA) to the FDA, fueled by positive interim results showcased at the recent ASCO 2025 conference. The ongoing trial is expected to enroll 40 patients and has received both Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug Designation from the FDA and EMA. ImmixBio's CEO highlighted the increasing interest from clinicians and patients, positioning NXC-201 as a promising treatment option for a condition with a growing prevalence expected to affect over 37,000 patients in the U.S. by 2025.

Potential Positives

Expected to become the first FDA-approved cell therapy for the orphan indication of relapsed/refractory AL Amyloidosis, addressing a significant unmet medical need.
Surpassed the 50% enrollment milestone in the NEXICART-2 clinical trial, indicating robust participation and interest among clinicians and patients.
NXC-201, the company's lead candidate, has received both Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug Designation (ODD) from the FDA, enhancing its development prospects.
NEXICART-2 has a registrational design, pointing towards potential expedited pathways for FDA submission and approval.

Potential Negatives

The press release highlights the ongoing risks related to the clinical trials, including the possibility that further data may not align with previous findings.
There is a risk that the company may fail to secure additional funding necessary to continue clinical trials, which could impede progress.
No product has yet received FDA approval, raising concerns about the company's viability and future commercial success.

FAQ

What is the NEXICART-2 clinical trial about?

NEXICART-2 is a Phase 1/2 trial evaluating CAR-T therapy NXC-201 for relapsed/refractory AL Amyloidosis.

What milestone did Immix Bio achieve in the NEXICART-2 trial?

Immix Bio surpassed the 50% enrollment milestone in the NEXICART-2 clinical trial.

What is NXC-201?

NXC-201 is a BCMA-targeted CAR-T cell therapy designed to filter out non-specific activation.

What designations has NXC-201 received?

NXC-201 has received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation (ODD) from the FDA.

Why is AL Amyloidosis significant?

AL Amyloidosis causes severe organ damage and has no FDA-approved treatments, making it a critical area for new therapies.

Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.

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GABRIEL S MORRIS (CFO) has made 2 purchases buying 4,825 shares for an estimated $10,192 and 0 sales.
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Full Release

– On track for first FDA Biologics License Application (BLA) approved cell therapy in orphan indication relapsed/refractory AL Amyloidosis –

Los Angeles, CA, Sept. 18, 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 that 50% enrollment milestone has already been surpassed in NEXICART-2, its relapsed/refractory AL Amyloidosis clinical trial of sterically-optimized CAR-T NXC-201. Immix continues to enroll expediently toward BLA submission.

“With excitement generated by our clinical results presented at ASCO, surpassing 50% enrollment in NEXICART-2 demonstrates the growing interest among relapsed/refractory AL Amyloidosis clinicians and patients, where no drugs are FDA approved today,” said Ilya Rachman, M.D., Ph.D., Chief Executive Officer of Immix Biopharma. Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, “Growing excitement accelerates NEXICART-2 BLA submission for FDA approval, and supports future commercial awareness.”

NEXICART-2 interim results were presented at the American Society for Clinical Oncology (ASCO 2025) by Heather Landau, MD of Memorial Sloan Kettering Cancer Center and 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 can be accessed here .

About NEXICART-2
NEXICART-2 (NCT06097832) is an ongoing multi-site U.S. Phase 1/2 clinical trial of sterically-optimized CAR-T NXC-201 in relapsed/refractory AL Amyloidosis, with a registrational design. Interim results were presented at ASCO 2025 in an oral presentation. NEXICART-2 is expected to enroll 40 patients.

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. 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 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. NEXICART-2 primary endpoint was met at interim results presented at ASCO 2025. 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, causing 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 12% per year according to Staron, et al Blood Cancer Journal, to approximately 37,270 patients in 2025.

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

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
[email protected]

Company Contact
[email protected]