Immix Biopharma expands NEXICART-2 trial sites to 18, aiming for FDA approval of its CAR-T therapy for AL Amyloidosis.
Quiver AI Summary
Immix Biopharma, Inc. has announced significant progress in its NEXICART-2 clinical trial for relapsed/refractory AL Amyloidosis, now expanding to 18 trial sites across the U.S. This acceleration aims to address the unmet medical needs of patients in this area, where FDA-approved treatments are currently lacking. Interim results from the trial were presented at the ASCO 2025 conference, highlighting the company's efforts to potentially submit its first Biologics License Application (BLA) for a cell therapy targeting this orphan indication. Immix Biopharma's lead candidate, the CAR-T cell therapy NXC-201, has already received several designations from the FDA, including Regenerative Medicine Advanced Therapy and Orphan Drug Designation. The company remains focused on advancing its clinical programs amid the growing prevalence of AL Amyloidosis.
Potential Positives
- NEXICART-2 clinical trial now expanded to 18 sites, indicating increased accessibility for patients.
- Company on track for the first Biologics License Application (BLA) for a cell therapy in an unaddressed orphan indication.
- Positive interim results for NEXICART-2 presented at ASCO 2025, enhancing credibility and visibility in the medical community.
Potential Negatives
- The press release emphasizes the need for expanded clinical trial sites due to the lack of FDA-approved drugs for AL Amyloidosis, indicating a significant unmet medical need and potential challenges in therapeutic development.
- Forward-looking statements highlight multiple risks and uncertainties regarding the success of ongoing clinical trials and the company's ability to secure additional funding, which may hinder progress towards FDA approval.
- None
FAQ
What is the NEXICART-2 clinical trial about?
The NEXICART-2 trial focuses on evaluating cell therapy for patients with relapsed/refractory AL Amyloidosis.
How many sites are involved in the NEXICART-2 trial?
There are currently 18 clinical trial sites involved in the NEXICART-2 study across the United States.
What is the significance of the interim results presented?
The interim results indicate progress toward a Biologics License Application (BLA) for the first FDA-approved cell therapy for AL Amyloidosis.
Who presented the interim results at ASCO 2025?
Dr. Heather Landau from Memorial Sloan Kettering Cancer Center presented the interim results at ASCO 2025.
What recognition has NXC-201 received from the FDA?
NXC-201 has received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation from the FDA.
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.
$IMMX Insider Trading Activity
$IMMX insiders have traded $IMMX stock on the open market 2 times in the past 6 months. Of those trades, 2 have been purchases and 0 have been sales.
Here’s a breakdown of recent trading of $IMMX stock by insiders over the last 6 months:
- GABRIEL S MORRIS (CFO) purchased 2,225 shares for an estimated $5,070
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Full Release
– National Footprint of NEXICART-2 Trial Sites Expanded –
– On track for first Biologics License Application (BLA) approved cell therapy in unaddressed orphan indication –
– NEXICART-2 interim results were presented at ASCO 2025 –
LOS ANGELES, CA, July 07, 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 accelerated U.S. NEXICART-2 clinical trial progress in relapsed/refractory AL Amyloidosis. NEXICART-2 now includes 18 clinical trial sites in its national footprint.
“We are thrilled to report that NEXICART-2 is progressing faster than we expected. Responding to the unmet need across the country, we are expanding the NEXICART-2 clinical trial footprint to deliver cell therapy to this underserved population, where no FDA drugs are approved today,” said Ilya Rachman, M.D., Ph.D., Chief Executive Officer of Immix Biopharma. Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, “These additional new sites further accelerate our path to BLA submission for FDA approval.”
NEXICART-2 interim results 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 ). 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 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 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.
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]
