Immix Biopharma provides updates on its CAR-T therapy NXC-201 and plans for partnerships in Other Serious Diseases.
Quiver AI Summary
Immix Biopharma, Inc. announced updates regarding its cell therapy NXC-201, which targets relapsed/refractory AL Amyloidosis and other serious diseases. The company is focused on completing clinical trials for NEXICART-2, planning to submit a Biologics License Application, and is optimistic about NXC-201’s potential as a one-and-done treatment in various other serious diseases, aiming to partner out these programs. CEO Ilya Rachman highlighted the promising clinical results expected to be shared at scientific forums, while CFO Gabriel Morris noted that partnerships could support the path to FDA approval and future developments. NXC-201 has received several designations from the FDA and EMA, indicating its potential therapeutic significance.
Potential Positives
- Company on track for the first approved Biologics License Application (BLA) in cell therapy for relapsed/refractory AL Amyloidosis, indicating a significant milestone in product development.
- NXC-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug Designation (ODD) from the US FDA, highlighting its potential for treating serious diseases.
- Plans to partner-out Other Serious Disease programs could expand the company’s reach and resources, facilitating further development and commercialization of its therapies.
- Forthcoming clinical data to be released at scientific forums could enhance visibility and credibility in the biopharmaceutical industry.
Potential Negatives
- Company plans to partner-out Other Serious Disease programs, indicating a potential lack of confidence in their ability to develop these programs independently.
- Risk factors noted include the possibility that ongoing clinical trial data for CAR-T NXC-201 may not be favorable, which could impact future development and market entry.
- No drugs developed by the company have received FDA pre-market approval, highlighting a significant hurdle in their commercialization efforts.
FAQ
What is Immix Biopharma's lead product candidate?
Immix Biopharma's lead product candidate is the sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201.
What diseases is NXC-201 being developed for?
NXC-201 is primarily developed for relapsed/refractory AL Amyloidosis and may be explored for other serious diseases.
What is the status of the NEXICART-2 clinical trial?
The NEXICART-2 clinical trial is ongoing, with interim results recently presented at ASCO 2025.
How does Immix Biopharma plan to advance other serious disease programs?
Immix Biopharma plans to seek partnerships to license out its Other Serious Disease programs.
What designations has NXC-201 received from the FDA?
NXC-201 has been granted Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation (ODD) by 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
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- GABRIEL S MORRIS (CFO) purchased 2,225 shares for an estimated $5,070
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Full Release
– Dosing ongoing and planned in a handful of Other Serious Diseases (OSD) –
– Company plans to partner-out Other Serious Disease programs –
– On track for first Biologics License Application (BLA) approved cell therapy in lead indication relapsed/refractory AL Amyloidosis –
LOS ANGELES, CA, Aug. 06, 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 important updates about its plan to address other serious diseases with its sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201 with a “digital filter” that filters out non-specific activation. The Company plans to release forthcoming clinical data at upcoming scientific forums.
“While we are singularly focused on completing NEXICART-2 in relapsed/refractory AL Amyloidosis for BLA submission, promising NXC-201 clinical results could offer extraordinary one-and-done solutions in a number of other serious diseases. We plan to explore licensing-out these OSD programs through external partnerships,” said Ilya Rachman, M.D., Ph.D., Chief Executive Officer of Immix Biopharma. Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, "We believe partnerships could fuel our path to NEXICART-2 BLA submission for FDA approval and future development programs.”
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.
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]