Immix Biopharma Announces Class-Leading Safety Profile, Allowing Potential Future Indication Expansion
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.
Immix Biopharma (NASDAQ:IMMX) ha annunciato dati promettenti sulla sicurezza della sua terapia CAR-T NXC-201, sottolineando la assenza di neurotossicit脿 nei casi di malattia a basso volume. L'azienda sta portando avanti il trial clinico NEXICART-2 verso una richiesta di Biologics License Application (BLA) per il trattamento dell'AL Amiloidosi recidivante/refrattaria.
Il profilo di sicurezza favorevole della terapia posiziona NXC-201 per una possibile espansione ad altre malattie immuno-mediate e gravi. I risultati intermedi sono stati presentati al ASCO 2025 dalla Dott.ssa Heather Landau del Memorial Sloan Kettering Cancer Center, mentre l'azienda mantiene il focus sulla presentazione della BLA per l'approvazione FDA.
Immix Biopharma (NASDAQ:IMMX) anunci贸 datos prometedores sobre la seguridad de su terapia CAR-T NXC-201, destacando la ausencia de neurotoxicidad en casos de enfermedad de bajo volumen. La compa帽铆a est谩 avanzando con el ensayo cl铆nico NEXICART-2 hacia una solicitud de Biologics License Application (BLA) para el tratamiento de Amiloidosis AL recidivante/refractaria.
El perfil favorable de seguridad de la terapia posiciona a NXC-201 para una posible expansi贸n a otras enfermedades inmunomediadas y graves. Los resultados interinos fueron presentados en el ASCO 2025 por la Dra. Heather Landau del Memorial Sloan Kettering Cancer Center, mientras la empresa mantiene el enfoque en la presentaci贸n de la BLA para la aprobaci贸n de la FDA.
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鞚� 旃橂鞝滌潣 鞖办垬頃� 鞎堨爠靹� 頂勲頃勳潃 NXC-201鞚� 雼るジ 氅挫棴毵り皽 氚� 欷戩 歆堩櫂鞙茧 頇曥灔霅� 臧�電レ劚鞚� 鞐挫柎欷嶋媹雼�. 欷戧皠 瓴瓣臣電� ASCO 2025鞐愳劀 氅旊毽柤 鞀 旒�韯半 鞎� 靹柬劙鞚� Heather Landau 氚曥偓臧� 氚滍憸頄堨溂氅�, 須岇偓電� FDA 鞀轨澑鞚� 鞙勴暅 BLA 鞝滌稖鞐� 歆戩頃橁碃 鞛堨姷雼堧嫟.
Immix Biopharma (NASDAQ:IMMX) a annonc茅 des donn茅es prometteuses sur la s茅curit茅 de sa th茅rapie CAR-T NXC-201, mettant en avant l'absence de neurotoxicit茅 dans les cas de maladie 脿 faible volume. La soci茅t茅 fait progresser son essai clinique NEXICART-2 en vue d'une demande de Biologics License Application (BLA) pour le traitement de l'amylose AL en rechute/r茅fractaire.
Le profil de s茅curit茅 favorable de la th茅rapie positionne NXC-201 pour une 茅ventuelle extension 脿 d'autres maladies immuno-m茅di茅es et graves. Les r茅sultats interm茅diaires ont 茅t茅 pr茅sent茅s lors de l'ASCO 2025 par le Dr Heather Landau du Memorial Sloan Kettering Cancer Center, tandis que la soci茅t茅 reste concentr茅e sur la soumission de la BLA pour l'approbation de la FDA.
Immix Biopharma (NASDAQ:IMMX) gab vielversprechende Sicherheitsdaten f眉r seine CAR-T-Therapie NXC-201 bekannt und hob die Abwesenheit von Neurotoxizit盲t bei F盲llen mit geringer Krankheitslast hervor. Das Unternehmen treibt die NEXICART-2-Studie voran, um eine Biologics License Application (BLA) f眉r die Behandlung der rezidivierenden/refrakt盲ren AL-Amyloidose einzureichen.
Das g眉nstige Sicherheitsprofil der Therapie positioniert NXC-201 f眉r eine potenzielle Ausweitung auf andere immunvermittelte und schwere Erkrankungen. Zwischenresultate wurden auf dem ASCO 2025 von Dr. Heather Landau vom Memorial Sloan Kettering Cancer Center pr盲sentiert, wobei das Unternehmen den Fokus auf die BLA-Einreichung zur FDA-Zulassung beibeh盲lt.
- 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
- Clinical trial still ongoing with only interim results available
- Limited data focused only on low-volume disease cases
Insights
NXC-201's excellent safety profile strengthens regulatory prospects for AL Amyloidosis while enabling potential broader applications.
The safety profile emerging from Immix Biopharma's NXC-201 CAR-T therapy represents a significant clinical advantage in the cell therapy landscape. The complete absence of neurotoxicity in low-volume disease is particularly noteworthy since neurotoxicity (including immune effector cell-associated neurotoxicity syndrome or ICANS) remains one of the most concerning adverse events with CAR-T therapies. For context, approved CAR-T products like Yescarta and Kymriah report neurotoxicity rates between 20-60% in their trials.
This safety advantage stems from NXC-201's sterically-optimized design, which likely modifies the spatial arrangement of the CAR construct to reduce off-target effects while maintaining efficacy. The implications are two-fold: first, it strengthens the therapy's regulatory prospects in relapsed/refractory AL Amyloidosis, an orphan indication where Immix is pursuing the first-ever CAR-T approval. Second, this favorable safety profile creates a foundation for expanding into additional indications with lower risk/benefit thresholds.
AL Amyloidosis represents a strategic initial target - a rare disease caused by abnormal plasma cells producing misfolded light chain proteins that deposit in tissues and organs. The NEXICART-2 trial appears to be progressing well toward BLA submission, though specific efficacy metrics aren't detailed in this release. The company's emphasis on "accelerating progress" suggests confidence in their regulatory timeline, while the multiple institutional publications (MSKCC, Cleveland Clinic) indicate growing clinical recognition.
鈥� Absence of neurotoxicity of any grade in low-volume disease to-date 鈥�
鈥� On track for first Biologics License Application (BLA) approved cell therapy in orphan indication relapsed/refractory AL Amyloidosis 鈥�
鈥� Potential future indication expansion planned 鈥�
LOS ANGELES, July 11, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (鈥淚mmixBio鈥�, 鈥淐ompany鈥�, 鈥淲e鈥� or 鈥淯s鈥� or 鈥滻MMX鈥�), 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.
鈥淲e 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,鈥� said Ilya Rachman, M.D., Ph.D., Chief Executive Officer of Immix Biopharma. Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, 鈥淥ur near-term efforts are laser- focused on our path to NEXICART-2 BLA submission for FDA approval.鈥�
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鈥檚 website under publications (ASCO Post and , MSKCC , Cleveland Clinic ).听 A webcast of the Company鈥檚 Key Opinion Leader (KOL) event to discuss the NXC-201 ASCO 2025 interim results, including safety results, can be accessed .听
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 鈥渄igital filter鈥� 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.听 Interim results were presented at ASCO 2025 in an oral presentation by Heather Landau, M.D. of Memorial Sloan Kettering Cancer Center.听 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 鈥渆xpects鈥�, 鈥渃ontemplates鈥�, 鈥渁nticipates鈥�, 鈥減lans鈥�, 鈥渋ntends鈥�, 鈥渂elieves鈥�, 鈥渆stimates鈥�, 鈥減otential鈥�, 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 鈥淩isk Factors鈥� included in the Company鈥檚 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
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FAQ
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