Immix Biopharma Announces Accelerated NEXICART-2 Clinical Trial Progress in relapsed/refractory AL Amyloidosis
Immix Biopharma (NASDAQ:IMMX) reported accelerated progress in its NEXICART-2 clinical trial for relapsed/refractory AL Amyloidosis. The trial has expanded to 18 clinical trial sites nationwide, marking significant advancement toward becoming the first FDA-approved cell therapy for this orphan indication.
The company presented interim results at ASCO 2025, with Dr. Heather Landau of Memorial Sloan Kettering Cancer Center leading the presentation. The expansion addresses an urgent unmet need, as currently there are no FDA-approved drugs for this condition.
Immix Biopharma (NASDAQ:IMMX) ha annunciato un'accelerazione nei progressi del suo studio clinico NEXICART-2 per l'amiloidosi AL recidivante/refrattaria. Lo studio si 猫 esteso a 18 centri clinici su tutto il territorio nazionale, segnando un importante passo avanti verso il conseguimento della prima terapia cellulare approvata dalla FDA per questa indicazione orfana.
L'azienda ha presentato risultati preliminari al ASCO 2025, con la dott.ssa Heather Landau del Memorial Sloan Kettering Cancer Center a guidare la presentazione. Questa espansione risponde a un bisogno urgente non soddisfatto, dato che attualmente non esistono farmaci approvati dalla FDA per questa patologia.
Immix Biopharma (NASDAQ:IMMX) inform贸 un avance acelerado en su ensayo cl铆nico NEXICART-2 para amiloidosis AL recidivante/refractaria. El estudio se ha ampliado a 18 sitios cl铆nicos en todo el pa铆s, marcando un progreso significativo hacia convertirse en la primera terapia celular aprobada por la FDA para esta indicaci贸n hu茅rfana.
La compa帽铆a present贸 resultados interinos en el ASCO 2025, con la Dra. Heather Landau del Memorial Sloan Kettering Cancer Center liderando la presentaci贸n. Esta expansi贸n responde a una necesidad urgente no cubierta, ya que actualmente no existen medicamentos aprobados por la FDA para esta condici贸n.
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须岇偓电� ASCO 2025鞐愳劀 欷戧皠 瓴瓣臣毳� 氚滍憸頄堨溂氅�, 氅旊毽柤 鞀 旒�韯半 鞎� 靹柬劙鞚� Heather Landau 氚曥偓臧� 氚滍憸毳� 欤茧弰頄堨姷雼堧嫟. 鞚措矆 頇曤寑電� 順勳灛 FDA 鞀轨澑 鞎诫鞚� 鞐嗠姅 鞚� 歆堩櫂鞐� 雽�頃� 旮搓笁頃� 氙胳订臁� 靾橃殧毳� 頃搓舶頃╇媹雼�.
Immix Biopharma (NASDAQ:IMMX) a annonc茅 des progr猫s acc茅l茅r茅s dans son essai clinique NEXICART-2 pour l'amylose AL en rechute/r茅fractaire. L'essai s'est 茅tendu 脿 18 sites cliniques 脿 travers le pays, marquant une avanc茅e significative vers la premi猫re th茅rapie cellulaire approuv茅e par la FDA pour cette indication orpheline.
La soci茅t茅 a pr茅sent茅 des r茅sultats interm茅diaires lors de l'ASCO 2025, avec la Dre Heather Landau du Memorial Sloan Kettering Cancer Center 脿 la t锚te de la pr茅sentation. Cette expansion r茅pond 脿 un besoin urgent non satisfait, car il n'existe actuellement aucun m茅dicament approuv茅 par la FDA pour cette maladie.
Immix Biopharma (NASDAQ:IMMX) berichtete 眉ber beschleunigte Fortschritte in seiner NEXICART-2-Studie bei rezidivierender/refrakt盲rer AL-Amyloidose. Die Studie wurde auf 18 klinische Studienzentren landesweit ausgeweitet, was einen bedeutenden Schritt in Richtung der ersten von der FDA zugelassenen Zelltherapie f眉r diese seltene Indikation darstellt.
Das Unternehmen pr盲sentierte Zwischenergebnisse auf der ASCO 2025, wobei Dr. Heather Landau vom Memorial Sloan Kettering Cancer Center die Pr盲sentation leitete. Die Erweiterung adressiert einen dringend bestehenden ungedeckten Bedarf, da derzeit keine von der FDA zugelassenen Medikamente f眉r diese Erkrankung verf眉gbar sind.
- Expansion to 18 clinical trial sites nationally indicates strong trial progress
- Potential to be first FDA-approved cell therapy for AL Amyloidosis
- Trial progressing faster than company expectations
- Addressing unmet medical need with no current FDA-approved treatments
- Still in clinical trial phase with no guaranteed FDA approval
- No specific efficacy or safety data disclosed in the announcement
鈥� National Footprint of NEXICART-2 Trial Sites Expanded 鈥�
鈥撎� On track for first Biologics License Application (BLA) approved cell therapy in unaddressed orphan indication 鈥�
鈥撎� NEXICART-2 interim results were presented at ASCO 2025 鈥�
LOS ANGELES, CA, July 07, 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 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.
鈥淲e 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,鈥� said Ilya Rachman, M.D., Ph.D., Chief Executive Officer of Immix Biopharma. Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, 鈥淭hese additional new sites further accelerate our path to BLA submission for FDA approval.鈥�
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鈥檚 website under publications (ASCO Post and , MSKCC ). A webcast of the Company鈥檚 Key Opinion Leader (KOL) event to discuss the NXC-201 ASCO 2025 interim results can be accessed听.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 and .
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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LifeSci Advisors
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FAQ
What is the current status of IMMX's NEXICART-2 clinical trial for AL Amyloidosis?
How many clinical trial sites are involved in IMMX's NEXICART-2 study?
What makes IMMX's NEXICART-2 treatment significant for AL Amyloidosis?
Where were the NEXICART-2 interim results presented by IMMX?
What is the target indication for IMMX's NEXICART-2 therapy?
