Immix Biopharma’s NXC-201 NEXICART-2 Clinical Trial Data Selected for Oral Presentation at ASCO 2025
Immix Biopharma (IMMX) announced that Phase 1/2 interim data from its NXC-201 NEXICART-2 trial in relapsed/refractory AL Amyloidosis has been selected for oral presentation at ASCO 2025. The presentation, titled 'Safety and efficacy data from NEXICART-2, the first US trial of CAR-T in R/R light chain (AL) amyloidosis, NXC-201,' will be delivered by Dr. Heather Landau, Director of Amyloidosis Program at Memorial Sloan-Kettering Cancer Center.
The presentation is scheduled for Tuesday, June 3, 2025, between 9:45am and 12:45pm CDT in Chicago, as part of the Oral Abstract Session on Hematologic Malignancies—Plasma Cell Dyscrasia (Abstract #7508).
Immix Biopharma (IMMX) ha annunciato che i dati provvisori di Fase 1/2 del suo studio NXC-201 NEXICART-2 sull'amiloidosi AL recidivante/refrattaria sono stati selezionati per una presentazione orale all'ASCO 2025. La presentazione, intitolata 'Dati di sicurezza ed efficacia da NEXICART-2, il primo studio USA di CAR-T nell'amiloidosi a catena leggera (AL) recidivante/refrattaria, NXC-201,' sarà tenuta dalla Dott.ssa Heather Landau, Direttrice del Programma di Amiloidosi presso il Memorial Sloan-Kettering Cancer Center.
La presentazione è prevista per martedì 3 giugno 2025, dalle 9:45 alle 12:45 CDT a Chicago, nell'ambito della Sessione Orale sugli Abstract delle Malattie Ematologiche Maligne—Discrasie delle Cellule Plasmatiche (Abstract #7508).
Immix Biopharma (IMMX) anunció que los datos provisionales de la Fase 1/2 de su ensayo NXC-201 NEXICART-2 en amiloidosis AL recidivante/refractaria han sido seleccionados para una presentación oral en ASCO 2025. La presentación, titulada 'Datos de seguridad y eficacia de NEXICART-2, el primer ensayo en EE.UU. de CAR-T en amiloidosis de cadena ligera (AL) recidivante/refractaria, NXC-201,' será presentada por la Dra. Heather Landau, Directora del Programa de Amiloidosis en el Memorial Sloan-Kettering Cancer Center.
La presentación está programada para el martes 3 de junio de 2025, entre las 9:45 y las 12:45 CDT en Chicago, como parte de la Sesión Oral de Resúmenes sobre Malignidades Hematológicas—Discrasia de Células Plasmáticas (Resumen #7508).
Immix Biopharma (IMMX)는 재발/불응성 AL 아밀로이드증에 대한 NXC-201 NEXICART-2 임상 1/2상 중간 데이터가 ASCO 2025 구두 발표로 선정되었다고 발표했습니다. '재발/불응성 경쇄(AL) 아밀로이드증에 대한 미국 최초의 CAR-T 임상인 NEXICART-2, NXC-201의 안전성 및 유효성 데이터'라는 제목의 발표는 Heather Landau 박사가 Memorial Sloan-Kettering 암센터 아밀로이드증 프로그램 책임자로서 진행할 예정입니다.
발표는 2025년 6월 3일 화요일, 시카고 CDT 기준 오전 9시 45분부터 12시 45분 사이에 혈액학적 악성종양—형질세포 이상증 구두 초록 세션(Abstract #7508)에서 진행됩니다.
Immix Biopharma (IMMX) a annoncé que les données intermédiaires de phase 1/2 de son essai NXC-201 NEXICART-2 dans l'amylose AL en rechute/réfractaire ont été sélectionnées pour une présentation orale à l'ASCO 2025. La présentation, intitulée « Données de sécurité et d'efficacité de NEXICART-2, le premier essai américain de CAR-T dans l'amylose à chaînes légères (AL) en rechute/réfractaire, NXC-201 », sera donnée par la Dr Heather Landau, directrice du programme d'amylose au Memorial Sloan-Kettering Cancer Center.
La présentation est prévue le mardi 3 juin 2025, entre 9h45 et 12h45 CDT à Chicago, dans le cadre de la session orale des résumés sur les hémopathies malignes—dyscrasie des plasmocytes (Résumé #7508).
Immix Biopharma (IMMX) gab bekannt, dass Zwischenberichte der Phase 1/2-Daten aus der NXC-201 NEXICART-2-Studie bei rezidivierender/refraktärer AL-Amyloidose für eine mündliche Präsentation auf der ASCO 2025 ausgewählt wurden. Die Präsentation mit dem Titel 'Sicherheits- und Wirksamkeitsdaten von NEXICART-2, der ersten US-Studie zu CAR-T bei rezidivierender/refraktärer Leichtketten-(AL)-Amyloidose, NXC-201,' wird von Dr. Heather Landau, Direktorin des Amyloidose-Programms am Memorial Sloan-Kettering Cancer Center, gehalten.
Die Präsentation ist für Dienstag, den 3. Juni 2025, zwischen 9:45 und 12:45 Uhr CDT in Chicago geplant und findet im Rahmen der mündlichen Abstract-Sitzung zu hämatologischen Malignomen—Plasmazelldyskrasie (Abstract #7508) statt.
- First US trial of CAR-T therapy for AL amyloidosis, indicating potential market leadership
- Selection for oral presentation at major conference (ASCO) suggests promising clinical data
- Trial led by prestigious Memorial Sloan-Kettering Cancer Center researcher
- None.
— Oral presentation Tuesday, June 3, 2025 in Chicago —
LOS ANGELES, April 23, 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 Phase 1/2 interim readout data from its U.S. NXC-201 NEXICART-2 trial in relapsed/refractory AL Amyloidosis has been selected for oral presentation at the upcoming 2025 American Society of Clinical Oncology Annual Meeting (ASCO 2025) being held in Chicago, Illinois, May 30 – June 3, 2025, presented by lead investigator Heather Landau, M.D., Director of Amyloidosis Program and a Bone Marrow Transplant Specialist & Cellular Therapist at Memorial Sloan-Kettering Cancer Center in New York.
ASCO Presentation Details
| Title | “Safety and efficacy data from NEXICART-2, the first US trial of CAR-T in R/R light chain (AL) amyloidosis, NXC-201” |
| Presentation Date/Time (Central Daylight Time) |
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Event details are available on the Immix website in the Presentation & Events section at https://immixbio.com/investors/#investor-presentation.
About NEXICART-2
NEXICART-2 (NCT06097832) is an ongoing single-arm multi-site U.S. Phase 1/2 clinical trial of sterically-optimized CAR-T NXC-201 in relapsed/refractory AL Amyloidosis. NEXICART-2 is expected to enroll 40 patients with preserved heart function (excluding patients with pre-existing heart failure) who have not been exposed to prior BCMA-targeted therapy. The primary endpoint of the Phase 1 portion is safety. The primary endpoint of the Phase 2 portion is efficacy.
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. Initial data from ex-U.S. study NEXICART-1 has demonstrated high complete response rates in relapsed/refractory AL Amyloidosis. Phase 1/2 U.S. study NEXICART-2 is ongoing. 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 AL Amyloidosis
AL amyloidosis is caused by abnormal plasma cells in the bone marrow, which produce misfolded amyloid proteins that 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
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. NXC-201 is being evaluated in the U.S. study NEXICART-2 (NCT06097832) as well as the ex-U.S. study NEXICART-1 (NCT04720313). NXC-201 has demonstrated no neurotoxicity in AL Amyloidosis, supporting expansion into other serious diseases. 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 29, 2024 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
mmoyer@lifesciadvisors.com
Company Contact
irteam@immixbio.com
FAQ
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