Immix Biopharma Further Expands U.S. Clinical Sites for relapsed/refractory AL Amyloidosis Trial NEXICART-2
Immix Biopharma (IMMX) reports significant expansion of its NEXICART-2 clinical trial for relapsed/refractory AL Amyloidosis, with 14 U.S. sites now actively enrolling patients - adding 10 new sites since their last update. The company notes that patient enrollment is exceeding expectations and anticipates completing the trial ahead of schedule.
Additionally, Phase 1/2 interim readout data from the NEXICART-2 trial has been selected for oral presentation at ASCO 2025 (May 30 - June 3) in Chicago. The presentation will be delivered by Dr. Heather Landau, Director of Amyloidosis Program at Memorial Sloan-Kettering Cancer Center.
Immix Biopharma (IMMX) annuncia una significativa espansione del suo trial clinico NEXICART-2 per l'amiloidosi AL recidivante/refrattaria, con 14 centri negli Stati Uniti attualmente attivi nell'arruolamento dei pazienti - aggiungendo 10 nuovi siti rispetto all'ultimo aggiornamento. L'azienda sottolinea che l'arruolamento dei pazienti sta superando le aspettative e prevede di completare lo studio in anticipo rispetto ai tempi previsti.
Inoltre, i dati intermedi di fase 1/2 del trial NEXICART-2 sono stati selezionati per una presentazione orale all'ASCO 2025 (dal 30 maggio al 3 giugno) a Chicago. La presentazione sarà tenuta dalla Dott.ssa Heather Landau, Direttrice del Programma Amiloidosi presso il Memorial Sloan-Kettering Cancer Center.
Immix Biopharma (IMMX) informa sobre una expansión significativa de su ensayo clínico NEXICART-2 para amiloidosis AL en recaída/refractaria, con 14 centros activos en EE. UU. que están reclutando pacientes, sumando 10 nuevos sitios desde su última actualización. La compañía señala que el reclutamiento de pacientes está superando las expectativas y anticipa completar el ensayo antes de lo previsto.
Además, los datos intermedios de la fase 1/2 del ensayo NEXICART-2 han sido seleccionados para una presentación oral en ASCO 2025 (del 30 de mayo al 3 de junio) en Chicago. La presentación será realizada por la Dra. Heather Landau, Directora del Programa de Amiloidosis en el Memorial Sloan-Kettering Cancer Center.
Immix Biopharma (IMMX)는 재발/불응성 AL 아밀로이드증을 위한 NEXICART-2 임상시험의 상당한 확장을 보고하며, 현재 미국 내 14개 기관에서 환자 등록을 활발히 진행 중이라고 밝혔습니다. 이는 지난 업데이트 이후 10개 기관이 추가된 것입니다. 회사는 환자 등록이 예상보다 빠르게 진행되고 있으며, 시험을 예정보다 조기에 완료할 것으로 기대하고 있습니다.
또한, NEXICART-2 임상시험의 1/2상 중간 결과 데이터가 시카고에서 2025년 5월 30일부터 6월 3일까지 열리는 ASCO 2025에서 구두 발표로 선정되었습니다. 발표는 메모리얼 슬론케터링 암센터의 아밀로이드증 프로그램 디렉터인 Heather Landau 박사가 진행할 예정입니다.
Immix Biopharma (IMMX) annonce une expansion significative de son essai clinique NEXICART-2 pour l'amylose AL en rechute/réfractaire, avec 14 sites aux États-Unis actuellement en phase de recrutement actif - soit 10 nouveaux sites ajoutés depuis leur dernière mise à jour. La société indique que le recrutement des patients dépasse les attentes et prévoit de terminer l'essai avant la date prévue.
De plus, les données intermédiaires de phase 1/2 de l'essai NEXICART-2 ont été sélectionnées pour une présentation orale à l'ASCO 2025 (du 30 mai au 3 juin) à Chicago. La présentation sera assurée par le Dr Heather Landau, directrice du programme d'amylose au Memorial Sloan-Kettering Cancer Center.
Immix Biopharma (IMMX) berichtet über eine bedeutende Erweiterung seiner klinischen NEXICART-2-Studie für rezidivierende/refraktäre AL-Amyloidose mit nun 14 aktiven US-Studienzentren, die Patienten einschreiben – 10 neue Standorte wurden seit dem letzten Update hinzugefügt. Das Unternehmen stellt fest, dass die Patienteneinschreibung die Erwartungen übertrifft und erwartet, die Studie vorzeitig abzuschließen.
Zusätzlich wurden Zwischenergebnisse aus Phase 1/2 der NEXICART-2-Studie für eine Mundliche Präsentation auf der ASCO 2025 (30. Mai – 3. Juni) in Chicago ausgewählt. Die Präsentation wird von Dr. Heather Landau, Direktorin des Amyloidose-Programms am Memorial Sloan-Kettering Cancer Center, gehalten.
- Patient enrollment is exceeding expectations
- Rapid expansion to 14 U.S. clinical sites with 10 new additions
- Trial completion expected ahead of schedule
- NXC-201 interim data selected for oral presentation at prestigious ASCO 2025
- None.
– Patient enrollment exceeding expectations –
– 14 U.S. sites actively enrolling; 10 U.S. sites added since last update –
– Anticipate completing NEXICART-2 clinical trial ahead of schedule –
LOS ANGELES, CA, May 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 14 U.S. sites are actively enrolling in U.S. multi-site study NEXICART-2. This milestone adds 10 sites since the Company’s most recent update. The company anticipates completing NEXICART-2 clinical trial ahead of schedule.
“Based on robust enrollment and demand, we are proud to expand our NEXICART-2 clinical trial footprint to a significant number of national AL Amyloidosis centers,” said Ilya Rachman, M.D., Ph.D., Chief Executive Officer of Immix Biopharma. Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, “Working with these world-class sites, we believe we are well positioned to complete NEXICART-2 on time or even ahead of schedule.”
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.
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. U.S. Phase 1/2 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 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
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. multi-center study NEXICART-2 (NCT06097832). 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 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
mmoyer@lifesciadvisors.com
Company Contact
irteam@immixbio.com
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