Immix Biopharma Announces 50% Enrollment Milestone Surpassed in its ongoing relapsed/refractory AL Amyloidosis Clinical Trial, NEXICART-2
Immix Biopharma (NASDAQ:IMMX) has announced surpassing the 50% enrollment milestone in its NEXICART-2 clinical trial, evaluating NXC-201, a sterically-optimized CAR-T therapy for relapsed/refractory AL Amyloidosis.
The company is advancing toward its goal of achieving the first FDA-approved cell therapy Biologics License Application (BLA) for this orphan indication, where currently no FDA-approved treatments exist. The trial's interim results were presented at ASCO 2025 by Dr. Heather Landau of Memorial Sloan Kettering Cancer Center, with growing interest from clinicians and patients following the presentation.
Immix Biopharma (NASDAQ:IMMX) ha annunciato di aver superato il traguardo del 50% di arruolamento nello studio clinico NEXICART-2, che valuta NXC-201, una terapia CAR-T ottimizzata stericamente per l’AL amiloidosi ricaduta/refrattaria.
L'azienda avanza verso l’obiettivo di ottenere la prima Biologics License Application (BLA) approvata dalla FDA per questa indicazione orfana, per la quale attualmente non esistono trattamenti approvati dalla FDA. I risultati interimini dello studio sono stati presentati al ASCO 2025 da Dr. Heather Landau del Memorial Sloan Kettering Cancer Center, con crescente interesse da parte di medici e pazienti dopo la presentazione.
Immix Biopharma (NASDAQ:IMMX) ha anunciado haber superado el hito de más del 50% de reclutamiento en su ensayo clínico NEXICART-2, que evalúa NXC-201, una terapia CAR-T optimizada estéricamente para la amiloidosis AL refractaria/relapsante.
La empresa avanza hacia su objetivo de lograr la primera Solicitud de Licencia Biológica (BLA) aprobada por la FDA para esta indicación huérfana, donde actualmente no existen tratamientos aprobados por la FDA. Los resultados interinos del ensayo fueron presentados en ASCO 2025 por la Dra. Heather Landau del Memorial Sloan Kettering Cancer Center, con un creciente interés de médicos y pacientes tras la presentación.
Immix Biopharma (NASDAQ:IMMX) 은 NEXICART-2 임상시험에서 등록 50% 돌파를 달성했다고 발표했습니다. 이는 재발/난치성 AL 아밀로이드증을 위한 입체적으로 최적화된 CAR-T 치료제인 NXC-201을 평가합니다.
회사는 이 고아 질환에 대해 FDA 승인된 최초의 세포 치료제 생물학적 제형(BLA)를 확보한다는 목표를 향해 나아가고 있으며, 현재 FDA 승인을 받은 치료법은 존재하지 않습니다. 중간 결과는 ASCO 2025에서 Memorial Sloan Kettering Cancer Center의 Heather Landau 박사가 발표했고, 발표 이후 임상의 및 환자들의 관심이 커지고 있습니다.
Immix Biopharma (NASDAQ:IMMX) a annoncé avoir dépassé le cap des 50% de recrutement dans son essai NEXICART-2, évaluant NXC-201, une thérapie CAR-T optimisée steriquement pour l’amylose AL réfractaire/relapsée.
L’entreprise progresse vers son objectif d’obtenir la première demande de licence biologique (BLA) approuvée par la FDA pour cette indication orpheline, où aucun traitement approuvé par la FDA n’existe actuellement. Les résultats intermédiaires de l’essai ont été présentés lors du ASCO 2025 par le Dr Heather Landau du Memorial Sloan Kettering Cancer Center, suscitant un intérêt croissant chez les cliniciens et les patients après la présentation.
Immix Biopharma (NASDAQ:IMMX) hat bekannt gegeben, dass im NEXICART-2-Studie, die NXC-201 evaluiert, eine sterisch optimierte CAR-T-Therapie für rezidivierte/refraktäre AL-Amyloidose die 50%-Recruiting-Marke überschritten wurde.
Das Unternehmen arbeitet darauf hin, das Ziel zu erreichen, die erste von der FDA genehmigte Zelltherapie Biologics License Application (BLA) für diese seltene Indikation, für die derzeit keine FDA- genehmigten Behandlungen existieren. Die Zwischenergebnisse der Studie wurden auf ASCO 2025 von Dr. Heather Landau vom Memorial Sloan Kettering Cancer Center präsentiert, wobei das Interesse von Klinikern und Patienten nach der Präsentation wächst.
Immix Biopharma (NASDAQ:IMMX) أعلنت عن تجاوز مرحلة تسجيل 50% في تجربة NEXICART-2، التي تقيم NXC-201، علاج CAR-T محسن استرياً لمرض الأميلويدوز AL المتكرر/المقاوم.
تتقدم الشركة نحو هدفها في تحقيق أول طلب تسجيل بيولوجي (BLA) معتمد من FDA لهذه الإشارة النادرة، حيث لا توجد حالياً علاجات معتمدة من FDA. تم تقديم النتائج المؤقتة للدراسة في ASCO 2025 من قبل الدكتورة هيذر لاندو من مركز ميموريال ساينت كيتنج للسرطان، مع تزايد الاهتمام من الأطباء والمرضى بعد العرض.
Immix Biopharma（纳斯达克股票代码：IMMX）宣布在其 NEXICART-2 临床试验中超过 50% 的入组里程碑 的里程碑，评估 NXC-201，这是用于复发/难治性 AL淀积性疾病的立体优化 CAR-T 治疗。
该公司正朝着实现该孤儿适应症的 FDA 批准的首个细胞治疗生物制剂申请（BLA） 的目标迈进，目前尚无 FDA 批准的治疗方法。该试验的中期结果由 Memorial Sloan Kettering Cancer Center 的 Heather Landau 医生在 ASCO 2025 上公布，公布后临床医生和患者的关注度持续上升。
- None.
- Still in clinical trial phase with no guaranteed FDA approval
- Remaining 50% enrollment needs to be completed before BLA submission
– On track for first FDA Biologics License Application (BLA) approved cell therapy in orphan indication relapsed/refractory AL Amyloidosis –
Los Angeles, CA, Sept. 18, 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
“With excitement generated by our clinical results presented at ASCO, surpassing
NEXICART-2 interim results were presented at the American Society for Clinical Oncology (ASCO 2025) by Heather Landau, MD of Memorial Sloan Kettering Cancer Center and can be accessed on the Company’s website under publications (ASCO Post article and video, MSKCC article, Cleveland Clinic article). A webcast of the Company’s Key Opinion Leader (KOL) event to discuss the NXC-201 ASCO 2025 interim results can be accessed here.
About NEXICART-2
NEXICART-2 (NCT06097832) is an ongoing multi-site U.S. Phase 1/2 clinical trial of sterically-optimized CAR-T NXC-201 in relapsed/refractory AL Amyloidosis, with a registrational design. Interim results were presented at ASCO 2025 in an oral presentation. NEXICART-2 is expected to enroll 40 patients.
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. 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 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. NEXICART-2 primary endpoint was met at interim results presented at ASCO 2025. 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, causing 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 “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
FAQ
What milestone did Immix Biopharma (IMMX) announce for its NEXICART-2 trial?
What is the significance of NXC-201 for AL Amyloidosis treatment?
Where were the NEXICART-2 interim results presented?
What is the current status of IMMX's NEXICART-2 clinical trial?
What is the market opportunity for IMMX's NXC-201 therapy?
