Immix Biopharma Expands U.S. Clinical Sites for relapsed/refractory AL Amyloidosis Trial NEXICART-2
Immix Biopharma (NASDAQ: IMMX) has expanded its U.S. clinical trial sites for the NEXICART-2 study, evaluating CAR-T NXC-201 in relapsed/refractory AL Amyloidosis patients. New sites include Cleveland Clinic, UC Davis, and Sutter Health, joining lead site Memorial Sloan Kettering Cancer Center. This expansion aims to increase patient access and enrollment opportunities across the U.S.
The study builds on positive data from the ex-U.S. NEXICART-1 trial, which showed a 92% overall response rate in relapsed/refractory AL Amyloidosis patients. NXC-201 is currently the only CAR-T therapy in development for AL Amyloidosis. The expansion supports upcoming interim and final read-outs of NEXICART-2, as Immix Biopharma continues its mission to advance treatment options for this patient population.
Immix Biopharma (NASDAQ: IMMX) ha ampliato i suoi siti di sperimentazione clinica negli Stati Uniti per lo studio NEXICART-2, che valuta il CAR-T NXC-201 in pazienti con amiloidosi AL recidivante/refrattaria. I nuovi siti includono Cleveland Clinic, UC Davis e Sutter Health, che si uniscono al sito principale, il Memorial Sloan Kettering Cancer Center. Questa espansione mira ad aumentare l'accesso dei pazienti e le opportunità di arruolamento in tutto il territorio statunitense.
Lo studio si basa su dati positivi provenienti dallo studio NEXICART-1 al di fuori degli Stati Uniti, che ha mostrato un tasso di risposta globale del 92% nei pazienti con amiloidosi AL recidivante/refrattaria. NXC-201 è attualmente l'unica terapia CAR-T in fase di sviluppo per l'amiloidosi AL. L'espansione supporta i prossimi dati intermedi e finali dello studio NEXICART-2, mentre Immix Biopharma continua la sua missione di migliorare le opzioni terapeutiche per questa popolazione di pazienti.
Immix Biopharma (NASDAQ: IMMX) ha ampliado sus sitios de ensayo clínico en EE. UU. para el estudio NEXICART-2, que evalúa CAR-T NXC-201 en pacientes con amiloidosis AL en recaída/refractaria. Los nuevos sitios incluyen Cleveland Clinic, UC Davis y Sutter Health, uniéndose al sitio principal, el Memorial Sloan Kettering Cancer Center. Esta expansión tiene como objetivo aumentar el acceso de los pacientes y las oportunidades de inscripción en todo EE. UU.
El estudio se basa en datos positivos del ensayo NEXICART-1 fuera de EE. UU., que mostró una tasa de respuesta general del 92% en pacientes con amiloidosis AL en recaída/refractaria. NXC-201 es actualmente la única terapia CAR-T en desarrollo para la amiloidosis AL. La expansión apoya los próximos informes interinos y finales del NEXICART-2, mientras Immix Biopharma continúa su misión de avanzar en opciones de tratamiento para esta población de pacientes.
Immix Biopharma (NASDAQ: IMMX)는 재발성/불응성 AL 아밀로이드증 환자에서 CAR-T NXC-201을 평가하는 NEXICART-2 연구를 위해 미국의 임상 시험 사이트를 확대했습니다. 새로 추가된 사이트에는 Cleveland Clinic, UC Davis 및 Sutter Health가 포함되어 있으며, 주요 사이트인 Memorial Sloan Kettering Cancer Center에 합류하게 됩니다. 이번 확장은 미국 전역에서 환자의 접근과 등록 기회를 증가시키는 것을 목표로 합니다.
이 연구는 재발성/불응성 AL 아밀로이드증 환자에서 92%의 전체 반응률을 보여준 해외 NEXICART-1 시험의 긍정적인 데이터를 기반으로 합니다. NXC-201은 현재 AL 아밀로이드증에 대한 개발 중인 유일한 CAR-T 치료입니다. 이 확장은 NEXICART-2의 향후 중간 및 최종 결과를 지원하며, Immix Biopharma는 이 환자 집단을 위한 치료 옵션을 발전시키기 위한 사명을 계속하고 있습니다.
Immix Biopharma (NASDAQ: IMMX) a élargi ses sites d'essai clinique aux États-Unis pour l'étude NEXICART-2, qui évalue CAR-T NXC-201 chez des patients atteints d'amylose AL récurrents/réfractaires. Les nouveaux sites incluent Cleveland Clinic, UC Davis et Sutter Health, rejoignant le site principal, le Memorial Sloan Kettering Cancer Center. Cette expansion vise à accroître l'accès des patients et les opportunités d'inscription à travers les États-Unis.
L'étude s'appuie sur des données positives issues de l'essai NEXICART-1 hors des États-Unis, qui a montré un taux de réponse global de 92% chez des patients atteints d'amylose AL récurrents/réfractaires. NXC-201 est actuellement la seule thérapie CAR-T en développement pour l'amylose AL. L'expansion soutient les prochaines évaluations intermédiaires et finales de NEXICART-2, alors qu'Immix Biopharma continue sa mission d'avancer les options de traitement pour cette population de patients.
Immix Biopharma (NASDAQ: IMMX) hat seine klinischen Prüfungsstandorte in den USA für die NEXICART-2-Studie erweitert, die CAR-T NXC-201 bei Patienten mit rezidivierter/unrefraktärer AL-Amyloidose bewertet. Neue Standorte sind Cleveland Clinic, UC Davis und Sutter Health, die sich dem führenden Standort Memorial Sloan Kettering Cancer Center anschließen. Diese Erweiterung zielt darauf ab, den Patienten Zugang und Zulassungsmöglichkeiten in den USA zu erhöhen.
Die Studie baut auf positiven Daten aus der NEXICART-1-Studie außerhalb der USA auf, die eine Gesamtansprechrate von 92% bei Patienten mit rezidivierter/unrefraktärer AL-Amyloidose zeigte. NXC-201 ist derzeit die einzige CAR-T-Therapie in der Entwicklung für AL-Amyloidose. Die Erweiterung unterstützt die bevorstehenden Zwischen- und Endauswertungen von NEXICART-2, während Immix Biopharma weiterhin seine Mission verfolgt, die Therapieoptionen für diese Patientengruppe voranzutreiben.
- Expansion of clinical trial sites to include prestigious institutions like Cleveland Clinic and UC Davis
- 92% overall response rate reported in the ex-U.S. NEXICART-1 trial
- NXC-201 is the only CAR-T therapy in development for AL Amyloidosis
- Best responder in NEXICART-1 experienced a 28.0 month duration of response
- None.
The expansion of clinical trial sites for NEXICART-2 is a significant development for Immix Biopharma's AL Amyloidosis program. The addition of prestigious institutions like Cleveland Clinic and UC Davis enhances the trial's credibility and potential patient reach. The 92% overall response rate from the ex-U.S. trial is remarkably high, suggesting NXC-201 could be a game-changer in treating this rare disease. However, it's important to note that this data is from a small sample size (13 patients) and needs validation in larger studies. The
This expansion of clinical trial sites is a positive indicator for Immix Biopharma (NASDAQ: IMMX). It suggests confidence in the NXC-201 program and could accelerate patient enrollment, potentially leading to faster trial completion and data readouts. The inclusion of prestigious institutions may also enhance the company's credibility with investors and potential partners. However, investors should note that expanding clinical trials also increases burn rate, which could impact the company's cash position. The mention of "upcoming interim and final read-outs" implies potential near-term catalysts that could significantly affect stock price. Given the promising early data and the unmet need in AL Amyloidosis, successful trial results could lead to substantial value creation. However, as with all clinical-stage biotech companies, there remains significant risk until regulatory approval is achieved.
- New Sites Expand Opportunities for Patient Access and Enrollment
- Clinical Trial Sites Added Include Cleveland Clinic, UC Davis, and Sutter Health
- Lead site Memorial Sloan Kettering Cancer Center (MSKCC)
- Data from ex-U.S. clinical trial reported at ASGCT 2024 showed a
92% overall response rate
LOS ANGELES, CA, Aug. 28, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us”, “IMMX”) (Nasdaq: IMMX), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and immune-mediated diseases, today announced the addition of three additional clinical trial sites for its U.S. relapsed/refractory AL Amyloidosis clinical trial NEXICART-2. The newly added centers include some of the leading programs in the world in AL Amyloidosis. New sites expand opportunities for patient access to CAR-T NXC-201 across the U.S. MSKCC remains the lead clinical site.
The NEXICART-2 study is intended to evaluate the safety and efficacy of CAR-T NXC-201 in relapsed/refractory AL Amyloidosis patients with adequate cardiac function who have not been exposed to prior BCMA-targeted therapy. The study builds on positive data from the initial ex-U.S. study, NEXICART-1, presented at the 27th Annual Meeting of The American Society of Gene and Cell Therapy (ASGCT 2024) which showed a
“In our mission to advance treatment options for relapsed/refractory AL Amyloidosis patients, we are proud to expand our NEXICART-2 clinical trial footprint to a national scale with the addition of these world-class sites and exceptional principal investigators,” said Ilya Rachman, M.D., Ph.D., Chief Executive Officer of Immix Biopharma. Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, “Working with our outstanding team and partners, these additional sites support upcoming interim and final read-outs of NEXICART-2.”
NXC-201 is the only CAR-T therapy currently in development in AL Amyloidosis, mentioned in a review article entitled “Systemic Light Chain Amyloidosis” published in June, 2024 New England Journal of Medicine.
About NEXICART-2
NEXICART-2 (NCT06097832) is an open-label, single-arm, multi-site U.S. Phase 1b/2 dose expansion clinical trial of CAR-T NXC-201 in relapsed/refractory AL Amyloidosis. NEXICART-2 is expected to enroll 40 patients with adequate cardiac function who have not been exposed to prior BCMA-targeted therapy. The study is designed with a standard 6 patient safety-run in to evaluate two doses (three patients each at 150 million CAR+T cells and 450 million CAR+T cells), with the potential for further escalation to 800 million CAR+T cells (all 3 dose levels were evaluated in the NEXICART-1 study and have produced complete responses in relapsed/refractory AL Amyloidosis patients). The study aims to evaluate the safety and efficacy of NXC-201 in this patient population. Primary endpoints are complete response rate and overall response rate, according to consensus recommendations (Palladini et al. 2012).
About NEXICART-1
NEXICART-1 (NCT04720313) is an open-label, ex-U.S. Phase 1b/2 clinical trial of NXC-201 (formerly HBI0101) in patients with relapsed/refractory multiple myeloma and relapsed/refractory AL amyloidosis (including AL Amyloidosis patients with impaired cardiac function and including AL Amyloidosis patients exposed to prior BCMA-targeted therapy). The primary objective of the study is to characterize the safety and efficacy, as well as confirm the recommended Phase 2 dose (RP2D) of NXC-201 (which has already been confirmed). NEXICART-1 clinical results, most recently from ASGCT 2024, are available at https://immixbio.com/pipeline/#publications.
About NXC-201
NXC-201 is a sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy. Initial data from Phase 1b/2 ex-U.S. study NEXICART-1 has demonstrated no neurotoxicity of any kind in AL Amyloidosis.
NXC-201 is being studied in a comprehensive clinical development program for the treatment of patients with relapsed/refractory AL amyloidosis, with the potential to expand into immune-mediated diseases. The NXC-201 NEXICART-2 (NCT06097832) U.S. clinical trial builds on a robust clinical dataset. NXC-201 has been awarded Orphan Drug Designation (ODD) in AL Amyloidosis 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 damage to multiple organs, including heart failure, and leads 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 immune-mediated 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. Phase 1b/2 trial NEXICART-2 (NCT06097832) as well as the ex-U.S. study NEXICART-1 (NCT04720313). NXC-201 has demonstrated no neurotoxicity of any kind in AL Amyloidosis and short duration of cytokine release syndrome (CRS), supporting expansion into immune-mediated diseases. NXC-201 has been awarded Orphan Drug Designation (ODD) in AL Amyloidosis by the US 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 receipt of, timing of receipt, finalization of the terms of, and allocation of funds in connection with, the grant discussed above and potential benefits of our product candidate CAR-T NXC-201. 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 1b/2 clinical trials for CAR-T NXC-201 will not be favorably consistent with the initial data initial data readouts, (ii) the risk that the Company may not be able to advance to registration-enabling studies for CAR-T NXC-201 or other product candidates, (iii) that success in early phases of pre-clinical and clinicals trials do not ensure later clinical trials will be successful; (iv) that no drug product developed by the Company has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (v) 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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