Journal of Clinical Oncology Publishes NXC-201 Positive Clinical Results in relapsed/refractory AL Amyloidosis
Immix Biopharma (IMMX) announced the publication of positive clinical results for its CAR-T cell therapy NXC-201 in the Journal of Clinical Oncology. The study, conducted outside the U.S., involved 16 patients with relapsed/refractory AL Amyloidosis who had received a median of 4 prior treatments. The therapy demonstrated a 75% complete response rate (12/16 patients) and showed a favorable safety profile in frail patients.
The company is currently conducting a U.S. trial focusing on patients with preserved heart function, excluding those with pre-existing heart failure. The U.S. multi-site trial, which began in mid-2024, is currently dosing at the expansion cohort level. Notably, there are currently no FDA-approved drugs for relapsed/refractory AL Amyloidosis.
Immix Biopharma (IMMX) ha annunciato la pubblicazione di risultati clinici positivi per la sua terapia CAR-T NXC-201 nel Journal of Clinical Oncology. Lo studio, condotto al di fuori degli Stati Uniti, ha coinvolto 16 pazienti con amiloidosi AL recidivante/refractaria che avevano ricevuto una mediana di 4 trattamenti precedenti. La terapia ha dimostrato un 75% di tasso di risposta completa (12/16 pazienti) e ha mostrato un profilo di sicurezza favorevole in pazienti fragili.
L'azienda sta attualmente conducendo uno studio negli Stati Uniti focalizzato su pazienti con funzione cardiaca preservata, escludendo coloro con insufficienza cardiaca preesistente. Lo studio multi-sito negli Stati Uniti, che è iniziato a metà 2024, sta attualmente somministrando il trattamento a livello di coorte di espansione. È importante notare che attualmente non ci sono farmaci approvati dalla FDA per l'amiloidosi AL recidivante/refractaria.
Immix Biopharma (IMMX) anunció la publicación de resultados clínicos positivos para su terapia con células CAR-T NXC-201 en el Journal of Clinical Oncology. El estudio, realizado fuera de los EE. UU., involucró a 16 pacientes con amiloidosis AL en recaída/refractaria que habían recibido una mediana de 4 tratamientos previos. La terapia mostró una tasa de respuesta completa del 75% (12/16 pacientes) y presentó un perfil de seguridad favorable en pacientes frágiles.
La empresa está realizando actualmente un ensayo en EE. UU. centrado en pacientes con función cardiaca preservada, excluyendo a aquellos con insuficiencia cardiaca preexistente. El ensayo multicéntrico en EE. UU., que comenzó a mediados de 2024, está actualmente administrando dosis a nivel de cohorte de expansión. Cabe destacar que actualmente no existe ningún medicamento aprobado por la FDA para la amiloidosis AL en recaída/refractaria.
Immix Biopharma (IMMX)는 Journal of Clinical Oncology에 CAR-T 세포 치료제 NXC-201에 대한 긍정적인 임상 결과를 발표했다고 전했습니다. 미국 외부에서 진행된 이 연구는 재발성/내성 AL 아밀로이드증 환자 16명이 포함되었으며, 이들은 평균 4회의 이전 치료를 받았습니다. 치료는 75%의 완전 반응률 (12/16 환자)를 보여주었고, 약한 환자에게서 유리한 안전성 프로필을 나타냈습니다.
회사는 현재 기존 심부전 환자를 제외한 심장 기능이 보존된 환자들에 대한 미국 임상 시험을 진행하고 있습니다. 2024년 중반에 시작된 미국의 다기관 시험은 현재 확장 집단 수준에서 투여를 진행 중입니다. 주목할 점은 재발성/내성 AL 아밀로이드증에 대해 FDA 승인 약물이 현재 존재하지 않는다는 것입니다.
Immix Biopharma (IMMX) a annoncé la publication de résultats cliniques positifs pour sa thérapie cellulaire CAR-T NXC-201 dans le Journal of Clinical Oncology. L'étude, réalisée en dehors des États-Unis, a impliqué 16 patients atteints d'amylose AL récurrents/réfractaires qui avaient reçu une médiane de 4 traitements antérieurs. La thérapie a montré un taux de réponse complet de 75% (12/16 patients) et a présenté un profil de sécurité favorable chez des patients fragiles.
La compagnie mène actuellement un essai aux États-Unis se concentrant sur des patients avec une fonction cardiaque préservée, excluant ceux ayant une insuffisance cardiaque préexistante. L'essai multicentrique aux États-Unis, qui a débuté au milieu de 2024, est actuellement en phase de dosage au niveau de la cohorte d'expansion. Il est à noter qu'il n'existe actuellement aucun médicament approuvé par la FDA pour l'amylose AL récurrente/réfractaire.
Immix Biopharma (IMMX) hat die Veröffentlichung positiver klinischer Ergebnisse für seine CAR-T-Zelltherapie NXC-201 im Journal of Clinical Oncology angekündigt. Die Studie, die außerhalb der USA durchgeführt wurde, umfasste 16 Patienten mit rezidivierender/therapieresistenter AL-Amyloidose, die im Durchschnitt 4 vorherige Behandlungen erhalten hatten. Die Therapie zeigte eine 75% vollständige Ansprechrate (12/16 Patienten) und wies ein günstiges Sicherheitsprofil bei fragilen Patienten auf.
Das Unternehmen führt derzeit eine US-Studie durch, die sich auf Patienten mit erhaltener Herzfunktion konzentriert und solche mit bestehender Herzinsuffizienz ausschließt. Die multizentrische Studie in den USA, die Mitte 2024 begann, befindet sich derzeit in der Dosierung auf dem Niveau der Erweiterungsgruppe. Bemerkenswert ist, dass es derzeit keine von der FDA zugelassenen Medikamente für die rezidivierende/therapieresistente AL-Amyloidose gibt.
- 75% complete response rate (12/16 patients) in clinical trial
- Favorable safety profile demonstrated in frail patients
- Publication in prestigious Journal of Clinical Oncology
- U.S. trial actively progressing with expansion cohort dosing
- patient sample size (only 16 patients)
- U.S. trial excludes patients with pre-existing heart failure, limiting potential market
Insights
- Chimeric antigen receptor T-cell (CAR-T) cell therapy NXC-201 is a novel approach to treat relapsed/refractory AL Amyloidosis
- NXC-201 demonstrated compelling clinical activity, rapid and deep complete responses in frail and resistant relapsed/refractory AL Amyloidosis patients
LOS ANGELES, Dec. 16, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” or “IMMX”), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and select immune-mediated diseases, announced today the Journal of Clinical Oncology (JCO) published NXC-201 clinical results in relapsed/refractory AL Amyloidosis. The data reported on 16 enrolled patients in NEXICART-1 who had received a median 4 prior lines of therapy prior to treatment with NXC-201. Results showed a complete response (CR) rate of
"We are pleased that JCO has recognized the impact of NXC-201’s positive clinical results in relapsed/refractory AL Amyloidosis, where no FDA drugs are approved today," said Ilya Rachman, M.D., Ph.D., Chief Executive Officer of Immix Biopharma. “Building on these positive ex-U.S. results, our ongoing U.S. study is focused on relapsed/refractory AL Amyloidosis patients with preserved heart function (excluding patients with pre-existing heart failure), who we believe will benefit most from NXC-201 treatment.” Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, “As we discussed in our December 10 conference call, we designed our U.S. NXC-201 trial to include patients represented by the preserved heart function segment. Our multi-site U.S. NXC-201 trial began in mid-2024, and is currently dosing at the expansion cohort dose level.”
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 pre-existing heart failure and including AL Amyloidosis patients exposed to prior BCMA-targeted therapy). The primary objective of the study is to characterize the safety and efficacy of NXC-201. NEXICART-1 clinical results are available at https://immixbio.com/the-science-pipeline-and-publications/ .
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 preserved heart function (excluding patients with pre-existing heart failure) 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) (both 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. Primary endpoints are complete response rate and overall response rate, according to consensus recommendations (Palladini et al. 2012).
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 high complete response rates and 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 in the U.S., with the potential to expand into select 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 select 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 select 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 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 1b/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 1b/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
What are the clinical results of NXC-201 for IMMX's AL Amyloidosis treatment?
How many patients were included in IMMX's NEXICART-1 trial for NXC-201?
When did IMMX begin its U.S. trial for NXC-201?
What patient population is IMMX targeting in its U.S. NXC-201 trial?
Are there any FDA-approved drugs for relapsed/refractory AL Amyloidosis?
