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Immix Biopharma on Track to Dose NXC-201 Patients in United States

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Immix Biopharma, Inc. (Nasdaq: IMMX) is on track to dose NXC-201 patients in the U.S. with no change in patient enrollment timing. The company is set to dose relapsed/refractory AL Amyloidosis patients with CAR-T NXC-201 at the New York City lead site and other leading U.S. sites in mid-2024. U.S. site initiation visits are scheduled for April and May 2024. Immix Biopharma aims to provide additional treatment alternatives for patients with AL Amyloidosis, where there are currently no FDA approved drugs.
Immix Biopharma, Inc. (Nasdaq: IMMX) è in linea con il programma per somministrare il farmaco NXC-201 ai pazienti negli Stati Uniti, senza variazioni nella tempistica di arruolamento dei pazienti. L'azienda prevede di trattare pazienti con amiloidosi AL recidiva/refrattaria con il CAR-T NXC-201 nel sito principale di New York City e in altri importanti centri statunitensi a metà del 2024. Le visite di iniziazione dei siti negli Stati Uniti sono programmate per aprile e maggio 2024. Immix Biopharma mira a fornire ulteriori alternative terapeutiche per i pazienti affetti da amiloidosi AL, per la quale attualmente non esistono farmaci approvati dalla FDA.
Immix Biopharma, Inc. (Nasdaq: IMMX) está en camino de administrar la dosis de NXC-201 a pacientes en EE. UU. sin cambios en el cronograma de inscripción de pacientes. La compañía está lista para tratar a pacientes con Amiloidosis AL recidivante/refractaria con CAR-T NXC-201 en el sitio líder de la Ciudad de Nueva York y otros importantes sitios de EE. UU. a mediados de 2024. Las visitas de inicio de los sitios en EE. UU. están programadas para abril y mayo de 2024. Immix Biopharma tiene como objetivo proporcionar alternativas de tratamiento adicionales para pacientes con Amiloidosis AL, donde actualmente no hay medicamentos aprobados por la FDA.
Immix Biopharma, Inc. (Nasdaq: IMMX)는 미국 내 NXC-201 환자에게 약물 투여 일정에 변동 없이 차질 없이 진행하고 있습니다. 회사는 2024년 중반 뉴욕 시티 주도 사이트 및 기타 주요 미국 사이트에서 재발/내성 AL 아밀로이드증 환자들에게 CAR-T NXC-201을 투여할 예정입니다. 미국 사이트 개시 방문은 2024년 4월과 5월에 예정되어 있습니다. Immix Biopharma는 현재 FDA에서 승인된 약물이 없는 AL 아밀로이드증 환자들을 위한 추가적인 치료 대안을 제공하고자 합니다.
Immix Biopharma, Inc. (Nasdaq: IMMX) est sur la bonne voie pour administrer la dose de NXC-201 aux patients aux États-Unis sans changement dans le calendrier d'inscription des patients. La société est prête à traiter les patients atteints d'amylose AL récidivante/réfractaire avec le CAR-T NXC-201 sur le site principal de New York et d'autres sites de premier plan aux États-Unis à la mi-2024. Les visites d'initiation des sites américains sont prévues pour avril et mai 2024. Immix Biopharma vise à fournir des alternatives de traitement supplémentaires pour les patients atteints d'amylose AL, où il n'y a actuellement aucun médicament approuvé par la FDA.
Immix Biopharma, Inc. (Nasdaq: IMMX) liegt im Zeitplan, um Patienten in den USA ohne Änderungen beim Einschreibungszeitpunkt mit NXC-201 zu dosieren. Das Unternehmen plant, Mitte 2024 Patienten mit rezidivierender/refraktärer AL-Amyloidose mit CAR-T NXC-201 am führenden Standort in New York City und anderen führenden US-Standorten zu behandeln. Die Einleitungsbesuche der US-Standorte sind für April und Mai 2024 geplant. Immix Biopharma zielt darauf ab, zusätzliche Behandlungsalternativen für Patienten mit AL-Amyloidose bereitzustellen, für die derzeit keine von der FDA zugelassenen Medikamente vorhanden sind.
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  • Scheduling U.S. site initiation visits April and May 2024
  • On track to dose relapsed/refractory AL Amyloidosis patients with CAR-T NXC-201 at New York City lead site and other leading U.S. sites mid-2024
  • No change in patient enrollment timing

LOS ANGELES, April 18, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio”, “Company”, “We” or “Us” or “IMMX”), a clinical-stage biopharmaceutical company trailblazing cell therapies in AL Amyloidosis and other autoimmune diseases, today announced that Immix Biopharma is on track to dose NXC-201 patients in the U.S. with no change in patient enrollment timing.

“We are on track to dose relapsed/refractory AL Amyloidosis NXC-201 patients at our New York City lead site and other leading U.S. sites in mid-2024. U.S. site clinical trial agreements have been signed, and site initiation visits are being scheduled,” said Ilya Rachman, MD PhD CEO of Immix Biopharma. “Building on our existing NXC-201 clinical dataset, our U.S. relapsed/refractory AL Amyloidosis clinical trial design is focused on patients with adequate cardiac function who are most likely to experience the greatest clinical benefit from NXC-201. We are committed to providing additional treatment alternatives for relapsed/refractory AL Amyloidosis patients, where there are no FDA approved drugs today.”

About NEXICART-2

NEXICART-2 (NCT06097832) is an open-label, single-arm, multi-site Phase 1b dose expansion clinical trial in relapsed/refractory AL Amyloidosis for CAR-T NXC-201 in the United States. NEXICART-2 is expected to enroll 40 patients with adequate cardiac function over a period of approximately 18 months from first patient dosing. The objectives are the safety and efficacy of NXC-201. The expected primary endpoints are complete response rate and overall response rate according to consensus recommendations (Palladini et al. 2012).

About NXC-201

We believe NXC-201 (formerly HBI0101) is the only “Single-Day CRS” BCMA-targeted CAR-T cell therapy that is uniquely suited to target AL Amyloidosis and other autoimmune diseases. It is being studied in a comprehensive clinical development program for the treatment of patients with relapsed/refractory AL amyloidosis, and expanding into other autoimmune indications. These trials build on a robust NXC-201 clinical dataset initiated in February 2021. NXC-201 has been awarded Orphan Drug Designation (ODD) by the FDA in both AL Amyloidosis and multiple myeloma, and awarded EU ODD by the EMA in AL Amyloidosis.

About Immix Biopharma, Inc.

Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is a clinical-stage biopharmaceutical company trailblazing cell therapies in AL Amyloidosis and other autoimmune diseases. Our lead cell therapy is FDA IND cleared next generation CAR-T NXC-201, currently being evaluated in our ongoing Phase 1b/2 NEXICART-1 (NCT04720313) clinical trial, initiated in February 2021. NXC-201 has the potential to be the world’s first “Single-Day CRS” CAR-T (CRS median onset day 1, median duration 1 day), enabling the potential for a faster return home for patients and supporting ongoing expansion into autoimmune indications. NXC-201 has been awarded Orphan Drug Designation (ODD) by the FDA in both AL Amyloidosis and multiple myeloma, and ODD by the European Commission (EMA) in AL Amyloidosis. Learn more at www.immixbio.com and www.BeProactiveInAL.com.

Forward Looking Statements

This press release contains forward-looking statements regarding Immix Biopharma, Inc., including the potential benefits of our initial product candidates, CAR-T NXC-201 and IMX-110. Forward-looking statements 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/2a clinical trials for CAR-T NXC-201 and IMX-110 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 the CAR-T NXC-201 and IMX-110 product candidates, (iii) success in early phases of pre-clinical and clinicals trials do not ensure later clinical trials will be successful; (iv) 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 IMX-110, 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. 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.

Contacts
Mike Moyer
LifeSci Advisors
mmoyer@lifesciadvisors.com

Company Contact
irteam@immixbio.com

 


FAQ

When is Immix Biopharma set to dose NXC-201 patients in the U.S.?

Immix Biopharma is on track to dose NXC-201 patients in the U.S. in mid-2024.

What is the focus of Immix Biopharma's U.S. relapsed/refractory AL Amyloidosis clinical trial design?

The U.S. relapsed/refractory AL Amyloidosis clinical trial design by Immix Biopharma is focused on patients with adequate cardiac function who are most likely to experience the greatest clinical benefit from NXC-201.

What is the goal of Immix Biopharma in providing treatment alternatives for relapsed/refractory AL Amyloidosis patients?

Immix Biopharma aims to provide additional treatment alternatives for relapsed/refractory AL Amyloidosis patients, where there are no FDA approved drugs currently available.

Immix Biopharma, Inc.

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