Immix Biopharma Presents Positive NXC-201 Clinical Data at 66th American Society of Hematology (ASH) Annual Meeting in 16 Relapsed/Refractory AL Amyloidosis Patients
Immix Biopharma (IMMX) announced positive clinical data for NXC-201 in treating relapsed/refractory AL Amyloidosis patients, achieving a 75% complete response rate (12/16 patients) with median 4 prior lines of therapy. The data will be presented at the 66th American Society of Hematology (ASH) Annual Meeting in San Diego on December 9, 2024. NXC-201 is highlighted as the only CAR-T therapy in development for this condition, demonstrating promising results in this underserved patient population.
Immix Biopharma (IMMX) ha annunciato dati clinici positivi per NXC-201 nel trattamento dei pazienti affetti da amiloidosi AL recidivante/refrattaria, ottenendo un tasso di risposta completa del 75% (12/16 pazienti) con una media di 4 precedenti linee di terapia. I dati saranno presentati al 66° Congresso Annuale della Società Americana di Ematologia (ASH) a San Diego il 9 dicembre 2024. NXC-201 è evidenziato come l'unica terapia CAR-T in fase di sviluppo per questa condizione, mostrando risultati promettenti in questa popolazione di pazienti trascurata.
Immix Biopharma (IMMX) anunció datos clínicos positivos para NXC-201 en el tratamiento de pacientes con amiloidosis AL recidivante/refractaria, logrando una tasa de respuesta completa del 75% (12/16 pacientes) con una media de 4 líneas anteriores de terapia. Los datos se presentarán en el 66° Congreso Anual de la Sociedad Americana de Hematología (ASH) en San Diego el 9 de diciembre de 2024. NXC-201 se destaca como la única terapia CAR-T en desarrollo para esta condición, mostrando resultados prometedores en esta población de pacientes desatendida.
Immix Biopharma (IMMX)는 재발성/내성 AL 아밀로이드증 환자 치료를 위한 NXC-201의 긍정적인 임상 데이터를 발표하며, 75%의 완전 반응률(12/16 환자)을 달성하였고, 평균 4개의 이전 치료 라인을 가지고 있습니다. 이 데이터는 2024년 12월 9일 샌디에고에서 열리는 제66회 미국 혈액학회(ASH) 연례 회의에서 발표될 예정입니다. NXC-201은 이 질환에 대한 유일한 CAR-T 요법으로 강조되며, 소외된 환자 집단에서 유망한 결과를 보여주고 있습니다.
Immix Biopharma (IMMX) a annoncé des données cliniques positives pour NXC-201 dans le traitement des patients atteints de l'amylose AL récurrente/résistante, atteignant un taux de réponse complet de 75% (12/16 patients) avec une médiane de 4 lignes de traitement antérieures. Les données seront présentées lors de la 66e Réunion Annuelle de la Société Américaine d'Hématologie (ASH) à San Diego, le 9 décembre 2024. NXC-201 est mis en avant comme la seule thérapie CAR-T en développement pour cette affection, montrant des résultats prometteurs dans cette population de patients sous-servis.
Immix Biopharma (IMMX) hat positive klinische Daten für NXC-201 bei der Behandlung von rezidivierenden/refraktären AL-Amyloidose-Patienten veröffentlicht und eine vollständige Ansprechrate von 75% (12/16 Patienten) mit einem Median von 4 vorherigen Therapieansätzen erzielt. Die Daten werden auf dem 66. Jahreskongress der American Society of Hematology (ASH) am 9. Dezember 2024 in San Diego präsentiert. NXC-201 wird als die einzige CAR-T-Therapie für diese Erkrankung hervorgehoben und zeigt vielversprechende Ergebnisse in dieser benachteiligten Patientengruppe.
- 75% complete response rate in relapsed/refractory AL Amyloidosis patients
- Only CAR-T therapy in development for AL amyloidosis, indicating potential market exclusivity
- Successful results in heavily pretreated patients (median 4 prior lines of therapy)
- Small patient sample size (only 16 patients)
Insights
The 75% complete response rate in heavily pre-treated AL Amyloidosis patients represents a significant clinical achievement. With patients having received a median of 4 prior therapies, this response rate is particularly impressive for a relapsed/refractory population where treatment options are The development of NXC-201 as the only CAR-T therapy for AL amyloidosis addresses a critical unmet medical need.
The data suggests strong therapeutic potential, especially considering that AL amyloidosis patients typically show declining response rates with each subsequent line of therapy. This positions NXC-201 as a promising late-line treatment option. However, investors should note that while these results are encouraging, the sample size of 16 patients is relatively small and longer-term follow-up data will be important for confirming durability of response.
This clinical milestone significantly strengthens IMMX's market position in the AL amyloidosis space. Being the only CAR-T therapy in development for this indication provides a substantial first-mover advantage and potential market exclusivity. The 75% response rate could translate into meaningful commercial opportunities, particularly given the treatment options for relapsed/refractory patients.
For a company with a market cap of
75% (12/16) complete response rate observed in relapsed/refractory AL Amyloidosis patients with median 4 prior lines of therapy- Data will be presented on Monday, December 9, 2024 at 4:00 PM PT
LOS ANGELES, Nov. 25, 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, today announced that additional NEXICART-1 NXC-201 clinical data in relapsed/refractory AL Amyloidosis has been selected for oral presentation at the upcoming 66th American Society of Hematology (ASH) Annual Meeting to be held in San Diego, California, December 7-10, 2024.
“NXC-201 is the only CAR-T in development for relapsed/refractory AL amyloidosis patients,” said Ilya Rachman, MD PhD, Chief Executive Officer of Immix Biopharma. “NXC-201 continues to demonstrate promising results in this underserved patient population.” Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, “We are pleased to continue to demonstrate our focus and leadership in relapsed/refractory AL Amyloidosis at the upcoming 66th annual ASH meeting in San Diego.”
ASH Presentation Details (CAR-T NXC-201 in relapsed/refractory AL Amyloidosis)
| Event | 66th ASH Annual Meeting and Exposition, San Diego, CA |
| Title | “Efficacy and Safety of Anti-BCMA Chimeric Antigen Receptor T-Cell (CART) for the Treatment of Relapsed and Refractory AL Amyloidosis” |
| Presentation Date/Time (Pacific Time) |
|
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 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 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) (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 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 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 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
What was the response rate for NXC-201 in IMMX's AL Amyloidosis trial?
When will IMMX present the NXC-201 clinical data at ASH 2024?
Is IMMX's NXC-201 the only CAR-T therapy for AL Amyloidosis?
