vegasandre
11 months ago
NEWS Immix Biopharma Announces Complete Response in 9th Relapsed/Refractory AL Amyloidosis Patient in NXC-201 Clinical Trial at IMS 20th Annual Meeting
100% (9/9) overall response rate and 67% (6/9) complete response rate (MRD 10-5) observed in heavily pre-treated patients with daratumumab relapsed/refractory AL Amyloidosis as of the September 20, 2023 data cutoff
100% (4/4) overall response rate and 75% (3/4) complete response rate observed in t(11;14) relapsed/refractory AL Amyloidosis
Best responder duration of response was 19.2 months with response ongoing; median follow-up of 7.3 months (range: 2.5 โ 16.5 months) as of the data cutoff date of September 20, 2023
ImmixBio plans to submit a BLA for FDA approval in AL Amyloidosis once 40 patients are treated with NXC-201
The expected primary endpoint for NXC-201 in relapsed/refractory AL Amyloidosis is overall response rate
LOS ANGELES, Oct. 03, 2023 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (โImmixBioโ, โCompanyโ, โWeโ or โUsโ), today announced presentation of additional AL Amyloidosis clinical data from its Phase 1b/2a NEXICART-1 (NCT04720313) study of novel, autologous, BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy, NXC-201, at an oral presentation at the 20th International Myeloma Society Annual (IMS) Meeting being held in Athens, Greece on September 27-30 2023. One new patient and additional follow-up data from an additional 8 patients (9 total) are included in this update. All patients were DARZALEX ® (daratumumab) combination therapy relapsed/refractory and experienced a median of 6 earlier treatments that failed to stop worsening of disease (lines of therapy) prior to receiving NXC-201.
โThere are no approved drugs for relapsed/refractory AL Amyloidosis,โ said Polina Stepensky, M.D., Director of the Hadassah Medical Organizationโs Department of Bone Marrow Transplantation and Immunotherapy for Adults and Children, and principal study investigator. โNXC-201โs 100% response rate in relapsed/refractory AL amyloidosis patients, including t(11;14) and cardiac involved, indicates a potential broad mechanism of action. Additionally, as a one-time treatment, NXC-201 would present an attractive alternative to multi-drug combination, long-term daily or weekly regimens for relapsed/refractory AL amyloidosis patients.โ
โCurrently, AL Amyloidosis treatment involves repeat dosing and weekly distant travel to academic medical centers,โ said Ilya Rachman, M.D., Ph.D., Chief Executive Officer of Immix Biopharma. โOne-time treatment with NXC-201 could fill the void for relapsed/refractory AL Amyloidosis, where there are no therapies approved today, while restoring quality of life.โ
Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, โNXC-201โs uniquely favorable CAR-T tolerability profile and an apparent ability to clear disease-causing amyloid chains from the body within ~30 days could make it particularly suitable for treatment in a potential outpatient setting.โ
vegasandre
11 months ago
Immix Biopharma Announces 72-Patient NXC-201 Clinical Data at the IMS 20th Annual Meeting, 95% Overall Response Rate in Multiple Myeloma
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Immix Biopharma Announces 72-Patient NXC-201 Clinical Data at the IMS 20th Annual Meeting, 95% Overall Response Rate in Multiple Myeloma
Immix Biopharma, Inc.
Mon, Oct 2, 2023, 5:06 AM PDT11 min read
IMMX+20.91%
Immix Biopharma Announces 72-Patient NXC-201 Clinical Data at the IMS 20th Annual Meeting, 95% Overall Response Rate in Multiple Myeloma
Immix Biopharma Announces 72-Patient NXC-201 Clinical Data at the IMS 20th Annual Meeting, 95% Overall Response Rate in Multiple Myeloma
95% overall response rate observed in relapsed/refractory multiple myeloma patients not previously treated with BCMA-targeted therapy. Median progression free survival (mPFS) was 12.9 months as of the July 17, 2023 data cut-off
90% overall response rate observed in relapsed/refractory multiple myeloma at the therapeutic dose including patients with, and without prior BCMA-targeted therapy
Class-Leading Response Rate in BCMA-exposed patients (frequently excluded from BCMA CAR-T clinical trials) has the potential to meet an important market need
ImmixBio plans to submit a BLA for FDA approval in multiple myeloma once 100 patients are treated with NXC-201
The expected primary endpoints for NXC-201 in relapsed/refractory multiple myeloma are overall response rate and duration of response
vegasandre
12 months ago
NEWS! U.S. Food and Drug Administration Approves Orphan Drug Designation for Immix Biopharma NXC-201 as a Treatment for Amyloid Light Chain (AL) Amyloidosis
FDA Orphan Drug Designation (โODDโ) qualifies one-time treatment NXC-201 for:
7 years of U.S. market exclusivity after approval
Tax credits for qualified clinical testing
Waiver of the Prescription Drug User Fee (currently at almost $3 million for a new drug)
The Amyloidosis market was $3.6 billion in 2017, expected to reach $6 billion in 2025, according to Grand View Research
LOS ANGELES, Sept. 21, 2023 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (Nasdaq: IMMX) (โImmixBioโ or the โCompanyโ), a clinical-stage biopharmaceutical company pioneering personalized therapies for oncology and immunology, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) designation for NXC-201 for the treatment of a life-threatening blood disorder, Amyloid Light Chain (AL) Amyloidosis. NXC-201, a next generation CAR-T cell therapy, is currently being evaluated in a Phase 1b/2a clinical trial NEXICART-1 (NCT04720313).
The FDAโs Office of Orphan Products Development grants orphan designation status to drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the U.S. Orphan Drug Designation provides certain benefits, including financial incentives, to support clinical development and the potential for up to 7 years of market exclusivity in the U.S. upon regulatory approval.
โWe are pleased to receive FDAโs orphan drug designation in AL amyloidosis for NXC-201, the only clinical-stage CAR-T cell therapy in development for AL amyloidosis,โ said Ilya Rachman, MD PhD, Immix Biopharma Chief Executive Officer, adding, โWe are thrilled to potentially expand therapeutic options for relapsed and refractory AL amyloidosis patients, where we have observed to date in our NXC-201 clinical trials a 100% hematologic response rate and demonstrated organ responses in patient hearts, livers and kidneys, for AL amyloidosis patients who received a median of 6 earlier treatments that previously failed to halt the disease.โ Gabriel Morris, Immix Biopharma Chief Financial Officer, added, โWe believe one-time treatment NXC-201 could offer AL amyloidosis patients a convenient therapeutic option.โ