Immix Biopharma, Inc. operates as a biopharmaceutical company that engages in the development of therapies for cancer and inflammatory diseases. The company was founded by Ilya Rachman, Sean Senn, and Vladimir Torchilin in 2012 and is headquartered in Los Angeles, CA.
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- Immix Biopharma received strategic investment from Goose Capital, led by former Tanox CEO Dr. Nancy T. Chang, who previously developed FDA-approved drugs generating over $5 billion in sales. - The investment supports commercialization of NXC-201, a BCMA-targeted CAR-T therapy for relapsed/refractory AL Amyloidosis that met its primary endpoint in the NEXICART-2 trial. - NXC-201 has received FDA Regenerative Medicine Advanced Therapy designation and Orphan Drug Designation from both FDA and EMA. - The therapy features a "digital filter" technology designed to reduce non-specific activation in CAR-T cell treatment.
- Immix Biopharma's NXC-201 demonstrates a 75% complete response rate in relapsed/refractory AL Amyloidosis patients, offering hope where no FDA-approved drugs exist. - The NEXICART-1 Phase 1/2 study highlights a 31.5-month best response duration, with the response ongoing, showcasing the potential long-term benefits of NXC-201. - The FDA grants RMAT designation to NXC-201, potentially accelerating its development and review, offering earlier access to this promising therapy. - Enrollment is accelerating in the U.S. NEXICART-2 trial, building on positive early data, as Immix Biopharma aims for a program update in the first half of 2025.
- Immix Biopharma's NXC-201, a CAR-T therapy for relapsed/refractory AL amyloidosis, has advanced to the expansion cohort in the NEXICART-2 trial. - The expansion cohort will evaluate a higher dose of 450 million CAR+ T cells, following successful dosing of the initial cohort with 150 million cells. - Prior data from the NEXICART-1 study showed a 92% overall response rate and a 69% complete hematological response in AL amyloidosis patients. - NXC-201 has received orphan drug designation from the FDA for both multiple myeloma and AL amyloidosis, highlighting its potential in these areas.
- Rocket Pharmaceuticals completed enrollment in a Phase 2 trial of RP-A501 gene therapy for Danon disease, targeting LAMP2 expression and left ventricular mass reduction. - LX2006 gene therapy from Lexeo Therapeutics demonstrated improved biomarkers in patients with Friedreich Ataxia cardiomyopathy in early-stage trials. - Immix Biopharma dosed the first patient in a Phase 1b/2 trial of NXC-201 CAR-T therapy for relapsed/refractory light chain amyloidosis. - Verve Therapeutics dosed the first patient in a Phase 1b trial of VERVE-102, an in vivo base editing therapy targeting PCSK9 for heterozygous familial hypercholesterolemia.
- Immix Biopharma's stock hits a 52-week low amidst market challenges, reflecting investor concerns about the company's financial performance. - NXC-201, a CAR-T therapy, demonstrates a 92% overall response rate in an ex-U.S. study for AL Amyloidosis, leading to expansion of U.S. Phase 1b/2 trial. - The European Commission grants orphan drug designation to NXC-201 for multiple myeloma, supporting its development for this indication.
- Immix Biopharma broadens its NEXICART-2 trial for relapsed/refractory AL Amyloidosis by incorporating new clinical sites, enhancing patient accessibility. - The expansion includes leading AL Amyloidosis programs at Cleveland Clinic, UC Davis, and Sutter Health, with Memorial Sloan Kettering Cancer Center as the lead site. - NXC-201, a BCMA-targeted CAR-T cell therapy, demonstrated a 92% overall response rate in an ex-U.S. trial, showing promise for this challenging disease. - The NEXICART-2 trial aims to evaluate the safety and efficacy of NXC-201 in patients who have not previously received BCMA-targeted therapy.
- Immix Biopharma's NXC-201 has been administered to a significant number of patients with relapsed/refractory AL amyloidosis and multiple myeloma, showing potential in these challenging conditions. - The company believes NXC-201 could offer a viable alternative for patients awaiting CAR-T cell therapies, potentially expanding access to a wider range of hospitals. - NXC-201 is being developed as a potential outpatient CAR-T therapy, addressing limitations of current CAR-T treatments that are primarily administered in specialized centers. - Immix Biopharma aims to address the limitations of current CAR-T therapies, which, despite generating substantial sales, are only accessible in a small percentage of U.S. hospitals due to side effects.
• Immix Biopharma's NXC-201 has been granted Orphan Drug Designation by the European Commission for treating multiple myeloma, a rare and life-threatening condition. • The designation provides NXC-201 with 10 years of market exclusivity in the EU upon approval, along with access to centralized authorization procedures. • This regulatory milestone underscores NXC-201's potential clinical impact, particularly for frail relapsed/refractory multiple myeloma patients with limited treatment options. • NXC-201 is currently being evaluated in the NEXICART-1 clinical trial, showing a favorable tolerability profile and potential for 'Single Day CRS'.
- Nexcella, a subsidiary of Immix Biopharma, is set to begin dosing patients in the U.S. with NXC-201 for relapsed/refractory AL Amyloidosis in mid-2024. - The NEXICART-2 Phase 1b trial (NCT06097832) will enroll 40 patients with adequate cardiac function to assess the safety and efficacy of NXC-201. - NXC-201, a BCMA-targeted CAR-T cell therapy, has received Orphan Drug Designation from the FDA and EMA for AL Amyloidosis and multiple myeloma. - Memorial Sloan Kettering Cancer Center is the lead clinical site for the NXC-201 trial, marking a significant step in exploring new treatment options.
- Immix Biopharma's NXC-201, a BCMA-targeted CAR-T cell therapy, demonstrated a 100% overall response rate in relapsed/refractory AL amyloidosis patients in Phase 1/2a trials. - The FDA has cleared the IND application for NXC-201, enabling U.S. patient dosing and expanding studies of the therapy in relapsed/refractory AL Amyloidosis. - NXC-201 has also shown a 95% overall response rate in heavily pre-treated relapsed/refractory multiple myeloma patients with a median follow-up of 11.9 months. - A virtual KOL event will be hosted to discuss NXC-201's potential as a treatment option for relapsed/refractory AL Amyloidosis, featuring experts in the field.
