Immix Biopharma
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 2012-01-01
- Employees
- 17
- Market Cap
- $59.8M
- Website
- http://www.immixbio.com
- Introduction
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.
Instil Bio's PD-L1xVEGF Bispecific Antibody Shows Promise in NSCLC, Driving 48% Stock Surge
• Instil Bio's stock jumped 48.4% following positive updates on IMM2510/AXN-2510, a novel PD-L1xVEGF bispecific antibody showing 23% objective response rate in relapsed/refractory non-small cell lung cancer.
• The Phase 2 trial of IMM2510/AXN-2510 in first-line NSCLC in China is progressing well, with enrollment expected to complete by Q3 2025 and initial results anticipated later this year.
• Instil Bio plans to expand clinical development with a U.S. Phase 1b/2 trial in solid tumors by 2025, potentially accelerating the global development pathway for this promising immunotherapy.
Immix Biopharma's NXC-201 CAR-T Shows Promise in Relapsed/Refractory AL Amyloidosis
• 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.
Multiple Sclerosis Pipeline Shows Promise with Novel Therapies in Development
• The multiple sclerosis (MS) therapeutic landscape is expanding, with over 80 active pipeline therapies currently in development by more than 75 companies.
• Recent clinical trials have yielded mixed results, with some therapies showing promise in specific MS subtypes, such as non-relapsing secondary progressive MS (nrSPMS).
• Regulatory milestones have been achieved, including FDA approval for new formulations and fast-track designations for therapies targeting progressive MS.
• Emerging therapies in the MS pipeline include monoclonal antibodies, oral treatments, and CAR-T cell therapies, offering diverse mechanisms of action and routes of administration.
Immix Biopharma's NXC-201 Advances to Expansion Cohort in US AL Amyloidosis Trial
• 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.
Gene and Cell Therapies Show Promise in Treating Various Cardiac Diseases
• 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.
Ractigen's RAG-18 Receives FDA Orphan Drug Designation for Duchenne and Becker Muscular Dystrophy
• Ractigen Therapeutics' RAG-18, a small activating RNA (saRNA) therapy, has been granted Orphan Drug Designation by the FDA for treating Duchenne and Becker muscular dystrophy.
• RAG-18 previously received Rare Pediatric Disease Designation, making it the first saRNA therapy to achieve both designations, highlighting its potential for treating rare genetic conditions.
• The therapy aims to increase utrophin production by targeting the UTRN gene, offering a functional substitute for the deficient dystrophin protein in DMD and BMD patients.
• Preclinical data presented at OTS 2023 demonstrated RAG-18's ability to induce utrophin expression and ameliorate muscle damage in a mouse model of DMD.
Immix Biopharma Expands NXC-201 Clinical Trial Sites for AL Amyloidosis
• 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 Receives EU Orphan Drug Designation for Multiple Myeloma
• 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'.
Immix Biopharma's Nexcella to Initiate US Dosing of NXC-201 CAR-T Therapy for AL Amyloidosis
• 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 CAR-T Therapy Shows Promise in AL Amyloidosis and Multiple Myeloma
• 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.
Immix Biopharma Completes Engineering Batch of NXC-201 CAR-T Therapy for U.S. Clinical Trial Expansion
• Immix Biopharma successfully completed its third engineering batch of NXC-201, a BCMA-targeted CAR-T cell therapy, at its U.S. manufacturing site.
• This milestone supports the planned expansion of the NEXICART-1 clinical trial (NCT04720313) to include U.S. patients.
• NXC-201 has demonstrated a 100% overall response rate in relapsed/refractory AL Amyloidosis patients in earlier studies, receiving FDA Orphan Drug Designation.
• Immix Biopharma aims to position NXC-201 as a potential outpatient CAR-T therapy, expanding access beyond the current 5% of U.S. hospitals offering CAR-T treatments.
FDA Grants Orphan Drug Designation to Immix Biopharma's NXC-201 for AL Amyloidosis
• Immix Biopharma's NXC-201, a CAR-T cell therapy, receives Orphan Drug Designation from the FDA for treating Amyloid Light Chain (AL) Amyloidosis.
• The designation provides Immix Biopharma with benefits including potential market exclusivity, tax credits, and a waiver for prescription drug user fees.
• NXC-201 is currently in Phase 1b/2a clinical trials and has demonstrated a 100% hematologic response rate in AL amyloidosis patients in early trials.
• AL Amyloidosis, a rare disorder affecting 30,000-40,000 individuals in the US and Europe, has a market projected to reach $6 billion by 2025.
Nexcella's NXC-201 Shows Promise in Relapsed/Refractory Multiple Myeloma and AL Amyloidosis
• Nexcella's NXC-201, a BCMA-targeted CAR-T therapy, demonstrates promising clinical data in relapsed/refractory multiple myeloma and AL amyloidosis.
• Updated clinical data on NXC-201 will be presented at the 20th International Myeloma Society Annual Meeting in Athens, Greece.
• The NEXICART-1 trial, a Phase 1b/2a study, evaluates the safety and efficacy of NXC-201 in adults with relapsed/refractory multiple myeloma and AL amyloidosis.
• Nexcella plans to submit data to the FDA for NXC-201 in relapsed/refractory multiple myeloma and AL amyloidosis after treating a target number of patients.
Nexcella Completes Pre-IND Meeting with FDA for NXC-201 in Multiple Myeloma and AL Amyloidosis
• Nexcella, a subsidiary of Immix Biopharma, completed a Pre-IND meeting with the FDA regarding NXC-201 for AL amyloidosis and multiple myeloma.
• The FDA reviewed Nexcella's pre-IND package, offering guidance on clinical data, manufacturing plans, and the Phase 1b/2 study protocol for NXC-201.
• Nexcella plans to submit an IND application to the FDA for a Phase 1b/2 trial of NXC-201 in relapsed/refractory multiple myeloma and AL amyloidosis.
• NXC-201 has demonstrated promising response rates in early trials, with Nexcella aiming to submit data to the FDA after treating a specific number of patients.
Immix Biopharma Completes $5 Million Equity Offering to Advance Clinical Programs
• Immix Biopharma finalized a $5 million at-the-market equity offering, welcoming Bridgewest Group as an institutional investor.
• The funds will support the clinical development of NXC-201, an outpatient CAR-T therapy for multiple myeloma and AL amyloidosis.
• Proceeds will also advance the IMX-110 clinical trials, including a combination trial with BeiGene's tislelizumab.
• ImmixBio is focused on efficient execution of its clinical development plans with the newly acquired capital.
Nexcella's NXC-201 Shows Promise in Multiple Myeloma and AL Amyloidosis
• Nexcella's NXC-201 demonstrates a 90% overall response rate in relapsed/refractory multiple myeloma patients, all of whom were triple-class refractory, indicating its potential in challenging cases.
• In AL amyloidosis, NXC-201 achieved a 100% organ response rate and complete hematologic responses in all eight relapsed/refractory patients, showcasing its efficacy in this rare disease.
• NXC-201 exhibits a favorable safety profile, potentially enabling outpatient CAR-T treatment, which could significantly expand access to this therapy in community hospitals.
• An editorial in *Haematologica* highlighted NXC-201's efficacy in the context of FDA-approved BCMA CAR-T therapies, noting its comparable safety and efficacy profile.
© Copyright 2025. All Rights Reserved by MedPath