Core Insights - Immix Biopharma's NXC-201 achieved a complete response (CR) rate of 70% in the NEXICART-2 Phase 1/2 clinical trial for relapsed/refractory AL Amyloidosis, meeting its primary endpoint [1][4][3] - The trial reported no relapses or safety signals to date, indicating a favorable safety profile for NXC-201 [1][4] - Immix plans to submit a Biologics License Application (BLA) to the FDA for NXC-201 following these promising results [1][3] Clinical Trial Details - The NEXICART-2 trial is a U.S. multi-site, single-arm study evaluating NXC-201 in patients with relapsed/refractory AL Amyloidosis, with a data cutoff of April 11, 2025 [1][3][7] - Prior to treatment, patients had a median of 4 lines of therapy, and all had organ involvement from the disease [4] - After treatment, all patients normalized pathological disease markers, with 70% achieving complete responses [4] Safety and Efficacy - No neurotoxicity was observed, and only low-grade cytokine release syndrome was reported [4][9] - The remaining 3 patients who did not achieve CR are minimum residual disease (MRD) negative, suggesting potential future CRs [4] Market Context - Current treatments for relapsed/refractory AL Amyloidosis have a CR rate of less than 10%, highlighting a significant unmet medical need [5] - The U.S. prevalence of relapsed/refractory AL Amyloidosis is estimated to grow at 12% per year, reaching approximately 33,277 patients by 2024 [11] - The amyloidosis market was valued at $3.6 billion in 2017 and is projected to reach $6 billion by 2025 [11] Company Overview - Immix Biopharma is a clinical-stage biopharmaceutical company focused on developing cell therapies for AL Amyloidosis and other serious diseases [12] - NXC-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA and Orphan Drug Designation from both the FDA and EMA [9][12]

Oral presentation of CARTITUDE-1 study data showcases long-term outcomes after a single infusion of CARVYKTI® with one-third of patients with relapsed/refractory multiple myeloma progression-free for ≥5 years CARTITUDE-4 subgroup analyses featured in a poster presentation highlight consistent, durable progression-free and overall survival benefit vs. standard therapies across cytogenetic risk groups as early as second-line therapyPromising early results from ongoing Phase 1 dose-escalation studies of LB1908 ...

Core Insights - CARsgen Therapeutics has announced positive results from the pivotal Phase II clinical trial of satricabtagene autoleucel ("satri-cel") for treating Claudin18.2-positive advanced gastric/gastroesophageal junction cancer, which were published in The Lancet and presented at the 2025 ASCO Annual Meeting [1][2][3] Company Overview - CARsgen Therapeutics is focused on developing innovative CAR T-cell therapies to address unmet clinical needs in hematologic malignancies, solid tumors, and autoimmune diseases [7] - The company has established comprehensive capabilities for CAR T-cell research and development, including target discovery, preclinical research, clinical development, and commercial-scale production [7] Clinical Trial Details - The CT041-ST-01 trial is the first randomized controlled clinical study of CAR-T cell therapy for solid tumors, demonstrating significant clinical benefits such as improved progression-free survival (PFS), overall survival (OS), and tumor response rates in heavily pretreated patients [4] - The trial results indicate that satri-cel offers breakthrough efficacy for patients with limited treatment options and poor prognosis [4] Regulatory Designations - Satri-cel has received Breakthrough Therapy Designation and Priority Review from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for treating Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma [6] - The company plans to submit a New Drug Application (NDA) for satri-cel to the NMPA, anticipating it to be the first commercially available CAR-T product for solid tumors [4][6] Future Development Plans - CARsgen is exploring satri-cel's potential in adjuvant settings and as first-line sequential therapies to intervene earlier in the disease course and extend patient survival [4] - Ongoing trials include various phases for treating advanced gastric/gastroesophageal junction adenocarcinoma and pancreatic cancer [5]

– Patient enrollment exceeding expectations – – 14 U.S. sites actively enrolling; 10 U.S. sites added since last update – – Anticipate completing NEXICART-2 clinical trial ahead of schedule – LOS ANGELES, CA, May 23, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” or "IMMX”), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases, today announced that 14 U.S. sites are actively enrolling in U.S. multi-site study ...

Core Insights - Legend Biotech Corporation is presenting new data on CARVYKTI (ciltacabtagene autoleucel) for multiple myeloma at the 2025 ASCO and EHA meetings, highlighting its status as a market leader in CAR-T therapy for this condition [1][2] - The company is also showcasing preliminary results from ongoing Phase 1 studies targeting solid tumors, specifically lung and gastric cancers, indicating an expansion of its cell therapy pipeline [1][2] CARVYKTI Data - Long-term data from the CARTITUDE-1 study will be presented, showing that heavily pretreated patients with relapsed or refractory multiple myeloma achieved a median progression-free survival of over 5 years after a single CARVYKTI infusion, with a median follow-up of 60.3 months [3][10] - Data from the CARTITUDE-4 study will support a positive benefit-risk ratio for CARVYKTI across various patient subgroups, including those with high-risk cytogenetics [4][10] Solid Tumor Pipeline - Preliminary results from Phase 1 studies of LB2102 and LB1908, targeting small-cell lung cancer and gastroesophageal adenocarcinoma respectively, will be featured in poster presentations at ASCO [6][10] - LB2102 has been licensed to Novartis for further development, with Legend Biotech responsible for the Phase 1 clinical trial in the U.S. [7][8] Clinical Presentations - The company will present data at ASCO and EHA, including an oral presentation on long-term survival outcomes for CARVYKTI and poster presentations on subgroup analyses and preliminary results from solid tumor studies [10][12]

Immix Biopharma today reported ASCO abstract results from its U.S. multi-center NEXICART-2 Phase 1/2 clinical trial of NXC-201 demonstrating strong efficacy and favorable safety. – NXC-201 demonstrated a complete response (CR) rate of 71% (5/7 patients) – – No relapses recorded to-date; no safety signals identified – – Updated results with a later data cutoff, including endpoint analysis, will be presented at ASCO by lead investigator Heather Landau, MD, of Memorial Sloan Kettering Cancer Center – – KOL ev ...

– Virtual KOL Event Tuesday, June 3, 2025 3:00pm ET – – Attend the event here: https://lifescievents.com/event/immix-asco – LOS ANGELES, CA, May 21, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” or ”IMMX”), clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases, today announced that it will host a virtual Key Opinion Leader (KOL) event to discuss interim clinical data from the NEXICART-2 Phase 1/2 clinical trial ...

Company Overview - Immix Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for AL Amyloidosis and other serious diseases [7] - The lead candidate is NXC-201, a sterically-optimized BCMA-targeted CAR-T cell therapy [4][7] - NXC-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA and Orphan Drug Designation (ODD) from both the FDA and EMA [4][8] Clinical Trials - The NEXICART-2 trial is an ongoing single-arm multi-site U.S. Phase 1/2 clinical trial evaluating NXC-201 in relapsed/refractory AL Amyloidosis, expected to enroll 40 patients with preserved heart function [3] - The primary endpoint of the Phase 1 portion is safety, while the Phase 2 portion focuses on efficacy [3] - Initial data from an ex-U.S. study, NEXICART-1, has shown high complete response rates in relapsed/refractory AL Amyloidosis [4] Market Insights - The U.S. prevalence of relapsed/refractory AL Amyloidosis is estimated to grow at 12% per year, reaching approximately 33,277 patients in 2024 [6] - The amyloidosis market was valued at $3.6 billion in 2017 and is projected to reach $6 billion by 2025 [6] Upcoming Events - Phase 1/2 interim readout data from the NEXICART-2 trial will be presented at the 2025 American Society of Clinical Oncology Annual Meeting in Chicago on June 3, 2025 [1][2] - The presentation will be led by Dr. Heather Landau, Director of the Amyloidosis Program at Memorial Sloan-Kettering Cancer Center [1]

Company Overview - Immix Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for AL Amyloidosis and other serious diseases [8] - The lead candidate is NXC-201, a sterically-optimized BCMA-targeted CAR-T cell therapy [5][8] - NXC-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA and Orphan Drug Designation (ODD) from both the FDA and EMA [5][9] Clinical Trials - The ongoing NEXICART-2 trial (NCT06097832) is a single-arm multi-site Phase 1/2 clinical trial evaluating NXC-201 in relapsed/refractory AL Amyloidosis [4] - The trial aims to enroll 40 patients with preserved heart function who have not previously received BCMA-targeted therapy [4] - The primary endpoint for Phase 1 is safety, while for Phase 2 it is efficacy [4] Upcoming Presentation - Interim readout data from the NEXICART-2 trial will be presented at the 2025 American Society of Clinical Oncology Annual Meeting (ASCO 2025) in Chicago [2] - The presentation is scheduled for June 3, 2025, and will be led by Dr. Heather Landau from Memorial Sloan-Kettering Cancer Center [2][3] Market Insights - The U.S. prevalence of relapsed/refractory AL Amyloidosis is estimated to grow at 12% per year, reaching approximately 33,277 patients in 2024 [7] - The amyloidosis market was valued at $3.6 billion in 2017 and is projected to reach $6 billion by 2025 [7]