SOMERSET, N.J., Aug. 26, 2025 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today announced that Ying Huang, Ph.D., the company’s Chief Executive Officer, will participate in a fireside chat at the Morgan Stanley Global Healthcare Conference in New York, NY on Tuesday, September 9, 2025, at 4:05 p.m. ET. The live webcast will be available to investors and other interested parties by accessing the Investor Relations section of Legend’s websit ...

Company Overview - Arcellx, Inc. (NASDAQ: ACLX) is advancing its lead CAR-T cell therapy, anitocabtagene Autoleucel (anito-cel), aimed at treating patients with relapsed/refractory multiple myeloma (r/r MM) [2] Industry Insights - The article highlights the importance of deep-dive analysis in the pharmaceutical sector, particularly for investors interested in biotech companies [2]

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]

Core Insights - Legend Biotech Corporation announced long-term results from the CARTITUDE-1 study, showing that 33% of heavily pretreated relapsed/refractory multiple myeloma patients remained progression-free for five years after a single infusion of CARVYKTI [1][4][6] Group 1: Study Results - In the CARTITUDE-1 study, at a median follow-up of 61.3 months, patients treated with CARVYKTI demonstrated a median overall survival (OS) of 60.7 months [4] - Among 97 patients, 32 (33%) remained progression-free for five years or more without further myeloma treatment [4][6] - A subset analysis of 12 patients who underwent minimal residual disease assessments showed all remained progression-free and MRD-negative for five years [3] Group 2: Safety and Efficacy - Safety signals were consistent with the known profile of CARVYKTI, with no new movement or neurocognitive treatment-emergent adverse events reported [5] - Two new cases of second primary malignancies were reported, both solid tumors [5] - The CARTITUDE-4 study indicated that CARVYKTI improved progression-free survival (PFS) and overall survival (OS) compared to standard therapies in high-risk subgroups [7][9] Group 3: Future Developments - Ongoing Phase 1 studies of LB1908 and LB2102 in gastroesophageal and lung cancers, respectively, show promising early results, indicating potential for next-generation cell therapies [8][11] - Legend Biotech entered an exclusive global license agreement with Novartis for certain CAR-T cell therapies targeting DLL3, including LB2102 [15][17]

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]

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, currently being evaluated in the NEXICART-2 study [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][7] Clinical Trial Updates - The NEXICART-2 clinical trial is actively enrolling patients, with 14 U.S. sites currently participating, an increase of 10 sites since the last update [1][2] - The company anticipates completing the NEXICART-2 clinical trial ahead of schedule due to robust enrollment and demand [2] - The trial aims to enroll 40 patients with preserved heart function who have not previously received BCMA-targeted therapy, focusing on safety and efficacy as primary endpoints [3] Market Insights - The U.S. prevalence of relapsed/refractory AL Amyloidosis is estimated to grow at 12% annually, reaching approximately 33,277 patients by 2024 [6] - The AL Amyloidosis market was valued at $3.6 billion in 2017 and is projected to reach $6 billion by 2025 [6] Upcoming Presentations - 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 from May 30 to June 3, 2025 [2]

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]

Core Insights - Immix Biopharma reported strong efficacy and favorable safety results for its NXC-201 therapy in the NEXICART-2 Phase 1/2 clinical trial for relapsed/refractory AL Amyloidosis, with a complete response (CR) rate of 71% [1][4][3] - The company has received FDA Regenerative Medicine Advanced Therapy (RMAT) designation for NXC-201, indicating significant progress towards regulatory approval [3][9] - The upcoming ASCO presentation on June 3, 2025, will provide updated results and further analysis of the trial data [5][2] Company Overview - Immix Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for AL Amyloidosis and other serious diseases [12] - The lead candidate, NXC-201, is a BCMA-targeted CAR-T cell therapy that has shown promising results in initial studies [9][12] - The company aims to enroll 40 patients in the ongoing NEXICART-2 trial, which is designed to evaluate the safety and efficacy of NXC-201 [8] Clinical Trial Details - The NEXICART-2 trial is a U.S. multi-site, single-arm study assessing NXC-201 in patients with relapsed/refractory AL Amyloidosis [8] - Prior to treatment, patients had a median of 4 lines of therapy, and all had organ involvement due to the disease [4] - No relapses or significant safety signals have been reported to date, with only low-grade cytokine release syndrome observed [4][3] Market Context - The prevalence of relapsed/refractory AL Amyloidosis is estimated to grow at 12% per year, reaching approximately 33,277 patients in 2024 [11] - The AL Amyloidosis market was valued at $3.6 billion in 2017 and is projected to reach $6 billion by 2025 [11]

Company Overview - Immix Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for AL Amyloidosis and other serious diseases [12] - The lead candidate is NXC-201, a sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy [12] - NXC-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA and Orphan Drug Designation (ODD) from both the FDA and EMA [9][12] Clinical Trials - The ongoing NEXICART-2 trial (NCT06097832) is a single-arm multi-site Phase 1/2 clinical trial evaluating NXC-201 in patients with relapsed/refractory AL Amyloidosis [8] - The trial aims to enroll 40 patients with preserved heart function and has safety as the primary endpoint for Phase 1 and efficacy for Phase 2 [8] - Initial data from the ex-U.S. study NEXICART-1 has shown high complete response rates in relapsed/refractory AL Amyloidosis [9] Market Insights - 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] Key Opinion Leaders - A virtual KOL event is scheduled for June 3, 2025, featuring experts discussing interim clinical data from the NEXICART-2 trial [1][2] - Notable speakers include Dr. Heather Landau, Dr. Shahzad Raza, and Dr. Jeffrey Zonder, who will share their clinical experiences with NXC-201 [2][4][6][7]

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]