BEIJING, Dec. 09, 2025 (GLOBE NEWSWIRE) -- InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that over 20 studies of its novel BTK inhibitor orelabrutinib were presented at the 67th Annual Meeting of the American Society of Hematology (ASH). Orelabrutinib has demonstrated remarkable efficacy and safety in multiple lymphoma studies, including marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), chr ...

Group 1 - Bristol Myers Squibb is advancing lymphoma research with new data on targeted protein degradation and cell therapy presented at ASH 2025 [1] - The company aims to enhance treatment options for lymphoma patients through innovative therapeutic approaches [1] - The presentation at ASH 2025 highlights the potential of these new therapies in improving patient outcomes [1]

Core Insights - CASI Pharmaceuticals, Inc. is developing CID-103, an anti-CD38 monoclonal antibody aimed at treating organ transplant rejection and autoimmune diseases [1] - The company presented data from a Phase 1 open-label study of CID-103 for immune thrombocytopenia (ITP) at the 67th American Society of Hematology Annual Meeting [1] Study Details - The Phase 1 study involved adult patients with ITP and utilized a dose escalation approach with intravenous infusions of CID-103 [1] - Patients were assigned to sequential dose-escalating cohorts receiving CID-103 at doses of 30 mg (n=1), 150 mg (n=1), 300 mg (n=3), 600 mg (n=3), and 900 mg (n=3) [1] - A priming dose of CID-103 was administered prior to the cohort dose, either at 30 mg or 150 mg [1]

Core Insights - BI-1206 shows potential to overcome resistance mechanisms to rituximab in treating non-Hodgkin's lymphoma [1] - 47% of patients achieved complete responses (CR), with an overall response rate of 80% [1] - The safety profile is favorable, with 87% of adverse events being mild or moderate, and no treatment-related discontinuations [1] - The safety run-in portion of the study is complete, showing no significant differences in safety or efficacy between the two dose levels [1] - The signal-seeking expansion phase of the study is currently ongoing [1] Company Overview - BioInvent International AB is focused on discovering and developing novel and first-in-class immune-modulatory antibodies for cancer immunotherapy [1] - The company presented new data from its ongoing trial of BI-1206 at the 2025 American Society of Hematology Annual Meeting [1] Industry Context - Anti-CD20 antibodies, such as rituximab, are critical for the treatment of non-Hodgkin's lymphoma [1]

Core Insights - Syndax Pharmaceuticals presented new data on Revuforj (revumenib) at the 67th ASH Annual Meeting, highlighting its efficacy and safety in treating acute leukemia, particularly in patients with NPM1m, KMT2Ar, and NUP98r mutations [1][2][3] Efficacy and Safety Data - The overall response rate (ORR) for revumenib was reported at 77% (10/13) in a retrospective review, with a complete remission (CR) rate of 31% (4/13) and 75% (9/12) achieving measurable residual disease (MRD) negativity [1][4][5] - In a Phase 2 SAVE trial, the ORR was 86% (18/21) and the CR rate was 76% (16/21), with 100% MRD negativity among responders [6][11] - Revumenib demonstrated a favorable safety profile, with only 24% (4/17) experiencing Grade 3 or 4 non-hematological adverse events, and low rates of dose reductions and discontinuations at 6% each [5][13] Clinical Trials and Future Directions - Syndax has initiated pivotal frontline trials for revumenib in patients unfit for intensive chemotherapy and in fit patients, aiming to expand clinical data supporting its use [2][23] - Multiple ongoing and planned trials are evaluating revumenib in combination with standard therapies for newly diagnosed patients with specific genetic mutations [22][23] Pediatric Applications - A retrospective review of revumenib as post-HSCT maintenance in children showed that all ten patients were alive at a median follow-up of 19 months, with a 90% relapse-free survival rate [7][8] Company Overview - Syndax Pharmaceuticals is focused on advancing innovative cancer therapies, with Revuforj being a first-in-class menin inhibitor approved for treating relapsed or refractory acute leukemia [22][40]

Core Insights - Galapagos NV announced promising Phase 2 data for GLPG5101, a CAR T-cell therapy for high-risk mantle cell lymphoma (MCL), showing high complete response rates and minimal residual disease negativity with durable responses [1][5] Group 1: Study Results - The ATALANTA-1 study reported an objective response rate (ORR) of 100% and a complete response rate (CRR) of 96% among infused patients [5] - At a median follow-up of 9 months, both duration of response (DOR) and progression-free survival (PFS) rates were 83% [5] - Among minimal residual disease (MRD)-evaluated patients, 90% were MRD-negative at complete response, with 7 out of 9 MRD-negative patients remaining in complete response at the data cut-off [5] Group 2: Safety Profile - GLPG5101 demonstrated a favorable safety profile, with the most common Grade ≥ 3 treatment-emergent adverse events being hematologic [5] - No Grade ≥ 3 cytokine release syndrome (CRS) was observed, and only one case of Grade ≥ 3 immune effector cell-associated neurotoxicity syndrome (ICANS) occurred [5] Group 3: Manufacturing and Administration - GLPG5101 is a second-generation anti-CD19/4-1BB CAR-T product administered as a single fixed intravenous dose, with a 7-day vein-to-vein time [1][4] - The study evaluated three dose levels: 50×10^6, 110×10^6, and 250×10^6 CAR+ viable T-cells [4] - The low dropout rate of 4% and elimination of the need for bridging therapy allowed more patients to access treatment [1][2] Group 4: Company Strategy - Galapagos intends to wind down its cell therapy activities while continuing to operate the business and conduct ongoing clinical studies [3] - The company remains open to viable proposals for acquiring all or part of its cell therapy business during the wind-down process [3]

Core Viewpoint - Ascentage Pharma presented promising results from a Phase Ib/II study of Lisaftoclax in combination with azacitidine for treating myeloid malignancies at the 67th ASH Annual Meeting, highlighting its potential to address unmet medical needs in patients resistant to venetoclax [1][2][3]. Company Overview - Ascentage Pharma Group International is a global biopharmaceutical company focused on developing novel therapies for cancer, with a strong pipeline including Lisaftoclax, Olverembatinib, and APG-5918 [12][14]. Clinical Study Highlights - The study presented at ASH 2025 demonstrated a 31.8% overall response rate (ORR) in venetoclax-resistant patients and an 80% ORR in newly diagnosed high-risk MDS/CMML patients [6][15]. - The combination of Lisaftoclax and azacitidine showed a strong safety profile with no dose-limiting toxicities reported across all patient cohorts in the study involving 103 patients [10][15]. Drug Mechanism and Approval Status - Lisaftoclax is an orally administered Bcl-2 selective inhibitor that restores apoptosis in cancer cells and is currently approved in China for CLL/SLL patients who have received prior systemic therapy [4][14]. - The company is conducting four global registrational Phase III studies for Lisaftoclax across multiple indications, including CLL/SLL, AML, and MDS [4][16]. Expert Commentary - The Chief Medical Officer of Ascentage Pharma emphasized the therapeutic potential of Lisaftoclax for newly diagnosed or venetoclax-exposed patients, aiming to improve clinical management of myeloid malignancies [5].

Core Insights - Innovent Biologics announced initial data from the first-in-human trial of IBI3003, a novel trispecific antibody targeting GPRC5D, BCMA, and CD3 for relapsed or refractory multiple myeloma, showing favorable tolerability and encouraging efficacy signals, especially in high-risk patients [1][10][11] Group 1: Study Design and Patient Demographics - IBI3003 is designed to target both GPRC5D and BCMA to overcome single antigen escape in multiple myeloma [2] - The Phase 1 study enrolled 39 patients with a median age of 62 years, where 64.1% were classified as high-risk and 46.2% had extramedullary disease [5] - Patients had a median of 4 prior lines of therapy, with 76.9% being refractory to their last treatment [5] Group 2: Treatment Administration and Safety Profile - IBI3003 was administered subcutaneously once weekly, with a switch to every two weeks for patients achieving a partial response after 6 months [4] - The safety profile was manageable, with 97.4% of patients experiencing treatment-emergent adverse events, primarily hematological disorders [8][10] - The incidence of cytokine release syndrome (CRS) was 64.1%, with all cases being Grade 1-2 and resolved with treatment [8] Group 3: Efficacy Results - Among patients treated with 120 g/kg, the overall response rate (ORR) was 83.3%, including stringent complete response in 4 cases and very good partial response in 7 cases [7][9] - The minimal residual disease negativity rate was 100% among patients achieving complete response or better [14] - Encouraging efficacy was particularly noted in high-risk patients, including those with extramedullary disease or prior anti-BCMA and/or anti-GPRC5D therapies [10][11] Group 4: Future Outlook - The company is conducting ongoing dose optimization for IBI3003 in the Phase 1 study, with expectations for deeper anti-tumor responses with continued treatment [10][12] - There is an urgent clinical need for effective treatments in patients with relapsed or refractory multiple myeloma, particularly those with high-risk features [11]

Core Insights - BeOne Medicines Ltd. announced new data on sonrotoclax, a next-generation BCL2 inhibitor, showing significant clinical benefits as both a monotherapy and in combination therapies for B-cell malignancies, particularly at the 67th American Society of Hematology Annual Meeting [1][2] Summary by Category Clinical Data - Sonrotoclax demonstrated an overall response rate (ORR) of 52.4% in patients with relapsed/refractory mantle cell lymphoma (MCL), with a complete response (CR) rate of 15.5% in a Phase 1/2 study [3] - The median duration of response (DOR) was 15.8 months, with a median time to response (TTR) of 1.9 months and a median progression-free survival (PFS) of 6.5 months [4] - In combination therapies, sonrotoclax plus zanubrutinib achieved a 100% ORR in 135 efficacy-evaluable patients, with a CR/CRi rate of 55% [7] Safety and Tolerability - Treatment with sonrotoclax monotherapy was generally well tolerated, with manageable adverse events; the most common grade 3 treatment-emergent adverse events included neutropenia (19.1%), infections (16.5%), and pneumonia (10.4%) [5] - The combination therapies also showed good tolerability, with no treatment-emergent adverse events leading to death or significant complications [13][14] Regulatory Status - Sonrotoclax is under Priority Review by the U.S. Food and Drug Administration (FDA) for potential accelerated approval, having received Breakthrough Therapy Designation and Fast Track Designation for MCL and other conditions [5][17] Market Potential - Sonrotoclax could become the first BCL2 inhibitor approved for relapsed/refractory MCL in the U.S., with the potential to transform treatment outcomes for patients with limited options [3][6]

Core Insights - Rigel Pharmaceuticals announced updated data from its ongoing Phase 1b study of R289, an oral prodrug of R835, targeting relapsed or refractory lower-risk myelodysplastic syndrome (MDS) [1][2] - The study results were presented at the 67th American Society of Hematology Annual Meeting, highlighting the potential of R289 as a treatment option for patients with transfusion-dependent lower-risk MDS [1][2] Study Overview - The Phase 1b study is evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of R289 in patients with relapsed or refractory lower-risk MDS [2] - Enrollment in the dose escalation phase was completed in July 2025, with the dose expansion phase starting in October 2025, involving up to 40 patients [2] Key Data Highlights - As of October 28, 2025, 33 patients were enrolled, with a median age of 75 and a median of 3 prior therapies [4] - R289 was generally well tolerated, with 33% of evaluable transfusion-dependent patients achieving durable red blood cell transfusion independence (RBC-TI) [3][4] - The most common treatment-emergent adverse events included diarrhea (30%), constipation (27%), and fatigue (27%) [4] Efficacy Results - Among evaluable transfusion-dependent patients, 6 out of 18 (33%) achieved RBC-TI lasting more than 8 weeks, with a median time to onset of 1.9 months [4] - Peak hemoglobin increases ranged from 2.9 to 6.1 g/dL compared to baseline in patients achieving RBC-TI [4] Regulatory Designations - R289 has received Orphan Drug designation and Fast Track designation from the FDA for the treatment of previously-treated transfusion-dependent lower-risk MDS [5]