Day: December 8, 2024

NHP Data Showed CD117 Monoclonal Antibody (mAb) Conditioning Successfully Achieved Long-term Engraftment of Base-edited Hematopoietic Stem Cells and Induced Robust Levels of Hemoglobin F mAb Dosing Well Tolerated Without Need for Supportive Care Beam on Track to Initiate Phase 1-enabling Studies by End of 2024 Beam to Host Investor Event on Dec. 8, 2024, at 8 p.m. PT SAN DIEGO, Dec. 08, 2024 (GLOBE NEWSWIRE) — Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, today announced new data for its Engineered Stem Cell Antibody Evasion (ESCAPE) conditioning platform. Presented in an oral session at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, the data demonstrated that conditioning and in vivo selection with an anti-CD117...

In Multiple Myeloma, Cemsidomide in Combination with Dexamethasone at Highest Dose Level Explored to Date Achieved 36 Percent Overall Response Rate (ORR) and 45 Percent Clinical Benefit Rate (CBR); Responses Seen Across All Dose Levels Multiple Myeloma Arm Demonstrated Well-Tolerated Safety Profile; On-Target Neutropenia Was Manageable With Low Rates of Febrile Neutropenia and Infections; No Treatment Emergent Adverse Events Leading to Dose Reduction In Non-Hodgkin’s Lymphoma, Cemsidomide Monotherapy Demonstrated a 38 Percent ORR and 19 Percent Complete Metabolic Response (CMR) Rate Across All Subtypes; In Peripheral T-Cell Lymphoma (PTCL), Cemsidomide Achieved a 44 Percent ORR and 25 Percent CMR Rate Cemsidomide is Well Positioned for Future Development in Multiple Myeloma Combination Regimens and Various Non-Hodgkin’s Lymphoma Subtypes...

Exploratory long-term follow-up analysis of the phase III POLARIX study indicated a positive trend in overall survival in favour of Polivy in combination with R-CHP for people with first-line diffuse large B-cell lymphoma (DLBCL)1 Patients treated with Polivy in combination with R-CHP required fewer subsequent treatments, potentially reducing burdens on patients and healthcare systems1 These encouraging five-year results continue to highlight the potential of this Polivy combination to improve outcomes in first-line DLBCL, an area that previously had little advancement in nearly two decadesBasel, 8 December 2024 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today data from a five-year follow-up of the pivotal phase III POLARIX study evaluating Polivy® (polatuzumab vedotin) in combination with MabThera®/Rituxan® (rituximab), cyclophosphamide,...

Scemblix demonstrated sustained superior major molecular response (MMR) vs. all investigator-selected TKIs (74.1% vs. 52%) and vs. imatinib alone (76.2% vs. 47.1%), meeting both ASC4FIRST 96-week key secondary endpoints1   Scemblix showed a clinically relevant 15.1% higher MMR rate vs. second generation (2G) TKIs (72.0% vs. 56.9%)1  96-week data extend favorable safety and tolerability profile for Scemblix vs. imatinib and 2G TKIs, with fewer grade ≥3 AEs and less than half the discontinuation rate due to AEs1  Latest results strengthen Scemblix as a standard of care following expanded indication in newly diagnosed and previously treated adult patents with Ph+ CML-CP and NCCN category 1 recommendation1-3Basel, December 8, 2024 – Novartis today announced positive, longer-term results from the pivotal Phase III ASC4FIRST trial with Scemblix®...

– ENERGIZE-T Study Achieved Primary and All Key Secondary Endpoints in Adult Patients with Transfusion-Dependent Alpha- or Beta-Thalassemia – – ENERGIZE-T is First Phase 3 Study to Demonstrate Efficacy of an Oral, Disease-Modifying Treatment for Transfusion-Dependent Alpha- and Beta-Thalassemia – – Company Filed for Regulatory Approval of Mitapivat (PYRUKYND®) for the Treatment of Adult Patients with Non-Transfusion-Dependent and Transfusion-Dependent Alpha- or Beta-Thalassemia in U.S., European Union, Kingdom of Saudi Arabia and United Arab Emirates – – Live and Webcast Investor Event with Agios Leadership and Medical Experts will be Hosted in San Diego on Monday, December 9 at 7:00 a.m. PT – CAMBRIDGE, Mass., Dec. 08, 2024 (GLOBE NEWSWIRE) — Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and pyruvate...

52% ORR per mIWG criteria, including 83% ORR for patients receiving 100 mg BID 88% ORR per PPR criteria, including 100% ORR for patients receiving 100 mg BID Median time to response 2.2 months with median duration of response and median PFS not yet reached Top-line data from APEX Part 2 on-track for mid-2025 Cogent to host investor webcast on Monday, December 9 at 8:00 a.m. ET WALTHAM, Mass. and BOULDER, Colo., Dec. 08, 2024 (GLOBE NEWSWIRE) — Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today reported positive updated data from Part 1 of the Company’s ongoing Phase 2 APEX clinical trial evaluating bezuclastinib in patients with advanced systemic mastocytosis (AdvSM) at the 66th American Society of Hematology (ASH 2024) Annual Meeting...

MP0533 phase 1/2a dose escalation study continues with overall acceptable safety profile to date as well as initial antileukemic and pharmacodynamic activity Clinical protocol amendment in process with optimized dosing scheme to overcome target-mediated drug disposition and test the full potential of MP0533 Switch-DARPin MP0621 demonstrates intended mechanism in vivo, achieving killing of cKit+ cells while reducing off-target effects seen with systemic anti-CD47 blockade ZURICH-SCHLIEREN, Switzerland and CONCORD, Mass., Dec. 08, 2024 (GLOBE NEWSWIRE) — Ad hoc announcement pursuant to Art. 53 LR – Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics (“Molecular Partners” or the “Company”), today announced the presentation...

The combination of acimtamig with AlloNK® demonstrated an overall response rate of 86% and complete response of 55% in 22 heavily pretreated patients with R/R cHL, who have exhausted all standard of care treatments The combination showed a well-manageable safety profile with no unexpected safety signalsMANNHEIM, Germany, Dec. 08, 2024 (GLOBE NEWSWIRE) — Affimed N.V. (Nasdaq: AFMD) (“Affimed”, or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced the presentation of data in a poster session at the 66th ASH Annual Meeting and Exposition. The dataset includes 22 patients from the run-in phase of the LuminICE-203 (AFM13-203) phase 2 open-label, multicenter, multi-cohort study. The trial evaluates the safety and efficacy of the combination...

Media Release COPENHAGEN, Denmark; December 8, 2024Preliminary analyses from the EPCORE® CLL-1 trial demonstrates overall response rate (ORR) of 61 percent and complete response (CR) rate of 39 percent in heavily pretreated patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) who received epcoritamab monotherapy In the study, 75 percent of evaluable responders achieved undetectable minimal residual disease (MRD), indicating no detectable disease following treatment with epcoritamab The data were selected as part of the 2024 American Society of Hematology’s (ASH’s) Annual Meeting Press Program in the Diagnosing and Treating Blood Cancers and “Almost Cancers” briefingGenmab A/S (Nasdaq: GMAB) today announced results from the Phase 1b/2 EPCORE® CLL-1 clinical trial evaluating epcoritamab (Abstract #883), a T-cell...

GUELPH, Ontario, Dec. 08, 2024 (GLOBE NEWSWIRE) — Current Water Technologies Inc. (TSX-V: WATR) (“CWTI” or “the Company” or “the Corporation“), announces that due to the ongoing postal strike in Canada, the Company’s annual meeting materials are being delayed. The Company’s Meeting materials may be viewed on the Company’s SEDAR+ corporate website at www.sedarplus.ca and are also available electronically at https://docs.tsxtrust.com/2198. Registered shareholders requesting a proxy for the meeting may contact TSX Trust Company at 1-866- 600-5869 or email tsxtis@tmx.com. Proxies, completed and signed, should be forwarded by deadline, 10:00 a.m. EST, Wednesday, December 18, 2024. Beneficial holders, who hold their shares through a broker, and have not received their information...