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Sonrotoclax Data at ASH 2025 Confirm Foundational Potential Across B-cell Malignancies
Businesswire· 2025-12-07 23:00
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]
Nurix Therapeutics (NasdaqGM:NRIX) 2025 Conference Transcript
2025-11-19 12:02
Summary of Nurix Therapeutics Conference Call Company Overview - **Company**: Nurix Therapeutics (NasdaqGM:NRIX) - **Event**: Jefferies London Healthcare Conference 2025 - **Date**: November 19, 2025 Key Points Industry and Product Focus - Nurix Therapeutics is focused on developing therapies for Chronic Lymphocytic Leukemia (CLL) and other indications using their BTK degrader platform, specifically Bexobrutideg and NX-5948 [3][4][5] Upcoming Events and Data Releases - The company will present data at the upcoming ASH conference, including follow-up data from Phase 1A and Phase 1B trials for Bexobrutideg and NX-5948 [3][4] - Key metrics to be reported include duration of therapy and duration of response, with patients having been on therapy for over two years [3][4] Pivotal Trial Design - The pivotal trial for Bexobrutideg will focus on a triple-exposed patient population in CLL, with a selected dose of 600 mg once daily based on Phase 1B data [4][6] - The trial aims for accelerated approval, allowing early market access, while full approval will follow a randomized control study [10][11] Competitive Landscape - The company anticipates competition from pirtobrutinib, a non-covalent BTK inhibitor from Eli Lilly, which is expected to gain full approval [8][10] - Nurix is positioning Bexobrutideg as a potential standard of care in the U.S. market for CLL [10] Combination Therapies - Nurix is planning combination studies with Bexobrutideg and other therapies, including venetoclax and anti-CD20 antibodies [22][23] - The company is also exploring the potential of combining with T-cell engagers [23] Autoimmune Indications - The company is developing Bexobrutideg for autoimmune diseases, leveraging its ability to degrade BTK, which may provide advantages over traditional inhibitors [26][27] - A new formulation for Bexobrutideg is in development, with plans for IND submission in 2026 [27] Partnerships and Pipeline - Nurix has partnerships with Gilead for an IRAK4 degrader and with Sanofi for a STAT6 degrader, both of which are in various stages of development [35][36] - The IRAK4 program is in Phase 1, while the STAT6 program is in IND enabling studies [35][36] Financial Position - Nurix recently raised $250 million, bringing total cash reserves to over $650 million, providing a strong financial runway through early 2028 [41][42] Future Considerations - The company is preparing for multiple decisions regarding its partnerships and potential opt-ins based on upcoming clinical data [38][41] Conclusion - Nurix Therapeutics is strategically positioned in the biotech space with a focus on innovative therapies for CLL and autoimmune diseases, backed by a strong financial position and promising clinical data on the horizon [41][42]