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靶向蛋白降解剂
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Nurix Therapeutics(NRIX.US)股价大涨!旗下BTK降解剂bexobrutideg获积极试验数据
智通财经网· 2025-12-09 02:37
Nurix Therapeutics专注于发现、开发和商业化口服小分子疗法,这些疗法旨在调节细胞蛋白水平,作为 癌症和免疫疾病的新型治疗方法。该公司的研发管线包括布鲁顿酪氨酸激酶(BTK)的靶向蛋白降解剂, 以及Casitas B细胞淋巴瘤原癌基因-B(CBL-B,一种调节T细胞活化的E3连接酶)的抑制剂。其蛋白降解 产品线中的候选药物NX-2127是一种口服可用的BTK降解剂,用于治疗复发或难治性B细胞恶性肿瘤。 资料显示,布鲁顿氏酪氨酸激酶(BTK)抑制剂是多种B细胞血液癌症的重要治疗选择。然而BTK抑制剂 耐药性的出现,以及BTK不依赖于激酶活性介导信号传导的功能,揭示了采用其它手段靶向BTK蛋白功 能的重要性。靶向BTK的蛋白降解剂通过直接诱导BTK蛋白被蛋白酶体降解,为克服BTK抑制剂耐药性 提供了有效策略。 值得一提的是,投行Needham在周一重申了对Nurix Therapeutics的"买入"评级,维持目标价为26美元。 该行分析师表示,对该公司市场前景的信心保持不变。在上个月,Truist首予Nurix Therapeutics"买入"评 级,目标价为30美元;BTIG则重申对Nurix ...
药石科技:公司在新分子业务方面已形成系统化布局
Zheng Quan Ri Bao Wang· 2025-10-31 09:11
Core Viewpoint - The company has established a systematic layout in its new molecular business, focusing on four cutting-edge areas: ADC, TPD, and TIDES, and has developed comprehensive service capabilities from early research to process development and production [1] Group 1: ADC (Antibody-Drug Conjugates) - The company utilizes an artificial intelligence research platform to create end-to-end service capabilities, including innovative linker design, linker-payload synthesis, targeted coupling technology, and stability research, providing one-stop support from candidate molecules to clinical application [1] Group 2: TPD (Targeted Protein Degradation) - In the TPD area, the company has designed and supplied CRBN molecular building blocks and novel linkers during the research phase, and has established a one-stop CMC service platform to offer full-cycle services from early API and formulation development to mid-to-late stage optimization and commercial production [1] Group 3: TIDES - To address bottlenecks in traditional solid-phase synthesis for long peptides and large-scale production, the company has focused on developing core technologies such as liquid-phase synthesis, enzymatic synthesis, and continuous flow synthesis, creating an integrated solution centered on non-natural amino acids and peptide technology to meet diverse customer needs [1] Group 4: Business Growth and Future Outlook - Although the new molecular business is still in its early stages, accounting for less than 10% of total revenue, it shows strong growth momentum with order growth exceeding 100%. The company is confident in the future prospects of this business and plans to continue investing in technology and capacity building to drive it as an important growth engine [1]
Nurix Therapeutics(NRIX) - 2025 FY - Earnings Call Transcript
2025-09-03 18:30
Financial Data and Key Metrics Changes - The company reported an overall objective response rate of 80% across all patients in the trial, indicating strong efficacy of the drug [13] - The market for bexabrutinib is currently estimated at $2 billion per year, with forecasts suggesting growth to $5 billion per year [18] Business Line Data and Key Metrics Changes - Bexabrutinib is positioned as the first degrader in its category, addressing resistance mutations in BTK inhibitors, which have generated sales of approximately $9 billion to $10 billion [9][10] - The company is also developing an IRAK4 degrader in collaboration with Gilead and a STAT6 degrader with Sanofi, targeting undruggable categories with significant potential [6][48] Market Data and Key Metrics Changes - The Phase III trial will be conducted in 20 to 30 countries, enrolling 400 to 500 patients, maximizing enrollment opportunities across geographies [16] - The third-line market, where the company has generated data, is valued between $1 billion and $2.5 billion [18] Company Strategy and Development Direction - The company aims to establish bexabrutinib as a significant player in the second-line treatment market, with ambitions for first-line treatment in combination therapies [18][33] - The strategy includes a focus on both oncology and autoimmune diseases, with plans to explore multiple sclerosis and dermatology as potential areas for expansion [43][60] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the safety profile of bexabrutinib, noting no dose-limiting toxicities or new arrhythmias observed in trials [13] - The company is optimistic about rapid enrollment in the Phase II trial due to enthusiasm from investigators and the promising results seen to date [28] Other Important Information - The company has invested over $250 million in the IRAK4 and STAT6 programs, indicating a strong commitment to these projects [48] - Future updates on the broader pipeline and other programs are expected in the fall [63] Q&A Session Summary Question: How should we think about the breakdown in terms of geography and the relevant investigator choice for the standard of care? - The company anticipates variations in treatment choices across geographies, with pirtobrutinib being primarily selected in the U.S. and Europe, while bendamustine-rituximab is more common outside these regions [20] Question: How do you think about the powering of the trial and expectations from the investigator choice arm? - The trial is powered for 400 to 500 patients, and management believes it will be well-powered to demonstrate superiority of bexabrutinib over the control arm [23] Question: What drove the decision for this trial design compared to competitors? - The design is capital efficient, allowing for a streamlined approach to achieve first approval while maintaining the potential for expansion in the future [25] Question: What are the expectations for enrollment timing for the Phase II and Phase III trials? - Enrollment for the Phase II trial is expected to take about a year, while the Phase III trial will take longer, with no specific forecast yet [28][29] Question: Is there a plan to bring in a partner to help with development costs? - The company intends to move forward independently for now, but partnerships could be considered in the future to maximize value [31] Question: How do you see differentiation between your molecules and competitors? - Differentiation will likely emerge based on safety profiles and off-target effects, which are harder to predict but crucial for long-term success [34] Question: What is the strategy for BexDeg in non-Hodgkin lymphoma and autoimmune diseases? - The company sees significant monotherapy opportunities in Waldenstrom's and plans to explore broader applications in autoimmune diseases, leveraging the advantages seen in oncology [36][39] Question: What updates can we expect for the IRAK4 and STAT6 programs? - The IRAK4 program is currently in healthy volunteer studies, while the STAT6 program has shown promising preclinical results, with both expected to advance in collaboration with Gilead and Sanofi [49][51]