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百奥赛图-B(02315)业务合作伙伴IDEAYA取得美国食品药品监督管理局对IDE034的IND批准
智通财经网· 2025-12-05 00:14
Core Viewpoint - IDEAYA Biosciences has received IND approval from the FDA for its dual-target B7H3/PTK7 ADC project, IDE034, marking a significant milestone in its collaboration with 百奥赛图-B [1][2] Group 1: Clinical Development - IDEAYA plans to initiate patient enrollment for the Phase I clinical trial of IDE034 in Q1 2026, targeting solid tumors co-expressing B7H3 and PTK7, including lung cancer, colorectal cancer, head and neck cancer, and ovarian/gynecological tumors [1] - The IND approval signifies a crucial step in advancing the clinical development of IDE034, showcasing the company's technical strength in the dual-antibody ADC discovery and development field [1][2] Group 2: Research and Development Progress - The approval of IDE034's IND represents an important R&D advancement for IDEAYA, validating its RenLite® platform and proprietary linker-payload technology in the discovery and optimization of dual-antibody ADCs [2] - Preclinical studies indicate that IDE034 demonstrates deep and durable tumor shrinkage in various B7H3/PTK7 positive tumor models, highlighting its strong anti-tumor activity [2] Group 3: Future Plans and Collaborations - IDEAYA intends to explore combination therapy strategies with its PARG inhibitor IDE161 to enhance the durability of treatment effects, with plans to present supporting data at major medical conferences in the first half of 2026 [2] - The co-expression rates of B7H3 and PTK7 in lung cancer, colorectal cancer, and head and neck cancer are approximately 30%, 46%, and 27%, respectively, indicating the broad clinical applicability of IDE034 [2] - The company aims to provide high-quality source molecules to partners and actively seek external licensing opportunities for early-stage potential assets [2]
百奥赛图(02315)技术平台频结硕果 连签默克、Tubulis等推进国际化合作
智通财经网· 2025-09-18 03:43
Core Insights - Baiaosaitu (02315) has recently announced multiple collaborations and R&D advancements with Merck, Tubulis, and IDEAYA, highlighting its platform strength in antibody drug development and innovative delivery technologies [1][2] Group 1: Collaborations and Partnerships - Baiaosaitu's partner IDEAYA Biosciences unveiled the bispecific antibody-drug conjugate (bsADC) IDE034 (BCG034) during its tenth anniversary R&D day, which targets B7-H3 and PTK7, demonstrating significant efficacy in specific tumor models [1] - The collaboration with Tubulis involves the introduction of Baiaosaitu's fully human antibodies to advance ADC product development and commercialization, with Baiaosaitu set to receive an upfront payment and potential milestone payments [2] - The partnership with Merck focuses on developing antibody-conjugated lipid delivery solutions for nucleic acid drugs, such as antibody-conjugated lipid nanoparticles (LNP) [2] Group 2: Product Development and Clinical Trials - The IDE034 drug, developed on Baiaosaitu's RenLite® platform, is expected to cover multiple indications, including lung cancer and colorectal cancer, with a clinical trial application planned for submission in Q4 of this year [1]