英矽智能首席医学官Sujata Rao表示，TEAD项目接连获得FDA孤儿药认定和临床试验批件使我们备受鼓舞。在临床前研发阶段，ISM6331验证了人工智能驱动的创新研发路径，也展示了英矽智能研发团队的顶尖实力。我们将尽快推进美国的患者招募工作，加快ISM6331在间皮瘤和其他Hippo通路相关肿瘤中的应用，满足未竟临床需求。Insilicom's smart pan-TEAD inhibitor ISM6331 received FDA orphan drug certification and clinical trial approval
Zhitong Finance App learned that after receiving Orphan Drug Designation (ODD) in June 2024, a clinical-stage biotechnology company driven by generative artificial intelligence (AI), ISM6331, a potential “best-in-class” (best-in-class) pan-TEAD inhibitor ISM6331, obtained IND approval from the US Food and Drug Administration (FDA) in July 2024 to treat mesothelioma. The number of innovative molecules that enabled Insili Intelligence to obtain approval for clinical trials reached 9.
ISM6331 is a potent non-covalent small molecule inhibitor with a novel molecular framework that targets the family of transcription-enhancing related domain (TEAD) proteins. As a key regulator of the Hippo pathway, it plays an important role in tumor progression, metastasis, cancer metabolism, immunity, and drug resistance.
Sujata Rao, chief medical officer of Insilis Intelligence, said that we are very encouraged that the TEAD project has successively received FDA orphan drug certification and clinical trial approval. In the pre-clinical R&D stage, ISM6331 verified the AI-driven innovative R&D path, and also demonstrated the top strength of the Insili Smart R&D team. We will promote patient recruitment in the US as soon as possible, accelerate the application of ISM6331 in mesothelioma and other HiPPO pathway-related tumors to meet unrealized clinical needs.
