KING OF PRUSSIA, PA — SEED Therapeutics announced that China’s National Medical Products Administration has cleared the Investigational New Drug application for ST-01156, enabling Chinese sites to participate in the company’s planned global expansion study for its first-in-human cancer therapy.
ST-01156, discovered using SEED’s RITE3 platform for precision E3 ligase targeting, is the company’s lead clinical candidate and has secured Orphan Drug and Rare Pediatric Disease designations from the U.S. Food and Drug Administration for Ewing sarcoma. SEED is currently conducting a dose-escalation trial in patients with advanced solid tumors and plans to broaden the program into a global study targeting RBM39-dependent cancers.
CEO Lan Huang said the NMPA’s clearance strengthens the company’s international clinical strategy and allows SEED to draw on a broader patient population. She noted that the expansion study will focus on tumors driven by RBM39 biology, building on the mechanistic foundation established in the company’s preclinical work.
President and Chief Scientific Officer James Tonra highlighted those data, which showed complete tumor regression in several xenograft models and strong target engagement across RBM39-driven malignancies. The expansion study is expected to assess ST-01156 in Ewing sarcoma, hepatocellular carcinoma, KRAS-mutant cancers, and additional RBM39-dependent tumors identified through patient-derived models.
ST-01156 degrades RBM39, a regulator of RNA splicing and transcription that is overexpressed across diverse cancers. The company plans to conduct the expansion study across the United States, Europe, China, and other regions as it advances toward a broader clinical evaluation of the therapy’s potential.
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