KING OF PRUSSIA, Pa. — August 11, 2025 — Leads & Copy — SEED Therapeutics, Inc. has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for ST-01156, enabling a first-in-human Phase 1 clinical trial for patients with advanced solid tumor and hematological malignancies.
The clinical trial will prioritize multiple cancers with preclinical evidence of RBM39 dependency, with first patient dosing expected in Q1 2026. ST-01156, SEED’s first clinical candidate, has received Orphan Drug and Rare Pediatric Disease designations from the FDA for Ewing sarcoma.
SEED’s RITE3™ platform identifies the optimal E3 ligase for targeting disease-causing proteins and discovering drug-like “molecular glues.” According to Dr. Lan Huang, Co-Founder, Chairman, and CEO of SEED, the FDA’s clearance validates SEED’s precision-engineered approach to protein degradation. Dr. James Tonra, President and Chief Scientific Officer of SEED, added that the company is excited to bring this optimized RBM39 degrader into the clinic.
Dr. Avram Hershko, Nobel Laureate and Co-Founder of SEED, noted that SEED’s approach builds upon the ubiquitin-proteasome system, potentially benefiting patients with hard-to-treat cancers. ST-01156 induces the degradation of RBM39, an important regulator of RNA splicing and transcription, and achieved complete tumor regression in preclinical models. Clinical development will be led by Dr. Eric Rowinsky.
SEED Therapeutics is a clinical-stage biotechnology company developing rationally designed molecular glue degraders for undruggable disease proteins. Its lead candidate, ST-01156, is a brain-penetrant RBM39 degrader entering clinical development for Ewing sarcoma and other RBM39-dependent cancers.
Eli Lilly and Eisai have been investors and research collaborators since SEED’s inception. The company’s pipeline includes nine programs spanning oncology, neurodegeneration, immunology, and virology.
Contact: Bill Desmarais, PhD, MBA, Chief Financial Officer & Chief Business Officer, SEED Therapeutics, (317) 608-8411, Bill.Desmarais@SeedTherapeutics.com, IR@seedtherapeutics.com, PR@seedtherapeutics.com
Source: SEED Therapeutics
