FDA Clears IND for SEED Therapeutics’ RBM39 Degrader ST-01156
• First Patient Dosing Expected in Q1 2026
• Clinical Trial to Prioritize Biomarker-Selected RBM39-Dependent Cancers
KING OF PRUSSIA, Pa., Aug. 11, 2025 (GLOBE NEWSWIRE) -- SEED Therapeutics, Inc. (“SEED”), a clinical-stage biotechnology company pioneering rational molecular glue degraders for historically undruggable disease drivers, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for ST-01156. The clearance enables initiation of a first-in-human Phase 1 clinical trial in patients with advanced solid tumor and hematological malignancies, prioritizing multiple cancers with convincing preclinical evidence of RBM39 dependency. First patient dosing is expected in the first quarter of 2026.
SEED’s proprietary RITE3™ platform rationally identifies the optimal E3 ligase for targeting disease-causing proteins and discovering drug-like “molecular glues” for multiple disease indications. ST-01156 is SEED’s first clinical candidate and has received Orphan Drug and Rare Pediatric Disease designations from the FDA for Ewing sarcoma, a rare pediatric malignancy with no new approved therapies in over 30 years.
“The FDA’s clearance of our IND for ST-01156 validates the power of SEED’s precision-engineered approach to protein degradation,” said Dr. Lan Huang, Co-Founder, Chairman, and CEO of SEED. “ST-01156 represents a fundamentally new class of medicines with many opportunities for impacting human health. Our near-term strategy is designed to explore several RBM39-dependent cancers, including Ewing sarcoma, neuroblastoma, and KRAS-driven solid tumors, an addressable patient population that exceeds one million worldwide.”
“ST-01156 represents the combination of a pioneering strategy for treating disease with expert translational science,” said Dr. James Tonra, President and Chief Scientific Officer of SEED. “We are excited to bring this optimized RBM39 degrader into the clinic supported by compelling preclinical data, including complete tumor regression in multiple tumor models and precise target engagement. The opportunities to rationally select cancers that will respond to RBM39 degradation are significant.”
“The ability to precisely degrade disease-causing proteins using small molecules represents a transformational advance in drug discovery,” said Dr. Avram Hershko, Nobel Laureate and Co-Founder of SEED. “SEED’s approach builds upon the fundamental principles of the ubiquitin-proteasome system, and I am proud to see this science translated into a novel therapy with the potential to benefit patients with hard-to-treat cancers.”
ST-01156 works by inducing the degradation of RBM39, an important regulator of RNA splicing and transcription that is overexpressed and required for growth and survival in a broad range of cancers. In preclinical models, ST-01156 achieved complete tumor regression in xenografts of Ewing sarcoma, neuroblastoma, and KRAS mutant colon cancer. Patient-derived cancer models have identified multiple RBM39-dependent cancers to inform biomarker-guided enrollment. SEED now transitions ST-01156 into clinical testing with clinical development led by Dr. Eric Rowinsky, a globally recognized oncology expert with contributions to the approval of more than a dozen cancer therapies.
About SEED Therapeutics
SEED Therapeutics is a clinical-stage biotechnology company developing rationally designed molecular glue degraders for undruggable disease proteins. Its proprietary RITE3™ platform enables targeted protein degradation with small-molecule precision. SEED’s lead candidate, ST-01156, is a brain-penetrant RBM39 degrader entering clinical development for Ewing sarcoma and other RBM39-dependent cancers.
SEED was co-founded by four pioneers in targeted protein degradation: Nobel Laureate Dr. Avram Hershko (ubiquitin-proteasome system discovery), Prof. Ning Zheng (University of Washington, HHMI Investigator; coined “molecular glue”), Prof. Michele Pagano (NYU Langone, HHMI Investigator; E3 ligase biology), and Dr. Lan Huang, SEED’s Chairman and CEO.
Eli Lilly has been a SEED cornerstone investor and research collaborator since SEED’s inception. Eisai later joined as a strategic investor and research collaborator. Together, these global pharmaceutical companies have advanced SEED’s mission to unlock previously undruggable disease targets.
The company’s pipeline includes nine programs spanning oncology, neurodegeneration, immunology, and virology.
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