SEED Therapeutics Receives IND Clearance from China’s NMPA for ST-01156

China Sites to Join Upcoming Global Expansion Study Evaluating RBM39-Dependent Cancers

KING OF PRUSSIA, Pa., Nov. 12, 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 China’s National Medical Products Administration (NMPA) has cleared the Investigational New Drug (IND) application for ST-01156. This clearance enables the inclusion of Chinese clinical sites in SEED’s planned global expansion study, which will follow the completion of the ongoing first-in-human dose-escalation trial of ST-01156 in patients with advanced solid tumors.

SEED’s proprietary RITE3™ platform rationally identifies the optimal E3 ligase to target disease-causing proteins and enables the discovery of drug-like molecular glues for multiple indications. ST-01156 is SEED’s first clinical candidate and has received Orphan Drug and Rare Pediatric Disease designations from the U.S. FDA for Ewing sarcoma, a rare pediatric malignancy with no new approved therapies in over 30 years.

“The NMPA’s clearance of our IND for ST-01156 marks an important step in SEED’s global development strategy,” said Dr. Lan Huang, Co-Founder, Chairman, and CEO of SEED. “With our dose-escalation study now underway, we are laying the groundwork for an expansion study focused on RBM39 mechanism-targeted cancers. The ability to include China as part of this program will broaden access to diverse patient populations and accelerate our understanding of ST-01156’s therapeutic potential.”

“We are excited to expand the upcoming ST-01156 study into China,” said Dr. James Tonra, President and Chief Scientific Officer of SEED. “Our preclinical data show complete tumor regression in multiple xenograft models and strong target engagement, providing a compelling rationale to evaluate ST-01156 across RBM39-dependent tumors such as Ewing sarcoma, hepatocellular carcinoma, and KRAS-mutant cancers.”

ST-01156 induces selective degradation of RBM39, a key regulator of RNA splicing and transcription that is overexpressed and required for 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 models have identified additional RBM39-dependent tumors that will help inform enrollment in the expansion study, which will include sites in the United States, Europe, China, and other regions.

About SEED Therapeutics

SEED Therapeutics is a clinical-stage biotechnology company pioneering rationally designed molecular glue degraders to treat diseases driven by undruggable proteins. Its proprietary RITE3™ platform enables targeted protein degradation with small-molecule precision.

SEED’s lead candidate, ST-01156, is an RBM39 degrader entering clinical development for Ewing sarcoma and other RBM39-dependent cancers.

SEED was co-founded by four scientific leaders:

• Nobel Laureate Prof. Avram Hershko, discoverer of the ubiquitin-proteasome system
• Dr. Lan Huang, solved the first E3 Ligase structure and a serial biotech entrepreneur
• Prof. Ning Zheng (University of Washington, HHMI Investigator), pioneer of RING-finger E3 Ligase structures and coined the term “molecular glue”
• Prof. Michele Pagano (NYU Grossman School of Medicine, HHMI Investigator), a preeminent expert on E3 ligase biology

Eli Lilly and Eisai are cornerstone investors and collaborators, supporting SEED’s mission to unlock undruggable disease targets. The company’s pipeline includes nine molecular glue programs across oncology, neurodegeneration, immunology, and virology.

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