ST-01156 / SEED Therapeutics - LARVOL DELTA

First-in-human clinical evaluation of ST-01156, an optimized and selective degrader of RNA-binding motif 39 (RBM39): A phase 1 study in advanced solid malignancies with a focus on RBM39-dependent cancers. (ASCO 2026) - P1 | "In addition to traditional safety and tolerability endpoints, dose escalation and Phase 2 dose derivation will be based on pharmacokinetic (PK) endpoints and real-time RBM39 targeting measurements in peripheral mononuclear cells. The optimal dose of ST-01156 derived from safety tolerability, PK and pharmacodynamic data will be evaluated in trial participants in the following expansion cohorts: A, ES; B, aHCC; C, KRAS-mutant cancers; and D, an adaptive cohort of cancers projected to be susceptible to RBM39 inhibition including BTC, EC, and cancers with DDR aberrations."

Clinical • First-in-human • Metastases • P1 data • Biliary Cancer • Biliary Tract Cancer • Endometrial Cancer • Ewing Sarcoma • Hepatocellular Cancer • Neuroblastoma • Oncology • Sarcoma • Solid Tumor • EWSR1 • KRAS • RBM39

SEED Therapeutics: Advancing precision oncology through molecular glue degraders (GlobeNewswire) - "ST-01156 (RBM39 molecular glue degrader) advanced into Phase 1 clinical development, with the first dose cohort completed. AACR 2026 data demonstrated: (i) Complete tumor eradication in a neuroblastoma in vivo model; (ii) Identification of MYC overexpression and CDKN2A/B deletion as potential predictive biomarkers."

Biomarker • Preclinical • Trial status • Biliary Tract Cancer • Ewing Sarcoma • Hepatocellular Cancer • Neuroblastoma

RBM39 degrader anticancer activity against neuroblastoma: CDKN2A/B deletion as a biomarker (AACR 2026) - P1 | "In the present study we further explored the MOA underlying the potent activity of RBM39 degraders in neuroblastoma, utilizing SEED Therapeutics' optimized RBM39 degrader ST-00937, and its deuterium derivative ST-01156 that was recently cleared by the FDA for clinical testing (NCT07197554). Conclusion RBM39 degraders demonstrate differential potency in 6 neuroblastoma cell lines and 4 patient-derived models in vitro, and total tumor regression in SH-SY5Y in vivo. DNA damage and increased p53-mediated apoptosis are confirmed in the sensitive neuroblastoma model SH-SY5Y, while resistance in CDKN2A/B-deleted lines suggests CDKN2A loss may serve as a predictive biomarker of resistance to RBM39-targed therapy."

Biomarker • Neuroblastoma • Oncology • Solid Tumor • CASP3 • CDKN2A • CDKN2B • MYC • RBM39

ST-01156, a novel oral RBM39 degrader (GlobeNewswire) - "ST-01156 Phase 1a enrolling at leading U.S. cancer centers: Dana-Farber, Massachusetts General Hospital, Memorial Sloan Kettering, MD Anderson Cancer Center, Hoag, and City of Hope. Presentation at AACR 2025 on ST-01156 mechanism and preclinical studies including complete tumor regression in Ewing sarcoma and other cancer models; new degrader approaches in KRAS G12D degradation."

Enrollment status • Preclinical • Biliary Tract Cancer • Ewing Sarcoma • Hepatocellular Cancer

SEED Therapeutics Doses First Patient in Phase 1 Trial of ST-01156, a Molecular Glue Degrader Targeting RBM39 (The Manila Times) - "In the Phase 1a study, ST-01156 will be administered orally, once daily for 5 days every 7 days, for 28 consecutive days. The primary objective of the open-label, first-in-human trial is to evaluate the safety, tolerability, and adverse event profile of ST-01156, as well as to identify the recommended dose level for subsequent clinical development."

Trial status • Biliary Tract Cancer • Ewing Sarcoma • Hepatocellular Cancer • Solid Tumor

A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid Malignancies (clinicaltrials.gov) - P1 | N=171 | Recruiting | Sponsor: SEED Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Biliary Cancer • Ewing Sarcoma • Hepatocellular Cancer • Oncology • Sarcoma • Solid Tumor

SEED Therapeutics Receives IND Clearance from China’s NMPA for ST-01156 (GlobeNewswire) - "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."

Trial status • Biliary Tract Cancer • Ewing Sarcoma • Hepatocellular Cancer • Solid Tumor

A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid Malignancies (clinicaltrials.gov) - P1 | N=171 | Not yet recruiting | Sponsor: SEED Therapeutics, Inc.

New P1 trial • Biliary Cancer • Ewing Sarcoma • Hepatocellular Cancer • Oncology • Sarcoma • Solid Tumor

FDA Clears IND for SEED Therapeutics’ RBM39 Degrader ST-01156 (GlobeNewswire) - "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."

IND • New P1 trial • Solid Tumor

BeyondSpring Reports First‑Quarter 2025 Financial Results and Provides Corporate Update (GlobeNewswire) - "SEED’s first‑in‑class RBM39 degrader, reported at AACR 2025 for its total tumor regression data in mechanism targeted cancer indication-Ewing Sarcoma, remains on track for IND filing mid‑2025..As a result of BeyondSpring entering into definitive agreements to sell a portion of its Series A-1 Preferred Shares of SEED in January 2025, SEED’s operations met the criteria as discontinued operations under ASC 205-20 for financial reporting purposes. SEED’s financials results are now presented as “discontinued operations” under U.S. GAAP. SEED continues to operate independently."

Commercial • IND • Ewing Sarcoma

BeyondSpring Reports 2024 Year-End Financial Results and Highlights Key Clinical & Strategic Milestones (GlobeNewswire) - "Expected 2025 Milestones - Plinabulin: 1H 2025: Updated data from Phase 2 of Study 303 in metastatic NSCLC progressed on PD-1/PD-L1 inhibitors. 2H 2025: Preliminary data from Phase 2 of Study 302 in 1L ES-SCLC. SEED: Mid-2025: Expected IND filing of RBM39 degrader. 2H 2025: RBM39 degrader expected to begin patient enrollment. 2H 2025: Tau degrader expected to achieve in vivo efficacy."

IND • New trial • P2 data • Non Small Cell Lung Cancer • Small Cell Lung Cancer

SEED Receives FDA Rare Pediatric Disease and Orphan Drug Designations for Lead Oncology Asset RBM39 Degrader… (GlobeNewswire) - "SEED is advancing ST-01156 toward an Investigational New Drug (IND) application, with an expected IND filing in the first half of 2025. The Rare Pediatric Disease designation positions SEED to potentially receive an FDA priority review voucher upon approval of ST-01156."

FDA event • IND • Orphan drug • Oncology • Solid Tumor