ST-01156 / SEED Therapeutics - LARVOL DELTA

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