3D MEDICINES (01244.HK): 3D189/GPS Phase 3 REGAL Hits Pre-specified 80 Events

NewTimeSpace News: On 29 October 2026, 3D Medicines Inc. (stock code: 01244) announced significant progress in its collaboration with SELLAS Life Sciences Group, Inc. on 3D189 (Galinpepimut-S, GPS). As of 28 October 2026, the pivotal Phase 3 REGAL trial evaluating GPS in patients with acute myeloid leukemia (AML) has reached the pre-specified 80th event (number of deaths), triggering the final analysis of the study.

The REGAL trial is an event-driven overall survival study. Following the 80th event, SELLAS will proceed with database lock, unblinding of study data, and statistical analysis of the primary endpoint, and will announce the preliminary topline primary endpoint results this quarter per the pre-specified statistical analysis plan (SAP). 3D189 is the Company's second product nearing commercialisation; if approved, it will be the world's first WT1 tumor vaccine. The Company acquired exclusive development and commercialization rights of 3D189 in Greater China in 2020.

The Company cautions that clinical results carry uncertainty and that data analysis, trial report submission and regulatory approval may be affected by multiple factors; it will disclose subsequent progress in accordance with the Listing Rules and urges investors to exercise prudence.