- Y-mAbs Therapeutics (YMAB, Financial) completed Part A of its Phase 1 Trial 1001, validating its GD2-SADA technology in treating metastatic solid tumors.
- GD2-SADA demonstrated a favorable safety profile with no treatment-related serious adverse events.
- The company plans to focus on expanding its radiopharmaceutical pipeline targeting lung, women's, and gastrointestinal cancers.
Y-mAbs Therapeutics (YMAB), a commercial-stage biopharmaceutical company, announced significant progress with its Radiopharmaceutical Business Unit through a virtual R&D update. The company highlighted successful results from Part A of its Phase 1 Trial 1001, which tested its GD2-SADA platform in patients with recurrent or refractory metastatic solid tumors. Findings confirmed that GD2-SADA was safe and well-tolerated, showing no treatment-related serious adverse events.
Building on these promising results, Y-mAbs plans to advance its novel universal radiohapten, "Proteus." This new development could enhance tumor uptake and retention, offering broader access to various isotopes with theranostic applications. The company aims to initiate a Bridge study (Part 2A) using Proteus in the first half of 2026, with Part B expected to follow in the first half of 2027.
In a strategic move to expand its radiopharmaceutical pipeline, Y-mAbs is targeting high-value oncology sectors, specifically lung cancer, women’s cancers, and gastrointestinal cancers. Additionally, the company intends to file an Investigational New Drug application for its first molecular imaging asset by the end of 2025, marking a comprehensive strategy to leverage its platform technology for multiple applications.
The company’s commitment to innovation and patient care is underscored by its continued investment in the development of its GD2-SADA platform, which has the potential to revolutionize treatment for certain cancers. Y-mAbs remains focused on accelerating the clinical advancement of its Self-Assembly DisAssembly Pretargeted radioimmunotherapy (SADA PRIT) technology.
