Y-mAbs Hosts Virtual Radiopharmaceutical R&D Update Highlighting Clinical Progress and Expanded Pipeline

Core Insights - Y-mAbs Therapeutics, Inc. is focused on developing and commercializing novel radiopharmaceuticals and antibody-based therapeutic products for cancer treatment, with a virtual R&D update scheduled to highlight progress in its Radiopharmaceutical Business Unit [1][2] Radiopharmaceutical R&D Update Highlights - The GD2-SADA Phase 1 Clinical Trial (Trial 1001) has completed Part A, demonstrating that GD2-SADA is safe, tolerable, and capable of achieving targeted in vivo conjugation of Lu-DOTA [3][4] - The company plans to initiate a Trial 1001 Bridge study (Part 2A) with an optimized Radiohapten, "Proteus," in the first half of 2026, with data readout expected in the second half of 2026 [3][12] - Part B of Trial 1001 is anticipated to start in the first half of 2027, with data readout expected in the second half of 2027 [3][12] Clinical Trial Details - The primary objective of Trial 1001 is to evaluate the safety and tolerability of GD2-SADA in patients with recurrent or refractory metastatic solid tumors, including small cell lung cancer and high-risk neuroblastoma [4] - In Part A, 22 patients were dosed, with nine patients showing positive GD2 expression and eligible for the therapeutic stage of the study [4] - Results indicated that the GD2-SADA Protein clearance rate is reliably correlated to dose concentrations, providing a roadmap for tailoring the clearance interval prior to isotope administration [4][5] Safety and Tolerability - Both GD2-SADA and Lu-DOTA administrations were generally safe and well-tolerated, with no treatment-related serious adverse events reported [5] Expanded Development Pipeline - Y-mAbs has selected lung cancer, women's cancers, and gastrointestinal cancers as target areas for its expanded oncology franchise [7] - The company plans to file an IND for its first molecular imaging asset by the end of 2025 [7] Company Overview - Y-mAbs is a commercial-stage biopharmaceutical company with a focus on novel radioimmunotherapy and antibody-based therapeutic cancer products, including the FDA-approved anti-GD2 therapy DANYELZA [9]