Y-mAbs Says First Patient Administered First Protein Dose And 177Lu-DOTA Imaging Dose In Phase 1 Clinical Trial Evaluating CD38-SADA Pre-Targeted Radioimmunotherapy In r/r NHL

NEW YORK, April 25, 2025 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (NASDAQ:YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel radioimmunotherapy and antibody-based therapeutic products for the treatment of cancer, today announced that the first patient has been administered both the first protein dose and the 177Lu-DOTA imaging dose in its Phase 1 clinical trial evaluating the Company's Self-Assembly and Disassembly ("SADA") Pre-targeted Radioimmunotherapy ("PRIT") platform for the treatment of patients with relapsed or refractory non-Hodgkin Lymphoma (r/r NHL). This Phase 1 trial (Trial 1201) is a dose-escalation, open-label, single-arm, multi-center trial investigating the safety and tolerability of the CD38-SADA: 177Lu-DOTA Drug Complex.

Trial 1201 is designed to investigate the pre-targeted delivery of the CD38-SADA protein that binds with high affinity to lymphoma cells, followed by the administration of a radioactive 177Lu-DOTA payload to selectively target the tumor-bound CD38-SADA molecules while minimizing radiation to normal tissues. Part A of the trial is CD38-SADA dose escalation with fixed 177Lu-DOTA payload doses to explore the optimal CD38-SADA protein dose and interval between the SADA protein administration and the payload. The primary endpoints of Part A include tumor imaging and occurrence of dose limiting toxicities in the dose limiting toxicities (DLT) evaluation period.