Y-mAbs Therapeutics announces first patient dosed in Phase 1 trial of GD2-SADA

Y-mAbs Therapeutics announced that the first patient has been dosed with both the protein dose and the 177Lu-DOTA imaging dose in its Phase 1 clinical trial, evaluating the Company’s pre-targeted radioimmunotherapy Self-Assembly and Disassembly-Bispecific, SADA, technology platform for the treatment of certain GD2-positive solid tumors, including small cell lung cancer, sarcoma and malignant melanoma. The two-step approach separating the administration of SADA protein from the administration of radioactive ligand is believed to differentiate SADA constructs from most other radioimmunotherapy approaches. "We are excited to advance our SADA platform into the clinic for the first time with the initiation of patient dosing in this trial. This is a significant milestone for Y-mAbs in our efforts to potentially build a global franchise of radiotherapeutic assets," said Thomas Gad, Founder, President, and Interim CEO. "SADA can potentially generate the clinical data to further unlock the potential of radiolabeled therapeutics in tumors that have not historically demonstrated meaningful responses. Further, during the first part of the study, Part A, we plan to collect imaging data to assess tumor targeting and assess the PK profile of GD2-SADA, as this could potentially allow for early evaluation of the program and more informed development decisions."