- Y-mAbs Therapeutics ( NASDAQ: YMAB ) said the U.S. Food and Drug Administration (FDA) cleared its application to start a phase 1 multicenter basket trial for GD2-SADA targeting malignant melanoma, sarcoma and small cell lung cancer.
- The trial will have three parts and the company expects to include ~59 patients at U.S. sites.
- The company said the GD2-SADA construct was created using its SADA technology —licensed from Memorial Sloan Kettering Cancer Center — which uses a pre-targeted payload delivery method where antibody constructs assemble in tetramers and bind to the tumor target.
- "The FDA acceptance of the IND for GD2-SADA marks an important milestone towards our mission of developing novel SADA treatments as we continue to execute our clinical development strategy for our pipeline of SADA constructs for the treatment of cancers with unmet medical need,” said Thomas Gad, founder, president and interim CEO.
For further details see:
Y-mAbs gets FDA nod to begin phase 1 study of GD2-SADA for certain cancers