Novel product candidate M2T-CD33 (LTI-214) was granted orphan drug designation by the US Food and Drug Administration for the treatment of acute myeloid leukemia.
M2T-CD33, which is manufactured by Leukogene Therapeutics, a preclinical-stage biopharmaceutical company, is an immunotherapy that targets CD33. According to the company, preclinical studies have shown a favorable safety profile with minimal off-target toxicity.
“We are honored that the FDA has recognized the therapeutic promise of LTI-214 by granting orphan drug designation,” said Sandeep Gupta, CEO of Leukogene, in a press release. “AML remains one of the most challenging hematologic cancers, and outcomes for relapsed or refractory patients remain poor. The LTI-214 program embodies our commitment to advancing new immunotherapy approaches that are both potent and safer for patients. This designation represents an important step toward our goal of transforming the treatment paradigm for AML.”
