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Chimeric Therapeutics gets FDA orphan drug status for its CDH17 cell therapy in gastric cancer.
Chimeric Therapeutics received FDA Orphan Drug Designation for its CHM CDH17 cell therapy targeting gastric cancer, granting development incentives and potential market exclusivity.
The therapy, aimed at the CDH17 protein in solid tumors, is in a Phase 1/2 trial for advanced colorectal and gastric cancers, with nine patients treated so far.
Imugene also received FDA support for its off-the-shelf CAR T-cell therapy azer-cel, confirming its clinical pathway and dosing strategy for diffuse large B-cell lymphoma.
Meanwhile, Kairos Minerals secured a mining agreement with the Nyamal Aboriginal Corporation for its Mt York Gold Project in Western Australia, and Lindian Resources began drilling at its Kangankunde rare earths project in Malawi to assess high-grade neodymium-praseodymium zones.
Chimeric Therapeutics obtiene el estatus de fármaco huérfano de la FDA para su terapia celular CDH17 en cáncer gástrico.