Canwell Pharma Inc. has obtained IND approval from the FDA for CAN-016, a novel antibody-drug conjugate (ADC). The company will initiate a phase I study in patients with HER2-expressing solid tumors who have experienced disease progression following prior ADC therapies.

Telomir Pharmaceuticals Inc. has submitted an IND application to the U.S. FDA for its lead candidate, Telomir-1 (Telomir-Zn), for the treatment of advanced and metastatic triple-negative breast cancer (TNBC). Telomir-1 is a first-in-class metal-modulating epigenetic agent designed to restore transcriptional control in tumor cells by targeting intracellular iron-zinc homeostasis.

Otsuka Pharmaceutical Co. Ltd. is taking a neuroplastogen approach to posttraumatic stress disorder (PTSD) through its planned $1.22 billion acquisition of Transcend Therapeutics Inc. The deal gives Tokyo-headquartered Otsuka access to Transcend’s lead asset, TSND-201, an oral neuroplastogen that has begun patient recruitment for a phase III study in the U.S.