HC-7366

Clinical Development of HC-7366

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In preclinical studies, we have observed robust anti-tumor and immunomodulatory activity with HC-7366 in a variety of models of solid tumors and hematological malignancies. HC-7366 is under investigation in a Phase 1a/b trial as monotherapy for treatment of advanced solid tumors including, head and neck squamous cell carcinoma (HNSCC), colorectal cancer (CRC), transitional cell carcinoma of the bladder, and other solid tumors.

Following compeltion of our Phase 1a trial, we plan to move into the Phase 1b portion of our solid tumor study and initiate a Phase 1b study in acute myeloid leukemia (AML).

GCN2 and the Integrated Stress Response

HC-7366 is a differentiated, orally bioavailable investigational small molecule activator of GCN2. GCN2 (General Controlled Nonderepressible 2), one of the kinases of the Integrated Stress Response (ISR) family responds to amino acid deprivation and is a key metabolic stress sensor in cells. Preclinically, hyperactivation of the ISR via GCN2 has been demonstrated to result in anti-tumor activity and amelioration of an immunosuppressive tumor microenvironment as a monotherapy and in combination with multiple standard-of-care agents across liquid and solid tumors.