On June 21, 2016 Curis, Inc. (Nasdaq:CRIS), a biotechnology company focused on the development and commercialization of innovative and effective therapeutics for the treatment of cancer, reported that the first patient was dosed in a Phase 1 trial of CA-170 (Press release, Curis, JUN 21, 2016, View Source [SID:1234513472]). Schedule your 30 min Free 1stOncology Demo! CA-170 is a first-in-class, orally available, small molecule that is designed to specifically target and inhibit the immune checkpoints, Programmed Death Ligand-1 (PD-L1) and V-domain Immunoglobulin Suppressor of T-cell Activation (VISTA). CA-170 is being developed under a collaboration and licensing agreement with Aurigene Discovery Technologies, Ltd.
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"Today, we are pleased to announce dosing of the first patient in our Phase 1 trial of CA-170," said Ali Fattaey, Ph.D., Curis’s president and CEO. "During the dose escalation stage of the trial, we look to characterize CA-170’s safety and activity in patients with solid tumors and lymphoma. In the expansion stage of the trial, we expect to identify specific indications and regulatory paths for this highly differentiated drug candidate."
Preclinical ex vivo experiments demonstrated that CA-170 induced effective proliferation and cytokine production by T cells that are specifically suppressed by PD-L1 or VISTA. In subsequent preclinical in vivo studies, CA-170 showed significant anti-tumor activity, similar to anti-PD-1 antibodies, in multiple tumor models.
In preclinical toxicology studies, CA-170 was considered to be safe when administered at multiple dose levels using a once daily oral dosing schedule.
The Phase 1 study is designed to: (1) evaluate the safety, tolerability, and pharmacokinetic profile of CA-170; (2) identify any dose-limiting toxicities; and (3) establish the recommended Phase 2 dose (RP2D) of CA-170 in patients with advanced solid tumors or lymphoma. During the expansion stage, the study is expected to assess the anti-cancer activity of CA-170 at the RP2D in patients with specified cancer types.