LEXINGTON, MA, USA I June 21, 2016 I Curis, Inc. (Nasdaq:CRIS), a biotechnology company focused on the development and commercialization of innovative and effective therapeutics for the treatment of cancer, today announced that the first patient was dosed in a Phase 1 trial of CA-170.
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.
“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.
About Curis, Inc.
Curis is a biotechnology company focused on the development and commercialization of innovative and effective drug candidates for the treatment of human cancers, including its lead development candidate, CUDC-907 that is being investigated in clinical studies in patients with lymphomas and solid tumors. Curis is engaged in a broad collaboration with Aurigene in the areas of immuno-oncology and precision oncology. As part of this collaboration, Curis has exclusive licenses to oral small molecule antagonists of the PD-1 and VISTA pathways, including PD-L1/VISTA antagonist CA-170, as well as to molecules designed to inhibit the IRAK4 kinase, including CA-4948. Curis is also party to a collaboration with Genentech, a member of the Roche Group, under which Genentech and Roche are commercializing Erivedge® for the treatment of advanced basal cell carcinoma, and are further developing Erivedge in other diseases including idiopathic pulmonary fibrosis and myelofibrosis. For more information, visit Curis’ website at www.curis.com.
SOURCE: Curis
Post Views: 96
LEXINGTON, MA, USA I June 21, 2016 I Curis, Inc. (Nasdaq:CRIS), a biotechnology company focused on the development and commercialization of innovative and effective therapeutics for the treatment of cancer, today announced that the first patient was dosed in a Phase 1 trial of CA-170.
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.
“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.
About Curis, Inc.
Curis is a biotechnology company focused on the development and commercialization of innovative and effective drug candidates for the treatment of human cancers, including its lead development candidate, CUDC-907 that is being investigated in clinical studies in patients with lymphomas and solid tumors. Curis is engaged in a broad collaboration with Aurigene in the areas of immuno-oncology and precision oncology. As part of this collaboration, Curis has exclusive licenses to oral small molecule antagonists of the PD-1 and VISTA pathways, including PD-L1/VISTA antagonist CA-170, as well as to molecules designed to inhibit the IRAK4 kinase, including CA-4948. Curis is also party to a collaboration with Genentech, a member of the Roche Group, under which Genentech and Roche are commercializing Erivedge® for the treatment of advanced basal cell carcinoma, and are further developing Erivedge in other diseases including idiopathic pulmonary fibrosis and myelofibrosis. For more information, visit Curis’ website at www.curis.com.
SOURCE: Curis
Post Views: 96
