LEXINGTON, MA, USA I June 01, 2016 I Curis, Inc. (CRIS), a biotechnology company focused on the development and commercialization of innovative and effective therapeutics for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application for CA-170. CA-170 is a first-in-class orally available small molecule that has been designed to target and inhibit the immune checkpoints, Programmed Death Ligand-1 (PD-L1) and V-domain Immunoglobulin Suppressor of T-cell Activation (VISTA).
“The acceptance of CA-170’s IND by the FDA marks an important milestone in the advancement of immuno-oncology therapy,” said Ali Fattaey, Ph.D., Curis’s president and CEO. “The last few years have seen the successful development and commercial launch of multiple checkpoint inhibitors to treat a broad range of human cancers. However, all checkpoint inhibitors developed thus far have been monoclonal antibodies, with similar pharmacokinetic properties, and can only be administered by IV infusion. Today, the FDA has cleared us to test the first small molecule checkpoint inhibitor, CA-170, that will be taken orally by cancer patients. We envision that the pharmacokinetic properties of a small molecule will likely provide an advantage in dosing flexibility of a checkpoint inhibitor, either as a monotherapy or in combination with other cancer treatment regimens. We believe that, if successful, CA-170 can provide a compelling treatment alternative for patients and physicians.”
CA-170 is an orally available, small molecule designed to selectively target and inhibit both PD-L1 and VISTA checkpoint regulators of immune activation. Preclinical data have demonstrated that CA-170 can induce effective proliferation and cytokine production by T cells in culture that are specifically suppressed by PD-L1 or VISTA. In addition, CA-170 demonstrated in vivo anti-tumor activity similar to anti-PD-1 or anti-VISTA antibodies in multiple mouse tumor models and appeared safe to administer based on toxicology studies.
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: 88
LEXINGTON, MA, USA I June 01, 2016 I Curis, Inc. (CRIS), a biotechnology company focused on the development and commercialization of innovative and effective therapeutics for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application for CA-170. CA-170 is a first-in-class orally available small molecule that has been designed to target and inhibit the immune checkpoints, Programmed Death Ligand-1 (PD-L1) and V-domain Immunoglobulin Suppressor of T-cell Activation (VISTA).
“The acceptance of CA-170’s IND by the FDA marks an important milestone in the advancement of immuno-oncology therapy,” said Ali Fattaey, Ph.D., Curis’s president and CEO. “The last few years have seen the successful development and commercial launch of multiple checkpoint inhibitors to treat a broad range of human cancers. However, all checkpoint inhibitors developed thus far have been monoclonal antibodies, with similar pharmacokinetic properties, and can only be administered by IV infusion. Today, the FDA has cleared us to test the first small molecule checkpoint inhibitor, CA-170, that will be taken orally by cancer patients. We envision that the pharmacokinetic properties of a small molecule will likely provide an advantage in dosing flexibility of a checkpoint inhibitor, either as a monotherapy or in combination with other cancer treatment regimens. We believe that, if successful, CA-170 can provide a compelling treatment alternative for patients and physicians.”
CA-170 is an orally available, small molecule designed to selectively target and inhibit both PD-L1 and VISTA checkpoint regulators of immune activation. Preclinical data have demonstrated that CA-170 can induce effective proliferation and cytokine production by T cells in culture that are specifically suppressed by PD-L1 or VISTA. In addition, CA-170 demonstrated in vivo anti-tumor activity similar to anti-PD-1 or anti-VISTA antibodies in multiple mouse tumor models and appeared safe to administer based on toxicology studies.
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: 88
