LEXINGTON, Mass., May 6, 2019 /PRNewswire/ -- Curis, Inc. (CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced that the Phase 1 study of CA-170 has reached its target enrollment of mesothelioma patients. The company began enrolling and dosing patients in this study in January.
"We are pleased to announce we have completed enrollment of the CA-170 study three months ahead of schedule. Last November, we outlined the reorganization of company resources to strengthen our focus on clinical execution. Today's announcement is a direct result of those efforts," said James Dentzer, President & CEO of Curis. "If the data from this phase of the trial, which is expected in the 2nd half of this year, is positive, we expect to initiate an expansion of the study."
CA-170 is an orally available, dual inhibitor of VISTA and PDL1, which the company believes could provide benefit in tumors with high levels of VISTA expression. Over 90% of mesothelioma cancers express high levels of VISTA.
CA-170 is the only anti-VISTA therapeutic currently being studied in a clinical trial. CA-170 has demonstrated favorable safety and tolerability, as well as preliminary anti-tumor activity in patients across multiple tumor types. The Phase 1 study is the first clinical trial of CA-170 to specifically target a patient population characterized by high levels of VISTA expression.
About the Study
The Phase 1, open-label, dose escalation and dose expansion trial evaluating the safety, pharmacokinetics, pharmacodynamics, and clinical effects of orally administered CA-170 in patients with advanced tumors and lymphomas. The dedicated mesothelioma cohort will evaluate CA-170 at two dose levels.
VISTA (V-domain Ig-containing Suppressor of T cell Activation) is an independent, inhibitory T cell checkpoint protein that is expressed on both immune cells and tumor cells. VISTA has been identified as a potential resistance mechanism to treatment with anti-PD1 antibodies in melanoma and anti-CTLA4 antibodies in prostate cancer. Recent literature indicates that high levels of VISTA expression have been found on various tumors, including mesothelioma, ovarian cancer, endometrial cancer, triple negative breast cancer, gastric cancer, and non-small cell lung cancer.
About Curis, Inc.
Curis is a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, including fimepinostat, which is being investigated in clinical studies in patients with DLBCL and solid tumors. Curis is also engaged in a collaboration with Aurigene to develop first-in-class therapeutics in immuno-oncology and precision oncology. As part of this collaboration, Curis has exclusive licenses to oral small molecule antagonists of immune checkpoints including, the VISTA/PDL1 antagonist CA-170, and the TIM3/PDL1 antagonist CA-327, as well as the IRAK4 kinase inhibitor, CA-4948. CA-170 is currently undergoing testing in a Phase 1 trial in patients with advanced solid tumors, lymphomas, and mesothelioma and in a Phase 2 trial in India conducted by Aurigene. CA-4948 is currently undergoing testing in a Phase 1 trial in patients with non-Hodgkin lymphoma. 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. For more information, visit Curis's website at www.curis.com.