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Curis Announces FDA Clearance of IND Application for CI-8993, the First-In-Class Monoclonal Anti-VISTA Antibody
- Phase 1a/1b dose escalation study to begin in the second half of 2020 - LEXINGTON, Mass., June 10, 2020 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a
About this update from Curis, Inc.
[{"type":"text","content":"- Phase 1a/1b dose escalation study to begin in the second half of 2020 -\n\n\n LEXINGTON, Mass., June 10, 2020 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CI-8993, the first-in-class monoclonal anti-VISTA antibody. Curis plans to initiate a Phase 1a/1b study of CI-8993 in the second half of 2020.\n\n \n \n \n \n \n \n\n \n\"The clearance of our IND is an important step for the advancement of VISTA therapies, as CI-8993 becomes the first anti-VISTA antibody in development to enter clinical testing,\" said James Dentzer, President and Chief Executive Officer of Curis. \"When activated, VISTA plays a critical role in suppressing T cell activity. Conversely, it has been shown in preclinical studies that blocking VISTA reduces the suppression of T cells and reactivates anti-tumor immune function. We are eager to leverage our extensive experience with VISTA and pioneer this first-in-class anti-VISTA antibody program.\"\nCertain cancers, such as mesothelioma, triple negative breast cancer, non-small cell lung cancer, and gynecologic malignancies, are known to be highly driven by VISTA. These cancers may be amenable to monotherapy treatment with anti-VISTA therapy.\nIn other cancers, anti-VISTA therapy may be more effective as part of a combination approach. VISTA is independent of, and complementary to, other immune checkpoints, including PD1 and CTLA4. Published studies have shown that VISTA expression increases up to 5-fold as a compensatory mechanism following anti-CTLA4 or anti-PD1 treatment. Further preclinical studies have explored this relationship more deeply and support the potential of combining anti-VISTA therapy with anti-PD1 or anti-CTLA4 therapies. \nThe multi-center, open-label Phase 1a/1b dose escalation study of CI-8993 in patients with relapsed / refractory solid tumors will evaluate approximately 50 patients, with the goal of identifying a recommended dose and schedule. Curis expects to initiate this study in the second half of 2020.\nAbout VISTA\nVISTA is a novel negative checkpoint ligand that is homologous to PD-1/PD-L1 and suppresses T cell activation. VISTA relieves negative regul...