Curis, Inc., a biotechnology company, focuses on developing and commercializing drug candidates for the treatment of human cancers. The company’s major advanced drug candidate is CUDC-907, an orally-available, small molecule inhibitor of histone deacetylase (HDAC), and phosphatidylinositol-3-kinase (PI3K enzymes). Based on findings of an ongoing Phase 1 clinical trial of this molecule in patients with relapsed or refractory lymphomas or multiple myeloma, the company initiated an open-label Phase 2 clinical trial of CUDC-907 in patients with MYC-altered relapsed or refractory diffuse large B-cell lymphoma (RR-DLBCL). The company is conducting a Phase 1 study in patients with solid tumors, including patients with nuclear protein in testis (NUT) midline carcinoma (NMC). In addition, the company is party to an exclusive collaboration agreement focused on immuno-oncology and selected precision oncology targets with Aurigene Discovery Technologies Limited (Aurigene), a specialized, discovery-stage biotechnology company and wholly-owned subsidiary of Dr. Reddy’s Laboratories. In 2015, the company exercised options to license the first two programs under this collaboration. The first licensed program is focused on the development of orally-available small molecule antagonists of programmed death -1 (PD-1) and v-domain ig suppressor of T cell activation (VISTA) pathways in the immuno-oncology field, including the development candidate designated CA-170, which is a PD-L1/VISTA antagonist. The second licensed program is focused on orally-available small molecule inhibitors of Interleukin-1 receptor-associated kinase 4 (IRAK4) in the precision oncology field, with the primary development candidate designated CA-4948. CA-170 is an oral small molecule drug candidate that is designed to selectively target PD-L1 and VISTA checkpoint proteins, both of which independently function as negative regulators of immune activation. CA-170 is being developed in collaboration with Aurigene, and in 2015, the company exercised its option to license this drug candidate and the associated program under the collaboration agreement with Aurigene. CA-4948 is an oral small molecule drug candidate that is designed to inhibit the IRAK4 kinase, which is an important transducer of toll-like receptor or certain interleukin receptor signaling pathways. In 2015, the company exercised the option to license this program under the collaboration agreement with Aurigene. In addition, in 2015, the company selected a third program for potential development under the collaboration, the second preclinical program within the immuno-oncology field, which is focused on evaluating small molecule antagonists with PD-1 and T-cell immunoglobulin and mucin domain containing protein-3 (TIM-3) immune checkpoint pathway-targeting properties, including compounds that target PD-L1 and TIM-3. The company’s other collaborators, F. Hoffmann-La Roche Ltd, or Roche, and Genentech Inc., or Genentech, a member of the Roche Group, are commercializing Erivedge (vismodegib), an orally-administered small molecule Hedgehog signaling pathway inhibitor, in advanced basal cell carcinoma, or BCC. Roche and Genentech are also continuing Erivedge’s clinical development in less severe forms of BCC, and initiated clinical studies of Erivedge in idiopathic pulmonary fibrosis (IPF), and myelofibrosis (MF). Genentech and Roche are responsible for the clinical development and commercialization of Erivedge and it is marketed and sold in the U.S. Erivedge is also approved for use in the European Union, Australia and various other countries, and Roche is selling Erivedge in territories outside of the U.S. The company’s proprietary pipeline also includes CUDC-427, an orally-available, small molecule antagonist of inhibitor of apoptosis (IAP proteins). In 2015, the company completed the dose escalation stage in the Phase 1 clinical trial of CUDC-427 in patients with solid tumors or lymphoma. CUDC-427 is designed to promote cancer cell death by antagonizing IAP proteins. CUDC-305 is an oral heat shock protein 90 inhibitor. The company intends to utilize its available resources for the continued development of CUDC-907 and drug candidates under its collaboration with Aurigene, including CA-170 and CA-4948. The company is seeking to collaborate with third parties for further development of CUDC-305. Intellectual Property In the U.S., as of December 31, 2015, the company had 93 issued or allowed patents expiring on various dates between 2016 and 2033, as well as various pending patent applications. Research and Development As of December 31, 2015, the company incurred expenses of $26,699,000 n research and development activities. History Curis, Inc. was founded in 2000 as a Delaware corporation.
curis inc (CRIS:NASDAQ GM)
4 Maguire Road
Lexington, MA 02421
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