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Company Description

Contact Info

4 Maguire Road

Lexington, MA 02421

United States

Phone: 617-503-6500

Fax: 617-503-6501

Curis, Inc., an oncology-focused company, focuses on developing and commercializing next generation targeted small molecule drug candidates for cancer treatment. The company’s primary investment is focused on the development of its proprietary targeted cancer drug candidates, including CUDC-907, an oral, small molecule drug candidate that is designed to inhibit histone deacetylase (HDAC) and phosphatidylinositol-3-kinase (PI3K) enzymes; and CUDC-427, an oral, small molecule drug candidate, which is designed to promote cancer cell death by antagonizing inhibitor of apoptosis (IAP) proteins. The company’s collaborators, F. Hoffmann-La Roche Ltd (Roche) and Genentech Inc. (Genentech), a member of the Roche Group, are commercializing and continuing the further development of Erivedge (vismodegib), an orally-administered small molecule Hedgehog pathway inhibitor; and its licensee, Debiopharm S.A. (Debiopharm), is conducting clinical studies of Debio 0932, a small molecule inhibitor of heat shock protein 90. Proprietary Drug Candidates CUDC-907 CUDC-907 is an orally bioavailable, small molecule drug candidate designed to inhibit primarily class I and IIB HDAC enzymes and PI3K alpha, delta and beta isoforms. In 2013, the company initiated a phase 1 clinical study of CUDC-907 in patients with relapsed or refractory lymphomas or multiple myeloma. This program is partially supported under a collaboration with The Leukemia & Lymphoma Society. Additionally, HDAC inhibitors, such as romidepsin or Istodax and vorinostat or Zolinza are approved for the treatment of certain hematologic malignancies, including cutaneous T-cell lymphoma and/ or peripheral cutaneous T-cell lymphoma, and various PI3K inhibitors are in clinical development for various hematologic and solid tumor indications. Primarily, CUDC-907 has shown potent antitumor activity in various hematologic tumor models, including non-Hodgkin’s lymphoma and multiple myeloma. CUDC-427 The company licensed from Genentech the worldwide rights for the development and commercialization of CUDC-427. Under the terms of the license agreement, the company has the sole right and responsibility for all research, development, manufacturing, and commercialization activities related to CUDC-427. In July 2013, the company initiated a single-agent, phase 1 dose escalation trial of CUDC-427 in patients with advanced and refractory solid tumors and lymphomas using twice-daily dosing with no rest period in 21-day cycles. In November 2013, it received written notification from the United States Food and Drug Administration (FDA) that the phase 1 study of CUDC-427 was placed on partial clinical hold following the report of death of a patient who progressed to liver failure approximately one month following the discontinuation of CUDC-427 dosing. Collaborations Erivedge (vismodegib) Capsule: Erivedge is an orally-administered small molecule Hedgehog pathway inhibitor developed under collaboration with Genentech. Erivedge is discovered by Genentech and jointly validated by Genentech and the company through a series of preclinical studies. Pursuant to this collaboration, Genentech and Roche are responsible for clinical development, and Genentech (in the U.S.), Roche (outside the U.S., excluding Japan), and Chugai Pharmaceutical Co., Ltd. (in Japan) are responsible for commercialization of Erivedge. The FDA approved Erivedge for treatment of adults with basal cell carcinoma (BCC) that has spread to other parts of the body or that has come back after surgery or that their healthcare provider decides cannot be treated with surgery or radiation. The company refers to this indication as advanced BCC. In May 2013, Australia’s Therapeutic Goods Administration approved Erivedge and in July 2013 the European Commission granted conditional approval for the marketing of Erivedge in all 28 European Union member states. In October 2013, Roche also initiated a phase 1b/2 clinical trial to investigate the safety and efficacy of Erivedge in patients with relapsed/refractory acute myelogenous leukemia, and relapsed/refractory high-risk myelodysplastic syndrome. In addition to Genent

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