CUDC-907 is a small molecule targeted drug candidate designed and discovered by us to inhibit PI3K and HDAC enzymes.  Curis is developing CUDC-907 based on published and internally generated data demonstrating that HDAC and PI3K inhibitors have synergistic interaction in certain preclinical cancer models, and based on published observations of clinical activity of such agents in hematological cancers. CUDC-907, with its synergistic mechanism of cancer signaling network disruption, has demonstrated potent preclinical antitumor activity in a variety of hematological tumor models including non-Hodgkin’s lymphoma and multiple myeloma. Curis believes that CUDC-907 has the potential to possess clinical advantages over single targeted agents.  In November 2011, Curis entered into an agreement with The Leukemia & Lymphoma Society, or LLS, under which LLS will provide up to $4 million in funding to support the early clinical development of CUDC-907 in patients with relapsed or refractory lymphoma and multiple myeloma.

In January 2013, Curis began a Phase I clinical of CUDC-907 in patients with relapsed or refractory lymphoma or multiple myeloma.  As a result, Curis has received an aggregate of $1.1 million in aggregate milestone payments under the terms of the agreement with LLS.  

About the CUDC-907 Phase I Dose Escalation Trial

The Phase I clinical trial is designed as a standard dose escalation study in which CUDC-907 will be orally administered to patients with relapsed or refractory lymphoma or multiple myeloma at up to four study centers in the United States.  The primary objectives of the trial are to determine the maximum tolerated dose (MTD) and recommended Phase II dose of oral CUDC-907.  The secondary objectives of this study are to assess safety and tolerability, to assess pharmacokinetics, to evaluate biomarker activity and to assess preliminary anti-cancer activity of CUDC-907 in this patient population.

In the absence of dose limiting toxicity, each patient will receive oral CUDC-907 once daily for a minimum of 21 days of continuous daily dosing (1 cycle), and may continue to receive additional cycles of study treatment until disease progression or other treatment discontinuation criteria are met.

About CUDC-907

CUDC-907 is a small molecule targeted drug candidate designed and discovered by Curis to inhibit PI3K and HDAC enzymes.  Concurrent inhibition of PI3K and HDAC has synergistic effect in certain preclinical cancer models, and based on published observations of clinical activity of such agents in hematological and other cancers.  CUDC-907 has demonstrated potent antitumor activity in a variety of hematological tumor models including non-Hodgkin’s lymphoma and multiple myeloma.

About the LLS Agreement

Under the agreement, LLS will fund approximately 50% of the direct costs of the development of CUDC-907, up to $4 million.  Curis is currently seeking to advance the molecule into a Phase I dose escalation clinical trial in patients with relapsed or refractory lymphomas or multiple myeloma in early 2013.  If this study is successful, LLS has also agreed to support Curis' subsequent Phase Ib or Phase IIa study in one or more specific indications as well as Curis' ongoing investigation of biomarkers for CUDC-907 in these diseases.

About The Leukemia & Lymphoma Society

The Leukemia & Lymphoma Society® (LLS) is the world's largest voluntary health agency dedicated to blood cancer.  The LLS mission:  Cure leukemia, lymphoma, Hodgkin's disease and myeloma, and improve the quality of life of patients and their families.  LLS funds lifesaving blood cancer research around the world and provides free information and support services.  Founded in 1949 and headquartered in White Plains, NY, LLS has chapters throughout the United States and Canada.  To learn more, visit www.LLS.org or contact the Information Resource Center at (800) 955-4572, Monday through Friday, 9 a.m. to 6 p.m. ET. www.LLS.org.