Curis Reports Dosing of First Patient in Phase 1 Trial of CUDC-907 in Patients with Advanced/Relapsed Solid Tumors

Curis, Inc.

, an oncology-focused biotechnology company developing novel drug candidates for the treatment of human cancers, today announced that the first patient has initiated treatment with CUDC-907 in a Phase 1 clinical trial in patients with advanced or relapsed solid tumors, including hormone receptor positive (HR+)/ HER2-negative breast cancer or midline carcinoma with certain NUT gene rearrangements. CUDC-907 is an oral, dual inhibitor of histone deacetylase (HDAC) and phosphoinositide 3-kinase (PI3K) enzymes that is currently under investigation in the first-in-human Phase 1 clinical study in patients with relapsed or refractory lymphomas and multiple myeloma. "We look forward to investigating the therapeutic potential of CUDC-907, a molecule with the unique ability to inhibit both HDAC and PI3K enzymes, in patients with hormone receptor positive breast cancer," said Pamela Munster, M.D., Principal Investigator of the study and Professor, Department of Medicine (Hematology/Oncology) at the University of California, San Francisco's Helen Diller Family Comprehensive Cancer Center. "Scientifically, CUDC-907 merits evaluation in patients with HR+ breast cancer in combination with hormonal therapy as HDACs are critical components of the estrogen receptor transcriptional complex. Additionally, the high prevalence of alterations in the PI3K pathway further supports the rationale of testing the molecule in this specific subset of patients with breast cancer." "We are excited to initiate this study with CUDC-907 in patients with HR+ breast cancer and in patients with NUT midline carcinoma or NMC, a rare, aggressive cancer, genetically defined by rearrangements of the NUT gene," said Ali Fattaey, Ph.D., President and Chief Executive Officer of Curis. "There are currently no therapies for patients with NMC. However, Curis' preclinical data and other published results in the field have demonstrated that NMCs may be sensitive to treatment with molecules that inhibit HDAC enzymes such as CUDC-907. Based on these data, we are eager to further investigate the potential of CUDC-907 in the treatment of patients with NMC."