Pharmaceutical Business review

Curis announces allowance of US patent covering compounds targeting HDAC and PI3K activities in a single molecule

This patent, along with prior patents issued to Curis, further strengthens the Company’s intellectual property portfolio of compounds including CUDC-907 that inhibit HDAC and PI3K enzymes in a single small molecule for the treatment of certain human diseases.

Collectively, these patents generically cover composition-of-matter and methods of use of CUDC-907 as well as a broad range of proprietary chemical entities that target HDAC and PI3K enzymes, and in some instances mammalian target of rapamycin (mTOR), within a single molecule for the treatment of certain human diseases.

"The allowance of the most recent patent application further enhances Curis’ strong intellectual property portfolio and protection around our promising drug candidate, CUDC-907. Additionally, it also emphasizes the novelty and importance of combining two distinct inhibitory moieties that target HDAC and PI3K enzymes in a single molecule," stated Michael Gray, Curis’ Chief Financial and Business Officer.

"We are encouraged by the progress being made in CUDC-907’s program and look forward to data from the expansion phase of the trial to understand the role of this molecule in the treatment of patients with diffuse large B cell lymphoma and multiple myeloma."

CUDC-907 is being investigated in a first-in-human Phase 1 study in patients with relapsed/ refractory lymphoma or multiple myeloma. As part of the Phase 1 study, Curis has also opened expansion cohorts to enroll patients with diffuse large B cell lymphoma and multiple myeloma. In addition, Curis also expects to initiate an additional study under a second open IND that will enroll patients with advanced solid tumors, including patients with hormone receptor positive breast cancer, among others.

CUDC-907 is an oral, dual inhibitor of Class I and II HDAC, as well as Class I PI3K enzymes. Specifically, CUDC-907 is designed to inhibit HDACs 1, 2, 3, 6 and 10 and PI3K-alpha, delta and beta isoforms. It is currently undergoing investigation in a first-in-human trial to assess its safety, pharmacokinetics and preliminary anti-cancer activity in patients with relapsed/ refractory lymphomas and multiple myeloma.

The development of CUDC-907 is in part funded by The Leukemia & Lymphoma Society (LLS) under an agreement established in 2011 between Curis and LLS’s Therapy Acceleration Program.