Curis, Inc., an oncology-focused drug development company seeking to develop novel drug candidates for the treatment of various cancers, has received key US patent No. 8,461,157, which claims methods of treating human diseases or disorders mediated by one or more of phosphoinositide 3-kinase (PI3K), mammalian target of rapamycin (mTOR) and histone deacetylase (HDAC) proteins, using compounds from a genus of small molecules with dual inhibitory properties, including but not limited to CUDC-907, a proprietary clinical stage dual inhibitor of PI3K and HDAC enzymes.
This patent, along with another related patent issued in February 2013 (US Patent No. 8,367,663), significantly enhances the intellectual property portfolio for Curis' proprietary chemical entities that target PI3K and HDAC, and in some instances mTOR, within a single molecule for the treatment of certain human diseases.
"We believe that this patent issuance significantly bolsters the intellectual property protection for Curis' proprietary dual targeted inhibitory molecules, including CUDC-907, a molecule that was invented by Curis scientists and is currently in phase I clinical testing in patients with relapsed or refractory lymphomas or multiple myeloma," stated Dan Passeri, Curis' chief executive officer. "As we continue to advance this current phase I study, we are also planning to initiate additional studies with CUDC-907 in solid tumours later this year."
CUDC-907 is a dual inhibitor of the Class I PI3K, as well as Class I and II HDAC subtypes. Specifically, CUDC-907 is designed to inhibit PI3K-alpha, delta and beta isoforms and HDACs 1, 2, 3, 6 and 10, the combined inhibition of which Curis believes has synergistic effects against cancer cells and their microenvironment. In preclinical studies, CUDC-907 has demonstrated the ability to suppress multiple nodes of cellular survival and proliferation signaling pathways. In addition, preclinical data have shown that CUDC-907 inhibits compensatory pathways that are often utilized in cancer cells during the emergence of resistance to standard-of-care agents.
CUDC-907 exhibits potent anti-proliferation activity against a broad range of cancer cell types in in vitro studies, including cell lines that exhibit reduced sensitivity to single-target PI3K inhibitors. CUDC-907 also inhibits tumor growth in preclinical xenograft models of blood cancers as well as solid tumors with K-RAS mutations that exhibit reduced sensitivity to single-target PI3K inhibitors. The development of CUDC-907 is in part funded by The Leukemia & Lymphoma Society (LLS) under an agreement established in 2011 between Curis and LLSs' Therapy Acceleration Programme.
Under the agreement between Curis and LLS, LLS is expected to fund approximately 50 per cent of the direct costs associated with the development of CUDC-907 through milestone payments that are contingent upon the achievement by Curis of specified clinical objectives, up to a maximum of $4 million. To date, Curis has earned $1.65 million in milestone payments from LLS. In January 2013, Curis initiated a phase I dose escalation clinical trial of CUDC-907 in patients with relapsed/ refractory lymphomas or multiple myeloma. If the phase I study is successful, the agreement also provides for LLS to support CUDC-907's 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, subject to the $4 million maximum funding amount. Under certain conditions associated with the successful partnering or commercialization of CUDC-907, Curis may be obligated to make payments to LLS up to a maximum of $10 million.
The Leukaemia & Lymphoma Society (LLS) is the world's largest voluntary health agency dedicated to blood cancer. Its mission: Cure leukaemia, 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.