IND application for lead candidate is anticipated before the end of the year.
Debiopharm inked a worldwide, exclusive license agreement for Curis’ heat shock protein (Hsp90) technology. The deal includes CUDC-305, the company’s lead Hsp90 inhibitor candidate, which is in preclinical development. An IND application is expected to be filed in Fall 2009. Debiopharm will assume all future development responsibilities and expenses.
Curis will receive an up-front license fee and near-term payments upon the approval of such applications. Curis is also eligible for additional milestones related to development and regulatory approval as well as royalties.
“We believe that the up-front license fee and near-term contingent payments will extend our cash runway well into 2011,” remarks Dan Passeri, Curis president and CEO. The firm reported having $26.8 million in cash on June 30.
“The agreement provides nondilutive capital that we expect will allow us to continue to seek to internally develop CUDC-101, our first-in-class HDAC/EGFR/Her2 inhibitor that is currently enrolling patients in a Phase I dose-escalation trial, as well as our other promising preclinical multitargeted development programs.”
Michael Gray, Curis’ COO and CFO adds, “We expect additional data during the second half of 2010 from our collaborator’s (Genentech) ongoing Phase II clinical trials of GDC-0449, a hedgehog pathway inhibitor, in advanced basal cell carcinoma, metastatic colorectal cancer, and advanced ovarian cancer. Positive results with GDC-0449 in any of these indications have the potential to be a significant value-creating event for Curis stockholders and could provide future milestone payments to further extend our cash runway and fund our further investment in our multitargeted inhibitor programs including CUDC-101.”