CellAct Pharma, a virtual German company, has signed a more than $250 million deal with Mundipharma for further development and commercialization of CAP7.1, a prodrug etoposide that has shown efficacy in phase 2 studies in patients with biliary tract cancers.
According to CellAct, this innovative drug, invented at Charité – Universitätsmedizin Berlin, Germany, enables the focused release of this chemotherapeutic agent into tumor cells in higher doses while maintaining a good safety and tolerability profile.
Furthermore, the treatment will be progressed through Phase III trials by EDO, a company with a worldwide network of clinical connections and expertise in developing cancer therapies.
Biliary tract cancer, including gallbladder tumors, is the second most common primary hepatobiliary cancer, after hepatocellular cancer.
Mundipharma said that in Phase II studies CAP7.1 showed efficacy in this difficult to treat patient population, with 56% of patients meeting the primary objective of disease control, including tumour shrinkages. CAP7.1 treated patients displayed an estimated one-year survival rate of 40%, which is approximately 20% higher compared with current standard of care.
Under the collaboration, CellAct will receive a double digit upfront payment and milestone payments. EDO will advance CAP7.1 into Phase III clinical trials and reformulate the drug to enable manufacturing scale-up. CellAct and Charité – Universitätsmedizin Berlin,will also both receive sales-related income through tiered royalties and milestone payments.
Dr Thomas Mehrling, Chief Executive Officer, EDO, said: “We are thrilled to be taking this promising treatment into the next phase of clinical trials. By working with a network of experienced clinical partners, EDO enables efficient drug development and we believe this will be of benefit to accelerate the development a potentially life-changing treatment in this area of great unmet patient need.”
Paul Medeiros, Senior Vice President Corporate and Business Development, said: “At Mundipharma, discovering and developing novel medicines to treat underserved oncological diseases is a key strategic priority. Our alliance with CellAct adds an important new potential therapy to our oncology portfolio and builds on our expertise in smart chemotherapies.”
Nalân Utku, Chief Executive Officer, CellAct, said: “The proven expertise of Mundipharma in medicines development and their commercial capabilities will enable the potential for CAP7.1 to help patients in this underserved disease area. This alliance will also provide a valuable exit for our investors Peppermint VC and NRW Bank who have been supporting this program for many years.”