CAP-7.1

August 14, 2017 By Alex Keown , BioSpace.com Breaking News Staff CAMBRIDGE, England – Germany-based CellAct struck a deal with the Mundipharma network of independent companies for its anticancer drug agent CAP7.1. CellAct announced the deal this morning, which could generate the small company more than $250 million, in addition to what it called “double-digit royalties.” What those royalties could be though were not specified. CAP7.1 is called a ‘smart chemotherapy’ that has the potential to treat orphan disease designated biliary tract cancer for which there are no second line treatment options. CAP7.1 is a novel pro-drug of anticancer agent etoposide which is metabolized into an active form by enzymes in the gastrointestinal tract that are particularly active in tumor cells. Treatment with CAP1.1 is designed to enable the release of the chemotherapeutic agent into tumor cells in higher doses while maintaining a good safety and tolerability profile, the company said in its announcement. “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,” CellAct Chief Executive Officer Nalân Utku said in a statement. Last year, CellAct announced Phase II data at the American Society of Clinical Oncology meeting in Chicago. The company said data taken from 39 patients demonstrated the efficacy of the treatment in reducing tumor sizes in biliary tract cancer patients. CAP7.1 showed efficacy in this difficult to treat patient population, with 56 percent of patients meeting the primary objective of disease control, including tumor shrinkages. CAP7.1 treated patients displayed an estimated one-year survival rate of 40%, which is approximately 20 percent higher compared with current standard of care. Analysis of the population PK indicated higher blood concentrations of etoposide resulted in the majority of patients maintaining an increase in tumor size below 20 percent, the company said in its ASCO abstract. As part of the deal with Mundipharma, CellAct said CAP7.1 will be advanced into Phase III trials by EDO , a Mundipharma company. Thomas Mehrling , CEO of EDO, said the company is “thrilled” to take CAP7.1 into Phase III 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,” Mehrling said in a statement. Biliary tract cancer, including gallbladder tumors, is the second most common primary hepatobiliary cancer, after hepatocellular cancer. CellAct said there are approximately 140,000 deaths each year from biliary tract cancer, which is a 22 percent increase in fatalities since 1990. Despite the availability of surgery and chemotherapy options for early and locally advanced disease, patients are not able to access any indicated second line treatments, CellAct said.