The Mundipharma network of independent associated companies announced that it has acquired from CellAct the worldwide development, commercialization and manufacturing rights to CAP7.1.
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.
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 profile1. 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.2 Estimates suggest there are almost 140,000 deaths each year from biliary tract cancer; a 22% increase since 19903. 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.
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.1 CAP7.1 treated patients displayed an estimated one-year survival rate of 40%, which is approximately 20% higher compared with current standard of care.4
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.”
About the Mundipharma network
The Mundipharma global network of privately-owned independent associated companies was founded in 1956 by doctors, and now operates in over 120 countries worldwide. We are focused on developing business partnerships to identify and accelerate meaningful technology across an increasingly diverse portfolio of therapy areas including respiratory, oncology, pain, and biosimilars. Consistent with our entrepreneurial heritage, we like to think we see what others don’t by challenging conventional wisdom and asking different and challenging questions. By working in partnership with all our stakeholders, the Mundipharma network develops medicines that create value for patients, payers and wider healthcare systems.
For more information please visit: www.mundipharma.com.
EDO is a member of the Mundipharma network of independent associated companies.EDO is focused on the preclinical and clinical development of treatments for cancer types where there are currently limited options for patients. The company collaborates with its worldwide network of clinical connections and experienced partners to develop competitively differentiated compounds successfully for a range of cancer types.
As a privately-funded company it can offer rapid decision making combined with commercial flexibility and excellent execution.For further information, please visit www.edoncology.com.
1. Ulrich-Frank Pape, Stefan Kasper, Marianne Sinn, Karel Caca, Jan Kuhlmann, Ulrich Keilholz, Arndt Vogel, and Nalan Utku. Randomized, multicenter phase II trial of CAP7.1 in patients with advanced biliary tract cancers. Journal of Clinical Oncology 2016; 34:4_suppl, 441-441
2. Hennedige TP, Neo WT, Venkatesh SK. Imaging of malignancies of the biliary tract- an update. Cancer Imaging. 2014;14(1):14
3. GBD 2013 Mortality and Causes of Death Collaborators. Global, regional, and national age-sex specific all-cause and cause-specific mortality for 240 causes of death, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet 2015; 385:117-71
4. Mihalache F, Tantau M, Diaconu B, Acalovschi M. Survival and quality of life of cholangiocarcinoma patients: a prospective study over a 4 year period. J Gastrointestin Liver Dis. 2010 Sep;19(3):285-90.