Mundipharma and CellAct announce deal for development of smart chemo

CellAct has provided the Mundipharma network, of independent associated companies, the worldwide development, commercialisation and manufacturing rights to CAP7.1  

CAP7.1 is a novel pro-drug of anticancer agent etoposide, which is metabolised into its active form by enzymes in the gastrointestinal tract that are particularly active in tumour cells.

CAP7.1 is a novel smart chemotherapy, with the potential to treat orphan disease designated biliary tract cancer, for which there is no second line treatment options.

This innovative drug, invented at Charité — Universitätsmedizin Berlin, Germany, enables the focused release of the chemotherapeutic agent into tumour cells in higher doses while maintaining a good safety and tolerability profile.1

EDO, a member of the Mundipharma network, will handle the treatments’ progression through Phase III trials, a company with a worldwide network of clinical connections and expertise in developing cancer therapies.

Dr Thomas Mehrling, CEO at 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.”

Biliary tract cancer, including gallbladder tumours, 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 1990.3 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.

Paul Medeiros, Senior VP of Corporate and Business Development at EDO, 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.”

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

The total deal value CellAct will recieve is upwards of $250 million plus double-digit royalties. 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 both receive sales-related income through tiered royalties and milestone payments.

Nalân Utku, CEO at 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 programme for many years.”

References:

  1. Ulrich-Frank Pape, et al., “Randomized, multicenter phase II trial of CAP7.1 in patients with advanced biliary tract cancers,” Journal of Clinical Oncology 34(4 suppl.), 441-441 (2016).
  2. T.P. Hennedige, W.T. Neo and S.K. Venkatesh, “Imaging of malignancies of the biliary tract — an update,” Cancer Imaging 14(1), 14 (2014).
  3. Mohsen Naghavi et al., “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 385(9963), 117-71 (2014)
  4. F. Mihalache, et al., “Survival and quality of life of cholangiocarcinoma patients: a prospective study over a 4 year period,” J Gastrointestin Liver Dis. 19(3), 285-90 (2010).