CellAct punches above its weight with Mundipharma deal

Mundipharma's EDO unit will take the drug into phase 3 for biliary tract cancer.

German biotech CellAct has brought its cancer drug CAP7.1 through to phase 2 testing with a little over $10 million in financing—and has now claimed the reward of a $250 million partnership with Mundipharma.

The deal (PDF)—an example of the virtues that can follow from being a "virtual" biotech—will see Mundipharma's cancer specialist unit EDO take the reins of the program in phase 3, pushing forward with trials of CAP7.1 in biliary tract cancer.

CAP7.1 is a new prodrug formulation of the established chemotherapy agent etoposide that, according to CellAct, has some key advantages over the parent drug, including the ability to concentrate into tumors, potentially increasing the efficacy of the drug while also reducing side effects. The drug is a new chemical entity that release etoposide only in the presence of enzymes (carboxylesterases) that are commonly found in higher concentrations in tumor tissue.

Financial details aren't being divulged, other than to say that Mundipharma is fronting a "double-digit" sum for the rights, development and commercial milestone payments and double-digit royalties. The pharma group is also committing to developing a new, commercial-scale formulation of CAP7.1 in preparation for marketing.

Ten-year-old CellAct reported phase 2 data with CAP7.1 last year that showed an overall response rate of 56% with the drug and an estimated 1-year survival rate of 40%—around twice what would be expected with current therapy.

If approved, the drug would slot into Mundipharma's portfolio alongside its current range of chemotherapies, including DepoCyte (liposomal cytarabine), Levact (bendamustine) and Folotyn (pralatrexate).

CellAct's co-founder and managing director, Nalân Utku, M.D., 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." She added that the deal gives CellAct's current investors Peppermint VC and NRW Bank a "valuable exit point."

The drug has orphan status for biliary tract cancer, which kills about 140,000 people each year and has been increasing in incidence since the 1990s, although the reasons for that remain unclear. There are no second-line therapies for patients after surgery or chemotherapy.