Under the terms of the deal, Merck Serono willgain exclusive worldwide rights to develop and commercialize Sym004, whileSymphogen will receive from Merck an upfront payment of some $28.5 million aswell as payments for clinical development, regulatory and sales performancemilestones. Symphogen will also be eligible for potential royalties on networldwide sales.
This current clinical program for Sym004 forpatients with advanced metastatic colorectal cancer and in squamous cellcarcinoma of the head and neck "builds upon the long history of scientific andclinical success with Erbitux and complements Merck's existing EGFR franchise,"Merck Serono notes in a news release about the deal.
Specifically, Sym004 is under evaluation in aPhase I/II trial for the treatment of patients with advanced KRAS wild-typemetastatic colorectal cancer who have previously progressed on treatment withstandard chemotherapy and a marketed anti-EGFR monoclonal antibody. Inaddition, there is an ongoing single-arm, open-label Phase II trial in patientswith squamous cell carcinoma of the head and neck who have failedanti-EGFR-based therapy.
"Sym004 further strengthens our early developmentpipeline by adding a product that is thought to act via a proposed synergisticmechanism of action not previously studied, but more specifically, it has thepotential to become a key asset complementing our already highly successfulErbitux franchise," said Dr. Susan Jane Herbert, head of global businessdevelopment and strategy for Merck Serono. "This collaboration once againreflects our strong commitment to fighting cancer and to providing newtreatment options to patients."
As the companies describe the investigationalcompound, it is made up of a pair of antibodies that not only block ligandbinding, receptor activation and downstream signaling "but are also thought toelicit removal of the EGFR receptors from the cancer cell surface by inducingEGFR internalization and degradation," according to Merck Serono.
"We believe that Merck is uniquely well positionedto develop Sym004 based on its deep knowledge of the EGFR area," saidKirsten Drejer, CEO of Symphogen. "This transaction further validates theantibody mixture approach as a highly attractive option."