Merck KGaA is paying Symphogen €20 million (about $25 million) up front for an exclusive worldwide license to develop the latter’s anticancer candidate Sym004, an antibody mixture targeting EGFR. Under terms of the licensing deal Symphogen could receive up to another €225 million (roughly $283 million) in clinical development and regulatory milestones, plus €250 million (about $314 million) in potential sales performance milestone payments and royalties. Sym004 is currently undergoing a Phase I/II-stage trial as a treatment for advanced KRAS wild-type metastatic colorectal cancer (mCRC) in patients with disease that has progressed following treatment with chemotherapy and a marketed anti-EGFR antibody. An open-label Phase II study in patients with squamous cell carcinoma of the head and neck (SCCHN) who have failed anti-EGFR-based therapy is also ongoing.
Sym004 is a recombinant IgG1 antibody product comprising two antibodies against EGFR. The treatment is designed to inhibit cancer cells via three separate mechanisms of action: inhibition of ligand binding, activation, and downstream EGFR signaling; internalization and degradation of the EGF receptor; and triggering immune-mediated cancer cell killing.
“Sym004 further strengthens our early development pipeline by adding a product that is thought to act via a proposed synergistic mechanism of action, but more specifically, it has the potential to become a key asset complementing our already highly successful Erbitux franchise,” comments Susan Jane Herbert, Ph.D., head of global business development and strategy for Merck Serono.
Symphogen is focused on the development of targeted recombinant antibody mixtures for the prevention or treatment of cancer, infectious diseases, and autoimmune disorders. The firm’s pipeline is based on its Symplex™ antibody discovery platform, SymSelect™ functional lead selection platform, and Sympress™ manufacturing platform.
Symphogen’s lead candidate, Sym001 (anti-Rhesus D, rozrolimupab), is novel human recombinant mixture of 25 anti-Rhesus D (RhD) antibodies, which is in Phase II development as an alternative to existing anti-RhD hyperimmune immunoglobulins for the treatment of idiopathic thrombocytopenic purpura (ITP) and the prevention of hemolytic disease of newborns. Positive data from a Phase II study in 61 ITP patients were published in August. Sym001 is being co-developed with Biovitrum.