Merck KGaA abandons Symphogen's cancer drug ahead of Phase III

Symphogen CEO Kirsten Drejer

Merck KGaA, in the process of paring down its pipeline, is walking away from a $625 million deal with Symphogen and handing back the company's lead asset, a targeted cancer treatment in midstage trials.

Both companies said the decision is in no way a response to any new safety of efficacy data tied to the drug, now in Phase IIb, and Symphogen believes it has the cash and expertise to move forward on its own. The treatment, Sym004, is a combination of two antibodies designed to attack the EGFR receptors on cancer cells and halt tumor growth.

Merck KGaA bought into Sym004's promise back in 2012, paying about $25 million up front and promising $600 million more in development and commercial milestones. The drug has since shown promise in squamous cell carcinoma and metastatic colorectal cancer, Symphogen said, leading Merck KGaA to kick off three new studies on the treatment. The most advanced, a Phase IIb trial in colorectal cancer, is still ongoing, and now the Danish biotech is expanding its R&D operation to pick up where its partner left off and build out its pipeline for the future.

The company plans to cut the ribbon on a clinical development unit in New Jersey, sending Ivan Horak, head of R&D, to oversee the effort. At the same time, Symphogen has recruited Novo Nordisk ($NVO) research veteran Esper Boel to lead its antibody discovery operation back in Demark with a particular focus on immuno-oncology. The overarching goal, CEO Kirsten Drejer said, is to pivot into becoming a standalone clinical biotech, keeping Sym004 moving while investing in next-generation anticancer antibodies.

"With more than €70 million ($79 million) in cash to execute its strategy, the rights to an advancing clinical program and several pipeline programs being readied for development, we can harvest the productivity of our research efforts and move the company forward with an eye toward commercial oncology opportunities," Drejer said in a statement.

Beyond its top prospect, Symphogen is working up a 6-antibody combo treatment that targets EGFR, HER2 and HER3, aiming to get that therapy into the clinic later this year. The biotech is also running through preclinical studies on an antibody mixture aimed at c-MET, slated to begin Phase I in 2016.

As for Merck KGaA, the decision to abandon Sym004 stemmed from "an ongoing assessment of all pipeline assets," according to a spokeswoman. The German giant is instead focusing its oncology efforts on the PD-L1 inhibitor MSB0010718C, partnered with Pfizer ($PFE), and the Phase III TH-302, licensed from Threshold Pharmaceuticals.

- read the announcement

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