Date: 2015-01-29
Type of information: Termination of an agreement
Compound: Sym004
Company: Merck KGaA, Merck Serono (Germany) Symphogen (Denmark)
Therapeutic area: Cancer - Oncology
Type agreement: licensing
Action mechanism: Sym004 is novel investigational antibody mixture targeting the epidermal growth factor receptor (EGFR). Sym004 is composed of two anti-EGFR mAbs targeting different non-overlapping epitopes. Sym004 not only blocks ligand binding, receptor activation/phosphorylation and downstream signaling but also shows a unique ability to induce rapid and efficient removal of the EGFR receptors from the cancer cell surface by inducing EGFR internalization and degradation. Sym004 also has the potential to treat tumors with acquired resistance to other EGFR-targeted agents.
Disease: advanced metastatic colorectal cancer, squamous cell carcinoma of the head and neck
Details: Merck Serono has signed an exclusive worldwide license agreement was signed with Symphogen for Sym004, an investigational antibody mixture targeting the epidermal growth factor receptor (EGFR). Sym004 is currently being evaluated in a Phase I/II trial for the treatment of patients with advanced KRAS wild-type metastatic colorectal cancer (mCRC) who have previously progressed on treatment with standard chemotherapy and a marketed anti-EGFR monoclonal antibody. In addition, a singlearm, open-label Phase II trial in patients with squamous cell carcinoma of the head and neck (SCCHN) who have failed anti-EGFR–based therapy is currently ongoing. As of July 2012, 88 patients have been treated with Sym004 in clinical trials. The adverse events from preliminary clinical data include diarrhea, skin rash, mucosal inflammation, nausea, infusion-related reaction and hypomagnesemia. Exposure data from the patients, after weekly repeated infusions, do not indicate an anti-drug antibody response.
Financial terms: Under the agreement, Merck Serono will gain exclusive worldwide rights to develop and commercialize Sym004. In exchange, Symphogen will receive from Merck an upfront payment of € 20 million as well as payments for clinical development, regulatory and sales performance milestones. Symphogen will also be eligible for potential royalties on net worldwide sales.
Latest news: * On January 29, 2015, Symphogen announced several new corporate initiatives that reposition the company to focus on its proprietary pipeline of clinical oncology programs. The announcements address the regained rights to Sym004, a novel antibody mixture currently in a Phase 2b program, and a prioritization of the company's discovery activities in immuno-oncology. Symphogen's collaborative partner, Merck KGaA, is conducting an ongoing assessment of its pipeline assets and has decided to return the rights of Sym004 to Symphogen for further development. The decision to return the rights is not related to any new safety or efficacy findings regarding Sym004. The regained Sym004 product rights provides Symphogen with a valuable opportunity to retain the value of this attractive clinical candidate, an investigational antibody mixture targeting the epidermal growth factor receptor (EGFR), currently in Phase 2b and 1b trials.
