Symphogen A/S, a private biopharmaceutical company developing recombinant antibody mixtures, a class of antibody therapeutics under investigation for the treatment or prophylaxis of serious human diseases such as cancer or infectious and autoimmune diseases, today announced that an exclusive worldwide license agreement was signed with Merck KGaA, Darmstadt, Germany, 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 single-arm, 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.
Under the agreement, Symphogen will receive from Merck an upfront payment of € 20 million. Symphogen is also eligible to receive up to € 225 million for clinical development and regulatory milestones, € 250 million in potential combined sales performance milestones and royalties on net worldwide sales. In exchange, Merck will gain exclusive worldwide rights to develop and commercialize Sym004.
"We believe that Merck is uniquely well positioned to develop Sym004 based on its deep knowledge of the EGFR area," said Kirsten Drejer, Chief Executive Officer of Symphogen. "This transaction further validates the antibody mixture approach as a highly attractive option."
"Sym004 further strengthens our early development pipeline by adding a product that is thought to act via a proposed synergistic mechanism of action not previously studied, but more specifically, it has the potential to become a key asset complementing our already highly successful Erbitux franchise," commented Dr. Susan Jane Herbert, Head of Global Business Development and Strategy for Merck Serono. "This collaboration once again reflects our strong commitment to fighting cancer and to providing new treatment options to patients."
Sym004 is comprised of two antibodies that are not only designed to block ligand binding, receptor activation and downstream signaling but are also thought to elicit removal of the EGFR receptors from the cancer cell surface by inducing EGFR internalization and degradation.
As of July 2012, 88 patients have been treated with Sym004 in clinical trials. The adverse events from the 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.