Symphogen licenses EGFR antibody mixture to Merck
COPENHAGEN, Denmark—Private biopharmaceutical company Symphogen A/S, which focuses on the development of recombinant antibody mixtures, has announced the signing of an exclusive worldwide license agreement with Merck KGaA for Sym004, an investigational antibody mixture that targets the epidermal growth factor receptor (EGFR), which has long been associated with lung cancer.
Per the terms of the agreement, Merck will pay Symphogen a total of € 20 million (approximately $25.26 million) upfront, with an additional € 225 million (approximately $284.18 million) possible in clinical development and regulatory milestones and another € 250 million (approximately $315.76 million) possible in combined sales performance milestones. Symphogen is also eligible to receive royalties on net worldwide sales. In return, Merck is granted exclusive worldwide rights for the development and commercialization of Sym004.
"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," Dr. Susan Jane Herbert, head of Global Business Development and Strategy for Merck Serono, said in a press release about the agreement. "This collaboration once again reflects our strong commitment to fighting cancer and to providing new treatment options to patients."
Sym004 is currently undergoing a Phase I/II trial in patients with advanced KRAS wild-type metastatic colorectal cancer who have previously progressed on treatment with standard chemotherapy and a marketed anti-EGFR monoclonal antibody. The compound is also being evaluated in a single-arm, open-label Phase II trial in patients suffering from squamous cell carcinoma of the head and neck who have failed anti- EGFR-based therapy. Enrollment for the former study was completed in June of last year, and the latter study was initiated in August of last year. The primary endpoint of the Phase II trial in squamous cell carcinoma patients is progression-free survival at 24 week, with secondary endpoints of objective tumor response, time to progression, biomarkers, pharmacokinetic profile and safety.
Sym004 consists of two anti-EGFR monoclonal antibodies that target different non-overlapping epitopes. The compound blocks ligand binding, receptor activation/phosphorylation and downstream signaling, in addition to demonstrating the ability to induce rapid removal of EGFR receptors from the surface of cancer cells by inducing EGFR internalization and degradation. Sym004 has also shown the potential to treat tumors that present acquired resistance to other anti-EGFR agents.
"We believe that Merck is uniquely well positioned to develop Sym004 based on its deep knowledge of the EGFR area," Kirsten Drejer, CEO of Symphogen, said in a press release. "This transaction further validates the antibody mixture approach as a highly attractive option."
As of July of this year, a total of 88 patients have been treated with Sym004 in clinical trials, and exposure data do not indicate an anti-drug antibody response. So far, adverse events in response to the compound, according to preliminary clinical data, consist of skin rash, diarrhea, nausea, mucosal inflammation, hypomagnesemia (low levels of magnesium) and infusion-related reaction.