Copenhagen, Denmark and PRINCETON, New Jersey – Symphogen A/S today announced that it has initiated a Phase 1/2 human clinical trial in the US to evaluate the safety, tolerability and efficacy of its drug candidate Sym004 for the treatment of advanced solid tumors. Sym004 is composed of two anti-epidermal growth factor receptor (EGFR) monoclonal antibodies targeting different nonoverlapping EGFR epitopes.
 
The preclinical results that were recently published in Cancer Research hold great promise for Sym004 and we are very excited about advancing this compound into the clinic,” stated Kirsten Drejer, M.Sc. and Ph.D., Chief Executive Officer of Symphogen.

“Sym004’s novel mechanism of action appears to exhibit anti-cancer effects on EGFR-resistant tumors. EGFR, which is a proven and attractive therapeutic target, represents a potential multi-billion dollar market opportunity. We look forward to reporting data from Part A of this trial in early 2011 and continuing to advance Sym004 into a Phase 2 extension of the trial as quickly as possible.”

The Phase 1/2 clinical trial is an open-label, multi-center dose escalation trial study to evaluate the safety and tolerability of Sym004 of multiple doses of Sym004 in patients with advanced solid tumors. The first part of the trial is being conducted at the South Texas Accelerated Research Therapeutics (START) Clinic, San Antonio, Texas and Vall d’Hebron University Hospital in Barcelona, Spain.
 
The trial will consist of two parts; in both parts, Sym004 will be administered intravenously once weekly. In Part A, Sym004 will be studied in a heterogeneous population of patients with refractory or recurrent advanced solid tumors and late stage cancer. In Part B, which is a phase 2 extension of the trial, the maximum tolerated dose will be studied in patients with refractory or recurrent advanced metastatic colorectal cancer and the wild type form of the KRAS protein. The presence of wild type KRAS is known to be predictive of response for other anti-EGFR targeted therapeutics.
 
Secondary endpoints will include an evaluation of objective tumor response, duration of overall response, progression free survival, overall survival, immune response, skin rash and biomarkers.

“Our team at South Texas Accelerated Research Therapeutics (START) in San Antonio is very excited to work with Symphogen on the first clinical trial of the Sym004 in cancer patients,”

said Dr. Anthony Tolcher, Director of Clinical Research at START.

“Sym004 represents a novel approach to targeting EGFR with the potential to be an important step forward in the treatment of patients with cancer.”

“There is definitely strong market need for more efficacious anti-EGFR antibody therapies and we look forward to reviewing the Phase I data for Sym004 early next year”

stated Josep Tabernero, M.D., Head of Gastrointestinal Tumors and Phase I Unit at Vall d’Hebron University Hospital in Barcelona, Spain.

“My early-stage research experience with EGFR-family inhibitors leads me to believe that there is significant promise for this drug candidate.

About Sym004
Sym004 inhibits cancer cells by blocking ligand binding, receptor activation/phosphorylation, and downstream signaling and has also showed a unique ability to induce rapid and efficient removal of the EGFR receptors from the cancer cell surface by inducing EGFR internalization and degradation in preclinical studies. In preclinical studies Sym004 was significantly more effective than the two marketed EGFR inhibitors, cetuximab and panitumumab, and has the potential to treat tumors with acquired resistance to other EGFR-targeted agents, including both monoclonal antibodies and small molecule tyrosine kinase inhibitors.
 
About Symphogen
Symphogen is developing superior antibody therapeutics (monoclonal and monoclonal mixtures) to help people with serious diseases and significant unmet medical needs. With its proprietary, unique Symplex? discovery and Sympress? manufacturing platforms, the company captures the diversity and specificity of the natural immune response in rationally designed recombinant antibody compositions. Symphogen is maturing a diversified pipeline of internal and partnered products across multiple indications including cancer, autoimmune and infectious disease. Symphogen is a private biopharmaceutical company headquartered in Copenhagen, Denmark, with a US subsidiary in Princeton, New Jersey.