Symphogen to Report Preliminary Safety Data from a Phase 1 Study of Sym004

Symphogen A/S has reported preliminary safety and exploratory efficacy data from a Phase 1 clinical study of Sym004, an investigational anti-EGFR monoclonal antibody mixture, administered biweekly, that will be presented in a poster at the upcoming American Society for Clinical Oncology (ASCO) Annual Meeting being held May 30 - June 3, 2014 in Chicago, IL.

The poster, entitled, Phase 1 study of biweekly (Q2W) anti-EGFR monoclonal antibody (mAb) mixture Sym004 in patients (29 pts) with metastatic colorectal cancer (mCRC) resistant to previous anti-EGFR treatment (abstract #3551) will be on view in the poster session on Gastrointestinal (Colorectal) Cancer (31 May 2014, 8:00 - 11:45 AM, McCormick Place Convention Center in Chicago, IL).

Sym004 is a drug mixture of two mAbs targeting non-overlapping epitopes of EGFR which have been shown in pre-clinical studies to demonstrate synergistic inhibition of EGFR.

Chief Scientific and Medical Officer of Symphogen, Ivan Horak, MD, FACP, commented: “I am very pleased to see that the safety profile of this bi-weekly regimen is consistent with previous findings observed with the weekly schedule and the clinical activity of Sym004 in this very difficult to treat patient population with metastatic colorectal cancer, who are resistant to approved anti-EGFR antibodies. This administration schedule offers the potential to combine Sym004 with biweekly chemotherapy regimens used in first and second line therapy of metastatic CRC.”

The ASCO data reports on 29 patients, whose median age was 64 years. Of the 29 patients, 86% had received more than two prior lines of therapy. One cohort of 12 patients was treated at 12 mg/kg and an additional 17 patients were treated at 18 mg/kg of Sym004 Q2W.

Safety Findings
No new or unexpected toxicities were identified. Drug-related adverse effects were manageable with dose reduction and supportive medication. In the 12 and 18 mg/kg cohorts, grade 3 skin rash was seen in 4/12 [33%] and 7/17 [41%] patients, respectively (no grade 4), and grade ≥ 3 hypomagnesaemia was seen in 3/12 [25%] and 6/17 [35%] patients, respectively. Grade 3 diarrhea was seen in one patient of each cohort (8%; 6%; no grade 4). Infusion-related reactions were observed in 2/29 (7%) patients (grade 1 and 2, each).

Efficacy Findings
Antitumor activity, measured as disease control (stable disease [SD] + partial response [PR]), was documented in 14/29 (48%) patients.