Symphogen to Report Preliminary Safety and Exploratory Efficacy Data from a Phase 1 Study of Sym004, Anti-EGFR Monoclonal Antibody Mixture at ASCO

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Symphogen A/S, a private biopharmaceutical company with leadership in recombinant antibody mixtures for therapeutic use, today 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.

About SYM004
Sym004 is comprised of two antibodies that are not only designed to block ligand binding,  block receptor activation and downstream signaling but are also removal of the EGFR receptors from the cancer cell surface by inducing EGFR internalization and degradation.

Sym004 was out-licensed to Merck KGaA in 2012 following phase 2 clinical data in late stage cancer patients.

For additional information, please contact:
Ivan Horak, MD FACP

Chief Scientific & Medical Officer
Phone: +1 9089389313 (US cell) +45 20 55 26 04 (DK cell)
E-mail: idh@symphogen.com
Kirsten Drejer, PhD
Chief Executive Officer
Phone: + 45 22 10 99 59
E-mail: kd@symphogen.com
Shari Annes
Annes Associates
Phone: +1 650-888-0902
E-mail: sannes@annesassociates.com

About Symphogen
Symphogen is a private biopharmaceutical company leading the field of recombinant antibody mixtures for therapeutic use in oncology. Symphogen is dedicated to bringing truly innovative oncology products to the market, creating optimally selected antibody mixtures that address multiple oncology targets in a single drug product. The company has collaborations for the development of antibody therapeutics in the infectious disease area with Genentech, and in immuno-oncology with Shire. Symphogen has offices in Denmark and New Jersey, US and its investors include Essex Woodlands Health Ventures, Novo A/S, PKA, Sunstone Capital, Gilde Healthcare Partners, Danica Pension, Takeda Ventures, Inc., and Genentech.

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