USPTO grants patent to Symphogen's Sym004 to treat solid tumors

Symphogen, a private biopharmaceutical company developing superior antibody therapeutics, said the company had been granted a US patent for Sym004 as well as other antibody compositions containing at least two distinct anti-EGFR antibodies having certain binding characteristics. The United States Patent and Trademark Office on February 15, 2011 issued to the company U.S. Patent No. 7,887,805, titled "Recombinant anti-epidermal growth factor receptor antibody compositions." The US patent provides protection through 2028. Patent applications are pending in additional countries.

Separately, Symphogen said that preclinical data demonstrating the superiority of the now proprietary Sym004 to the reference monoclonal antibody (mAb) was highlighted today in Paris, France in a Plenary Session of the 9th International Symposium on Targeted Anticancer Therapies (TAT Symposium). Sym004 is a novel drug candidate based on a 1:1 mixture of two anti-EGFR monoclonal antibodies (mAbs) directed against distinct non-overlapping epitopes in EGFR extracellular domain III.

… Preclinical data at TAT Symposium

Preclinical data presented today at the TAT Symposium in Paris, showed Sym004, a novel and proprietary candidate for the treatment of solid tumors, exhibited more pronounced growth inhibition in vitro and superior efficacy in in vivo models as compared to the reference anti-EGFR mAb cetuximab. The rate at which Sym004 induced rapid and efficient removal of the ligand-binding receptor from the cancer cell surface by triggering EGFR internalization and degradation was reported to have exceeded that of cetuximab. Like anti-EGFR mAbs in current clinical use, Sym004 has been previously shown to inhibit cancer cell growth and survival by blocking ligand-binding receptor activation and downstream signaling. Dr. Rodrigo Dienstmann, MD, Medical Oncologist, of the Vall d'Hebron University Hospital in Barcelona, Spain made the oral presentation entitled titled: "Sym004: A novel synergistic anti-EGFR antibody mixture with superior anti-cancer efficacy." The abstract will be published in the April 20 issue of Annals of Oncology.

… Sym004 to be highlighted at AACR and other meetings

The preclinical safety and pharmacokinetic data for Sym004 has been accepted for a poster presentation at the upcoming 102^nd Annual meeting of the American Association for Cancer Research in Orlando, Florida April 2-6, 2011.

Later this year, Symphogen plans to present safety data from its first clinical study of Sym004 at a major medical meeting. Sym004 is currently being evaluated for the treatment of advanced solid tumors with particular focus in patients with KRAS wildtype advanced metastatic colorectal cancer (mCRC) that have previously progressed to standard chemotherapy and marketed anti-EGFR mAbs. A phase I-II, first-in-human study is presently ongoing at centers in USA and Spain. The main objective of the phase I component of the trial is to evaluate the safety and tolerability of multiple ascending doses of Sym004 in patients with solid tumors. The phase II part of the trial will include patients with mCRC and begin in the first quarter of 2011.

According to Kirsten Drejer, Ph.D., Chief Executive Officer of Symphogen, "The issuance of a US Patent is clearly a key milestone achievement for the company as the patent provides protection through 2028 and reinforces our leadership in innovative new antibody-based cancer therapy. The fact that major oncology meetings have chosen to highlight our data is equally important as we build awareness for our clinical opportunities. We are confident that a drug based on a mixture of antibodies as opposed to a single antibody has the potential to target EGFR more effectively than mAbs used today in clinical settings."