Symphogen, a private biopharmaceutical company developing superior antibody therapeutics (monoclonal, monoclonal mixtures and polyclonal) to treat cancer, infectious and autoimmune diseases, announced today that it closed a €100 million placement of Preferred Stock to a group of investors. Novo A/S led the round. Essex Woodlands Fund VIII joined previous investments made by Funds V and VI. Together, Novo A/S and Essex Woodlands are contributing 70% of the investment, which is scheduled to occur over three equal tranches. The Danish Pension Fund PKA also joined as a new investor. The € 100 million raised is the largest ever financing for a private European biotech company. Symphogen intends to use the proceeds to accelerate advancement of its lead clinical oncology product Sym004 as well as its other clinical and preclinical oncology opportunities both for proprietary pursuit and partnering.
“Our overall goal is to progress Symphogen's early stage clinical oncology pipeline; to enhance our platform; and to move our preclinical oncology programs to proof-of-concept in humans. Our work in infectious diseases and our partnerships with Genentech and Meiji Seika Kaisha, Ltd. remain fully funded.”
Kirsten Drejer, PhD., Symphogen Chief Executive Officer, commented, "Our overall goal is to progress Symphogen's early stage clinical oncology pipeline; to enhance our platform; and to move our preclinical oncology programs to proof-of-concept in humans. Our work in infectious diseases and our partnerships with Genentech and Meiji Seika Kaisha, Ltd. remain fully funded."
Symphogen's Drejer will present an overview of the company's business, financial and clinical strategies next week in San Francisco at the J.P. Morgan 29th Annual Healthcare Conference, January 10, 2011 at 10 am at the Westin St. Francis Hotel, Elizabethan Rooms C and D. The presentation will be made available on the company's website at www.symphogen.com.
Joining Symphogen's Board of Directors as Chairman is Goran A. Ando, MD.
Dr. Ando commented, "We now have unique financial resources to build a sustainable and eventually profitable biopharmaceutical company. By leveraging Symphogen's proprietary platform and its initial clinical successes, the investors believe that the company is positioned to commercialize proprietary oncology products on its own as well collaborate on new products with partners in other focus disease areas, including infectious and autoimmune disease."
Multiple Milestones Achieved in 2010
During 2010, Symphogen announced key milestones in several of its programs, including:
- The initiation of Phase 1 trial of Sym004 in patients with advanced solid tumors. Sym004 has been shown to exhibit superior anti-cancer efficacy in vivo in a range of tumor xenograft models as compared to marketed monoclonal anti-EGFR antibodies by a mechanism of action that is distinct from that of monoclonal antibodies;
- An Orphan Drug designation for Rozrolimupab (Sym001) in ITP; and more recently, reacquisition of full development rights. Phase 2 data is expected to be reported late in 2011;
- Receipt of a milestone payment from Genentech for an antibody therapeutic against an infectious disease target; and
- Several journal publications, including an article in CANCER RESEARCH, in January 2010, reporting pre-clinical data demonstrating the superior efficacy of anti-EGFR monoclonal antibody combination Sym004.
- Endorsements by key cancer researchers, as follows:
Dr. Josep Tabernero, M.D., Head of the Medical Oncology Department and Phase I Unit at Vall d'Hebron University Hospital in Barcelona, Spain commented, "There is definitely strong market need for more efficacious anti-EGFR antibody therapies. My early-stage research experience with EGFR-family inhibitors leads me to believe that there is significant promise for the Sym004 drug candidate, and we look forward to reviewing the Phase I data later this year."
Dr. Samuel Broder, Former Director of the National Cancer Institute and a consultant to the company, noted, "Symphogen has made a major discovery in reproducibly targeting receptor tyrosine kinases for internalization and degradation. This represents a paradigm shift in science, and has deep ramifications for value creation through internal programs, pharma/biotech partnerships, or both."
Lead Oncology Product
Symphogen's lead oncology product candidate, Sym004, entered into Phase 1/2 development in April 2010 in the US and Europe to evaluate its safety, tolerability and efficacy for the treatment of advanced solid tumors. Sym004 is composed of two anti-epidermal growth factor receptor (EGFR) monoclonal antibodies targeting different non-overlapping EGFR epitopes. Data from the first part of this two-part trial are expected in early 2011; a Phase 2 extension of the trial should follow soon thereafter.
Commented CEO Drejer, "The US FDA's approval to begin clinical development of a mixed antibody product represents a significant milestone for Symphogen and a pioneering achievement in next-generation antibody-based therapeutics."
Sym004 is a recombinant IgG1 antibody product consisting of two antibodies against the epidermal growth factor receptor (EGFR). Sym004 is unique by inhibiting cancer cells by three separate and complimentary mechanisms of actions. Sym004 inhibits ligand binding, activation and subsequent downstream signaling of the EGF receptor. In addition, Sym004 induces rapid and efficient internalization and degradation of the EGF receptor and finally Sym004 induces immune-mediated killing of the cancer cells.