Welcome and thank you for visiting Symphogen’s website. Symphogen is a biotechnology company that is developing recombinant antibody therapeutics for the treatment and prevention of diseases. Our website will provide you information on our Company, and on our unique antibody discovery and manufacturing technologies, our pipeline of recombinant antibody product candidates, the therapeutic areas that we are working in, and the advantages of recombinant antibodies, in particular recombinant polyclonal antibodies, over other therapeutics.
CEO Kirsten Drejer
Antibody therapeutics are forecasted to be the most commercially attractive pharmaceutical product segment expecting a growth from EUR 22 billion (USD 32 billion) in 2008 to approximately EUR 40 billion (USD 58 billion) by 2014.
In January 2011, Symphogen secured a financing of DKK 745 million (EUR 100 million) from a strong syndicate of existing and new investors. The proceeds from this financing are expected to support Symphogen’s activities for at least 4-5 years and will be used to assist the company in growing from being an antibody technology provider with an early stage clinical pipeline towards a profitable biopharmaceutical company with a significant pipeline of product candidates within cancer, infectious and autoimmune diseases.
Since its incorporation in 2000 Symphogen has devoted most of its resources to developing proprietary antibody discovery and manufacturing platforms, drug discovery, and pre-clinical and early clinical drug development. Through these efforts, Symphogen has emerged as the leader within the development of antibody mixtures.
Symphogen intends to capitalize its leading position within antibody mixtures by focusing its resources on the early part of the drug development value chain. By entering into strategic research collaborations and by out-licensing its product candidates before the initiation of expensive late stage clinical trials, Symphogen plans to generate a sustainable revenue stream with the aim of becoming a profitable R&D-based biopharmaceutical company before its own or partnered products candidates reach the market.
2010 has been a busy, productive and challenging period with significant progress within our clinical cancer program and our discovery projects. In March, Symphogen initiated a Phase 1 clinical trial for its lead anticancer product, Sym004, in the U.S. and Europe. The product is a mixture of two monoclonal antibodies targeting two non-overlapping epitopes in the extracellular domain of the epithelial growth factor receptor (EGFR; HER-1; erbB-1) that work highly synergistically when combined. We expect to finalize the Phase 1 part of the trial during the first quarter of 2011. Following this dose-escalation study a small proof of concept study in 16 metastatic colorectal cancer patients will be performed during spring/summer 2011. Two additional small proof of concept studies have been discussed with Key Opinion Leaders (KOLs) in the U.S. and Europe.
Additional discovery product opportunities within the HER-receptor family were matured during the year. In particular, the Sym005 project targeting the HER-2 receptor has produced superior in vitro and in vivo efficacy data when compared to trastuzumab (Herceptin®). In addition, Symphogen has initiated an ambitious discovery program which aims to identify novel and differentiated antibody mixtures against Receptor Tyrosine Kinases relevant for human solid tumors and malignant hematological diseases. The program has shown significant progress and continued to deliver exciting data during the year with the first targets entering the lead optimization phase. Symphogen’s lead product, rozrolimupab (Sym001), a recombinant polyclonal antibody product consisting of twenty five different Rhesus D specific antibodies, is being tested in a Phase 2 multicenter clinical trial for the treatment of idiopathic thrombocytopenic purpura (ITP). In 2010, we were granted orphan-drug designation of rozrolimupab (Sym001) for treatment of primary immune thrombocytopenia. The trial is expected to be completed during 2011.
Symphogen and Genentech have initiated a second program under a strategic collaboration fully funded by Genentech with the aim to develop a superior antibody therapeutic against undisclosed infectious disease targets. In November, Symphogen received an undisclosed milestone payment under the collaboration.
Our technology platforms are still evolving. During the year the SympressTM II expression platform continued to provide increasing yields while maintaining compositional stability of the antibody mixtures. The Symplex™ platform has been expanded to successfully include repertoires of memory B cells and lambda light chains. Procedures for identifying rare memory B cells, potentially one in a million, have been developed and are currently being implemented in the Sym009 program. Furthermore, the power and speed of the Symplex™ and SymSelect™ platform have been demonstrated on a significant number of additional targets within infectious diseases and cancer.
In 2010, Symphogen made significant progress towards introducing mixtures of antibodies as superior therapeutics for treatment of serious human diseases. During the year, significant progress has taken place within business development, where we are experiencing an increasing interest from pharmaceutical companies who want to enter into research and development collaborations with Symphogen in order to take advantage of the strength of our integrated antibody technology platforms. In particular, it is a pleasure to observe how the pharmaceutical industry is now recognizing Symphogen and its activities and how the industry has become open to discuss the need for antibody mixtures addressing more than one epitope. Also on the regulatory front we have seen significant progress. In December, the FDA announced draft guidance for combination products. We believe that these guidelines correlate very well with Symphogen’s approach for development of antibody mixtures and that they reflect our understanding of the discussions we have had with the FDA throughout the years.
I want to take this opportunity to thank all employees at Symphogen for their substantial achievements during the year and for their commitment to progress antibody mixtures to become next generation antibody therapeutics. Finally, without the continued and strong support, including financial support, from our high quality investors we would not have been able to build a pipeline offering multiple anticancer and infectious disease product opportunities.
