BioWorld International Correspondent

Symphogen A/S raised $25 million in a Series D funding that attracted one new investor.

Takeda Research Investment Inc., of Palo Alto, Calif., the investment arm of Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, joined existing shareholders LD Pensions, Essex Woodlands Health Ventures, Scandinavian Life Science Venture, Novo A/S and Vaekstfonden.

Copenhagen, Denmark-based Symphogen now has raised about $60 million since its formation in 2000 and is about to move its first project into the clinic, Sym001, a recombinant polyclonal antibody treatment for alleviating idiopathic thrombocytic purpura and preventing hemolytic disease of newborns. It is positioned as a replacement for existing anti-D immunoglobulin products derived from human blood.

The company will file an investigational new drug application in late spring, and by the summer, aims to administer the first human dose in healthy volunteers, Chief Financial Officer Thomas Feldthus told BioWorld International.

That will yield efficacy data by late 2006 or early 2007, he said, and if successful, the company would then hope to progress directly to pivotal trials.

The company has three other projects at earlier stages of preclinical development. Sym002 is a recombinant polyclonal antibody for post-exposure prophylaxis against vaccinia virus and for adverse events associated with smallpox vaccination. Sym003 is an anti-respiratory syncytial virus (RSV) antibody preparation for prevention of RSV infection in children. The company also has Sym004, for developing a polyclonal antibody panel against cancers associated with complex antigens.

Symphogen also is close to entering its first out-licensing agreements for its proprietary polyclonal antibody technology platforms. "I expect we will have two deals this year, probably within six months," Feldthus said. Infectious disease and cancer are the two main areas.

The successful GMP production of recombinant polyclonal antibodies in quantities sufficient for undertaking clinical trials has been a major milestone for the company. The challenges facing Symphogen are the reverse of those developing monoclonal antibodies. With the latter, the regulatory pathway is well developed, while the efficacy of individual products has to be demonstrated in clinical trials.

"In our case, when we are looking at replacing blood products, we know it works. We have to show we can produce it," Feldthus said.

The Sym001 therapy comprises 25 different recombinant antibodies, expressed in standard Chinese hamster ovary (CHO) cells, but "if you want to produce a recombinant polyclonal antibody in a cost-effective way, you need to produce it in one batch," Feldthus said. Symphogen's Sympress antibody expression and manufacturing system is designed to ensure batch-to-batch consistency, even though each one contains a mixed population of recombinant CHO clones.

All antibodies in a given polyclonal preparation are expressed as IgG1 proteins, and site-specific integration of each cloned antibody gene is employed to eliminate growth bias due to positional effects.

The process development and scale-up work was performed with the help of contract manufacturing partner Biovitrum AB, of Stockholm, Sweden.

The new funding will support the company's current programs to late 2008 or early 2009. By early 2008, Feldthus said, its pipeline should be developed sufficiently to warrant an initial public offering.