Berlin, Germany, March 11, 2014 - Glycotope GmbH, a leading company in glycobiology, has raised EUR 55 million in additional equity for the development of its two most advanced new cancer drugs, PankoMab-GEX(TM) and CetuGEX(TM), both in Phase IIb trials. The money will be used to complete Phase IIb trials with several hundred patients in Europe and the United States before the end of 2016. The Company's investors, which have now provided total financing in excess of EUR 130 million, are Munich-based Jossa Arznei GmbH (Strüngmann Group) and ELSA GmbH (Eckert Life Science Accelerator) in Berlin.
In addition, Glycotope could secure the funding for final clinical development of its improved fertility hormone, FSH-GEX(TM). The Phase III clinical trials are expected to begin in summer 2014 and to involve roughly 1,000 female patients at international clinics in Europe and about the same number in a further trial in the United States. If the studies confirm the good results seen in the previous development phases, Glycotope could achieve worldwide approval for FSH-GEX(TM) as early as 2017.
"We are extremely encouraged with the confidence shown by our investors and by the fact that - thanks to these funding commitments - Glycotope is becoming one of Germany's largest independent biotech companies," commented Dr. Steffen Goletz, CEO and founder of Glycotope. "Our innovative technologies for optimizing sugar structures on proteins, among other things, enable us to increase the tolerability, effectiveness, and affordability of a large number of proven medications."
Glycotope specializes in the glycosylation of proteins and is one of Germany's largest independent biotech companies. Founded in 2001 at the Max-Delbrück-Center for Molecular Medicine in Berlin, it now has more than 180 employees at two locations in Berlin and Heidelberg. In addition to the development projects described above, Glycotope has a broad portfolio of other clinical candidates.
The new therapeutics at a glance
FSH-GEXTM is the first fully human glycosylated FSH (follicle-stimulating hormone), recombinantly expressed in human cells and glycooptimized to mimic endogenous human FSH for the treatment of women with fertility problems. FSH-GEXTM has shown superior activity as well as excellent tolerability in the Phase II study for Assisted Reproductive Technologies when compared to the treatment with market leading Gonal-f(R). Phase III clinical trials will start this year.
PankoMab-GEX(TM) is the first human glycosylated and glycooptimized antibody against a novel tumor-specific carbohydrate-protein mixed epitope (TA-MUC1) that is abundantly present on a larger set of tumor indications, metastasis and cancer stem cells, while being virtually absent on normal cells. In Phase I studies PankoMab-GEXTM showed excellent tolerability, no significant toxicity and strong anti-tumor activity as a single agent in various indications including ovarian and lung carcinoma. Last year a Phase IIb clinical study of maintenance therapy for ovarian carcinoma was started and first patients were treated with PankoMab-GEXTM.
CetuGEX(TM) is a novel anti-epidermal growth factor receptor (EGFR) monoclonal antibody (mAb) with an optimized and human glycosylation for a greatly enhanced anti-tumor activity and reduced side-effects as well as a much broader patient and indication coverage. The Phase I study showed strong and long term anti-tumor activity as single agent and a largely improved side-effect profile. CetuGEX(TM) has successfully entered Phase IIb clinical development.
TrasGEX(TM) is a novel glycooptimized anti-Her2 receptor (EGFR) monoclonal antibody (mAb) with greatly enhanced anti-tumor activity and a much broader coverage of patients and indications. The Phase I/IIa study has recently been successfully completed affirming its strong, long term anti-tumor activity.
All products were glycooptimized, fully human glycosylated and produced with exceptional quality, reproducibility and yields using GlycoExpress(TM). GlycoExpress(TM) (GEXTM) is the broadest, most potent and validated glycooptimization and production technology for the improvement of the vast majority of antibodies and protein biopharmaceuticals.