A global leader in optimizing the glycosylation of biopharmaceuticals, announced today that the Company completed randomization of patients on June 13th, 2013 in the Phase II clinical trial of its glycooptimized and fully human therapeutic protein FSH-GEX™ (follicle-stimulating hormone) to treat women undergoing intra-cytoplasmic sperm injection (ICSI) therapy. The completion of randomization means that even the last patient is now being treated with FSH. This study milestone was completed on time and in less than five months after the inclusion of the first patient into the study (first patient in).
The Phase II, multicenter, multinational, randomized clinical trial is investigating the efficacy and safety of varying doses and dosing regimens of FSH-GEX™ in comparison with daily 150 IU Gonal-f® in over 240 women undergoing ICSI treatment. The primary end point of the Phase II trial comprises follicular response; the secondary end points include number and quality of oocytes, implantation rate, pregnancy rates, and pharmacodynamic effects on biomarkers. The trial is expected to report at the beginning of Q4 2013 and the Phase III clinical trial is expected to start in the first half of 2014.
“Completing randomization in this first large Phase II trial with a fully human glycosylated and glycooptimized GlycoExpress™ product is a major milestone for us and our investors. Based on the superior activity of FSH-GEX™ seen in the first trials with human volunteers, we are keen to see its performance in the randomized patient setting. FSH-GEX™ is the first of our glycooptimized, fully human non-antibody molecules validating our unique GlycoExpress™ platform and proving our commitment to deliver better therapies to patients in an efficient, cost effective manner,” said Dr Steffen Goletz, CEO, CSO and Founder of Glycotope.
The follicle-stimulating hormone FSH-GEX™ is based on Glycotope’s proprietary GlycoExpress™ platform of glycoengineered proprietary human cell lines and produced recombinantly with fully human and optimized glycosylation. FSH-GEX™ has proven to be safe and well tolerated in Phase I single and multiple dose escalation trials with healthy volunteers and thereby showed a highly improved efficacy in direct head-to-head comparisons with marketed recombinant and urinary FSH products.
About FSH and In Vitro Fertilization
The follicle-stimulating hormone (FSH) is responsible for follicle maturation. Its main clinical use is administration during the onset of in vitro fertilization procedures to induce maturation of multiple oocytes for retrieval.
Currently, approved preparations of FSH originate from either human urine or recombinant sources from non-human cells. While urinary versions of FSH carry a heterogeneous but human glycosylation, the generally better biological safety of recombinant products makes them the product of choice for most patients, despite a non-human glycosylation profile and higher product costs associated with the treatment.
Glycotope’s glycooptimized and fully human version of FSH, FSH-GEX™, combines the advantages of both product types into one single product. The aim of the project was to generate a BioSuperior molecule virtually resembling the FSH of a healthy woman. Using GlycoExpress™, which allows for fully human glycosylation and optimization of this process, FSH-GEX™ showed an improved activity in human in vitro assays as well as in the first trials and superior production yields and reproducibility of quality by production in GlycoExpress™. It thereby provides the safety advantages of a recombinant protein with the advantages of a fully human and optimized glycosylation.
Glycotope, founded in 2001 in Berlin, focuses on the development of innovative antibodies for the treatment of various cancer types. These GlycoBodies target glycostructures on cell surfaces. In addition, Glycotope develops so-called BioSuperiors, antibody and non-antibody recombinant biopharmaceuticals with optimized and fully human sugar structures for clinical superiority. Key to the glycooptimization technology is a toolbox of glycoengineered proprietary human cell lines that allow the glycooptimization of proteins in respect to a whole series of different determining sugars and is based on fully human glycosylation. GlycoExpress™ allows the selection of the most appropriate and best suitable human glycoform of a product and a high yield production superior in reproducibility, quality and yield. Glycooptimization via GlycoExpress™ provides improved efficacy, bioavailability, immunogenicity and broadens the potential patient populations and indications, as well as providing a much improved cost-effectiveness. Glycotope has currently four products in clinical development from late stage Phase I to late stage Phase II. The Company’s additional pipeline includes preclinical non-antibody and antibody biopharmaceuticals for various indications.
Together with its subsidiary Glycotope Biotechnology in Heidelberg, Glycotope has evolved into a leading fully integrated glycobiology company, covering the entire workflow from discovery, molecule optimization, clone and process development, preclinical and clinical drug development to GMP production. With more than 160 employees and a strong and broad IP-platform, Glycotope today is one of the largest biotechnology companies in Germany.