Combining the safety advantages of a recombinant protein with the advantages of fully human glycosylation

Glycotope’s FSH-GEX® is a fully human glycosylated recombinant FSH (follicle-stimulating hormone), expressed in human cells and glyco-optimized FSH. FSH is responsible for follicle maturation and is administered during the onset of in vitro fertilization procedures to induce maturation of multiple oocytes for retrieval.

Glycotope’s strategy is to seek partners to out-license existing clinical programs in our non-oncology portfolio. FSH-GEX® provides potential partners an opportunity to develop and commercialize a full human glycosylated recombinant FSH that has demonstrated a highly promising profile in the clinic and in pre-clinical studies.
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Utilizing the Company’s unique technology platform, Glycotope has developed a mature pipeline of first-in-class and best-in-class biopharmaceuticals. Three oncology products are currently in advanced clinical development

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Disease awareness, and the opportunity

FSH-GEX® is being developed for infertility therapy, particularly for follicle maturation during in-vitro fertilization (IVF).

Key trials/data

In single and multiple Phase I dose escalation studies FSH-GEX® was well tolerated and showed clear linearity over the tested dose levels. In the single dose and more strongly in the multiple dose study, FSH-GEX® dosed equally has a stronger effect on follicle growth than both comparator compounds Gonal-f® and Bravelle.

In a Phase 2 clinical trial, FSH-GEX® dosed at 75 IU was at least as active as 150 IU Gonal-f® in all FSH mediated parameters and endpoints. These data confirm the superior preclinical as well as Phase 1a and 1b data regarding biological activity and clinical efficacy. Furthermore, the results at a dose regimen with 150 IU FSH-GEX® applied every second day and 75 IU FSH-GEX® administered on a daily basis were fully comparable, allowing for a flexible or alternative dosing regimen with the same product.

The treatment with FSH-GEX® was safe and very well tolerated, while Gonal-f® showed the highest rate of OHSS (Ovarian hyperstimulation syndrome) during the trial. No inductions of anti-drug antibody (ADA) responses were observed in FSH-GEX® dosed patients.

Differentiation/mode of actions/specificity

Most approved preparations of FSH are derived either from human urine or recombinant sources from non-human cells. Purification of FSH from urine is a very complex process and there are safety concerns with contaminations. A generally better safety profile today makes recombinant proteins the products of choice for most patients despite higher product costs and the fact that recombinant products from non-human cells may induce immunogenic or allergic reactions due to lack of human sugar structures.