Utilizing the company’s unique technology platform for the pipeline development

Glycotope has developed a mature biopharmaceuticals pipeline and is currently seeking development and commercialization partners for several of its pre-clinical and clinical stage assets.

Development Pipeline status

With the combined advantages of optimized sialylation, galactosylation, fucosylation, branching and absence of non-human sugar structures, GEX® products may result in higher efficacy, fewer side effects and/or broader coverage of patients and indications.

Partnering Pipeline status

With the combined advantages of optimized sialylation, galactosylation, fucosylation, branching and absence of non-human sugar structures, GEX® products may result in higher efficacy, fewer side effects and/or broader coverage of patients and indications.

Partnership Opportunities

Development pipeline:

Glycotope´s development pipeline is focused around the Glyco-epitope TA-MUC1 (tumor-associated MUC1). TA-MUC1 is a highly tumor-specific carbohydrate/protein mixed epitope on the tumor marker MUC1. It is specifically recognized by Gatipotuzumab and its derived 2nd generation bispecific molecules (T cell engager and immuno-cytokine) by binding to a carbohydrate-induced conformational epitope on MUC1. Thereby, the feature of tumor-specific binding via cancer-characteristic glycan structures (Tn or TF) is combined with high-affinity binding due to involvement of a specific peptide epitope part (PDTRP).

Gatipotuzumab (previously known as PankoMab-GEX®) – Glycotope’s first-in-class antibody against the Glyco-epitope TA-MUC1 that showed a good safety profile and anti-tumor activity in a single agent Phase 1 study. In the selected Ph II single-agent maintenance setting no clinical activity was shown in ovarian cancer patients with prior chemotherapy, but the good safety profile was confirmed. Thereby, targeting TA-MUC1 by Gatipotuzumab provides strong rationale for combination approaches with complementary drugs or development as bispecific antibodies modulating the patients´ immune system to improve anti-tumor efficacy.

GATTO (Ph Ib combination trial with Gatipotuzumab and anti-EGFR mAbs)

This clinical trial was initiated based on the association and crosstalk of TA-MUC1 and EGFR in several carcinomas. It was designed as open-label, dose de-escalation, multicenter study in patients with metastatic solid tumors expressing EGFR by immunohistochemistry (NSCLC, CRC, BC, GYN, others). The study focusses on safety, tolerability and efficacy of Gatipotuzumab / anti-EGFR combination. Preliminary safety and efficacy results support the original hypothesis, an extension phase in additional patients is initiated.

Gatipotuzumab-based T cell engager (PM-CD3)

A bispecific T cell engaging antibody recognizing TA-MUC1 on tumor cells and the CD3 receptor on T cells for treatment of solid tumors. Upon dual binding, T cells are recruited to the tumor, become activated, proliferate and finally induces potent and robust anti-tumor cytotoxicity. TA-MUC1 is the ideal tumor target for a T cell engager due to its unique tumor specificity which is critical for safety in patients. Efficacy and safety were comprehensively investigated during preclinical development.

Gatipotuzumab-based immuno-cytokine (PM-IL15)

Our anti-TA-MUC1 antibody fused to the cytokine Interleukin-15. Cytokines have long been used for cancer therapy to activate the immune system, but side effects and short half-life limit their therapeutic application. From that, PM-IL15 was designed to combine the potential of IL-15 therapy with TA-MUC1 mediated tumor targeting. PM-IL15 attracts and activates immune cells (e.g. T and NK cells) directly at the tumor site thereby turning an “immune desert” into a “hot” tumor and inducing tumor cell lysis. The molecule is very potent for itself but also a valuable combination partner for different therapies requiring an inflamed tumor immune landscape like checkpoint antibodies, bispecific antibodies, cell therapies (e.g. CAR-T), vaccines, etc. In vitro and in vivo Proof-of-concept data are available.

Partnering pipeline:

Tomuzotuximab (previously known as CetuGEX®) – a novel glyco-optimized anti-epidermal growth factor receptor (EGFR) monoclonal antibody (mAb) that showed promising therapeutic activity in a single agent Phase 1 dose escalation study in patients with various solid tumors. The compound was tested in a Phase 2 study in recurrent/metastatic squamous cell carcinomas of the head and neck and is currently used as one of the investigated anti-EGFR mAbs of the GATTO Ph Ib combination trial with Gatipotuzumab.

PDL-GEX® – first glycooptimized antagonistic anti-PD-L1 checkpoint antibody with highly innovative potential demonstrating that our glyco-optimization technology does not only improve cytotoxic but also immunomodulatory effector functions of therapeutic mAbs. By its increased T cell re-activation by blocking the PD-1/PD-L1 axis and enhanced ADCC activity against tumor and immune suppressor cells both indication range as well as number of responding patients may be expanded compared to approved PD-L1 inhibitors. PDL-GEX® is furthermore an ideal combination partner for a multitude of other anti-cancer drugs.

CD40-GEX® – Humanized agonistic anti-CD40 antibody in different isotypes and glycosylation variants. The compound supports antigen presentation thereby improving immune crosstalk and anti-tumor T cell responses. Glyco-optimization has been shown not only to improve ADCC activity of the IgG1 format but also dendritic cell maturation translating into enhanced T cell responses. Thereby CD40-GEX® provides strong rationale for synergies, e.g. with checkpoint blockade, cancer vaccination strategies or targeted therapies.

Follitropin epsilon (FSH-GEX®) – the only non-oncology asset and the first fully human glycosylated FSH (follicle-stimulating hormone) that has successfully completed a Phase II study.