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.

Timigutuzumab (previously known as TrasGEX®) – an anti-HER2-receptor antibody with optimized and fully human glycosylation for the treatment of a variety of cancer indications. The drug has completed a Phase 1 dose escalation study with good safety profile and clinical activity with complete and partial responses in late stage patients with multiple prior treatments including responses in patients who did not react to Herceptin®.

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.