Glycotope Doses First Patients in Phase IIb Study with PankoMab-GEX™ for the Maintenance Therapy of Ovarian Carcinoma
- First therapeutic glycooptimized antibody against a novel tumor-specific carbohydrate-protein mixed epitope on a series of cancer cells
- Excellent tolerability, no significant toxicity and strong anti-tumor activity observed as single agent in a Phase I trial
A global leader in developing therapeutic antibodies targeting glycosylated epitopes on cancer cells and optimizing the glycosylation of biopharmaceuticals, today announced the enrollment and treatment of first patients in its Phase IIb clinical trial of PankoMab-GEX™ for maintenance therapy of patients with ovarian cancer. PankoMab-GEX™ is the first fully human glycosylated and glycooptimized antibody against a novel tumor-specific carbohydrate-protein mixed epitope (TA-MUC1) abundantly present on a larger set of tumor indications, metastasis and cancer stem cells, and virtually absent on normal cells.
The double-blind, randomized, placebo-controlled Phase IIb study is designed to evaluate the efficacy and safety of maintenance therapy with PankoMab-GEX™. A total of approximately 210 patients suffering from recurrent ovarian carcinoma and at least stable under current chemotherapy are planned to be enrolled at 41 sites in seven European countries and Russia.
The primary endpoint of the Phase IIb trial is progression free survival. Secondary endpoints include further efficacy data such as time to progression, objective response rate, clinical benefit rate and overall survival as well as pharmacokinetic and safety data.
PankoMab-GEX™ showed excellent tolerability, no significant toxicity and strong anti-tumor activity in a single agent Phase I trial in patients with progressive disease and with various indications including ovarian and lung carcinoma. Patients with progressive ovarian cancer which were resistant or sensitive to their most recent platinum containing therapy and with no further treatment option showed in 80% of the cases clinical benefit with an average duration of more than 210 days.
“The initiation of this Phase IIb trial is an important milestone for Glycotope, not only in the clinical development of PankoMab-GEX™ but also for our comprehensive pipeline of cancer specific GlycoBodies,” said Dr. Steffen Goletz, CEO, CSO and Founder of Glycotope. “The results PankoMab-GEX™ achieved already as single agent in a clinical Phase I trial in patients progressive at treatment start are very encouraging with significant tumor reduction, complete and partial responses with long lasting disease stabilization of up to 25 months and the virtual lack of relevant toxicities.”
PankoMab-GEX™ is a potent humanized and glycooptimized therapeutic antibody (IgG1) recognizing Glycotope’s novel carbohydrate-induced conformational TA-MUC1 epitope expressed on the majority of tumor cells in a wide variety of cancers. The epitope comprises a tumor-specific carbohydrate antigen together with the immunodominant peptide region of MUC1, combining high tumor-specificity, high number of binding sites and affinity. It is abundantly present on primary tumors, metastasis and cancer stem cells and virtually absent on normal cells. Main target indications include ovarian, lung, breast and gastrointestinal tumors, and other, mostly with over 90% of the patients and tumor cells. PankoMab-GEX™ expresses a series of potent anti-tumor modes of action, including antibody-dependent cellular cytotoxicity (ADCC), tumor cell phagocytosis and apoptosis induction, strongly enhanced by glycooptimization through Glycotope’s GlycoExpress™ platform. This allows a significantly improved treatment outcome compared to non-glycooptimized biotherapeutics. PankoMab-GEX™ is the lead molecule of Glycotopes’s GlycoBody technology which represents the Company’s treasure box of more than 200 monoclonal antibodies.
Glycotope, founded 2001 in Berlin, focuses on the development of innovative antibodies for the treatment of various cancer types. These GlycoBodiesTM target glycostructures or carbohydrate-peptide mixed epitopes 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.