Berlin, Germany, September 27, 2013 - Glycotope GmbH, a global leader in optimizing the glycosylation of biopharmaceuticals and carbohydrate-specific antibodies (GlycoBodies), announced today that it is presenting first-in-human results of their phase I study of PankoMab-GEX(TM), a glycoengineered antibody against their novel TA-MUC1 epitope which is tumor-specific and abundantly present on many solid cancers, at this year`s European Cancer Congress (ECCO 17). The annual congress is taking place from September 27 to October 01 in Amsterdam. Glycotope is participating with a poster presentation in the session "Drug Development" on Sunday, September 29, 2013, in Hall 4.
Eligible patients with TA-MUC1 positive advanced solid tumors, progressing after standard treatments, were enrolled into this phase I trial. Primary endpoints were safety and tolerability. Pharmacokinetics, immunogenicity and anti-tumor activity were also assessed.
PankoMab-GEXTM clearly demonstrated clinical activity as single agent in heavily pre-treated patients with far advanced cancers and could be safely administered at all tested doses and schedules with a very favorable safety, side effect and pharmacokinetic profile.
|Poster Title||First-in-human phase I study of PankoMab-GEXTM, a novel glycooptimized anti-TA-MUC1 monoclonal antibody|
|Session Title||Drug Development|
|Date and Time||Sunday, September 29, 9.30 am - 12:00 am|
|Location||Amsterdam RAI Exhibition and Convention Centre, Hall 4|
PankoMab-GEXTM is a potent humanized and glycooptimized therapeutic antibody (IgG1) recognizing the 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, mostly with over 90% of the patients. PankoMab-GEXTM 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 GlycoExpressTM platform. This allows significantly improved treatment outcome compared to non-glycooptimized biotherapeutics. Preliminary results of the Phase I single agent study of PankoMab-GEXTM show very good tolerability, safety profile and pharmacokinetic properties as well as strong signals for high anti-tumor activity including complete and partial reponses as well as very lasting clinical benefit in various cancers including ovarian and lung carcinoma.
PankoMab-GEXTM is the lead molecule of Glycotopes`s GlycoBody technology which represents the Company`s treasure box of more than 200 monoclonal antibodies.
Glycotope, founded in 2001 in Berlin, focuses on the development of innovative antibodies for the treatment of various cancer types. These GlycoBodiesTM 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(TM) 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(TM) 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.
Dr. Steffen Goletz, CEO & CSO
Robert-Roessle-Str. 10, D-13125 Berlin, Germany
Phone: +49-(0)30 94 89-2600
Fax: +49-(0)30 94 89-2609
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Source: Glycotope GmbH via Thomson Reuters ONE