GLYCOTOPE moves PankoMabTM towards Phase-II Clinical Development

Berlin, Germany, June 14th, 2012 – GLYCOTOPE is due to successfully complete Phase I of its glycooptimized therapeutic antibody PankoMabTM and will move the compound to Phase II of clinical development in ovarian cancer with further indications planned to follow.

PankoMab-GEXTM is based on Glycotope’s unique and proprietary GlycoBodiesTM technology and recognizes carbohydrate based tumor epitopes. This humanized and tumor-specific antibody is particularly suitable for e.g. ovarian and lung cancers and binds to over 90% of cases in several solid cancer indications. PankoMab-GEXTM expresses a series of potent anti-tumor modes of action 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 studies of PankoMabTM show very good tolerability, no significant toxicity and strong signals for high anti-tumor activity and specificity. “We are very excited about PankoMab-GEXTM’s clinical potential” says Dr. Steffen Goletz, CEO, CSO and Founder of Glycotope. “The data show  long-term anti-tumor efficacy including even complete response in patients progressive upon treatment start. This will be further investigated in Phase II studies.”

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GLYCOTOPE moves FSH-GEXTM into Phase-II Clinical Development

Berlin, Germany, June 08th, 2012 – After successful completion of Phase I, the German biotech company GLYCOTOPE moves its glycooptimized therapeutic protein FSH-GEXTM into Phase II of clinical development in In-Vitro-Fertilisation.

FSH-GEXTM is based on Glycotope’s unique and proprietary GlycoExpressTM platform of glycooptimized human cell lines. The follicle-stimulating hormone FSH-GEXTM is produced recombinantly with a fully human and optimized glycolysation. Phase I studies of FSH-GEXTM (single dose escalation, multiple dose escalation) have been successfully completed, showing no toxicity and providing in a direct head-to-head comparison strong signals for highly improved efficacy vs. marketed urinary and recombinant products.

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Glycotope wins CPhI Innovation Gold Award

Berlin, Germany, October 27th, 2011/ – Glycotope GmbH, a global leader in optimizing the glycosylation of biopharmaceuticals, has received the prestigious CPhI Innovation Gold Award. Among the 50 entrants in the competition, Glycotope was selected as the winner for the innovative nature and commercial impact of its GlycoExpressTM technology of human cell lines to develop and manufacture biopharmaceuticals with an improved glycosylation leading to potentially significant therapeutic and economic benefits. Dr. Steffen Goletz, CEO, CSO & Founder of Glycotope is “proud, that in winning the award, Glycotope is joining technological leaders such as Thermo Fisher Scientific Inc., BASF, Novozymes A/S, DSM or Dow Pharmaceutical Sciences Inc.”

About Glycotope:

GLYCOTOPE, founded in 2001 in Berlin, focuses on the optimization and humanization of therapeutically relevant sugar structures on biopharmaceuticals known as glycosylation and on the development of innovative antibodies targeting glycostructures on cell surfaces. Biologics developed in Glycotope´s GlycoExpressTM technology of glycoengineered human cell lines receive a fully human and optimized glycosylation, leading to a largely improved activity, an elongated half-life time and/or reduced immunogenicity and hence important therapeutic benefits for a significantly increased number of patients. In addition, the GlycoExpress platform is superior in productions yields, product quality and reproducibility compared to other production platforms.

Glycotope´s product portfolio now encompasses a variety of antibodies and non-antibody biologics, 4 of which are currently in the clinical stage. This pipeline includes antibodies against novel targets for cancer therapy (e.g. GT-MAB 2.5-GEX™) and significantly improved versions of antibodies as well as other already marketed therapeutic proteins, so called Biobetters.

Together with Glycotope-Biotechnology in Heidelberg, Glycotope evolved into a leading integrated glycobiology company, covering all phases in drug development such as lead discovery and optimization, preclinical and process development, GMP production and clinical development. With more than 140 employees, the group has grown to one of the largest Biotech organisations in Germany.

About the CPhI Innovation Award

The internationally acclaimed CPhI Innovation Awards were established to recognise, celebrate and honour those companies and organisations that are breaking new ground in the pharmaceutical, contract services, packaging and biopharmaceutical. Entry categories are open to all exhibitors at the events and were expanded to reflect the zoned layout of the 2011 events. Submissions were accepted from the following areas: APIs, Custom Manufacturing, Intermediates, Excipients/Formulation, Fine Chemicals, Finished Dosage, Contract Services, Drug Delivery Systems and Biopharmaceuticals. When choosing the finalists, the judges looked for the innovations that encouraged the imagination and are commercially practical.

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Glycotope Enrolls First Patients in Phase I Trial with TrasGEX™, a Glycooptimized HER2 Biobetter Antibody

Berlin, Germany, September 19, 2011 - Glycotope GmbH, a leading company in the field of glycomics, announced today the enrollment of the first patients in a phase I dose finding trial to evaluate safety and tolerability of TrasGEX™. TrasGEX™ is a biobetter of the marketed Trastuzumab / Herceptin™ targeting the HER2-receptor, commonly overexpressed in a variety of cancers. TrasGEX™ has been glycooptimized to yield a manifold higher anti-tumor activity and is supposed to be suitable for the treatment of an enlarged patient spectrum. It was developed using GlycoExpress™, the company’s development and production platform based on glycoengineered human cell lines for biopharmaceuticals with fully human and optimized glycosylation.

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Glycotope Enrolls First Patients in Phase I Trial for FSH-GEX™

Berlin, Germany, May 18th, 2011/ B3C newswire / – After the two monoclonal antibodies GT-MAB 2.5-GEX™ and CetuGEX™, the German biotech company Glycotope has recently received approvals to initiate clinical trials for its first glycooptimized non-antibody protein therapeutic FSH-GEX™. FSH-GEX™ is a follicle-stimulating hormone which will be developed for in vitro fertilisation and the treatment of anovulatory infertility. It is produced recombinantly with a fully human glycosylation. In April Glycotope has enrolled the first subjects into a phase I clinical trial in the Netherlands to evaluate the safety, tolerability, dosing requirements and pharmacokinetics of the product.

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Glycotope Biotechnology Expands GMP Production Facility to 11 kg Antibody per Year

Berlin, Heidelberg, April 5th, 2011/ b3c newswire / -Glycotope Biotechnology GmbH in Heidelberg, Germany, a full subsidiary of Berlin based Glycotope GmbH, has initiated the setup of further clean room facilities as a first step in the expansion of its GMP-production capacities. By mid 2011, the company will thus be able to produce 4kg of recombinant antibodies per year and up to 11 kg upon completion of works towards the end of 2011. In sum, additional 1400 m² of facility and office space will be created.

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