- Contract with German based biopharma manufacturer for clinical trials in patients with Alzheimer’s disease

HALLE/SAALE, LAUPHEIM, Germany, 07 October 2015 – Probiodrug AG (Euronext Amsterdam: PBD), a biopharmaceutical company developing novel therapeutic solutions to treat Alzheimer’s disease (AD), has announced today an agreement with the German-based Biopharma Manufacturer Rentschler Biotechnologie GmbH to develop PBD-C06, a pGlu-Abeta-specific monoclonal antibody.

The contract comprises all stages of production and processing from initial cell line development through to the manufacturing of material for preclinical and clinical studies. Rentschler is a renowned independent contract manufacturer with an excellent track record of producing biopharmaceuticals for over 40 years.

PBD-C06 is a chimeric, de-immunized monoclonal antibody selected as a candidate with the best safety, efficacy and pharmacological profile from among several pre-clinical candidates. It targets pGlu-Abeta, aiming to selectively clear the brain of pGlu-Abeta while leaving non-toxic forms of Abeta untouched. In AD animal models PBD-C06 reduced pGlu-Abeta and total Abeta levels and positively affected memory function.

Commenting on the announcement, Dr Inge Lues, Chief Development Officer at Probiodrug said: “Following our very satisfying preclinical proof of concept with our anti-pGlu Abeta antibody in various Alzheimer–like animal models, we have initiated an important step towards evaluating our lead antibody in a clinical setting. We are very pleased to work with Rentschler. Their experience and track record as a service-oriented biopharmaceutical manufacturing partner is well known, and they are committed to implementing Probiodrug’s aggressive project timelines.”

Dr Klaus B. Schoepe, Senior Vice President of Project Management at Rentschler Biotechnologie added: “We are excited to support Probiodrug in developing and producing the monoclonal antibody PBD-C06. We are confident our long-term expertise will deliver a first-class quality product and meet the challenging timelines of this project, which is targeting a disease affecting a substantial number of elderly people.”

To date Probiodrug has progressed two complementary strategies for tackling pGlu-Abeta, with two medicine candidates in development:
• PQ912, a small molecule inhibitor of Glutaminyl Cyclase, now in phase 2, and
• PBD-C06, a pGlu-Abeta-specific mAB in preclinical stage

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