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
For more information, please contact:
Dr Konrad Glund, CEO
Mary Clark, Supriya Mathur, Alexia Faure
Tel: +44 (0) 203 440 5657
Rentschler Biotechnologie GmbH
Dr Marion Schrader, Senior Director Marketing
Notes to Editors:
About Probiodrug AG
Headquartered in Halle, Germany, Probiodrug AG (Euronext Amsterdam: PBD) is a biopharmaceutical company focused on the development of new therapeutic products for the treatment of Alzheimer’s disease.
Founded in 1997, the company successfully developed a novel therapeutic concept for diabetes – the DP4 inhibitors – which provided the basis for a novel class of antidiabetics – the gliptins. Its core capabilities are based on its long-standing expertise in the elucidation of the structure and function of enzymes involved in the modification of proteins and peptides, which play a central role in pathological conditions.
Today Probiodrug’s aim is to become a leading company in the development of Alzheimer’s disease treatments and to thereby provide a better life for Alzheimer’s disease patients. It has identified a new therapeutic concept linked to disease initiation and progression. The development approaches are targeting pyroglutamate-Abeta (pGlu-Abeta) as a therapeutic strategy to fight Alzheimer’s disease. The Company has medical use and composition of matter patents related to the inhibition of Glutaminyl Cyclase (QC) and anti-pGlu-Abeta- specific monoclonal antibodies, providing it, in the Company’s view, with a leading position in this field of research.
About Rentschler Biotechnologie GmbH
Rentschler is a CDMO with over 40 years proven track record. Delivering successful projects allows the company to make an essential contribution to the global availability of biopharmaceuticals. Focused on the utilization of mammalian cell lines, Rentschler’s long experience covers the development and production of recombinant proteins in compliance with international GMP standards. The customized solutions range from supporting drug candidate selection, cell line and process development capabilities as well as GMP manufacturing to comprehensive analytics and fill & finish. Rentschler’s state-of-the-art manufacturing facility includes bioreactors up to 3,000 L stainless steel and up to 2,000 L single-use. The long-term experience with international regulatory affairs can reduce not only the time-to-market but support the overall success of the client’s project. Rentschler’s full-service concept allows flexibility on the individual project requirements.
About Alzheimer’s disease
Alzheimer’s disease is a neurological disorder, which is the most common form of dementia, and ultimately leads to death. Because Alzheimer’s disease cannot be cured and is degenerative, the affected patients must increasingly rely on others for assistance. Today, 44 million people worldwide currently live with the condition and this number is expected to almost double by 2030 and to more than triple by 2050 to over 132 million. Alzheimer’s also has an estimated, global societal cost of over $600 billion (World Alzheimer Report 2014).
Forward Looking Statements
Information set forth in this press release contains forward-looking statements, which involve a number of risks and uncertainties. The forward-looking statements contained herein represent the judgment of Probiodrug AG as of the date of this press release. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.