24-2-2009 | Drug development program started based on Human Cell Line.

Alloksys Life Sciences BV (Bunnik, The Netherlands), CEVEC Pharmaceuticals GmbH (Cologne, Germany) and PharmaCell BV (Maastricht, The Netherlands) announce the start of Theraptech, a 2.4 million Euro therapeutic protein development program subsidized under the European Trans Bio Program. The major objective of the Theraptech project is to develop a recombinant human alkaline phosphatase (rhuAP) using the novel versatile human CAPÔ cell line, which has been shown to efficiently express glycosylated proteins. The rhuAP produced in CAPÔ cells is expected to feature improved pharmacokinetic and safety profile allowing for repeated dosing of alkaline phosphatase in chronic diseases. Based on a the anti-inflammatory mechanism of action of alkaline phosphatase towards e.g. TNF a, IL-6 and IL-8, as shown in both pre-clinical and clinical studies in acute conditions, we propose it to be developed as a therapeutic protein in major chronic diseases such as Rheumatoid Arthritis. The combined expertise of the members participating in the consortium covers the entire spectrum of activities needed to drive the project from molecular biology to GMP-production and recombinant product testing in preclinical and clinical trials, pushing towards a clinical phase II compliant product within the 3-year-time frame of the project.

Commenting on this unique co-operation, PharmaCells’ CEO, Maurice Horsten, commented “Combining the strengths of our companies provides us with an excellent opportunity to build on PharmaCells’ motto Humanizing Medicine® and to push this important project forward to the benefit of many patients around the world”. Cevec’s CEO Dr Rainer Lichtenberger added: “ CEVEC is excited about the strong scientific and commercial prospects of the Theraptech project. rhuAP will turn out to perfectly demonstrate the unique strengths of CEVEC’s proprietary CAP cell expression technology, in combination with the proven capabilities of our partners “.  On the scientific importance Alloksys’ COO, Dr Ruud Brands commented: ”rhuALP, based on the proposed mechanism of action in innate immune modulation, may enable the application in a wide array of disabilitating chronic inflammatory conditions, thereby eliminating the potentially adverse effects of currently marketed blockbuster products ”.

About Alloksys Life Sciences BV
Alloksys, established in 2005 and located in Bunnik, The Netherlands Alloksys Life Sciences BV is a biopharmaceutical company dedicated to the R&D of therapeutic proteins for the treatment of both acute and chronic inflammatory diseases. The lead phase II compound bIAP, an innate-immune system-modulating compound is developed for the indication: prevention of ischemia-reperfusion damage in invasive surgery.  Chronic applications atherosclerosis, rheumatoid arthritis, Alzheimer and asthma are targeted.  Alloksys established an integral research network comprising of several academic and biotech collaborations, both nationally and international. Partnerships with pharmaceutical companies for co-development of these indications are welcomed.

About CEVEC Pharmaceuticals GmbH
CEVEC Pharmaceuticals GmbH, operational since 2004 and located in Cologne, Germany, is a biopharmaceutical company that specializes in developing and producing therapeutic proteins and monoclonal antibodies with human glycosylation patterns. CEVEC’s novel proprietary and patent-protected human CAP? and CAP-T expression systems are ideal for manufacturing complex biopharmaceutical molecules. CEVEC is licensing out its human cell-based expression platform as well as the biological product candidates in internal development through partnerships with renowned pharmaceutical and biotech companies.

About PharmaCell
PharmaCell provides contract services in the area of human cell & tissue banking & culturing as well as human cell line development and manufacturing of (bio) pharmaceuticals. Next to a GMP license, PharmaCell is the only commercial company in The Netherlands to hold an official license as Registered Tissue Establishment.
PharmaCell is also actively engaged in Research & Development work, both on behalf of some of its customers as well as in research consortia together with Universities, Academic Hospitals and other (bio)tech companies.