MRC Technology and Biolex Therapeutics announced today that MRCT had successfully completed the humanization of a novel antibody targeting CD20, indicated in non-Hodgkin’s lymphoma and rheumatoid arthritis

LONDON, UK and PITTSBORO, NC, USA | July 14, 2008 | MRC Technology (MRCT) (London, UK) and Biolex Therapeutics, Inc. (Pittsboro, North Carolina, USA) announced today that MRCT had successfully completed the humanization of a novel antibody targeting CD20, indicated in non-Hodgkin’s lymphoma and rheumatoid arthritis. Biolex is applying its proprietary glycosylation optimization technology to the antibody, BLX-301, to enhance efficacy and potency of the product candidate and potentially reduce certain side effects.

"We are delighted to have been able to provide Biolex with a humanized version of its CD20 antibody. The project was completed on schedule and the resulting antibody retained all desired binding characteristics," said Dr. Tarran Jones, Director of MRCT’s Therapeutic Antibody Group (TAG). "This collaborative project marks the 35th monoclonal antibody that we have successfully humanized using our proprietary humanization technology over the past 20 years."

Biolex will retain all development and commercialization rights to the humanized antibody, and MRCT will receive regulatory milestone payments and royalties upon its successful development. Additional financial terms were not disclosed.

"We have been pleased to collaborate with MRCT on this project and appreciate the successful track record they have demonstrated in the area of antibody humanization," said Mr. Jan Turek, President & CEO of Biolex Therapeutics. "Applying the glycosylation optimization capabilities of our LEX System(SM) to a humanized antibody provides the potential for a next-generation product that offers a therapeutic advantage while also addressing the relatively low potency and problematic side-effect burden of the current standard of care."

Antibody Humanization

Antibody humanization, also known as CDR-grafting (CDR is a synonym for complementarity determining region) was first invented at the MRC Laboratory of Molecular Biology in the UK by Dr. Sir Greg Winter and patented by the MRC in the late 1980s. CDR-grafting involves the genetic transfer of mouse CDRs (which are responsible for antigen binding) into human frameworks of a variable region. A variable region is one domain of an immunoglobulin chain, a whole antibody itself comprising of one light and one heavy immunoglobulin chain. The key to success in antibody humanization is the careful analysis of the mouse antibody to identify key framework residues important for the preservation of antibody function in the humanized antibody.

About Medical Research Council Technology (MRCT)

MRCT is the exclusive commercialization catalyst for the UK Medical Research Council (MRC), working to translate cutting edge scientific discoveries into commercial products. MRCT bridges the gap between innovative basic science and making medicine. By providing both chemical tools and therapeutic antibody candidates, we give pharmaceutical and biotechnology companies new starting points for drug discovery and development, based on MRC advances in science.

About Therapeutic Antibody Group (TAG)

MRCT’s TAG scientists have a proven track record of success in antibody humanization which extends over 20 years and has produced 11 clinical candidates and two regulatory approved humanized antibodies: Elan/Biogen Idec’s Tysabri® and Chugai/Roche’s Actemra®. TAG collaborates with MRC scientists to translate innovative antibody-based drug targets into potent and selective therapeutic antibody candidates which can then be partnered with industry. In addition, MRCT provides the pharmaceutical and biotechnology industry access to the world-class antibody humanization expertise of TAG.

About Biolex Therapeutics

Biolex is a clinical-stage biopharmaceutical company that uses its patented LEX System(SM) to develop hard-to-make therapeutic proteins and to optimize monoclonal antibodies. The LEX System is a novel technology that genetically transforms the aquatic plant Lemna to enable the production of biologic product candidates. The company’s product candidates are designed to provide superior efficacy/tolerability profiles and to address large, proven pharmaceutical markets. Biolex’s lead product candidate, Locteron®, is in Phase 2 clinical trials and is the only controlled-release interferon alfa in clinical development for the treatment of chronic hepatitis C. Biolex has also developed two other product candidates that capitalize on the benefits of the LEX System which it is advancing toward clinical trials: BLX-155, a direct-acting thrombolytic designed to dissolve blood clots in patients; and BLX-301, an anti-CD20 antibody it is optimizing for the treatment of non-Hodgkin’s B-cell lymphoma and other diseases.

SOURCE: MRC Technology