Next-generation CTLA4-Ig for the Treatment of Rheumatoid Arthritis

MAXY-4 is a next-generation CTLA4-Ig protein designed to have improved potency relative to Orencia® and LEA29Y (Belatacept, a modified CTLA4-Ig), both manufactured by Bristol-Myers Squibb. CTLA4-Ig fusion proteins work by blocking binding to the human B7 receptor, thereby hindering activation of the immune system.

Using our proprietary MolecularBreeding^TM Directed Molecular Evolution platform, we have generated a family of novel proteins with significantly higher specific binding to human B7 receptors compared to Orencia® and LEA29Y. We have selected a set of lead molecules based upon preclinical data and are in the process of selecting the clinical candidate based upon additional preclinical data.

Clinical Proof-of-Concept
Clinical proof-of-concept for blocking B7 binding has already been demonstrated by Orencia®, which has been approved in the U.S., Canada and the European Union. This product has demonstrated clinical efficacy in the treatment of juvenile and adult rheumatoid arthritis (RA) patients with inadequate response to methotrexate or tumor necrosis factor (TNF) inhibitors. Patients receiving Orencia plus methotrexate or a disease-modifying anti-rheumatic drug (DMARD) showed significant improvement compared to those receiving placebo plus methotrexate or a DMARD[i].

Bristol-Myers Squibb has ongoing clinical studies of Orencia® for the treatment of other autoimmune diseases such as Crohn’s disease, lupus, psoriasis and ulcerative colitis. Clinical development of LEA29Y for the prevention of kidney transplant rejection has also been initiated.

Market Opportunity
The worldwide market for rheumatoid arthritis, a key opportunity for MAXY-4, has grown to over $4 billion dollars (annual sales of biologic DMARDs). The increasing global incidence of severe rheumatoid arthritis and the emergence of new therapies with improved clinical benefit are predicted to sustain market expansion in this disease area.

A significant segment of the RA population continues to be refractory to current biological DMARDs and clinical benefit (as measured by ACR50 score) is estimated at less than 50% at six months post therapy. Hence, significant opportunity remains available for the introduction of new biologic therapies, such as MAXY-4, that may provide a differentiated benefit over existing therapies.

Other indications in the autoimmune disease field, including Crohn’s disease, lupus, psoriasis, transplant rejection and ulcerative colitis, represent additional large market opportunities for the MAXY-4 program.

We currently retain all rights to MAXY-4 product candidates.

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