InNexus Biotechnology and Genhelix Biopharmaceutical Co. have signed a Letter of Intent to set the stage for a planned strategic collaboration to focus on developing novel antibodies engineered with InNexus' DXL technology.

The research and licensing agreement between the collaborators is expected to be completed later this year. InNexus will conduct preclinical development for a DXL therapeutic against an undisclosed target, with Genhelix providing GMP production and commercial manufacturing. DXL antibodies are biologics engineered with the novel ability to link with one another (self-binding) upon reaching their target, exhibiting marked enhancements for ADCC and CDC functions over the source antibody, according to an InNexus statement.

The planned alliance follows InNexus' recent successful meeting with the FDA, where the agency expressed support for the company's product development plans, following a comprehensive review of the proposed clinical pathway for its lead preclinical candidate, DXL625 (CD20) for the prospective treatment of Non-Hodgkin's Lymphoma and/or Chronic Lymphocytic Leukemia. The agency also provided a Manufacturing Exception Approval, allowing InNexus to manufacture all clinical material needed for DXL625's Phase l trial in its facilities located on the campus of Mayo Clinic in Scottsdale, AZ.

Jeff Morhet, chief executive officer of InNexus, commented, "Our organizations are poised to strategically collaborate as partners focused on the development of new products, while maintaining our respective business competencies. This collaboration provides significant opportunities for both companies, and represents a creative approach to partnering that brings Resources and capabilities together while the partners stay focused."

David Marcos Martinez, chief executive officer of Genhelix, remarked, "The antibody industry is growing at an unprecedented rate. Today, it is estimated to have over $30 billion in worldwide sales, and antibodies are expected to be the pharmaceutical industry's leading choice for the development of new therapeutic compounds. We are excited to be working with Mr. Morhet, his team and the partnership, as both organizations have enormous potential."