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The research and licensing agreement between the collaborators is expected to be completed later in 2009. 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, said InNexus.
The planned alliance follows InNexus's recently announced successful meeting with the FDA, where the agency expressed clear 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, added InNexus.
The agency also provided a manufacturing exception approval allowing InNexus to manufacture all clinical material needed for DXL625's Phase I human trial, in its facilities located on the campus of Mayo Clinic in Scottsdale, Arizona.
Jeff Morhet, CEO of InNexus, said: "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."
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