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Biotech company Genmab signed an agreement with Johnson & Johson’s Janssen Biotech to develop a monoclonal antibody product using Genmab’s HexaBody technology.
Genmab, a Copenhagen, Denmark-based biotechnology company focused on differentiated antibody therapeutics for cancer, announced on June 11, 2019 that it has entered into an exclusive worldwide license and option agreement with Johnson & Johnson’s Janssen Biotech to develop and commercialize HexaBody-CD38, a next-generation human CD38 monoclonal antibody (mAb) product using Genmab’s proprietary HexaBody technology.
Under the terms of the agreement, Genmab will collaborate exclusively with Janssen on HexaBody-CD38 and will fund R&D activities until completion of clinical proof-of-concept studies in multiple myeloma and diffuse large B-cell lymphoma. Based on the data from these studies, Janssen may exercise its option and receive a worldwide license to develop, manufacture, and commercialize HexaBody-CD38. Should this occur, Janssen will pay Genmab a $150-million option exercise fee and up to $125 million in development milestones as well as a flat royalty rate of 20% on sales of HexaBody-CD38 until a specified time in 2031, followed by 13Â20% tiered royalties on sales thereafter.
Should Janssen not exercise its option, the terms of the agreement allow Genmab to continue to develop and commercialize HexaBody-CD38 for Darzalex (daratumumab)-resistant patients and in all other indications except those multiple myeloma or amyloidosis indications where Darzalex is either approved or is being actively developed. Genmab’s daratumumab treats certain multiple myeloma indications and is in clinical development for additional multiple myeloma indications, other blood cancers, and amyloidosis. The agreement is the outcome of Genmab’s pre-clinical research on novel CD38 targeting concepts. For HexaBody-CD38, Genmab obtained promising pre-clinical data in a panel of multiple myeloma, lymphoma, and leukemia models.
According to Genmab, the HexaBody technology builds on natural antibody biology and enhances the assembly of antibody hexamers (clusters of six) after target-binding at the cell surface. This results in enhancement of immune effector functions, including complement-mediated killing (complement-dependent cytotoxicity [CDC]). Genmab states that the HexaBody technology can transform antibodies with limited or absent CDC into potent, cytotoxic antibodies.
Additional terms of the collaboration were not disclosed.