Copenhagen, Denmark; June 11, 2019 – Genmab A/S (Nasdaq Copenhagen: GEN) announced today it has entered into an exclusive worldwide license and option agreement with Janssen Biotech, Inc. (Janssen) to develop and commercialize HexaBody-CD38, a next-generation human CD38 monoclonal antibody product incorporating Genmab’s proprietary HexaBody technology. Under the terms of the agreement, Genmab will collaborate exclusively with Janssen on HexaBody-CD38, with Genmab funding research and development 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 USD 150 million option exercise fee and up to USD 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 13-20% 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-resistant patients, and in all other indications except those multiple myeloma or amyloidosis indications where DARZALEX is either approved or is being actively developed.
The agreement is the outcome of pre-clinical research on novel CD38 targeting concepts conducted by Genmab. For HexaBody-CD38, Genmab obtained promising pre-clinical data in a panel of multiple myeloma, lymphoma and leukemia models.
“With this agreement, we hope to build upon the successful and productive relationship that we have established with Janssen. As a result of our collaboration, DARZALEX has dramatically improved outcomes for patients with multiple myeloma, yet there are still unmet needs for patients. We are excited that Genmab’s world-class antibody expertise and passion for innovation has led to the novel HexaBody-CD38 product concept. Encouraging pre-clinical data suggest that HexaBody-CD38 could be superior to daratumumab for certain tumor cell types and may expand and extend the promise of CD38-targeted therapies for more patients with multiple myeloma, lymphoma, leukemia, and potentially beyond,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Additional details of the collaboration are not being disclosed and this news does not materially impact Genmab’s 2019 Financial Guidance.
Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer. Founded in 1999, the company has two approved antibodies, DARZALEX® (daratumumab) for the treatment of certain multiple myeloma indications, and Arzerra®(ofatumumab) for the treatment of certain chronic lymphocytic leukemia indications. Daratumumab is in clinical development for additional multiple myeloma indications, other blood cancers and amyloidosis. A subcutaneous formulation of ofatumumab is in development for relapsing multiple sclerosis. Genmab also has a broad clinical and pre-clinical product pipeline. Genmab’s technology base consists of validated and proprietary next generation antibody technologies – the DuoBody® platform for generation of bispecific antibodies, the HexaBody® platform, which creates effector function enhanced antibodies and the HexElect® platform, which combines two co-dependently acting HexaBody molecules to introduce selectivity while maximizing therapeutic potency. The company intends to leverage these technologies to create opportunities for full or co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies. For more information visit www.genmab.com.