Genmab and Janssen Team Up to Develop Next-Generation CD38 Antibody

Partnership handshake

Denmark-based Genmab A/S and Janssen Biotech will collaborate on a successor to multiple myeloma drug Darzalex with the development of a next-generation CD38 antibody product for the treatment of multiple myeloma and diffuse large B-cell lymphoma.

Earlier this year the two companies won approval for a split-dosing regimen of Darzalex, a drug approved in the United States for treating multiple myeloma. The two companies intend now to incorporate Genmab’s proprietary HexaBody technology, which creates effector function enhanced antibodies, in the development of the HexaBody-CD38 antibodies. Next-generation HexaBody-CD38 could potentially add to the Darzalex multiple myeloma franchise and expand the potential of CD38-targeted therapies in further indications, Genmab said.

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Under terms of the latest agreement, Genmab will fund research and development activities until the completion of proof-of-concept studies in both indications. Based on the data generated from those studies, Janssen may exercise its option to then develop and potentially commercialize HexaBody-CD38. If Janssen does exercise that option, the company will pay Genmab $150 million upfront and then up to $125 million in milestone payments. Additionally, the J&J subsidiary would pay a flat royalty of 20% on sales of HexaBody-CD38 until 20131, then 12 to 20% thereafter. If Janssen does not exercise its option, Genmab can develop and commercialize HexaBody-CD38 for Darzalex-resistant patients on its own. Additional details of the collaboration are not being disclosed and this news does not materially impact Genmab’s 2019 financial guidance.

The agreement is the outcome of preclinical 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, the company said. Genmab’s HexaBody technology builds on natural antibody biology and enhances the assembly of antibody hexamers after target binding at the cell surface. This results in enhancement of immune effector functions including complement-mediated killing. The HexaBody technology can transform antibodies with limited or absent CDC into potent, cytotoxic antibodies, according to company information.

Genmab Chief Executive Officer Jan van de Winkel said his company hopes to build on the “successful and productive relationship” it has already established with Janssen. Their initial collaboration improved Darzalex outcomes for patients with multiple myeloma, he said, but added that 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,” van de Winkel said in a statement.

Two weeks ago, Genmab announced its intention to raise up to $500 million through an initial public offering on the Nasdaq exchange. The company’s ordinary shares are currently listed on Nasdaq Copenhagen under the GEN symbol.

Darzalex has been the primary cash cow for Copenhagen-based Genmab. Last year the company earned $262 million in royalties and $90 million in milestone payments from Janssen on $2 billion in net Darzalex sales. The Darzalex funds accounted for about 76% of Genmab’s annual revenues in 2o18. The company also has another approved product, Arzerra (ofatumumab), which was developed and marketed with Novartis, for specific indications of chronic lymphocytic leukemia.

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