Genmab will fund research and development (R&D) activities of the CD38 monoclonal antibody (mAb) until completion of clinical proof of concept studies. Credit: Linda Bartlett.

Genmab has signed a global licence and option agreement with Janssen Biotech for the development and commercialisation of a human CD38 monoclonal antibody (mAb).

Called HexaBody-CD38, the mAb will incorporate Genmab’s proprietary HexaBody technology, which creates effector function enhanced antibodies. The companies are aiming to expand the potential of CD38-targeted therapies to additional indications.

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Genmab will sponsor research and development (R&D) activities of the therapeutic until completion of clinical proof-of-concept studies in patients with multiple myeloma and diffuse large B-cell lymphoma.

Based on the results of these studies, Janssen may exercise its option for a worldwide licence to develop, manufacture and commercialise the mAb. If used, Genmab will receive a $150m option exercise fee and up to $125m in development milestones.

Janssen will also pay a 20% royalty on sales of HexaBody-CD38 until 2031, followed by 13%-20% tiered royalties thereafter.

If the company decides not to exercise its option, Genmab will continue the development and commercialisation of the product for Darzalex-resistant patients and additional indications. However, the agreement excludes multiple myeloma or amyloidosis indications.

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Genmab CEO Jan van de Winkel said: “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.

“Encouraging pre-clinical data suggest that HexaBody-CD38 could be superior to daratumumab for certain tumour cell types and may expand and extend the promise of CD38-targeted therapies for more patients with multiple myeloma, lymphoma, leukaemia, and potentially beyond.”

HexaBody-CD38 yielded promising data in multiple myeloma, lymphoma and leukaemia models.

Genmab and Janssen previously partnered to develop Darzalex (daratumumab), a CD38-targeting anti-cancer drug intended to treat amyloidosis, multiple myeloma and blood cancers.