On March 10, 2015 Halozyme Therapeutics reported that Genmab A/S announced plans for a Phase 1 clinical trial of a subcutaneous formulation of the anti-CD38 antibody daratumumab using the ENHANZE technology (Press release, Halozyme, MAR 10, 2015, View Source [SID:1234502241]). In December 2014, Janssen Biotech, Inc. (Janssen) entered into an agreement with Halozyme Therapeutics for the purpose of developing and commercializing products combining proprietary Janssen compounds with Halozyme’s ENHANZE technology. This agreement has the potential to lead to the development of a subcutaneous formulation of daratumumab. Daratumumab is being developed under a collaboration between Janssen and Genmab A/S since August 2012 when Genmab granted Janssen an exclusive worldwide license to develop, manufacture, and commercialize daratumumab.
Daratumumab, a human monoclonal antibody that targets CD38 on the surface of multiple myeloma cells, is in clinical development as a single agent and in combination with standard of care therapies in several settings of multiple myeloma. Daratumumab may also have potential in other hematologic malignancies in which CD38 is expressed, including non-Hodgkins lymphoma and various leukemias.
ENHANZE is Halozyme’s proprietary drug delivery platform based on the Company’s patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration. ENHANZE may also benefit subcutaneous biologics by reducing the need for multiple injections.