Genmab to Initiate Phase I Trial of Multiple Myeloma Therapy

Genmab to Initiate Phase I Trial of Multiple Myeloma Therapy

Biotech company Genmab A/S is planning on initiating a phase I clinical trial to evaluate the subcutaneous compound daratumumab, which is an anti-CD38 antibody expected to become a treatment for multiple myeloma. The study will be conducted using ENHANZE, a technology that was developed by Halozyme Therapeutics, Inc.

Genmab will use the ENHANZE technology to combine compounds from Janssen Biotech, Inc., since Halozyme and Janssen established a partnership last December focused on the development and commercialization of products using one’s products and the other’s technology. The agreement includes the development of daratumumab as a subcutaneous formulation.

Daratumumab is a human monoclonal antibody designed to target CD38 in multiple myeloma cells, according to a press release from Halozyme. The antibody is being developed as part of the partnership established by Janssen and Genmab in August 2012, as Genmab provided Janssen the exclusive license for the development, manufacturing and commercialization of daratumumab worldwide.

The three companies have been working together on daratumumab, which may become a therapeutic option not only for multiple myeloma, but also for other hematologic conditions with CD38 expression, such as non-Hodgkins lymphoma and leukemia. Daratumumab is expected to work as a single agent to be combined with other therapies already used as standard of care.

The investigators working on daratumumab will use Halozyme’s ENHANZE technology in the phase I clinical trial of daratumumab, since the drug delivery platform was based on the patented recombinant human hyaluronidase enzyme (rHuPH20) that is able to eliminate the limitations traditionally associated with the amount of biologics that can be subcutaneously administered.

The use of rHuPH20 in the development of daratumumab is expected to support the compound’s administration, as well as improve the time needed by a healthcare practitioner to administer it, decrease the time needed for the drug to be absorbed, and reduce the number of injections. Halozyme is dedicated to providing novel oncology treatments and has established several partnerships recently, including with Roche, Pfizer and Baxter, in addition to Janssen and Genmab.

Multiple myeloma is characterized by the existence of modified neoplastic plasma cells in the bone marrow and is usually an incurable disease. A recent study entitled “Combined immune checkpoint protein blockade and low dose whole body irradiation as immunotherapy for myeloma” also revealed that blocking a combination of checkpoint receptors in a context of low-dose, lymphodepleting whole body radiation could result in increased anti-tumor immunity.