On October 31, 2017 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported that Janssen Biotech, Inc. has initiated the first of three planned Phase 3 clinical trials evaluating a subcutaneous (SC) delivery of Darzalex (daratumumab) with Halozyme’s proprietary ENHANZE technology (Press release, Halozyme, OCT 31, 2017, View Source [SID1234521351]).
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The initial Phase 3 study is in amyloidosis patients, with additional Phase 3 studies in multiple myeloma and smoldering myeloma patients planned for near-term initiation.
The subcutaneous formulation of daratumumab has an estimated administration time of approximately 5 minutes compared to the multi-hour intravenous infusion, potentially offering new benefits to patients, caregivers and health systems. Halozyme’s ENHANZE technology enables the administration of medications with an injection under the skin rather than an infusion into a vein.
“Our goal has been to make the injection of life saving medicines less disruptive to patients using Halozyme’s ENHANZE technology,” said Dr. Helen Torley, president and CEO of Halozyme. “These studies aim to demonstrate the transformative potential of ENHANZE when combined with Darzalex.”
The Phase 3 study follows a Phase 1b clinical trial that demonstrated the safety, pharmacokinetics and anti-tumor activity of the subcutaneous formulation in relapsed or refractory multiple myeloma patients.
Halozyme will receive a $15 million milestone payment from Janssen following dosing of the third patient in a Phase 3 trial.
Darzalex is a human monoclonal antibody that targets CD38 on the surface of cells and is in clinical development by Janssen in a range of cancers and immune diseases.
Halozyme Collaboration with Janssen Biotech, Inc.
In December 2014, Halozyme and Janssen entered into a collaboration and license agreement. Under the terms of the agreement, Halozyme has granted Janssen a worldwide license to develop and commercialize products for up to five targets, combining rHuPH20 with Janssen’s proprietary compounds. CD38, which is targeted by daratumumab, is the first of these five targets. Halozyme is eligible to receive payments upon Janssen’s achievement of specified development, regulatory and sales-based milestones, totaling up to $113 million per target. Halozyme is also entitled to royalty payments based on net sales of products using the ENHANZE technology.
About ENHANZE Technology
Halozyme’s proprietary ENHANZE drug-delivery technology is based on its 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. ENHANZE may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.