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‘Enhanze’ing subcutaneous therapies
SAN DIEGO—Halozyme Therapeutics, Inc., a biotechnology company developing novel oncology and drug-delivery therapies, announced today that argenx SE has dosed the first subject in a Phase 1 clinical trial evaluating the safety, pharmacokinetics and pharmacodynamics of efgartigimod (ARGX-113), using Halozyme’s proprietary Enhanze drug delivery technology.
As argenx’s website says, “Efgartigimod is a first-in-class investigational antibody fragment being evaluated for the treatment of patients with severe autoimmune diseases associated with high levels of pathogenic immunoglobulin G, or IgG, where a severe unmet medical need exists. Efgartigimod is thought to degrade circulating disease-causing autoimmune antibodies and is being investigated in large and orphan indications like myasthenia gravis, immune thrombocytopenia and skin blistering diseases, and likely has wider therapeutic potential.”
Initiation of this study triggers a $5 million milestone payment to Halozyme during the current quarter under the global collaboration and license agreement between the two companies.
“Since the signing of our collaboration with argenx earlier this year, we have made strong progress and I am delighted that the first Phase 1 trial has been initiated in such a short amount of time,” said Dr. Helen Torley, president and CEO of Halozyme. “We look forward to expanding our work with argenx to bring the potential benefits of subcutaneous administration to more patients suffering from severe autoimmune diseases through our 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. 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.
Halozyme has been busy with their Enhanze technology. Earlier in July the company noted that its collaborator Janssen Biotech, Inc. had submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration for the subcutaneous delivery of Darzalex (daratumumab) for patients with multiple myeloma.
“Janssen’s BLA submission for subcutaneous Darzalex represents an important development for our Enhanze drug delivery technology business,” mentioned Torley in a press release. “We are delighted that an approval of the subcutaneous formulation may soon provide patients with multiple myeloma a new therapeutic option that offers the potential of Darzalex with a shorter administration time.”
Janssen’s BLA submission followed the announcement of positive results from the company’s Phase 3 COLUMBA study, which investigated subcutaneously administered Darzalex in comparison to intravenous Darzalex in patients with relapsed and refractory multiple myeloma. Subcutaneous Darzalex, using Enhanze drug delivery technology, was found to be non-inferior to intravenous Darzalex with regard to the co-primary endpoints of overall response rate and Maximum Ctrough concentration on day 1 of the third treatment cycle.
In June, Halozyme also entered into a Cooperative Research and Development Agreement (CRADA) with the National Institute of Allergy and Infectious Diseases’ Vaccine Research Center (VRC), part of the National Institutes of Health. This enables the VRC’s use of Halozyme’s Enhanze drug delivery technology to develop subcutaneous formulations of broadly neutralizing antibodies (bnAbs) against HIV for HIV treatment.
The two bnAbs selected for the CRADA are VRC07-523LS and N6LS. The VRC will engage in early phase studies in healthy adults investigating the safety, tolerability, dose and pharmacokinetics of formulating these bnAbs with Enhanze for the purpose of optimizing subcutaneous administration of these antibodies.
“We are excited to collaborate with NIAID as they seek to develop new therapies that potentially address a large unmet need in the field of HIV treatment and prevention,” Torley commented. “This CRADA is an example of the value Enhanze can potentially bring to the treatment of infectious diseases, particularly in the early stages of development.”