Drug developer argenx has gained rights to Halozyme’s ENHANZE® drug delivery technology to develop autoimmune disease treatments for up to three targets, the companies said today, through a collaboration and license agreement that could generate more than $530 million for Halozyme.

The agreement gives argenx access to ENHANZE for any product targeting the human neonatal Fc receptor FcRn—including argenx’s lead pipeline candidate efgartigimod (ARGX-113) and up to two additional targets.

Efgartigimod is a first-in-class antibody fragment designed to treat patients with severe autoimmune diseases associated with high levels of pathogenic immunoglobulin G, or IgG, antibodies for which few innovative biologic treatments have been approved and severe unmet medical need exists.

“What has made autoimmune disease attractive is both the size of the market opportunity and the inherent benefits that subcutaneous administration potentially brings to autoimmune disease patients and their healthcare providers,” Halozyme told GEN through a spokesperson.

According to argenx, efgartigimod has potential in many large and orphan indications, including multiple sclerosis, immune thrombocytopenia, systemic lupus erythematosus, myasthenia gravis, and skin blistering.

“As we look towards commercialization, if approved, efgartigimod is now equipped with a well-established subcutaneous delivery technology in addition to the clinical activity and favorable tolerability profile we have observed in studies to date,” argenx COO Keith Woods said in a statement. “We believe that by offering both intravenous and subcutaneous formulations, we have the opportunity to capture patient preferences across all indications within our efgartigimod portfolio.”

ENHANZE is based on Halozyme’s patented recombinant human hyaluronidase enzyme (rHuPH20), which has enabled some biologics and compounds that are administered intravenously to instead be delivered subcutaneously.

According to Halozyme, rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously—while ENHANZE may also benefit subcutaneous biologics by reducing the need for multiple injections.

Potential time-saver

As a result, argenx and Halozyme reason, the deal holds the potential for shortening drug administration time, reducing healthcare practitioner time, and offering additional flexibility and convenience for patients.

“This collaboration is an example of the value ENHANZE can potentially bring while a product is still in development where the benefits of subcutaneous administration can be realized earlier by both patients and healthcare providers,” stated Halozyme president and CEO Helen Torley, MBChB, MRCP.

argenx agreed to pay Halozyme $30 million upfront, $10 million per target for future target nominations, and up to $160 million per selected target in payments tied to achieving development, regulatory, and sales-based milestones—plus royalties in the mid-single digits on sales of commercialized products.

“By gaining exclusive access to ENHANZE technology for our anti-FcRn asset, we also solidify our leadership position in this exciting new space that has the potential to disrupt the way severe autoimmune diseases are treated,” added Woods.

Ninth collaboration partner

Through the agreement, argenx becomes the ninth global biopharma collaboration and license partner for ENHANZE technology. The others include Alexion Pharmaceuticals, Baxalta (later bought by Shire, itself acquired by Takeda Pharmaceutical), Pfizer, Janssen (Johnson & Johnson), AbbVie, Eli Lilly, Bristol-Myers Squibb, and Roche.

Among ENHANZE-based treatments listed in Halozyme’s pipeline, the furthest along in development is Janssen’s Darzalex® (daratumumab), which is in Phase III studies for amyloidosis, smoldering myeloma, and two multiple myeloma indications. Janssen and Halozyme have agreed to develop up to five ENHANZE-based therapies for five potential targets.

Janssen is expected to file a BLA for subcutaneous Darzalex in the second half of this year, while Genentech, a member of the Roche Group, is awaiting FDA action in the first quarter on its BLA for a subcutaneous Herceptin® (trastuzumab).

To date, three ENHANZE-based treatments have reached the market. Herceptin for breast cancer has been approved in the European Union and some other countries outside the U.S. Another Roche product, known as Rituxan Hycela™ (rituximab/hyaluronidase human) in the U.S. and MabThera® SC (rituximax) outside the U.S., has gained approval in multiple blood cancers, while Hyqvia® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase]—now marketed by Takeda—has won approvals in primary immunodeficiency indications in the U.S., Europe, and some other countries.

ENHANZE technology has always had applicability across a wide range of indications, the Halozyme spokesperson told GEN, even though many of its early partners were focused on cancer.

The two targets to be selected can be in cancer as long as the targets being pursued have not already been taken by one of our other collaboration partners, Halozyme added.

To date, the collaborations have covered more than 50 therapeutic targets. According to Halozyme, five of the nine collaborations were inked in the past 18 months, generating $230 million in total upfront payments and creating the potential for more than $3.5 billion in milestones.

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