Collaboration to develop ultra-long acting medicines for HIV

ViiV Healthcare and Halozyme Therapeutics Inc. have entered a global collaboration and license agreement that gives ViiV exclusive access to Halozyme’s Enhanze® drug delivery technology, recombinant human hyaluronidase PH20 enzyme (rHuPH20), for specific targets used in the treatment and prevention of HIV. The technology provides ViiV with opportunities to develop ultra-long acting medicines (dosing intervals of three months or longer) for HIV.

Under the agreement, ViiV will pay $40 million upfront to exclusively licence four HIV small and large molecule targets and is obligated to make potential future payments of up to $175 million in development and commercial milestones. Halozyme will also be entitled to receive mid-single digit royalties on sales of commercialised medicines using the technology.

The PH20 enzyme breaks hyaluronan (HA), which is found in the body’s subcutaneous space and acts as a barrier to the flow of fluid. By breaking down HA locally at the injection site and temporarily removing that barrier (HA is naturally restored within 24 to 48 hours), large amounts of fluid can be injected into the subcutaneous space and dispersed. This facilitates the rapid delivery of large volume fluids by subcutaneous injection, potentially reducing the treatment burden of injectable drugs and providing optimised treatment options to patients.

The aim of the licencing is for ViiV to develop ultra-long acting medicines for HIV with its long-acting portfolio and pipeline products. According to the companies, the first experiments evaluating the technology for investigational, long-acting cabotegravir are expected to be initiated by the end of 2021. Cabotegravir is currently administered every two months for prevention of HIV. 

The license gives ViiV exclusive use of Halozyme’s proprietary rHuPH20 technology for four, specific HIV medicine targets that will expand opportunities for development of nearly all of ViiV’s pipeline assets. These assets are integrase inhibitors, nucleoside reverse transcriptase inhibitors (NRTI) and nucleoside reverse transcriptase translocation inhibitors (NRTTIs), capsid inhibitors and broadly neutralising monoclonal antibodies (bNAbs), that bind to the gp120 CD4 binding site.

Halozyme has licensed its technology to 11 pharma and biotech companies, for potential use in oncology, autoimmune disease, rare disease and infectious disease. Products have already been approved in oncology and immune deficiency indications. In addition, Halozyme currently has a Cooperative Research and Development Agreement with the National Institute of Allergy and Infectious Diseases’ Vaccine Research Center in the US, which includes a bNAb, N6LS, that ViiV Healthcare licensed from the National Institutes of Health in 2019.