Halozyme, Roche’s Ventana to Co-Develop Companion Diagnostic

Halozyme Therapeutics said today it will co-develop a companion diagnostic for its cancer drug candidate PEGPH20 with Ventana Medical Systems, a member of the Roche Group. The value of the collaboration was not disclosed.

Ventana will ultimately commercialize the in vitro diagnostic, an assay designed to identify high levels of hyaluronan (HA), a chain of natural sugars distributed throughout human tissue that can accumulate around cancer cells. 

The diagnostic—which will use Haolzyme’s HA binding protein—is being developed as the company prepares to launch a global Phase III trial next year to assess a combination of its PEGPH20 with Abraxane^® (nab-paclitaxel) and gemcitabine in metastatic pancreatic cancer patients with high HA levels.

PEGPH20 is an investigational PEGylated form of Halozyme's recombinant human hyaluronidase or rHuPH20. PEGPH20 is under clinical development for systemic treatment of tumors that accumulate HA.

The FDA has granted fast track status for the compound in combination with gemcitabine and nab-paclitaxel for metastatic pancreatic cancer, while the agency and the European Commission have both given PEGPH20 their orphan drug designations for pancreatic cancer.

“The agreement is an important milestone in our PEGPH20 program as we study the potential of PEGPH20 across multiple tumor types,” Halozyme president and CEO Helen Torley, M.B., Ch.B., said in a statement.

Added Doug Ward, vp with Ventana Companion Diagnostics: “The PEGPH20 program, coupled with our global reach, has the potential to improve the standard of care in pancreatic cancer for patients around the world.”

Ventana has agreed to pursue regulatory approvals for the diagnostic in Europe, the U.S., and other countries.

The pharma giant is also developing and commercializing combinations of Roche target compounds with Halozyme’s rHuPH20 using Halozyme’s ENHANZE™ drug delivery technology platform under an exclusive license granted in 2006 that was valued at more than $601 million plus royalties for Halozyme.

Roche now has rights to apply the technology to up to eight targets, including Roche’s marketed drugs Herceptin^® and MabThera.^® The European Commission has approved subcutaneous formulations of both drugs that use ENHANZE.

Halozyme is also using ENHANZE to develop drugs under collaborations with Baxter International, Johnson & Johnson’s Janssen Biotech, and Pfizer.