SAN DIEGO—Halozyme Therapeutics Inc. and Ventana Medical Systems Inc., a member of the Roche group, have begun a global agreement to collaborate on developing a companion diagnostic assay to be used with PEGPH20, Halozyme's investigational new drug. Though no financial details were disclosed, the agreement stipulates that Ventana will develop an in-vitro diagnostic, under design control, using Halozyme's proprietary HA binding protein, with the ultimate goal of submitting it for regulatory approval in the United States, Europe and other countries. Ventana will commercialize the test, should the collaboration prove successful.
"We are pleased to enter into this master collaboration agreement with Halozyme, which may produce the first diagnostic to target tumor-associated HA and possibly the first companion diagnostic assay in pancreatic cancer," Doug Ward, vice president of Ventana Companion Diagnostics, said in a press release. "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."
The assay will be used to detect high levels of hyaluronan (HA), a glycosaminoglycan—a chain of natural sugars distributed throughout the body's tissue—that can accumulate around cancer cells. Halozyme intends to roll out a global Phase 3 clinical study next year targeting metastatic pancreatic cancer patients with high HA levels using PEGPH20 in combination with ABRAXANE and gemcitabine.
PEGPH20 is an investigational PEGylated form of Halozyme's proprietary recombinant human hyaluronidase being developed for the systemic treatment of tumor that accumulate HA. The drug candidate is being investigated in clinical trials in patients with pancreatic ductal adenocarcinoma and patients with non-small cell lung cancer. The U.S. Food and Drug Administration has granted PEGPH20 orphan drug designation and Fast Track designation in combination with gemcitabine and nab-paclitaxel for the treatment of metastatic pancreatic cancer. The European Commission, on the recommendation of the Committee for Orphan Medicinal Products of the European Medicines Agency, has also designated the drug as an orphan medicinal product for treating pancreatic cancer.
"Ventana brings a high level of development, regulatory and commercial expertise to our companion diagnostic strategy, which will help ensure we are well prepared for the initiation of our phase 3 study in pancreatic cancer," said Dr. Helen Torley, president and CEO of Halozyme. "The agreement is an important milestone in our PEGPH20 program as we study the potential of PEGPH20 across multiple tumor types."
This is the second companion diagnostic agreement Ventana has announced in the last two months. In April, the company entered into a master collaboration agreement with Astellas Pharma Inc. to develop novel automated issue diagnostics to support therapeutic compounds currently in development. The initial projects will support early-stage clinical trials for Astellas' ASP5878, a novel small-molecule fibroblast growth factor receptor inhibitor that has demonstrated the ability to block the kinase activities of FGFR1, FGFR2, FGFR3 and FGFR4. In parallel, Ventana will develop an immunohistochemistry test that can identify FGF19 in certain solid tumors. No financial details were released.