Halozyme Therapeutics and Ventana Medical Systems, a member of the Roche Group, announced a global agreement to collaborate on the development of, and for Ventana to ultimately commercialize, a companion diagnostic assay for use with Halozyme's investigational new drug, PEGPH20.
The Ventana assay will be used to identify high levels of hyaluronan (HA). HA is a glycosaminoglycan – a chain of natural sugars distributed throughout human tissue – that can accumulate around cancer cells. Halozyme has announced plans for rollout of a global phase 3 clinical study in 2016 targeting metastatic pancreatic cancer patients with high HA levels using its PEGPH20 in combination with ABRAXANE® (nab-paclitaxel) and gemcitabine.
Under the agreement, Ventana will develop an in vitro diagnostic (IVD), under design control, using Halozyme's proprietary HA binding protein, with the intent of submitting it for regulatory approval in the United States, Europe and other countries.
"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."
"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," said Doug Ward, Vice President, 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."
The financial terms of the agreement were not disclosed.