SAN DIEGO—Targeted toward creating more personalized and effective medicine to combat pancreatic cancer, Halozyme Therapeutics Inc. and Ventana Medical Systems Inc. of the Basel, Switzerland-based Roche Group are collaborating on a joint global agreement to develop and ultimately commercialize a companion diagnostic assay for use with Halozyme’s investigational new drug, PEGPH20.
The partnership could lead to a first-of-its-kind treatment for pancreatic cancer, which accounts for about 3 percent of all cancers in the United States, and accounts for about 7 percent of cancer deaths, according to the American Cancer Society. It is estimated that about 48,960 people (24,840 men and 24,120 women) will be diagnosed with pancreatic cancer, and about 40,560 people (20,710 men and 19,850 women) will die of pancreatic cancer in 2015.
Pancreatic cancer often has a poor prognosis, even when diagnosed early. Pancreatic cancer typically spreads rapidly and is seldom detected in its early stages, which is a major reason why it is a leading cause of cancer death.
Under the terms of the agreement, 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, in turn, 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.
“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, stated in a recent news 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 collaboration also calls for Ventana to develop an in-vitro diagnostic 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 elsewhere.
“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,” Dr. Helen Torley, president and CEO of Halozyme, stated in a news release. “The agreement is an important milestone in our PEGPH20 program as we study the potential of PEGPH20 across multiple tumor types.”
Halozyme spokesman Jim Mazzola tells DDNews, “We are planning now to initiate our pivotal Phase 3 study at the end of the first quarter of 2016. We have not provided further details of the scope of the study, except to say it will be conducted in multiple countries. We will provide further details closer to initiation. Our intent in working with Ventana is to have the companion diagnostic tool approved prior to the start of the Phase 3 study.”
The financial terms of the agreement were not disclosed.
This pharma collaboration is one of many at Ventana, where the companion diagnostics team is developing patient stratifying diagnostic tools that can help identify those individuals who are most likely to benefit from specific treatments.
“We are currently studying our investigational new drug, Halozyme PEGPH20, in metastatic pancreatic cancer patients (a Phase 2 study) and non-small cell lung cancer patients (a Phase 1b study), and we reported encouraging results on May 31 from interim data in the Phase 2 study,” Mazzola says.
Halozyme’s Phase 2 clinical study of PEGPH20 showed a doubling of progression-free survival and improvement trend in overall survival in high HA metastatic pancreatic cancer patients.
This interim data was presented at the American Society of Clinical Oncology annual meeting by principal investigator Dr. Sunil Hingorani, an associate member of the Fred Hutchinson Cancer Research Center and an associate professor at University of Washington School of Medicine.
“The interim results from the ongoing study are very encouraging,” Hingorani stated in a news release. “We have a high unmet need in pancreas cancer, and the trend we observed toward longer survival rates and the slowing of disease progression are noteworthy in a cancer that has seen very few therapeutic developments in the past several years.”
Dr. Athena Countouriotis, senior vice president and chief medical officer, added, “We remain very encouraged by the interim data presented from our ongoing Phase 2 study, including the positive trend in overall survival, and we continue to plan for the first-quarter 2016 initiation of our Phase 3 study.”