On May 27, 2015 Halozyme and Ventana Medical Systems reported 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 (Press release, Halozyme, MAY 27, 2015, View Source [SID:1234504843]). Schedule your 30 min Free 1stOncology Demo! 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.
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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.
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.
Companion diagnostics (CDx) are tests designed to confirm the presence of a specific biomarker to assist physicians in selecting effective therapies for their patients, based on the individual characteristics of each person. Incorporating a companion diagnostic strategy into a drug development program may expedite the drug approval process and help generate more effective treatments with improved safety profiles for patients.
About Ventana Medical Systems, Inc.
Ventana Medical Systems, Inc. ("VMSI") (SIX: RO, ROG; OTCQX: RHHBY), a member of the Roche Group, innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics. VENTANA products are used in clinical histology and drug development research laboratories worldwide. The company’s intuitive, integrated staining, workflow management platforms, and digital pathology solutions optimize laboratory efficiencies to help reduce errors, support diagnosis and enable informed treatment decisions by anatomic pathology professionals. Together with Roche, VMSI is driving Personalized Healthcare through accelerated drug discovery and the development of companion diagnostics to identify the patients most likely to respond favorably to specific therapies.
Visit www.ventana.com to learn more.
About PEGPH20
PEGPH20 is an investigational PEGylated form of Halozyme’s proprietary recombinant human hyaluronidase under clinical development for the systemic treatment of tumors that accumulate hyaluronan.
The FDA granted orphan drug designation to PEGPH20 for treatment of pancreatic cancer and fast track for PEGPH20 in combination with gemcitabine and nab-paclitaxel for the treatment of metastatic pancreatic cancer. Additionally, the European Commission, acting on the recommendation from the Committee for Orphan Medicinal Products of the European Medicines Agency, designated investigational drug PEGPH20 an orphan medicinal product for the treatment of pancreatic cancer.
Clinical trials are currently ongoing for development of PEGPH20 in pancreatic ductal adenocarcinoma and in non-small cell lung cancer. More information may be found at: View Source