Halozyme

Halozyme Therapeutics and Roche’s Ventana Medical Systems have reached an agreement to jointly develop a companion diagnostic assay to treat cancer.

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Under the terms, Ventana will commercialise Halozyme’s investigational new drug, PEGPH20.

The Ventana assay will be used to identify high levels of hyaluronan (HA), which is a glycosaminoglycan that can accumulate around cancer cells.

Halozyme is planning to launch a Phase III clinical study to test PEGPH20 in combination with Abraxane (nab-paclitaxel) and gemcitabine on metastatic pancreatic cancer patients with high HA levels.

“The Ventana assay will be used to identify high levels of hyaluronan (HA), which is a glycosaminoglycan that can accumulate around cancer cells.”

Ventana will develop an in-vitro diagnostic (IVD), using Halozyme’s proprietary HA binding protein.

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The IVD, which is under design control, will be submitted to secure regulatory approval in the US, Europe and other countries.

Halozyme president Helen Torley said: “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 III study in pancreatic cancer.

“The agreement is an important milestone in our PEGPH20 programme as we study the potential of PEGPH20 across multiple tumour types.”

Ventana’s companion diagnostics team is developing patient stratifying diagnostic tools that will identify those individuals who are most likely to benefit from specific treatments.

Drug approval can be achieved sooner by combining companion diagnostic strategy and a drug development programme.

Image: Hyaluronic acid expressed in pancreatic cancer tissue at 40 times magnification. Photo: courtesy of Ventana Medical Systems.