Quintiles predicts PI3K demand and boosts assay offering

Phosphoinositide 3-kinases (PI3K) are involved in the activation of the enzyme protein kinase B and hence play a critical role in a number of key cellular processes, from growth and proliferation to motility and survival.

As a result mutations in genes encoding PI3K enzymes can have a significant impact on cellular behaviour, notably in cancers where mutant forms of PIK3CA are linked to tumour proliferation.

This, coupled with their role in the insulin pathway, has seen PI3Ks emerge as important therapeutic targets, which was a key driver for Quintiles’ expansion according to Sarah Bacus, CSO of Quintiles oncology translational medicine unit.

Dr Bacus suggested that: “Understanding this pathway will help support the clinical development of targeted therapies to this pathway and advances in personalised medicine.​

“We anticipated the need for a toolset to help biopharma companies understand this pathway, and now believe that Quintiles has the most comprehensive suite of PI3K biomarker assays available​.”

She went on to explain that the five assays the contract research organisation (CRO) provides are designed to help identify patients in whom the pathway is “activated” who will be better suited for treatment with drugs that target PI3K.

And in the research field, Quintiles hopes that the assay suite will enable trial sponsors to retrospectively determine a tumour’s PI3K profile to improve measurement of a candidate drug’s performance.

ASCO data indicates PI3K interest

Quintiles’ belief in likely demand for PI3K services is leant further weight by the number of presentations focused on the subject at this year’s American Society of Clinical Oncology (ASCO) conference in Chicago, Illinois this week.

Swiss drug major Novartis was perhaps the biggest name to discuss PI3K at ASCO, presenting data from Phase I trials of two candidate oral solid tumour treatments, BEZ235 and BKM120.

California biotech Exelixis also showcased data from trials of its PI3K inhibitor XL147, as did Seattle’s Calistoga Pharmaceutical for its candidate CAL 101 and New York’s Keryx Biopharmaceuticals for KRX-0401.

Cambridge, Massachusetts-based Merrimack Pharmaceuticals’ presentation was also PI3K focussed. The firm unveiled Phase I/II data indicating that its antibody MM-111, whose protein targets ErbB2 and ErbB3 are involved on the PI3K pathway, is safe and suitable for further studies.

Quintiles will be encouraged by this level interest which, coupled with the drug industry’s growing use of outsourced development expertise and the increasing demand for cancer therapies, could see PI3K biomarker analysis emerge as a significant money maker in the future.