The companies will focus on developing Foundation Medical’s companion diagnostics (CDx) platform to enable testing of Incyte’s proprietary treatment.
The initial CDx will include detection of activating fibroblast growth factor receptor (FGFR2) translocations. FGFR’s play a role in tumor cell survival and migration. Incyte stated that the activation of mutations, translocations and gene amplifications in FGFRs is closely related with the development and growth of cancers like cholangiocarcinoma.
The CDx will work as a tool in the development of pemigatinib, Incyte’s FGFR1/2/3 inhibitor. The drug is in ongoing Phase II studies investigating the safety and efficacy of pemigatinib as a monotherapy through Incyte’s FIGHT clinical development program.
Foundation’s CDx, FoundationOneCDx, is an in vitro diagnostic device that is intended to be used as a companion device to determine the efficacy of the treatment of targeted therapies. The US Food and Drug Administration (FDA) approved device also will provide tumor mutation profiling.
Several CROs have chosen to have companion diagnostic labs, such as Pfizer, Quintiles, and Almac.
Cholangiocarcinoma
Cholangiocarcinoma is a rare form of cancer that impacts the liver’s bile duct. The cancer is caused by mutations in the DNA of the bile duct cells. According to the Mayo Clinic, it is a type of tumor that is “very difficult to treat.”
In the US 6,000 people develop cholangiocarcinoma. It is much more prevalent in Asia and the Middle East.