11 September 2018 - - US-based biopharmaceutical company Incyte Corp. (NASDAQ: INCY) and US-based molecular information company Foundation Medicine, Inc have entered into an agreement for the development, regulatory support and commercialisation of companion diagnostics, with an initial focus on CDx development for pemigatinib (INCB54828), Incyte's selective FGFR1/2/3 inhibitor, in patients with cholangiocarcinoma, the company said.

The initial CDx, which will include detection of activating FGFR2 translocations, is expected to be incorporated into FoundationOneCDx, Foundation Medicine's FDA-approved comprehensive genomic profiling assay and broad CDx platform.

Fibroblast growth factor receptors (FGFRs) play an important role in tumor cell proliferation and survival, migration and angiogenesis (the formation of new blood vessels).

Activating mutations, translocations and gene amplifications in FGFRs are closely correlated with the development of various cancers.

Pemigatinib is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations.

Phase 2 studies investigating the safety and efficacy of pemigatinib monotherapy across several FGFR-driven malignancies are ongoing--the FIGHT (FIbroblast Growth factor receptor in oncology and Hematology Trials) clinical trial programme currently comprises FIGHT-201 in patients with metastatic or surgically unresectable bladder cancer, including with activating FGFR3 alterations; FIGHT-202 in patients with metastatic or surgically unresectable cholangiocarcinoma who have failed previous therapy, including with activating FGFR2 translocations; and FIGHT-203 in patients with myeloproliferative neoplasms with activating FGFR1 translocations.

FoundationOneCDx is a next generation, sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability and tumor mutational burden using DNA isolated from formalin-fixed paraffin embedded tumor tissue specimens.

FoundationOne CDx is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling.

Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms.

Incyte is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and commercialisation of proprietary therapeutics.

Foundation Medicine is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer.