Presenting infigratinib’s preclinical data

SAN FRANCISCO—QED Therapeutics, a biotechnology company focused on precision medicine for FGFR-driven diseases, announced yesterday the presentation of preclinical data demonstrating the potential of their lead investigational candidate infigratinib for treating FGFR-driven cancers derived from multiple tissue types. The data, in a poster entitled “Anti-tumor activity of infigratinib, a potent and selective inhibitor of FGFR1, FGFR2 and FGFR3, in FGFR fusion-positive cholangiocarcinoma and other solid tumors,” was presented during the currently ongoing AACR 2019 Annual Meeting.

Infigratinib (BGJ398) is an orally administered, FGFR1-3 selective tyrosine kinase inhibitor that has shown meaningful clinical activity in patients with chemotherapy-refractory cholangiocarcinoma with FGFR2 fusions and advanced urothelial carcinoma with FGFR3 genomic alterations. QED is also evaluating infigratinib in preclinical studies for the treatment of achondroplasia and other skeletal dysplasias. The company plans to conduct further clinical trials to evaluate the potential for infigratinib to treat patients with other FGFR-driven tumor types and rare disorders.

According to Sameek Roychowdhury, M.D., Ph.D., associate professor of medical oncology at The Ohio State University, “Recent data shows that fusion proteins involving FGFR have been identified in a diverse range of solid tumors including lung, breast, thyroid and prostate cancers, as well as cholangiocarcinoma and bladder cancer. Given the fact that scientists are identifying more tumor types driven by mutations in FGFRs, it expands the potential for a compound like infigratinib as an effective treatment for many more cancers than previously understood.”

Researchers identified FGFR fusion positive patient samples and developed patient-derived xenograft (PDX) models to ascertain the effect of infigratinib treatment. Specifically, they studied PDX models of cholangiocarcinoma, breast cancer, liver cancer, gastric cancer and glioma, and determined that treatment with infigratinib resulted in a reduction in tumor volume in all samples, compared to inactive treatment. In addition, the research details the identification and characterization of a novel FGFR fusion in prostate cancer.

“While previously presented data have shown the promise of infigratinib for the treatment of cholangiocarcinoma and urothelial carcinoma, this data provides a clear rationale for performing tumor-agnostic clinical trials across all molecularly defined solid tumors,” said Gary Li, Ph.D., senior vice president of translational medicine at QED Therapeutics. “We will support the prompt initiation of these trials in the hopes of developing an important treatment for patients with serious and life-threatening cancers such as bile duct, brain, bladder, lung, breast, thyroid and prostate cancer.”

The full poster can be viewed at www.qedtx.com/AACR2019/.