NEW YORK – FogPharma on Wednesday said that FOG-001, a direct beta-catenin inhibitor, will be the first agent it takes into the clinic.
FOG-001 targets beta-catenin, which is part of the Wnt signaling pathway. In at least 20 percent of human cancers, this signaling pathway is dysregulated. The company plans to file an investigational new drug application with the US Food and Drug Administration and begin clinical trials of FOG-001 by mid-2023 in patients with cancers driven by Wnt pathway abnormalities.
"Genetic evidence has long implicated beta-catenin as being a principal driver of human cancer, but this target had been frustratingly beyond therapeutic reach until the discovery of FOG-001," FogPharma CEO Gregory Verdine said in a statement. "We look forward to advancing our first Helicon drug candidate, FOG-001, into clinical development with the overarching aim of providing a fundamentally new and potentially significant treatment option for the large number of cancer patients whose disease is driven by derangement of the Wnt pathway."
FOG-001 was developed using FogPharma's polypeptide technology, called Helicon, with which the company is aiming to develop a new class of drugs that can penetrate cells like small molecules and precisely inhibit a range of targets like monoclonal antibodies.
FogPharma, based in Cambridge, Massachusetts, is also using its Helicon polypeptide platform to develop molecules that disrupt YAP1 and TAZ-TEAD pathways.