FogPharma Announces Selection of Clinical Development Candidate Directly Targeting β-Catenin

• FOG-001 represents the first development candidate arising from FogPharma’s pioneering Helicon modality, a new class of precision medicines that aim to combine the targeting strength and specificity of antibodies with the cell penetration of small molecules
• FOG-001, a first-in-class direct TCF-blocking β-catenin inhibitor, is on track to enter clinical development in 2023

CAMBRIDGE, Mass.–(BUSINESS WIRE)–FogPharma, a biopharmaceutical company pioneering a new class of precision medicines that could ultimately prove applicable to all therapeutic targets, including those previously considered “undruggable,” today announced the selection of its lead product development candidate, FOG-001, a first-and-only-in-class direct β-catenin inhibitor. FOG-001 represents the first of FogPharma’s proprietary, conformationally hyperstabilized α-helical polypeptides (Helicon polypeptides), a new class of therapeutics designed to combine the targeting strength and specificity of antibodies with the broad tissue distribution, intracellular target engagement and oral dosing optionality of small molecules.

Dysregulation of the Wnt/β-catenin signaling pathway has been shown to occur in at least 20% of all human cancers. In biochemical and cellular studies, FOG-001 has been shown to potently, precisely and selectively disrupt the interaction of β-catenin with its obligate transcription factor, TCF. Preclinical studies have demonstrated the ability of FOG-001 to cause tumor growth inhibition and regression by disrupting β-catenin-dependent signaling. FOG-001, the inaugural member of FogPharma’s TCF-Catenix family of direct-acting β-catenin antagonists, combines key features that distinguish it from previously reported Wnt/β-catenin pathway modulators: FOG-001 acts inside the cell, where it directly binds the key oncogenic driver β-catenin; and FOG-001 blocks TCF-β-catenin engagement at the most downstream node in the canonical Wnt pathway, thus abrogating the signal transmission mechanism by which most, if not all, known Wnt pathway mutations are believed to drive oncogenesis.

“The selection of FOG-001 as our development candidate, within two and a half years of initiating the discovery of a TCF-Catenix drug for a target widely considered “undruggable,” underscores the rapid progress being made at FogPharma as we seek to advance medicine by a quantum leap. We are rapidly achieving mastery in the rapid deployment of a new therapeutic modality designed to surmount the challenges of intractable disease-driving targets,” said Gregory Verdine, Ph.D., founder and chief executive officer of FogPharma. “Genetic evidence has long implicated β-catenin as being a principal driver of human cancer, but this target had been frustratingly beyond therapeutic reach, until the discovery of FOG-001. 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.”

FogPharma plans to file an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for FOG-001 and initiate clinical development by mid-2023.

About FogPharma’s Universal Druggability Platform

FogPharma’s Helicon peptide drug discovery engine integrates directed evolution, proprietary α-helix conformational hyperstabilization chemistry, highly multiplexed drug optimization technology, artificial intelligence including deep learning and machine learning, structure-based drug discovery, and multiscale manufacturing to rapidly discover Helicon polypeptide therapeutics against important, previously intractable targets with broad applicability to virtually all disease areas.

About FogPharma

FogPharma’s mission is to drastically reduce the burden of disease on patients and their families by inventing new types of drugs that squelch abnormal physiological processes in ways previously imagined but considered unattainable. The company is pioneering the discovery, development and commercialization of Helicon polypeptides, a new class of drugs that are designed to combine the cell-permeability and oral dosing optionality of traditional small molecule drugs with the high specificity, broad target accessibility and rapid discovery arc of monoclonal antibody drugs.

FogPharma was spun out of Harvard University in 2016 by pioneering academic scientist, serial life science entrepreneur, venture capitalist and successful biotech company builder Dr. Gregory Verdine. FogPharma is headquartered in Cambridge, Mass., and has raised more than $180 million to date from leading life sciences investors. For more information, please visit www.fogpharma.com.

©2022 Fog Pharmaceutical, Inc. FOGPHARMA is a registered trademark of Fog Pharmaceuticals, Inc.

Contacts

1AB

Katie Engleman

[email protected]