AUSTIN, Texas — Faeth Therapeutics has published preclinical proof-of-concept data in the British Journal of Cancer showing that its novel drug-diet combination significantly inhibited tumor growth in models of endometrial and breast cancer. The findings support Faeth’s multi-pronged approach targeting cancer metabolism through both pharmaceutical and nutritional interventions.
The study outlines a strategy known as PIKTOR, which combines two targeted therapies—serabelisib (FTH-001) and sapanisertib (FTH-003)—with an insulin-suppressing diet and standard chemotherapy. In preclinical models, this combination led to substantial tumor regression, reinforcing Faeth’s rationale for multi-node inhibition of the PI3K/AKT/mTOR pathway, a common driver of treatment resistance in hormone-sensitive cancers.
Faeth launched a Phase 2 trial earlier this year in partnership with The GOG Foundation to test the PIKTOR regimen in patients with advanced or recurrent endometrial cancer. The trial includes a substudy assessing the impact of the insulin-suppressing diet on treatment outcomes. Interim results are expected in early 2026, with full data anticipated later that year.
“This study confirms that integrating targeted therapies with precision nutrition can yield stronger anti-cancer effects in metabolically driven tumors,” said Dr. Oliver Maddocks, Faeth’s Chief Scientific Officer and senior author of the study. “By inhibiting multiple key signaling nodes while regulating insulin levels, we may overcome resistance and achieve more durable responses.”
The PI3K/AKT/mTOR pathway is highly mutated in endometrial and breast cancers and has long been considered a key therapeutic target. Yet past efforts using single-node inhibitors often resulted in limited success due to compensatory mechanisms and side effects such as hyperglycemia. Faeth’s approach, by targeting multiple nodes simultaneously and incorporating diet to control insulin, aims to broaden the therapeutic window and improve efficacy while reducing toxicity.
Dr. Lewis Cantley, a co-founder of Faeth and a pioneer in cancer metabolism research, called the findings a step forward in the treatment of cancers linked to obesity and metabolic dysfunction. “The ability to integrate dietary intervention with targeted therapy could be a game-changer, especially for cancers like endometrial and breast cancer where metabolism plays a central role,” he said.
Faeth Therapeutics was founded in 2019 by a team of leading cancer researchers including Cantley, Siddhartha Mukherjee, Scott Lowe, Greg Hannon, and Karen Vousden. Its lead program aims to establish precision nutrition as a foundational element in cancer therapy, particularly for metabolically active tumors.
