Faeth Therapeutics, Inc（FTH）のニュースとイベントFTHFaeth Therapeutics, Inc

Faeth Therapeutics Presents FTH-PIK-101 Data at European Oncology Congress

Faeth Therapeutics announced presentation of preclinical data at the European Society for Medical Oncology Congress 2026 in Madrid, Spain, in a poster entitled "Characterising the efficacy of multi-node PI3K/AKT/mTOR pathway inhibition with serabelisib and sapanisertib in combination with SERDs and a CDK4/6 inhibitor in models of HR+/HER2- breast cancer." These data support the design of FTH-PIK-101, the ongoing Phase 1b/2 clinical trial of PIKTOR with fulvestrant and/or other anticancer therapies in HR+/HER2- advanced breast cancer. In xenograft models with and without a PIK3CA mutation, oral PIKTOR inhibited tumor growth to a comparable or greater extent than intravenous gedatolisib. In combination with fulvestrant and palbociclib, standard-of-care treatments for HR+/HER2- breast cancer, PIKTOR completely inhibited tumor growth. In a cell-derived assay, PIKTOR achieved a greater degree of AKT kinase inhibition compared to single-node inhibitors, including other alpha-selective PI3K and/or mTOR inhibitors. Faeth believes these findings support the potential for an all-oral, multi-node option to improve on the standard of care in breast cancer, and expects FTH-PIK-201 topline data in second-line advanced endometrial cancer by year-end 2026 and FTH-PIK-101 interim data in 2027. Xenograft studies in mice with human breast cancer tumors: Design: Faeth ran four studies in mice implanted with human HR+/HER2- breast cancer cells: two with MCF7 cells, which carry a PIK3CA mutation, and two with HCC1428 cells, which do not. After tumors formed, mice received PIKTOR, gedatolisib, palbociclib, fulvestrant, or combinations of these. PIKTOR alone: PIKTOR slowed tumor growth compared with no treatment in both tumor types. PIKTOR versus gedatolisib: In the MCF7 model, tumor growth inhibition was comparable. In the HCC1428 model, PIKTOR achieved greater tumor growth inhibition than gedatolisib with or without the combination of fulvestrant and palbociclib. Combinations: PIKTOR enhanced the activity of fulvestrant and palbociclib. The triple combination halted tumor growth in the HCC1428 model and shrank tumors in the MCF7 model. Pathway assays: AKT activity: In cell lysates, PIKTOR reduced AKT activity to ~10% of uninhibited levels, a deeper reduction than any of the other PI3K and/or mTOR inhibitors tested. AKT is a central signaling node downstream of PI3K along the PAM axis that tumors rely on for growth and survival. Phosphorylation assay: In both breast cancer cell lines, Faeth measured PIKTOR's ability to alter phosphorylation levels of key PAM nodes. Phosphorylation status is another measure of pathway activity. PIKTOR suppressed phospho-AKT, phospho-S6, and phospho-4E-BP1, consistent with its design to block the PI3K/AKT/mTOR pathway at more than one point.

Faeth Therapeutics to Present PIKTOR Preclinical Data at European Oncology Congress

Faeth Therapeutics will present preclinical data at the European Society for Medical Oncology Congress 2026 in Madrid, Spain. The poster will be presented on Friday, October 23, and will showcase preclinical data intended to inform the ongoing development of PIKTOR in the FTH-PIK-101 Phase 1b/2 trial in HR+/HER2- breast cancer. In the poster, PIKTOR is tested as monotherapy and in combination with fulvestrant, oral SERDs and CDK inhibitors, which are standard and emerging treatments for patients with HR+ breast cancer. Data from mouse xenograft models will be accompanied by cellular assays showing that in these preclinical models, PIKTOR suppressed key signaling nodes in the PAM pathway, including AKT, at rates comparable to or exceeding those observed with tested single-node inhibitors. The poster also compares PIKTOR head-to-head with gedatolisib in two preclinical breast cancer xenograft models.

Faeth Therapeutics Appoints Dr. Karen Vousden to Board of Directors

Faeth Therapeutics "announced that Karen Vousden, Ph.D., has been appointed to its Board of Directors, effective September 11, 2026. Dr. Vousden is a cancer biologist recognized for her work on the regulation and function of the p53 tumor suppressor protein and on the metabolic dependencies of tumors. She has served as a Principal Group Leader at The Francis Crick Institute in London since 2017. She was Chief Scientist of Cancer Research UK from 2016 to 2022 and Director of the Beatson Institute for Cancer Research from 2002 to 2016. Dr. Vousden has served on the board of directors of Bristol Myers Squibb Company since 2018, where she is a member of the Science and Technology Committee and the Compensation and Management Development Committee. She is a Fellow of the Royal Society, the Royal Society of Edinburgh, the Academy of Medical Sciences, EMBO, the European Academy of Sciences, the American Association for Cancer Research and the American Academy of Arts and Sciences, and a Foreign Associate of the U.S. National Academy of Sciences. Dr. Vousden received her Ph.D. in genetics from Queen Mary College at the University of London. She is a scientific co-founder of Faeth."