AUSTIN, Texas, August 7, 2026
Faeth Therapeutics announced that it will present new pharmacokinetic/pharmacodynamic (PK/PD) modeling and translational research supporting the recommended Phase 2 dose of PIKTOR at the 2026 Summit for Novel Therapeutics in Oncology and Precision Medicine in Cancer (STOP Cancer) on August 8, 2026 in New York. The presentation will highlight how integrated PK/PD analyses, together with biomarker findings from earlier clinical studies, informed the dose selection currently being evaluated in the company’s ongoing Phase 2 FTH-PIK-201 trial for second-line advanced endometrial cancer. The findings represent an important step in optimizing PIKTOR’s clinical development strategy and strengthen the scientific rationale for advancing the investigational therapy in cancers driven by abnormalities in the PI3K/AKT/mTOR signaling pathway.
PK/PD Modeling Guided Optimal Phase 2 Dose Selection
The poster presentation, titled “Exposure/Response Analysis of an Oral Multi-Node PI3K/AKT/mTOR Pathway Inhibitor Combination of Serabelisib and Sapanisertib,” combines skin biopsy biomarker analyses with pharmacokinetic modeling generated from previous third-party clinical studies involving both investigational agents. These integrated data supported selection of 200 mg serabelisib and 3 mg sapanisertib administered three times weekly as the recommended Phase 2 dose for PIKTOR. The dosing regimen is currently being evaluated in Study FTH-PIK-201 (NCT06463028) involving patients with second-line advanced endometrial cancer. The company believes this exposure-response analysis provides a scientifically robust framework for balancing efficacy with tolerability while maximizing pathway inhibition across multiple molecular targets.
PIKTOR Targets One of Oncology’s Most Common Cancer Pathways
PIKTOR is an investigational all-oral combination therapy consisting of serabelisib, a selective PI3K-alpha inhibitor, and sapanisertib, an inhibitor of both mTORC1 and mTORC2. By simultaneously targeting multiple components of the PI3K/AKT/mTOR pathway, PIKTOR is designed to overcome resistance mechanisms that often limit the effectiveness of single-agent therapies. According to published research, dysregulation of this signaling pathway occurs in up to 50% of all solid tumors, making it one of the most frequently altered molecular pathways in oncology. Through multi-node inhibition, Faeth aims to provide a more comprehensive therapeutic strategy capable of improving outcomes in patients with difficult-to-treat cancers.
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Clinical Development Expands Across Endometrial and Breast Cancer
Faeth Therapeutics continues to advance PIKTOR across multiple oncology indications. The ongoing Phase 2 FTH-PIK-201 trial in advanced endometrial cancer is expected to generate topline data by the end of 2026, while the separate Phase 1b/2 FTH-PIK-101 study is evaluating the therapy in HR-positive/HER2-negative advanced breast cancer, with the first patient dosed in April 2026 and interim data anticipated in 2027. The upcoming STOP Cancer presentation reinforces the company’s precision oncology strategy by demonstrating how translational science and PK/PD modeling can guide clinical dose optimization. Positive results from the ongoing studies could further validate PIKTOR as a differentiated multi-node targeted therapy for cancers driven by PI3K/AKT/mTOR pathway alterations.
Source:Faeth Therapeutics press release
