serabelisib/sapanisertib (FTH-001/003) / Faeth Therap - LARVOL DELTA

CORRECTING and REPLACING Faeth Therapeutics' $92 Million Total Funding Powers PIKTOR Phase 2 Following 80% Response Rate in Endometrial Cancer (GlobeNewswire) - "Faeth's phase 1b study of serabelisib + sapanisertib ('PIKTOR') with paclitaxel demonstrated an 80% overall response rate in endometrial cancer patients, with a median progression-free survival of 11 months versus historical 3-4 months with chemotherapy alone. The strength of these results led the Gynecologic Oncology Group (GOG) Foundation, one of the premier U.S. clinical trial networks, to initiate a phase 2 trial (GOG-3111; NCT06463028), now enrolling patients....The $25 million will advance the phase 2 endometrial cancer program through a full data readout in Q3 2026."

Financing • P1 data • P2 data • Endometrial Cancer

Sapanisertib and serabelisib (PIKTOR) with paclitaxel and a diet substudy in patients with advanced/recurrent endometrial cancer (GOG-3111). (ASCO 2025) - P1, P2 | "The primary objective is to evaluate the objective response rate (ORR) and secondary objective is to evaluate efficacy via progression-free survival (PFS), PFS at 6 months, overall survival, clinical benefit rate, duration of response; and safety/tolerability of PIKTOR + paclitaxel. The substudy rationale is to evaluate the impact of diet on treatment tolerability and efficacy."

Clinical • IO biomarker • Metastases • Endometrial Cancer • Oncology • Solid Tumor • IR • PIK3CA

Multi-node inhibition targeting mTORC1, mTORC2 and PI3Kα potently inhibits the PI3K/AKT/mTOR pathway in endometrial and breast cancer models. (PubMed, Br J Cancer) - "Multi-node PI3K/AKT/mTOR pathway inhibition with serabelisib, sapanisertib and ISD is highly effective in preclinical models of endometrial and breast cancer, supporting continued clinical development in these and other solid tumours."

Journal • Preclinical • Breast Cancer • Endometrial Cancer • Oncology • Solid Tumor • EIF4EBP1 • PIK3CA

Interim data from Faeth’s Phase 2 clinical trial (Businesswire) - "Interim data from Faeth’s Phase 2 clinical trial...is anticipated by Q1 of next year, with complete results expected later in 2026."

P2 data • Endometrial Cancer

Faeth Therapeutics Shows Preclinical Proof-of-Concept for Drug-Diet Combination to Treat Cancer, in Peer-Reviewed Publication (Businesswire) - "Faeth Therapeutics...today announced publication of a preclinical proof-of-concept study supporting its rationale for targeting cancer metabolism through multi-node inhibition, including both therapeutics and an insulin-suppressing diet. The findings, published today in the peer-reviewed British Journal of Cancer, show that the three-pronged PIKTOR approach – using Faeth’s dual PI3K/AKT/mTOR pathway inhibitors FTH-001 (serabelisib) and FTH-003 (sapanisertib) along with dietary modification, added to paclitaxel – demonstrated tumor regression in endometrial and breast cancer models."

Preclinical • Breast Cancer • Endometrial Cancer

Faeth Therapeutics and The GOG Foundation, Inc. (GOG-F) Launch First Phase 2 Combination Trial for Sapanisertib-Serabelisib in Patients With Endometrial Cancer (Businesswire) - "Faeth Therapeutics...announced the first patient has been dosed in its Phase 2 combination trial of PIKTOR, which is FTH-001 (serabelisib) and FTH-003 (sapanisertib) with paclitaxel....The current study, An Open-label, Multi-Center, Phase 2 Clinical Trial Evaluating Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel, and a Substudy Evaluating PIKTOR With Paclitaxel Plus Diet, in Patients With Advanced or Recurrent Endometrial Cancer (FTH-PIK-201, GOG-3111) will expand on the strong Phase 1b data1 showing an 80% ORR in patients with endometrioid endometrial cancer with 11 months of progression-free survival."

Trial status • Endometrial Cancer

Faeth Therapeutics to Present at Raymond James Biotech Private Company Showcase (Businesswire) - "Faeth Therapeutics...will present today at the Raymond James Biotech Private Company Showcase. Oliver and Debbie will discuss Faeth’s lead PIKTOR program development plans...Faeth's lead program, FTH-001/003 or 'PIKTOR,' features the combination of serabelisib, a PI3Kɑ inhibitor, and sapanisertib, an mTORC 1/2 inhibitor....Additionally, Faeth's second clinical initiative involves FTH-002, a specially designed amino acid sachet administered alongside an amino acid-restricted diet and radio/chemotherapy."

Clinical • Breast Cancer • Endometrial Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor