serabelisib/sapanisertib (PIKTOR) / Faeth Therapeutics - LARVOL DELTA

Characterising the efficacy of multi-node PI3K/AKT/mTOR pathway inhibition with serabelisib and sapanisertib (PIKTOR) in combination with SERDs and CDK inhibitors in models of HR+/HER2- breast cancer (ESMO 2026) - No abstract available

Clinical • Combination therapy • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Faeth Therapeutics to Host Virtual KOL Event on Multi-Nodal Inhibition for the Treatment of Endometrial Cancer on October 6, 2026 (Businesswire) - "The event will provide an overview of the PAM pathway, a critical signaling network that regulates cell growth, survival, and metabolism....Management will compare single-node inhibition with PIKTOR, Faeth’s investigational multi-node inhibitor that uses a vertical pathway-blockade strategy combining the PI3K inhibitor serabelisib and the mTOR inhibitor sapanisertib. During the call, management will discuss recent translational work that led to the dose and schedule of PIKTOR currently being evaluated in its Phase 2 trial as well as clinical data from a prior Phase 1b trial. Management will also highlight the unmet need for novel therapies in endometrial cancer, where approximately 80% of tumors harbor a PAM pathway alteration, and treatment options following checkpoint inhibitor therapy remain limited. Topline data from the company’s Phase 2 trial is anticipated by year-end."

P1 data • P2 data • Endometrial Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer

Faeth Therapeutics Reports…Operational Updates (Businesswire) - "Topline results from the Phase 2 PIK-201 trial in endometrial cancer on track for year-end....' We look forward to reporting initial safety and efficacy data from PIK-101 in 2027'."

P1/2 data • P2 data • Endometrial Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer

Faeth Therapeutics Announces FDA Grant of Fast Track Designation for PIKTOR Plus Paclitaxel in Biomarker-Selected Advanced Endometrial Cancer (Businesswire) - "Faeth expects topline data from its ongoing Phase 2 trial in second-line advanced endometrial cancer (Study FTH-PIK-201) by year-end 2026."

Fast track • P2 data • Endometrial Cancer

Clinical Program Highlights (PharmiWeb) - “In April 2026, the first patient was dosed in the Phase 1b/2 trial evaluating PIKTOR for the treatment of HR+/HER2- advanced breast cancer (Study FTH-PIK-101). Interim data from the trial is expected in 2027; Topline Phase 2 data in patients with advanced endometrial cancer expected in second half 2026."

P1/2 data • P2 data • Breast Cancer • Endometrial Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer

Sensei Biotherapeutics Doses First Patient in Phase 1b/2 Trial of PIKTOR in HR+/HER2- Advanced Breast Cancer (PharmiWeb)

Trial status • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer

Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer (clinicaltrials.gov) - P1/2 | N=32 | Recruiting | Sponsor: Faeth Therapeutics

New P1/2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Sensei Biotherapeutics Reports Full Year 2025 Financial Results and Provides Corporate Update (Yahoo Finance) - "We are now focused on advancing PIKTOR through key clinical milestones, including topline data from the ongoing Phase 2 trial in advanced endometrial cancer and initiation of the planned Phase 1b trial in HR+/HER2- advanced breast cancer, both expected by year-end 2026."

New P1 trial • P2 data • Endometrial Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer

Sapanisertib and serabelisib (PIKTOR) with paclitaxel, and an insulin-suppressing diet (ISD) substudy, in patients with advanced/recurrent endometrial cancer (EC): GOG-3111 (SGO 2026) - No abstract available

Clinical • Metastases • Endometrial Cancer • Oncology • Solid Tumor

Concurrent with the acquisition, Sensei entered into a definitive agreement for the sale of Series B non-voting convertible preferred stock in a private placement financing, which is expected to result in gross proceeds to Sensei of approximately $200 million before deducting placement agent and other offering expenses. (Yahoo Finance) - "Sensei expects to use the proceeds primarily to advance PIKTOR through key clinical milestones, including topline data from an ongoing Phase 2 trial in second-line advanced endometrial cancer, as well as the initiation of a Phase 1b trial in HR+/HER2- advanced breast cancer, both expected by year end 2026, with remaining proceeds for general corporate purposes and completion of Sensei's ongoing Phase 1/2 trial of solnerstotug."

Financing • New P1 trial • P2 data • Endometrial Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Solid Tumor

Sensei Biotherapeutics Announces Acquisition of Faeth Therapeutics and $200 Million Concurrent Private Placement (Yahoo Finance) - "The acquisition brings Faeth’s lead asset PIKTOR, a proprietary investigational all-oral combination of serabelisib and sapanisertib that inhibits multiple nodes of the PI3K/AKT/mTOR pathway through PI3K-alpha and dual mTORC1/2 targeting, into Sensei’s pipeline."

M&A • Breast Cancer • Endometrial Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Ovarian Cancer

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