Faeth Therapeutics and The GOG Foundation, Inc. (GOG-F) Launch First Phase 2 Combination Trial for Sapanisertib-Serabelisib in Patients With Endometrial Cancer

• First patient dosed in Phase 2 trial for PIKTOR strategy, dual PI3K/AKT/mTOR pathway inhibitors with paclitaxel
• Builds on Phase 1b study that demonstrated 80% ORR in Endometrial cancer
• Partnering with The GOG Foundation, Inc. (GOG-F), a not-for-profit organization with the mission of transforming the standard of care in gynecologic oncology

Excerpt from the Press Release:

AUSTIN, Texas & PHILADELPHIA–(BUSINESS WIRE)–Faeth Therapeutics (Faeth), a clinical-stage biotechnology company focused on metabolism, and The GOG Foundation, Inc. (GOG-F), a not-for-profit organization with the purpose of promoting excellence in the quality and integrity of clinical and translational scientific research in the field of gynecologic malignancies, today 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 trial is the most advanced of its kind to investigate a novel approach of dual PI3Kɑ-mTORC1/2 inhibition targeting cancer metabolism in patients with endometrial cancer.

The PI3K/AKT/mTOR pathway is the most frequently mutated pathway in cancer and is essential for tumor metabolism. Endometrial cancer has the highest frequency of PI3K pathway mutations of any solid tumor, yet there are no approved therapies addressing this need. FTH-001, a PI3Kɑ inhibitor, and FTH-003, an mTORC 1/2 inhibitor, have both demonstrated potential in multiple previous cancer clinical trials and their combination represents a unique “multi-node” approach to targeting this pathway.

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)² 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.

Click the button below to read the entire Press Release:

Continue Reading The Press Release