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

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. The Phase 2 study is based on Faeth’s metabolism-focused platform for developing novel therapeutic approaches. Endometrial cancer is one of the leading causes of cancer death in women and there is a high unmet need in patients with advanced and relapsed disease who have progressed after first line carboplatin-based therapy.

“Thanks to Faeth’s ability to uncover novel metabolism-targeting strategies, we are positioned to leverage the PIKTOR approach for endometrial cancer and other solid tumors,” said Anand Parikh, J.D., Chief Executive Officer of Faeth Therapeutics. “Over its five decades, the GOG Foundation has established itself as a leading clinical partner against gynecologic cancers, and we are confident they will help us pave the way for the next generation of cancer treatments.”

“This unique approach to target cancer metabolism has demonstrated impressive early results. We look forward to this trial to hopefully confirm these early findings and perhaps transform the way we treat patients with endometrial cancer,” said David Starks, MD, Principal Investigator and Associate Professor, Avera Cancer Institute and University of South Dakota Sanford School of Medicine.

“Endometrial cancer is the leading cause of deaths among all gynecologic cancers. Finding better treatment options remains our highest priority. We are excited to partner with Faeth Therapeutics to further investigate this novel therapeutic approach,” said Brian Slomovitz, MD, Director, Gynecologic Oncology, Mount Sinai Medical Center and Uterine Cancer Trial Lead, GOG Partners.

About Faeth Therapeutics

Faeth Therapeutics is a clinical-stage biotechnology company at the forefront of oncology research with a robust clinical and preclinical pipeline powered by its AI-driven MetabOS discovery platform. Faeth’s lead program, PIKTOR, has shown outstanding clinical results and is now in a Phase 2 trial for patients with endometrial cancer. For additional information, visit www.faeththerapeutics.com.

About The GOG Foundation, Inc. (www.gog.org)

The GOG Foundation, Inc. is 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. The GOG Foundation is committed to maintaining the highest standards in clinical trials development, execution, analysis, and distribution of results. The GOG Foundation is the only clinical trialist group in the United States that focuses its research on patients with pelvic malignancies, such as cancer of the ovary (including surface peritoneal malignancies), uterus (including endometrium, soft tissue sarcoma, and gestational trophoblastic neoplasia), cervix, and vulva. The GOG Foundation is multi-disciplinary in its approach to clinical trials, and includes gynecologic oncologists, medical oncologists, pathologists, radiation oncologists, oncology nurses, biostatisticians (including those with expertise in bioinformatics), basic scientists, quality of life experts, data managers, and administrative personnel.

About GOG Partners

Supported by industry, GOG Partners is structured to work directly with pharmaceutical organizations and operate clinical trials outside the National Cancer Institute (NCI) framework. The GOG Partners shares the same mission of the GOG Foundation dedicated to transforming the care in Gynecologic Oncology. By providing an alternative venue for patient accrual and site infrastructure support, GOG Partners has helped provide additional trials and opportunities for patients outside the national gynecologic clinical trials network.

About Endometrial Cancer

Endometrial cancer is the most common reproductive cancer affecting women within the United States, estimated to account for approximately 65,950 newly diagnosed cases in 2022. [ACS, 2022^a] Although the average age at diagnosis for women with endometrial cancer is 60 years, a proportion of patients are diagnosed prior to menopause. [ACS, 2022^a] Endometrial endometrioid adenocarcinoma is most commonly diagnosed when confined to the uterus, representing 67% of cases; however, the National Comprehensive Cancer Network (NCCN) reports that in 2017, 21% and 8% of cases were diagnosed as regional and distant diseases, respectively. [NCCN v1.2022^c]

Despite currently available treatment options, it was estimated that there would be nearly 12,550 endometrial cancer related deaths in the United States in 2022. [ACS, 2022^b] Unfortunately, women with metastatic and recurrent endometrial cancer have unfavourable prognosis, with an estimated 5-year survival rate of 20%. [ACS, 2022^b]

^aAmerican Cancer Society. Key Statistics for Endometrial Cancer. 2022, February 14. Accessed on August 4, 2022, from https://www.cancer.org/cancer/endometrial-cancer/about/key-statistics.html
^bAmerican Cancer Society. Survival Rates for Endometrial Cancer. 2022, February 28. Accessed August 3, 2022 from https://www.cancer.org/cancer/endometrial-cancer/detection-diagnosis-staging/survival-rates.html
^cNational Comprehensive Cancer Network. Uterine Neoplasms. Version 1.2022-November 4, 2021. Accessed on August 10, 2022, from https://www.nccn.org/professionals/physician_gls/pdf/uterine.pdf

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