Actuate Therapeutics Announces Initiation of a Multicenter Randomized Trial of Elraglusib Plus FOLFIRINOX As First Line Therapy for Advanced Pancreatic Cancer

Elraglusib will be combined with FOLFIRINOX alone or with Losartan in multi-center Phase 2 clinical study initiated at Massachusetts General Hospital, Fred Hutchinson Cancer Research Center, University of Colorado, Denver, and Johns Hopkins University with study funding provided by the Lustgarten Foundation for Pancreatic Cancer Research

CHICAGO and FORT WORTH, Texas, Feb. 07, 2022 (GLOBE NEWSWIRE) — Actuate Therapeutics, Inc. (Actuate), a clinical stage biopharmaceutical company, today announced the opening of a randomized study of elraglusib (9-ING-41) plus FOLFIRINOX alone or with Losartan for patients with advanced pancreatic cancer in the first-line setting (NCT05077800). Elraglusib is Actuate’s proprietary small molecule glycogen synthase kinase-3 beta (GSK-3β) inhibitor which is being developed for adults and children with advanced refractory cancers. This multicenter investigator-initiated study, which is receiving substantial support from the Lustgarten Foundation for Pancreatic Cancer Research, is being led by Colin D. Weekes MD at the Massachusetts General Hospital and will also enroll patients at the University of Washington, University of Colorado Denver, and Johns Hopkins University.

“Novel approaches for patients with advanced pancreatic cancer are urgently required,” said Dr Weekes. “The pre-clinical and clinical data being generated with elraglusib in a spectrum of cancers, including pancreatic cancer, is extremely encouraging and we are delighted to have initiated this study with elraglusib. Elraglusib is the first clinically relevant specific GSK-3β inhibitor that we can thoroughly investigate. In preclinical models, elraglusib has multiple biologic effects relevant to targeting pancreatic cancer including direct cytotoxicity, reversal of chemoresistance, reversal of pathologic fibrosis, and there is increasing evidence of its immune-modulatory activity. In our study, we are particularly focused on elraglusib’s potential to synergize with TGF-β suppression mediated by Losartan. This study builds on the work of our investigative teams demonstrating the roles of TGF-β and GSK-3β in acquired chemotherapy resistance. This study uniquely attempts to harness the mechanisms that pancreatic cancer utilizes to combat the effects of chemotherapy as an Achilles heel for therapeutic intent. We believe that a multi-pronged attack as represented by elraglusib plus Losartan is a potentially sophisticated approach to a complex, often lethal, situation. It is an honour to lead this multicenter collaboration with my clinical and pre-clinical colleagues across the US and Europe. We are very grateful for the critical support of this program by the Lustgarten Foundation.”

“At the Lustgarten Foundation, we understand time is everything for patients and their families,” said Andrew Rakeman, PhD, VP of Research. “Dr. Weekes’ study will help us understand and address a critical issue in pancreatic cancer treatment—acquired chemotherapy resistance. This trial builds on exciting observations from previous preclinical and clinical research. The Foundation established the Clinical Accelerator Initiative for projects like this; bringing more trials based on the best science to the clinic and expanding our understanding of pancreatic cancer biology and treatment. We believe Dr. Weekes’ trial and others like it have the potential to change the way we think about treating pancreatic cancer, ultimately transforming it into a curable disease.”

“We are honored and excited to collaborate with Dr. Weekes, his colleagues at world-leading cancer research centers, and the Lustgarten Foundation on this important trial, which will advance the development of elraglusib for treating patients with one of the most challenging types of cancer,” said Daniel Schmitt, Actuate’s President & CEO. “The results we have seen to date with elraglusib combined with chemotherapy in pancreatic cancer are very promising, and this Phase 2 trial in combination with FOLFIRINOX leverages significant positive preclinical and clinical experience for potentially better outcomes for patients.”

Based on positive data from a prior Phase 2 open-label single arm study of elraglusib plus gemcitabine/nab-paclitaxel, Actuate has also recently initiated an international randomized controlled study of elraglusib in combination with gemcitabine/nab-paclitaxel, in patients with advanced pancreatic cancer in the first-line setting (NCT03678883, EudraCT#:2018-003739-32). Actuate is also conducting studies in pediatric patients with refractory tumors in preparation for a neuroblastoma-specific clinical program (NCT04239092). Actuate is also collaborating with investigators at the Dana-Farber Cancer Institute and Brigham and Women’s Hospital on a Phase 2 study focused on elraglusib combined with cytotoxic therapy for patients with advanced salivary gland carcinomas (NCT05010629).

About Actuate Therapeutics, Inc.
Actuate is a clinical stage pharmaceutical company focused on the development and commercialization of novel therapeutics for cancers and inflammatory diseases. For additional information, please visit the Company’s website at http://www.actuatetherapeutics.com.

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Actuate Therapeutics, Inc.
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