Actuate Therapeutics to Present Promising Preclinical Data Demonstrating Antitumor and Immune Activation Activity of Elraglusib Oral Tablet in Advanced Melanoma Models at ENA 2026

- Oral tablet formulation of elraglusib as a monotherapy significantly inhibited tumor growth and enhanced antitumor immune activity in an aggressive, poorly immunogenic melanoma model

- Phase 1/2 clinical trial evaluating Elraglusib Oral Tablet to be initiated in Q1 2027

CHICAGO and FORT WORTH, Texas, Nov. 04, 2026 (GLOBE NEWSWIRE) -- Actuate Therapeutics, Inc. (NASDAQ: ACTU) (“Actuate” or the “Company”), a clinical-stage biopharmaceutical company, focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers, today announced that new preclinical data evaluating oral elraglusib will be presented in a poster at the 38th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics (ENA 2026), taking place November 18-20, 2026, in Barcelona, Spain.

The study evaluated Elraglusib Oral Tablet as a single agent in the B16F10 syngeneic melanoma model, a poorly immunogenic, rapidly growing and highly aggressive tumor model. Daily oral administration of elraglusib significantly inhibited tumor growth and demonstrated favorable tolerability. Tumor immunophenotyping demonstrated that elraglusib treatment increased the accumulation of CD8+ T cells and natural killer (NK) cells within tumors while decreasing myeloid-like tumor suppressor cells (Ly6G+ neutrophil/PMN-MDSC-like) associated with an immunosuppressive tumor microenvironment.

The findings provide the first in vivo evidence of both direct antitumor activity and immunomodulatory effects of Elraglusib Oral Tablet in an immunocompetent mouse tumor model, suggesting that treatment can alter the tumor microenvironment dynamics from a less myeloid-suppressive state toward a more active immune state.

“This preclinical work further supports the mechanism of action for elraglusib and demonstrates that the higher exposures achieved with daily dosing of the Elraglusib Oral Tablet elicit direct antitumor activity and favorable immune cell dynamics within the tumor microenvironment, leading to robust inhibition of tumor growth in this aggressive B16F10 melanoma model,” said Daniel Schmitt, President and Chief Executive Officer of Actuate Therapeutics. “We believe these findings, including the reduction of myeloid-mediated immune suppression that makes poorly immunogenic tumors difficult to treat, support advancing elraglusib tablets into clinical studies as a single agent in patients with refractory metastatic melanoma.”

The poster will be available on Actuate’s website following its presentation at the symposium.

In May 2026, the U.S. Food and Drug Administration cleared Actuate's Investigational New Drug application for a Phase 1/2 study of oral elraglusib tablets in patients with advanced solid tumors. The study is planned for initiation in early 2027, initially focusing on treatment of patients with metastatic melanoma as a monotherapy, with potential to expand the trial into treatment of patients with non-small cell lung cancer, colorectal cancer, and pancreatic cancer.

Elraglusib has previously been evaluated as an IV formulation in other cancers, including clinical studies in patients with metastatic pancreatic ductal adenocarcinoma, Ewing Sarcoma and refractory neuroblastoma.

Actuate is a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers. Actuate’s lead investigational drug, elraglusib (a novel GSK-3β inhibitor), targets molecular pathways in cancer that are involved in activation of anti-tumor immunity through the regulation of multiple immune checkpoints and immune cell function in addition to targeting those promoting tumor growth and resistance to conventional chemotherapy.

For additional information, please visit the Company’s website at www.actuatetherapeutics.com or follow us on LinkedIn, X, and Facebook.

This press release contains forward-looking statements under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including statements regarding the expectations for the planned Phase1/2 clinical study of the Elraglusib Oral Tablet based on the results of the Company’s preclinical B16F10 syngeneic melanoma model study; the anticipated timing and design of a Phase 1/2 clinical trial of the Elraglusib Oral Tablet, and the potential benefits of oral elraglusib, including its potential to enhance antitumor activity, improve patient convenience and expand therapeutic applications. Forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially, including (i) success in early phases of preclinical clinicals trials do not ensure later clinical trials will be successful, (ii) the risk that we may not be able to commence or complete our expected Phase 1/2 trial of Elraglusib Oral Tablet or, if we can, that the Phase 1/2 trial may not produce positive results; (iii) the risk that the Company may not be able to obtain additional working capital with which to complete the Phase 1/2 clinical trial, or advance to the initiation of registration-enabling studies, for Elraglusib Oral Tablet as and when needed and (iv) those other risks disclosed under the caption “Risk Factors” in Actuate’s Annual Report of Form 10-K filed with the Securities and Exchange Commission on March 26, 2026 and in Actuate’s subsequent filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. Actuate does not undertake and specifically disclaims any obligation to update or revise such statements to reflect new circumstances or unanticipated events as they occur, except as required by law.