Actuate to Present Promising Data on Elraglusib in Advanced Salivary Gland Carcinoma at the AACR Annual Meeting 2025

Rhea-AI Summary

Actuate Therapeutics (NASDAQ: ACTU) will present significant data on their cancer drug elraglusib at the AACR Annual Meeting 2025 in Chicago from April 25-30. The presentation focuses on elraglusib's effectiveness in treating advanced salivary gland carcinoma when combined with chemotherapy and immunotherapy.

The first poster presentation (CT212) on April 29 will showcase elraglusib's performance as a GSK-3β inhibitor in advanced salivary cancers. Dr. Glenn Hanna from Dana Farber Cancer Institute reported encouraging response rates in non-Adenoid Cystic Carcinoma patients with nuclear GSK-3β overexpression.

Additionally, researchers from Brown University's Legorreta Cancer Center will present findings on April 28 demonstrating elraglusib's synergistic effects when combined with Jazz Pharmaceuticals' investigational compounds ONC206 and ONC212 for solid cancer treatment.

CHICAGO and FORT WORTH, Texas, April 17, 2025 (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 through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), today announced that data on elraglusib in advanced salivary gland carcinoma will be presented in a poster session at the American Association for Cancer Research (AACR) Annual Meeting 2025 taking place from April 25th – 30th at McCormick Place Convention Center, Chicago, IL. The abstracts will be published in the online Proceedings of the AACR.

Poster presentation details:
Title: Elraglusib, a glycogen synthase kinase 3 beta (GSK-3β) inhibitor, plus chemotherapy with or without immunotherapy for advanced salivary gland cancer
Session Title: Phase II Clinical Trials 2
Session Date and Time: April 29, 2025, 2:00 PM - 5:00 PM
Location: Poster Section 50
Abstract Presentation Number: CT212

"Elraglusib with chemotherapy and immune priming represents a novel sequential therapy approach to treat advanced salivary cancers. We were encouraged by the response rate among the non-Adenoid Cystic Carcinoma (ACC) population with nuclear GSK-3β overexpression given this difficult to treat and rare cancer type", said Dr. Glenn Hanna, Director of the Center for Cancer Therapeutic Innovation (CCTI), the early drug development program at Dana Farber Cancer Institute, who led the team conducting this clinical study.

Separately, an independent research group led by Dr. Wafik S El-Deiry from Legorreta Cancer Center at Brown University will present a poster demonstrating the synergistic effects of elraglusib in combination with ONC206 or ONC212, investigational compounds from Jazz Pharmaceuticals plc.

Poster presentation details:
Title: Elraglusib (9-ING-41), a glycogen synthase kinase-3β inhibitor in combination with imipridones for treatment of solid cancer
Session Title: Drug Combination Strategies for Cancer Treatment
Session Date and Time: April 28, 2025, 9:00 AM - 12:00 PM
Location: Poster Section Poster Section 19
Abstract Presentation Number: 1693

About Actuate Therapeutics, Inc.

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 promoting tumor growth and resistance to conventional cancer drugs such as chemotherapy through the inhibition of nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) and DNA Damage Response (DDR). Elraglusib may also mediate anti-tumor immunity through the regulation of multiple immune checkpoints and immune cell function. For additional information, please visit the Company’s website at http://www.actuatetherapeutics.com.

Forward-Looking Statements

This press release contains forward-looking statements about us, including our and other parties’ clinical trials and development plans, and our industry. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” or the negative of these terms or other comparable terminology are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. All statements, other than statements related to present facts or current conditions or of historical facts, contained in this press release are forward-looking statements. Accordingly, these statements involve estimates, assumptions, substantial risks and uncertainties which could cause actual results to differ materially from those expressed in them, including but not limited to that clinical and preclinical drug development involves a lengthy and expensive process with uncertain timelines and outcomes, results of prior preclinical studies and early clinical trials are not necessarily predictive of future results, and elraglusib may not achieve positive clinical results or favorable preclinical results or receive regulatory approval on a timely basis, if at all; that we may not successfully enroll additional patients or establish or advance plans for further development, including through conversations with the FDA or EMA and the standards such bodies may impose for such development; that elraglusib could be associated with side effects, adverse events or other properties or safety risks, which could delay or preclude regulatory approval, cause us to suspend or discontinue clinical trials or result in other negative consequences; preliminary and unpublished data may be subject to change following the availability of more data or following a more comprehensive review of the data and should not be relied upon as a final analysis; our reliance on third parties to conduct our non-clinical studies and our clinical trials and that third party studies reflect parameters and circumstances that are not established by us; our reliance on third-party licensors and ability to preserve and protect our intellectual property rights; that we face significant competition from other biotechnology and pharmaceutical companies; our ability to fund development activities, including because our financial condition raises substantial doubt as to our ability to continue as a going concern and we will require substantial additional capital to finance our operations, and a failure to obtain this necessary capital in the near term on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our development programs, commercialization efforts or other operations. In addition, any forward-looking statements are qualified in their entirety by reference to the factors discussed under the heading “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 13, 2025 and other filings with the SEC. Because the risk factors referred to above could cause actual results or outcomes to differ materially from those expressed in any forward-looking statements made by us or on our behalf, you should not place undue reliance on any forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made. New factors emerge from time to time, and it is not possible for us to predict which factors will arise. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Unless legally required, we do not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events.

Investor Contact
Mike Moyer
Managing Director
LifeSci Advisors, LLC
mmoyer@lifesciadvisors.com

FAQ

What are the key findings of Actuate's (ACTU) elraglusib trial in salivary gland cancer?

The trial showed promising response rates in non-Adenoid Cystic Carcinoma patients with nuclear GSK-3β overexpression, using elraglusib combined with chemotherapy and immunotherapy.

When and where will Actuate (ACTU) present their elraglusib data at AACR 2025?

The data will be presented on April 29, 2025, from 2:00 PM - 5:00 PM at McCormick Place Convention Center, Chicago, in Poster Section 50 (Abstract CT212).

What is the mechanism of action for Actuate's (ACTU) elraglusib?

Elraglusib works as a glycogen synthase kinase-3 beta (GSK-3β) inhibitor, targeting difficult-to-treat cancers.

What new combination therapy is being studied with Actuate's (ACTU) elraglusib?

Researchers are studying elraglusib's combination with Jazz Pharmaceuticals' compounds ONC206 and ONC212 for solid cancer treatment.

How is Actuate (ACTU) approaching the treatment of advanced salivary cancers?

Actuate is using a novel sequential therapy approach combining elraglusib with chemotherapy and immune priming for advanced salivary cancers.