Actuate Therapeutics to Host KOL Event on Topline Phase 2 Data of Elraglusib in Metastatic Pancreatic Ductal Adenocarcinoma During ASCO Annual Meeting
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Insights
Actuate's upcoming Phase 2 data for elraglusib in metastatic pancreatic cancer represents a potential new approach in a disease with dismal outcomes.
The Phase 2 trial (Actuate-1801 Part 3B) examines elraglusib plus gemcitabine/nab-paclitaxel (GnP) versus GnP alone in 286 previously untreated metastatic pancreatic ductal adenocarcinoma patients randomized 2:1. The study's primary endpoint - 1-year survival rate - addresses a critical metric in a disease where median survival rarely exceeds one year with current standards of care.
Mechanistically, elraglusib's inhibition of glycogen synthase kinase-3 beta (GSK-3β) represents a novel approach. Per the release, this inhibition may work through multiple complementary pathways: enhancing chemotherapy efficacy, activating anti-tumor immunity, and regulating gene expression affecting tumor metabolism and epithelial-mesenchymal transition.
The trial design includes appropriate secondary endpoints: disease control rate, objective response rate, progression-free survival, and adverse events. These provide comprehensive evaluation of both efficacy and safety signals.
The selection for oral presentation at ASCO rather than poster format indicates the abstract was deemed significant by the selection committee. Additionally, the companion biomarker presentation suggests Actuate is exploring predictive models to identify patients most likely to benefit - a critical consideration in modern oncology drug development.
The assembly of KOLs from prestigious institutions (Mayo Clinic, Northwestern, University of Arizona, and Massachusetts General Hospital) for post-presentation discussion reflects genuine clinical interest in this therapeutic approach, though their participation doesn't necessarily indicate endorsement of results.
- Fireside discussion to explore clinical impact of the topline Phase 2 data in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC) to be presented at ASCO
- In-person event and virtual webcast to be held on Saturday, May 31, 2025, at 6:30 pm CDT
CHICAGO and FORT WORTH, Texas, May 07, 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 it will host an in-person key opinion leader (KOL) event, during the 2025 American Society of Clinical Oncology (ASCO) annual meeting, to discuss the elraglusib topline clinical data from the randomized Phase 2 study (Actuate-1801 Part 3B).
The event will feature a fireside discussion moderated by Daniel Schmitt, President & Chief Executive Officer of Actuate, and will include four distinguished KOLs: Tanios Bekaii-Saab, MD, FACP, Mayo Clinic College of Medicine and Science, Devalingam Mahalingam, MD, Northwestern University Feinberg School of Medicine, Rachna Shroff, MD, MS, FASCO, University of Arizona Cancer Center, and Colin Weekes, MD, PhD, Massachusetts General Hospital.
The discussion will focus on the clinical relevance and potential impact of the study’s findings on current treatment paradigms, offering expert insights into how these results may shape future therapeutic strategies in mPDAC for patients and clinicians.
| Event Details: | |
| Date and Time: | Saturday, May 31, 2025, at 6:30 pm CDT |
| Format: | In-person and via live webcast |
| Registration: | Click here |
| A reply of the event will be available on the Investor Relations section of the Actuate website. | |
Featured Speakers
Tanios Bekaii-Saab, MD
Mayo Clinic
Dr. Bekaii-Saab is the David F. and Margaret T. Grohne Professor of Novel Therapeutics for Cancer Research at the Mayo Clinic College of Medicine and Science. He is the Chairman for the Division of Hematology/Medical Oncology at the Mayo Clinic in Phoenix, AZ. He is the co-leader of the Advanced Clinical and Translational Science Program and the Disease Group Leader for Gastrointestinal Cancers for the Enterprise-wide Mayo Clinic Cancer Center. Dr. Bekaii-Saab conducts clinical and translational research focused on developing anticancer agents for patients with gastrointestinal cancers. He earned his MD from the American University of Beirut in Lebanon and completed a residency in internal medicine at Indiana University Medical Center in Indianapolis. He then completed fellowships in clinical pharmacology and experimental therapeutics and hematology/oncology at Tufts University/New England Medical Center in Boston, Massachusetts, USA. Prior to joining Mayo, Dr. Bekaii-Saab was a fully tenured professor of Medicine and Pharmacy at the Ohio State University/ James Cancer Hospital.
Devalingam Mahalingam, MD, PhD
Northwestern University Feinberg School of Medicine
Dr. Mahalingam is a professor of medicine, a gastrointestinal oncologist, and clinical researcher at the Robert H. Lurie Comprehensive Cancer Center at Northwestern University. He currently serves as the Director of the Clinical Trials Office, Director for the Developmental Therapeutics (DT) Clinical Research Unit, and the DT Fellowship program. His passion for drug development and prior PhD in the field of apoptosis/autophagy have helped him to translate pre-clinical experiences into early clinical trials. He designed and executed multiple investigator-initiated clinical studies based on translational research in a variety of GI malignancies. To date, he has served as Principal Investigator on approximately 50 clinical trials, authored or co-authored over 100 manuscripts, and has been successful in obtaining NIH/NCI funding in various interventional therapeutic trials.
Rachna T. Shroff, MD, MS, FASCO
Arizona Cancer Center
Dr. Shroff is the Chief of Hematology and Oncology, Professor of Cancer Biology at the University of Arizona Cancer Center. She leads the GI Clinical Research Team and serves as associate director, clinical investigations for the University of Arizona. Dr. Shroff is a clinical and translational investigator focused on developing novel therapies for pancreatic and hepatobiliary cancers. She led numerous clinical trials focusing on pancreaticobiliary tumors and is the national PI for SWOG 1815, which investigated a triplet chemotherapy regimen as a potential new standard of care for biliary cancers. [Dr. Shroff holds multiple positions nationally, including as the Hepatobiliary Subcommittee co-chair for the Southwest Oncology Group (SWOG) and as Chair for GI ASCO 2024. Currently, she also is the co-moderator for the AACI Associate Director roundtable meetings and has represented the CRI team with industry partners for discussions at ASCO and AACR. She is also a member of the Scientific and Medical Advisory Board for the Cholangiocarcinoma Foundation.
Colin Weekes, MD
Massachusetts General Hospital
Dr. Colin Weekes is a medical oncologist specializing in gastrointestinal malignancies in the Tucker Gosnell Center for Gastrointestinal Cancers at the Massachusetts General Hospital Cancer Center, where he is also the Director of Medical Oncology Research for Pancreatic Cancer. He is the inaugural incumbent Christopher D. Horner Endowed Chair in Pancreatic Cancer. He is an Associate Professor at the Harvard Medical School. Dr. Weekes’ translational research career has focused on early drug development in gastrointestinal malignancies with a focus on pancreatic cancer. He has worked to translate laboratory findings into clinical strategies to improve the outcomes for patients with pancreatic cancer. Much of his translational research has led to the development of strategies to target various components of the tumor microenvironment and the consequent cellular signal transduction as a therapeutic strategy. In addition, Dr. Weekes has a longstanding interest in the equitable participation of patients of diverse backgrounds in clinical trials.
ASCO Presentation Details:
Abstract Title: Preliminary results from the randomized phase 2 study (1801 part 3B) of elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) versus GnP alone in patients (pts) with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC).
Abstract Number: 4006
Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Oral Presentation Date and Time: Saturday, May 31, 2025, 4:48 PM CDT
In addition to presenting Phase 2 data, the company will showcase a poster highlighting the potential of biomarker-driven prediction models for overall survival and patient enrichment in mPDAC.
Abstract Title: Machine learning and statistical prediction of overall survival (OS) from pre-dose plasma biomarkers in a randomized phase 2 trial (1801 Part 3B) of the GSK-3 inhibitor elraglusib in metastatic pancreatic ductal adenocarcinoma (mPDAC): Application toward patient enrichment.
Abstract Number: 4185
Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Poster Presentation Date and Time: Saturday, May 31, 2025, 9:00 AM – 12:00 PM CDT
The full, final text of the abstracts will be available at 5:00 PM ET on May 22, 2025
The Actuate-1801 Part 3B study (NCT03678883) is a randomized, controlled Phase 2 trial of elraglusib with GnP versus GnP alone in first-line mPDAC. The trial enrolled 286 mPDAC patients with no prior systemic treatment for metastatic disease, who were randomized 2:1 to the elraglusib treatment arm (elraglusib + GnP) or the control arm (GnP alone). Elraglusib is administered at a dose of 9.3 mg/kg by IV infusion on Day 1 of each week of a 28-day cycle. The primary endpoint is 1-year survival rate, with mOS the primary parameter for summarization of survival data at the end of the study. Secondary endpoints are DCR, ORR, PFS and AE.
Inhibition of GSK-3β may inhibit tumor growth and improve survival through several complimentary mechanisms that include enhancement of chemotherapy activity, activation of innate anti-tumor immunity, and regulation of gene expression, leading to alterations in tumor metabolism and Epithelial-to-Mesenchymal Transition (EMT).
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 preliminary and unpublished data may be subject to change and further interpretation 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; 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; our reliance on third parties to conduct our non-clinical studies and our clinical trials; 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 require additional capital to finance our operations beyond the second quarter of fiscal year 2025, 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
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