Actuate Therapeutics' Innovative Trial Combines Elraglusib in Cancer Treatment

Exciting New Collaboration in Cancer Research

Actuate Therapeutics, Inc. (NASDAQ: ACTU) has announced a groundbreaking initiative in the fight against advanced pancreatic cancer. This esteemed biopharmaceutical company is embarking on a Phase 1b clinical trial that combines elraglusib, a novel GSK-3? inhibitor, with Incyte's PD-1 inhibitor, retifanlimab, and the chemotherapy regimen modified FOLFIRINOX (mFOLFIRINOX). This transformative study is set to take place at the UPMC Hillman Cancer Center, showcasing a collaborative effort aimed at improving treatment outcomes for patients with this challenging disease.

Understanding the Trial's Objectives

The open-label, single-arm RiLEY trial will initially involve the enrollment of up to 12 patients diagnosed with advanced pancreatic adenocarcinoma. The primary aim of this clinical trial is to establish the recommended phase 2 dose (RP2D) for this innovative combination of therapies. Meanwhile, secondary objectives will focus on assessing the overall response rate (ORR), disease control rate (DCR), median progression-free survival (mPFS), overall survival (OS), along with monitoring the safety and tolerability of the treatment.

A Synergistic Approach to Treatment

Dr. Anwaar Saeed, the study's lead investigator and an Associate Professor of Medicine at UPMC, expressed enthusiasm for this pioneering study. He noted the potential of elraglusib, alongside retifanlimab and mFOLFIRINOX, to create a synergistic immune-modulatory approach for patients battling advanced pancreatic cancer. Previous generations of immune checkpoint inhibitors have paved the way by effectively restoring anti-cancer immune responses, but this new combination may enhance those effects further. Evidence suggests that elraglusib can stimulate specific immune cells and improve overall anti-tumor activity.

Previous Successes with Elraglusib

Interestingly, elraglusib has already shown promise in earlier studies. A Phase 2 trial examining the drug in combination with gemcitabine/nab-paclitaxel for first-line treatment of metastatic pancreatic adenocarcinoma has yielded encouraging results. This trial met its primary endpoint, demonstrating a significant increase in median overall survival and a notable reduction in mortality risk, alongside enhanced immune responses among patients.

Innovative Therapies for Challenging Conditions

According to Daniel Schmitt, President and CEO of Actuate, the combination treatment represents a compelling strategy to address the significant unmet needs within the realm of advanced pancreatic adenocarcinoma. The collaboration with UPMC Hillman Cancer Center and Incyte sets the stage for exploring new, synergistic treatment opportunities, specifically for patients who have not yet undergone systemic therapy. This study aligns with Actuate's vision of optimizing elraglusib's efficacy through a multi-agent approach.

Future Directions in Research

In addition to the RiLEY trial, elraglusib is being investigated in another innovative Phase 2 study, assessing its effectiveness when combined with FOLFIRINOX and losartan for treatment-naïve patients. Initial data from this study indicates promising outcomes, particularly for patients with extensive liver metastases.

About Actuate Therapeutics, Inc.

Actuate Therapeutics is dedicated to the development of cutting-edge therapies targeting high-impact, hard-to-treat cancers. The company's lead investigational drug, elraglusib, is designed to inhibit crucial molecular pathways involved in tumor growth and resistance to traditional therapies, potentially offering new hope to patients with aggressive cancers. Through its commitment to innovative research and development, Actuate aims to change the landscape of cancer treatment.

Frequently Asked Questions

What is the objective of the Phase 1b trial?

The primary objective is to determine the recommended phase 2 dose for the combination of elraglusib, retifanlimab, and mFOLFIRINOX.

How many patients will be enrolled in the trial?

The trial will initially enroll up to 12 patients diagnosed with advanced pancreatic adenocarcinoma, with opportunities for expansion based on efficacy results.

What is elraglusib and how does it work?

Elraglusib is a novel GSK-3? inhibitor that targets molecular pathways promoting tumor growth and may also enhance anti-tumor immunity.

Where will the trial be conducted?

The trial is being conducted at the UPMC Hillman Cancer Center, in collaboration with Incyte Corporation.

What other studies is Actuate Therapeutics involved in?

Actuate is also involved in a Phase 2 trial investigating elraglusib in combination with FOLFIRINOX and losartan for treatment-naïve patients with metastatic pancreatic adenocarcinoma.

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