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We are a clinical biotech company developing GSK-3 inhibitor drugs to treat metastatic pancreatic cancer. (Incorporated in Delaware)
We are focused on developing therapies for the treatment of high impact, difficult to treat cancers through the inhibition of glycogen synthase kinase-3 (GSK-3). We are developing elraglusib (formerly 9-ING-41), a small molecule that is designed to enter cancer cells and block the function of the enzyme GSK-3β, a master regulator of complex biological signaling cascades, including those mediated by oncogenes, that lead to tumor cell survival, growth, migration, and invasion. We believe that the blockade of GSK-3β signaling ultimately results in the death of the cancer cells and the regulation of anti-tumor immunity.
We have exclusively licensed a portfolio of GSK-3 inhibitors developed in a collaboration between the University of Illinois-Chicago (UIC) and Northwestern University (NU).
The lead drug in our portfolio is called elraglusib (9-ING-41), which is being evaluated in a randomized Phase 2 trial in patients with metastatic pancreatic cancer, our most advanced clinical indication to date.
Our lead program, Elraglusib Injection, is an intravenous solution of elraglusib that we are evaluating to treat patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). The study’s objective was to establish the safety profile of elraglusib when used alone or in combination with chemotherapy and to identify either a maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) to then inform the design of exploratory efficacy studies in Phase 2. Subjects in this study were diagnosed with a variety of cancer types and most patients had received two or more previous lines of chemotherapy prior to enrollment in the study.
Elraglusib is currently being evaluated as a weekly intravenous (IV) infusion in combination with the approved dosing regimen for GnP. This study completed enrollment four months faster than predicted and top line results are expected in the first quarter of 2025.
According to the American Cancer Society, the annual incidence of pancreatic cancer is expected to exceed 66,000 patients in the United States this year and approximately 70% of these patients will present with metastatic disease. The mOS in patients with mPDAC is 9-11 months and the ability to extend survival by even a few months would be considered meaningful in this patient population. Elraglusib has been granted Fast Track and Orphan Drug Designations from the U.S. Food and Drug Administration (FDA) for pancreatic cancer in the United States.
We have developed several oral dosage forms of elraglusib, including an oral liquid (Elraglusib Oral Liquid) and several solid dosage forms, including an Elraglusib Oral Tablet product candidate, which we believe will allow us to expand the number of cancer indications that we are able to target and allow us to further explore optimal dosing. A Phase 1 healthy volunteer study (Actuate-2203) was completed showing very favorable (>50%) bioavailability after a single dose of Elraglusib Oral Liquid. A clinical candidate tablet (Elraglusib Oral Tablet) has been developed and selected. Subject to our receipt of the proceeds of this offering, the Elraglusib Oral Tablet, manufactured under current Good Manufacturing Practices (cGMP), is expected to be released and available in the third quarter of 2024 and a first in human dose escalation study using Elraglusib Oral Tablet could begin in the fourth quarter of 2024. We are planning a Phase 1 study (Actuate-2401) to identify the MTD/ RP2D for Elraglusib Oral Tablet in patients with advanced, refractory adult cancers subject to our receipt of the proceeds of this offering. Several Phase 2 indications, including refractory, metastatic melanoma and refractory, metastatic colorectal cancer, have been identified for further clinical development of the Elraglusib Oral Tablet, based on data from the Actuate-1801 study once the MTD/RP2D for the oral tablet has been established, and which will require additional funds to complete these Phase 2 studies.
Our current pipeline consists of a “pipeline in a molecule” for elraglusib, which is being evaluated in mPDAC and pediatric malignancies. We are currently focused on advancing our trials in pancreatic cancer with Elraglusib Injection.
Note: Net loss and revenue are for the 12 months that ended March 31, 2024.
(Note: Actuate Therapeutics slightly downsized its IPO at pricing – to 2.8 million shares, down from 2.95 million shares in the prospectus – and priced the IPO at $8.00 – the low end of its $8.00-to-$10.00 price range – to raise $22.4 million on Monday night, Aug. 12, 2024.)
(Note: Actuate Therapeutics increased the size of its small-cap IPO to 2.95 million shares (2,950,000 shares) – up from 2.78 million shares – and kept the price range at $8.00 to $10.00 – to raise $26.55 million, according to an S-1/A filing dated July 23, 2024. Background: Actuate Therapeutics cut its small-cap IPO in half to 2.78 million shares (2,777,778 shares) – down from 5.56 million shares – and kept the price range at $8.00 to $10.00 – to raise $25.0 million, according to an S-1/A filing dated July 19, 2024. Background: Actuate Therapeutics, a Fort Worth, Texas-based biotech, filed its S-1 on May 24, 2024 – following its confidential IPO filing on March 4, 2024.)
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