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Actuate Therapeutics (NASDAQ: ACTU) announced promising data from a Phase 2 trial combining FOLFIRINOX with elraglusib and losartan for untreated metastatic pancreatic adenocarcinoma at the AACR Special Conference. The study highlights elraglusib's potential in overcoming FOLFIRINOX-induced chemoresistance through EMT downregulation.
Key findings include:
- Early evidence of increased clinical activity in the combination therapy
- Deep, durable responses observed in 3/6 patients with extensive liver metastases
- Promising safety profile and initial evidence of clinical activity
The ongoing trial (NCT05077800) will enroll up to 70 treatment-naïve patients, with primary objectives of determining safety, tolerability, and progression-free survival. Actuate supplies elraglusib, while the Lustgarten Foundation provides funding support.
Actuate Therapeutics (NASDAQ: ACTU) has received FDA Orphan Drug Designation (ODD) for elraglusib, their novel GSK-3β inhibitor, for the treatment of soft tissue sarcoma (STS). Elraglusib has shown promising results in multiple refractory cancer trials, demonstrating a favorable safety profile and antitumor activity across several solid tumors. The ODD underscores elraglusib's potential to address unmet medical needs in advanced cancers.
Key points:
- STS is projected to affect 13,590 new cases in the US in 2024
- Current treatments for metastatic STS are , with median overall survival of 6-12 months
- Elraglusib has shown significant STS cell apoptosis and synergistic effects with chemotherapy in preclinical studies
- ODD grants benefits including tax credits, FDA fee exemptions, and 7 years of post-approval marketing exclusivity
Actuate Therapeutics (NASDAQ: ACTU) provided an update on its Phase 1/2 trial of elraglusib in relapsed/refractory Ewing Sarcoma (r/r EWS). The study has shown promising results, with two ongoing durable complete responses and a ~62% disease control rate in the first 8 patients with r/r EWS and EWS-related sarcomas. The trial is evaluating elraglusib in combination with cyclophosphamide/topotecan. Notable outcomes include:
- Two patients with r/r EWS experiencing ongoing complete responses
- Two patients achieving stable disease
- One patient with Desmoplastic Small-Round-Cell Tumor achieving a partial response
Enrollment is ongoing, with topline data anticipated in 1H 2025. Actuate plans to meet with the FDA to discuss the design of a phase 2 study and options for accelerating elraglusib's development for EWS treatment.
Actuate Therapeutics (NASDAQ: ACTU), a clinical-stage biopharmaceutical company specializing in therapies for difficult-to-treat cancers, announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference in New York City. The conference will be held from September 9-11, 2024, with Actuate scheduled to present on Tuesday, September 10, 2024, at 4:00 PM ET.
The company's presentation will focus on its innovative approach to inhibiting glycogen synthase kinase-3 beta (GSK-3β), targeting cancers such as pancreatic cancer and Ewing sarcoma. The presentation will be available via webcast in the Investor section of Actuate's website. Additionally, Actuate's management team will be available for one-on-one meetings during the conference.
Actuate Therapeutics, Inc. (NASDAQ: ACTU), a clinical-stage biopharmaceutical company focused on developing therapies for difficult-to-treat cancers through GSK-3β inhibition, has announced that its President & CEO, Daniel Schmitt, will ring the Nasdaq opening bell on August 23, 2024. This ceremony marks the company's recent IPO and its new status as a Nasdaq-listed company.
The event, starting at approximately 9:15 am ET, will be held at the Nasdaq MarketSite Tower in New York City. Schmitt will be joined by members of Actuate's team, Board of Directors, Scientific Advisory Board, and guests. The ceremony will be live-streamed on Nasdaq's X and Facebook pages, allowing wider audience participation in this significant corporate milestone.
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