Actuate Therapeutics, Inc. - ACTU STOCK NEWS

Actuate Therapeutics (NASDAQ: ACTU) announced positive interim Phase 2 data for elraglusib combined with gemcitabine/nab-paclitaxel (GnP) in first-line treatment of metastatic pancreatic cancer. The trial met statistical significance on primary endpoints, showing a 43.6% one-year survival rate versus 22.5% in the control group (p=0.002) and a 37% reduction in death risk. Median overall survival increased to 9.3 months compared to 7.2 months in the control arm.

The study enrolled 286 patients randomized 2:1, demonstrating improved objective response rates (27.7% vs 20.5%) and disease control rates (42.6% vs 33.3%). Multiple patients achieved complete or partial responses with 100% reduction in target lesions. The treatment showed a favorable safety profile, with adverse events similar to the control group. Topline data is expected in 1H 2025.

Actuate Therapeutics (NASDAQ: ACTU), a clinical-stage biopharmaceutical company developing therapies for difficult-to-treat cancers, announced its upcoming addition to the Russell 2000® Index. The inclusion will be effective after U.S. market opens on December 23, 2024, as part of the fourth quarter IPO additions. The Russell 2000® Index, representing approximately 10% of the Russell 3000® Index's total market capitalization, measures the performance of the U.S. equity market's small-cap segment and includes about 2,000 of the smallest securities.

Actuate Therapeutics (NASDAQ: ACTU) announced that the FDA has granted rare pediatric disease designation to elraglusib, their GSK-3β inhibitor for treating Ewing sarcoma (EWS). The ongoing Phase 1/2 trial has shown promising results, including two durable Complete Responses in the first six patients with relapsed/refractory EWS. The trial has enrolled 8 patients treated with elraglusib combined with topotecan/cyclophosphamide. Topline Phase 1 data is expected in 2H 2025.

This designation makes Actuate eligible for a Priority Review Voucher upon marketing approval. EWS is the second most common primary malignant tumor in children and adolescents, with 25% of new patients having metastatic disease at diagnosis.

Actuate Therapeutics (NASDAQ: ACTU) announced its participation in Lantern Pharma's 'Webinar Wednesday' on October 30, 2024. The webinar will feature Andrew Mazar, Ph.D., Actuate's Chief Operating Officer, and Joseph McDermott, Ph.D, Lantern's computational biologist, discussing their multi-year collaboration focused on accelerating the development of elraglusib, Actuate's lead drug candidate.

The collaboration aims to identify and develop enrichment biomarkers for elraglusib, a GSK-3β inhibitor currently in Phase 2 trials for metastatic pancreatic cancer and Phase 1/2 trials for Ewing Sarcoma and related sarcomas.

Actuate Therapeutics (NASDAQ: ACTU) has announced the publication of novel mechanistic data for its development candidate, elraglusib, in Scientific Reports. The study, titled "Targeted inhibition of glycogen synthase kinase‑3 using 9‑ING‑41 (elraglusib) enhances CD8 T‑cell‑reactivity against neuroblastoma cells," reveals elraglusib's potential as an immune modulator in neuroblastoma treatment.

Key findings include:

• Elraglusib enhances MHC-I molecule surface expression on neuroblastoma cells
• It disrupts NK-κB signaling, promoting cancer cell apoptosis
• Boosts IFNγ signaling through the JAK/STAT pathway
• When combined with anti-PD-1 treatment, it enhances CD8+ T cell proliferation and activation

These insights suggest elraglusib's potential to activate the immune system in cancers previously unresponsive to checkpoint inhibitors. Elraglusib is currently in Phase 2 trials for metastatic pancreatic cancer and Phase 1/2 trials for Ewing Sarcoma and related sarcomas.

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.