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About Actuate Therapeutics Inc.
Actuate Therapeutics Inc. (NASDAQ: ACTU) is a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for the treatment of high-impact, difficult-to-treat cancers. The company's primary focus is on targeting glycogen synthase kinase-3 beta (GSK-3β), a critical enzyme involved in tumor cell survival, immune resistance, and cancer progression. By inhibiting GSK-3β, Actuate aims to disrupt oncogenic signaling pathways, enhance the efficacy of conventional cancer treatments, and activate the immune system to combat tumors more effectively.
Lead Investigational Therapy: Elraglusib
Actuate's flagship investigational drug, elraglusib (formerly 9-ING-41), is a novel small molecule designed to inhibit GSK-3β. Elraglusib has demonstrated promising preclinical and early clinical results in various cancers, including pancreatic cancer, Ewing sarcoma, and soft tissue sarcoma. The drug works by targeting molecular pathways that promote tumor growth, resistance to chemotherapy, and immune evasion. Additionally, elraglusib acts as a mediator of anti-tumor immunity, regulating immune checkpoints and enhancing immune cell function.
Clinical Development and Regulatory Achievements
Actuate Therapeutics is advancing elraglusib through multiple clinical trials, including Phase 2 studies in metastatic pancreatic cancer and Ewing sarcoma. These trials aim to evaluate the drug's safety, efficacy, and potential to improve survival rates in patients with limited treatment options. The company has achieved significant regulatory milestones, including Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for soft tissue sarcoma and Rare Pediatric Disease Designation for Ewing sarcoma. These designations highlight elraglusib's potential to address unmet medical needs in rare and challenging cancer types.
Innovative Approach to Cancer Therapy
Actuate's approach to cancer therapy is rooted in targeting the GSK-3β enzyme, a master regulator of biological signaling cascades that influence tumor survival, growth, and metastasis. By inhibiting GSK-3β, elraglusib enhances the effectiveness of chemotherapy, disrupts tumor metabolism, and improves immune system activation. This multifaceted mechanism positions Actuate as a pioneer in leveraging GSK-3β inhibition to tackle cancers that are resistant to conventional treatments.
Market Position and Future Outlook
Operating in the competitive oncology drug development space, Actuate Therapeutics distinguishes itself through its focus on GSK-3β inhibition and its commitment to addressing high-impact cancers with limited therapeutic options. The company's success will depend on its ability to demonstrate clinical efficacy, secure regulatory approvals, and establish partnerships for commercialization. With a robust pipeline and a targeted approach to cancer therapy, Actuate is well-positioned to make a meaningful impact in oncology.
Key Highlights
- Clinical-stage biopharmaceutical company specializing in difficult-to-treat cancers.
- Lead investigational drug, elraglusib, targets GSK-3β to disrupt tumor growth and enhance immune response.
- Regulatory achievements include Orphan Drug and Rare Pediatric Disease Designations.
- Active clinical trials in metastatic pancreatic cancer, Ewing sarcoma, and soft tissue sarcoma.
- Innovative approach combining chemotherapy enhancement and immune system activation.
Actuate Therapeutics (NASDAQ: ACTU) announced the completion of patient enrollment in its Phase 2 trial of elraglusib combined with FOLFIRINOX and losartan for untreated metastatic pancreatic ductal adenocarcinoma (mPDAC). The trial, led by Dr. Colin Weekes at Massachusetts General Hospital and supported by the Lustgarten Foundation, enrolled 56 treatment-naïve mPDAC patients. Initial data presented at the AACR Special Conference in September 2024 showed early evidence of enhanced clinical activity. The primary objectives are to assess safety, tolerability, and progression-free survival. Final results are expected in 2026.
CEO Daniel Schmitt highlighted the milestone and noted the potential of elraglusib, citing interim Phase 2 data showing statistically significant improvements in 1-year and median overall survival when combined with gemcitabine/nab-paclitaxel (GnP). The trial involves additional sites, including The University of Colorado and the University of Washington’s Fred Hutchinson Cancer Center. Dr. Weekes expressed optimism about the trial's potential to improve treatment options for mPDAC patients.
Actuate Therapeutics (NASDAQ: ACTU), a clinical-stage biopharmaceutical company specializing in cancer therapies through GSK-3β inhibition, has announced its participation in two major investor conferences in February 2025.
The company's President & CEO, Daniel Schmitt, will attend the BIO CEO & Investor Conference on February 10, 2025, in New York, participating in the 'IPO Class of 2024 Panel' and offering one-on-one meetings with registered attendees.
Additionally, Actuate will be present at the B. Riley Precision Oncology & Radiopharma Conference on February 28, 2025, also in New York, where management will participate in a fireside chat and hold one-on-one meetings arranged through B. Riley representatives.
Actuate Therapeutics (NASDAQ: ACTU) has received European Medicines Agency (EMA) Orphan Medicinal Product Designation for elraglusib in treating pancreatic ductal adenocarcinoma (PDAC). This designation follows a similar FDA Orphan Drug Designation and recent positive interim Phase 2 trial results.
The interim analysis of the Phase 2 trial showed that elraglusib, combined with gemcitabine/nab-paclitaxel (GnP), demonstrated statistically significant improvements in both 1-year survival rate (p=0.002) and median overall survival (hazard ratio 0.63, p=0.016) compared to GnP alone in metastatic PDAC patients.
The EMA designation, granted for conditions affecting fewer than 2 in 10,000 EU residents, provides benefits including potential 10-year market exclusivity, reduced regulatory fees, and centralized EU approval process. The company expects to report topline Phase 2 data in first half of 2025.
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 demonstrated favorable safety profile with treatment-emergent adverse events similar to the control group. The objective response rate was 27.7% and disease control rate 42.6% in the combination arm versus 20.5% and 33.3% in the control arm. The trial enrolled 286 patients and continues with topline data expected in 1H 2025.
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.
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