Actuate Therapeutics, Inc.
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Public, Subsidiary
- Established
- 2015-01-01
- Employees
- 11
- Market Cap
- -
Elraglusib Shows Promise for Advanced Salivary Gland Carcinoma in Upcoming AACR Presentation
• Actuate Therapeutics will present Phase II clinical trial data on elraglusib, their GSK-3β inhibitor, for advanced salivary gland carcinoma at the AACR Annual Meeting 2025 in Chicago.
• Researchers report encouraging response rates in non-Adenoid Cystic Carcinoma patients with nuclear GSK-3β overexpression when elraglusib is combined with chemotherapy and immune priming.
• A separate presentation from Brown University's Legorreta Cancer Center will showcase synergistic effects of combining elraglusib with Jazz Pharmaceuticals' investigational compounds ONC206 and ONC212 for solid tumors.
Promising Pipeline for Soft Tissue Sarcoma Treatment Expands with 130+ Therapies in Development
• Global soft tissue sarcoma pipeline constitutes 125+ companies developing 130+ treatment therapies, with significant progress in clinical trials across various stages of development.
• FDA grants Orphan Drug Designation to Actuate Therapeutics' elraglusib for soft tissue sarcoma treatment, highlighting its potential to address unmet needs in this rare cancer.
• Novel approaches include tumor-targeting antibody-cytokine fusion proteins, intratumoral administration techniques, and GSK-3β inhibition, offering hope for improved outcomes in this challenging disease.
Actuate Therapeutics' Elraglusib Shows Promise in Pancreatic Cancer as IPO Lock-up Expires
• Interim results from Phase II trial demonstrate significant survival benefits for Elraglusib combined with gemcitabine/nab-paclitaxel in metastatic pancreatic cancer patients.
• Actuate Therapeutics plans FDA engagement in first half of 2025 to discuss Phase III registration trial, following encouraging Phase II data.
• Company's lead candidate Elraglusib is also advancing in pediatric cancer trials, with topline data expected in second half of 2025.
Elraglusib Receives EMA Orphan Drug Designation for Pancreatic Cancer Treatment
• Actuate Therapeutics' elraglusib, a GSK-3β inhibitor, has received Orphan Medicinal Product Designation (OMPD) from the EMA for pancreatic cancer.
• Elraglusib is currently in a Phase 2 trial for metastatic pancreatic cancer, showing promising interim results when combined with gemcitabine/nab-paclitaxel.
• The EMA's orphan drug designation provides potential benefits, including market exclusivity, reduced regulatory fees, and a centralized EU approval process.
• Actuate Therapeutics plans to report topline data from the Phase 2 trial in the first half of 2025 and collaborate with regulatory agencies to advance elraglusib.
Elraglusib Plus Chemotherapy Shows Promise in Metastatic Pancreatic Cancer
• Actuate Therapeutics' elraglusib combined with gemcitabine/nab-paclitaxel (GnP) significantly improved survival rates in metastatic pancreatic cancer patients.
• The Phase 2 trial showed a 43.6% one-year survival rate with elraglusib-GnP, compared to 22.5% with GnP alone, demonstrating a 37% reduction in death risk.
• The combination therapy also increased median overall survival to 9.3 months versus 7.2 months with GnP alone, with a favorable safety profile.
• Actuate plans to engage with the FDA in the first half of 2025 to discuss topline data and potential next steps for elraglusib's development.
Elraglusib Receives FDA Orphan Drug Designation for Soft Tissue Sarcoma
• Actuate Therapeutics' elraglusib, a novel GSK-3β inhibitor, has been granted Orphan Drug Designation by the FDA for soft tissue sarcoma (STS).
• The FDA's decision underscores elraglusib's potential to address the unmet medical needs of patients with advanced cancers, including STS.
• Elraglusib has demonstrated a favorable safety profile and antitumor activity across several solid tumors, including melanoma and pancreatic cancer.
• A phase 2 trial is underway evaluating elraglusib in combination with gemcitabine and docetaxel for advanced sarcomas.
Actuate Therapeutics' Elraglusib Shows Promise in Relapsed/Refractory Ewing Sarcoma Trial
• Actuate Therapeutics' elraglusib demonstrates anti-tumor activity in relapsed/refractory Ewing sarcoma (r/r EWS) patients, with two ongoing complete responses.
• The Phase 1/2 trial of elraglusib combined with cyclophosphamide/topotecan shows a disease control rate of approximately 62% in the first eight patients.
• Enrollment is ongoing for the study, with topline data expected in the first half of 2025, potentially paving the way for a Phase 2 trial.
• Elraglusib, a GSK-3β inhibitor, offers a novel targeted approach for r/r EWS, addressing a significant unmet need due to limited treatment options.
Elraglusib Receives FDA Orphan Drug Designation for Pancreatic Cancer Treatment
• The FDA has granted Orphan Drug Designation to elraglusib, a GSK-3β inhibitor, for the treatment of patients with pancreatic cancer, addressing a high unmet medical need.
• Elraglusib is currently being evaluated in phase 2 trials, both as a monotherapy and in combination with other agents like gemcitabine and nab-paclitaxel, for advanced pancreatic cancer.
• The Orphan Drug Designation provides Actuate Therapeutics with benefits including assistance in drug development, tax credits, and potential marketing exclusivity.
• Elraglusib targets molecular pathways involved in tumor growth and resistance to chemotherapy, showing promise as a novel therapeutic approach for pancreatic cancer.
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