Actuate Therapeutics Publishes New Data on Elraglusib Combined with Chemotherapy for Salivary Gland Cancer
Actuate Therapeutics announced the publication of new data in Clinical Cancer Research from a Phase II study evaluating elraglusib in combination with carboplatin or cisplatin in patients with advanced, metastatic salivary gland cancers, including adenoid cystic carcinoma and other subtypes. The peer-reviewed paper is entitled "Elraglusib, a Glycogen Synthase Kinase 3beta Inhibitor, plus Chemotherapy with or without Immunotherapy in Patients with Recurrent, Metastatic Salivary Gland Carcinoma,". Elraglusib is a small-molecule inhibitor of GSK-3beta with immune-modifying properties that disrupts multiple cellular signaling pathways, inhibits tumor growth, and increases sensitivity to chemotherapy. This phase II clinical trial evaluated elraglusib combined with platinum chemotherapy in patients with advanced, metastatic salivary gland cancer, including both adenoid cystic carcinoma and non-ACC subtypes, with one cohort receiving sequential immune checkpoint inhibitor priming. A key finding in this study was that nuclear GSK-3beta expression was significantly higher in responders than non-responders. Across the 32-patient study population, median progression-free survival was 6.4 months, with 27% of patients progression-free at 1 year. Additionally, median overall survival reached 18.6 months for the entire cohort and 27.8 months among non-ACC patients, with 40% of all patients alive at 2 years. Key Highlights and Readouts: Both adenoid cystic carcinoma and non-ACC patients were enrolled, with a total enrollment of 32 patients, in partnership with the Center for Head and Neck Oncology at Dana-Farber Cancer Institute in Boston, Massachusetts. Median OS was 18.6 months. At 1 year, 58% of patients were alive; at 2 years, 40% remained alive. Non-ACC patients had a median OS of 27.8 months. Median PFS was 6.4 months; 27% of patients remained progression-free at 1 year. Historical PFS for this population is estimated at 4-9 months for ACC and less than6 months for non-ACC. Three patients, all of whom were non-ACC and had PD-L1 scores less than1%, had Partial Responses, indicating responses occurred despite low tumor immunogenicity. The median duration of response was 6.9 months. Two of three responders had CDKN2A/B and MTAP co-deletion, a molecular profile that typically predicts poor response to chemotherapy and immunotherapy-suggesting elraglusib may provide added benefit in this subgroup. Median nuclear GSK-3beta expression was 50% in responders vs. 2% in non-responders. Patients with above-median nGSK-3beta expression had longer median PFS and numerically longer OS. The combination was well tolerated: no treatment-related deaths occurred, and only 6% were discontinued due to toxicity. The most common treatment-related adverse events were anemia, nausea, and neutropenia.
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Actuate Therapeutics Announces Encouraging Phase II Results for Salivary Gland Cancers
Positive Study Results: Actuate Therapeutics reported favorable outcomes from a Phase II study of elraglusib combined with carboplatin or cisplatin for advanced metastatic salivary gland cancers, showing a median overall survival of 18.6 months.
Patient Demographics and Survival Rates: The study included 47% adenoid cystic carcinoma (ACC) and 53% non-ACC patients, with non-ACC patients experiencing a median overall survival of 27.8 months.
Progression-Free Survival: The median progression-free survival was 6.4 months, with only 27% of patients remaining progression-free at one year, contrasting with historical estimates for ACC and non-ACC.
Market Reaction: Following the announcement, Actuate shares increased by over 4% in pre-market trading, closing at $7.52, reflecting a 1.35% rise from the previous day.
HC Wainwright & Co. Affirms Buy Rating for Actuate Therapeutics, Keeps $20 Price Target Intact
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Actuate Therapeutics Reveals Pricing for $15.0 Million Public Stock Offering
Public Offering Announcement: Actuate Therapeutics, Inc. has priced an underwritten public offering of 2,142,858 shares of common stock at $7.00 per share, aiming to raise approximately $15 million for working capital and corporate purposes.
Use of Proceeds: The company plans to utilize the net proceeds from the offering for general corporate needs, with the offering expected to close on September 11, 2025, pending customary closing conditions.
Company Focus: Actuate Therapeutics is a clinical-stage biopharmaceutical company developing therapies for challenging cancers, with its lead drug, elraglusib, targeting pathways that promote tumor growth and resistance to conventional treatments.
Forward-Looking Statements: The press release includes forward-looking statements regarding the offering's timing and completion, emphasizing the inherent risks and uncertainties that could affect actual results.
Actuate Therapeutics Analyst Starts Coverage Positively; Check Out Tuesday's Top 3 Initiations
Analyst Ratings Updates: Top Wall Street analysts have revised their outlooks on several companies, with a focus on upgrades and new coverage initiations.
Actuate Therapeutics Coverage: B. Riley Securities analyst Mayank Mamtani initiated coverage on Actuate Therapeutics (ACTU) with a Buy rating and a price target of $20, while the stock closed at $7.98.
Gyre Therapeutics Coverage: HC Wainwright & Co. analyst Matthew Keller also initiated coverage on Gyre Therapeutics (GYRE) with a Buy rating and a price target of $18, closing at $8.18.
CareDx Coverage: William Blair analyst Andrew Brackmann started coverage on CareDx (CDNA) with a Market Perform rating, with shares closing at $12.75.
B. Riley Securities Begins Coverage of Actuate Therapeutics with a Buy Rating and Sets Price Target at $20
Real-time Intelligence: Benzinga Pro offers the fastest news alerts for traders to stay updated on market movements.
Exclusive Content: The platform provides exclusive stories and insights generated by Benzinga reporters.
Community Engagement: Over 10,000 serious traders are part of the Benzinga Pro community, sharing strategies and intelligence.
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Actuate Therapeutics To Collaborate with Incyte Corporation and the University of Pittsburgh on Clinical Trial of Elraglusib in Combination with Retifanlimab and mFOLFIRINOX in Patients with Advanced Pancreatic Cancer
Clinical Trial Announcement: Actuate Therapeutics has initiated a Phase 1b clinical trial at UPMC Hillman Cancer Center to evaluate the combination of elraglusib, retifanlimab, and modified FOLFIRINOX as a frontline therapy for advanced pancreatic adenocarcinoma, aiming to determine the recommended phase 2 dose and assess efficacy and safety.
Potential Benefits of Elraglusib: Previous studies have shown that elraglusib can enhance immune responses in cancer treatment, demonstrating significant improvements in overall survival rates when combined with other therapies, suggesting its potential as a novel approach in treating difficult cancers like pancreatic adenocarcinoma.
Actuate Therapeutics Announces Encouraging Phase II Results for Salivary Gland Cancers
Positive Study Results: Actuate Therapeutics reported favorable outcomes from a Phase II study of elraglusib combined with carboplatin or cisplatin for advanced metastatic salivary gland cancers, showing a median overall survival of 18.6 months.
Patient Demographics and Survival Rates: The study included 47% adenoid cystic carcinoma (ACC) and 53% non-ACC patients, with non-ACC patients experiencing a median overall survival of 27.8 months.
Progression-Free Survival: The median progression-free survival was 6.4 months, with only 27% of patients remaining progression-free at one year, contrasting with historical estimates for ACC and non-ACC.
Market Reaction: Following the announcement, Actuate shares increased by over 4% in pre-market trading, closing at $7.52, reflecting a 1.35% rise from the previous day.
HC Wainwright & Co. Affirms Buy Rating for Actuate Therapeutics, Keeps $20 Price Target Intact
Real-time Intelligence: Benzinga Pro offers the fastest news alerts to help traders stay informed and make winning trades in the stock market.
Exclusive Community: Joining Benzinga Pro connects users with over 10,000 serious traders and provides access to exclusive stories and insights from Benzinga reporters.
Actuate Therapeutics Reveals Pricing for $15.0 Million Public Stock Offering
Public Offering Announcement: Actuate Therapeutics, Inc. has priced an underwritten public offering of 2,142,858 shares of common stock at $7.00 per share, aiming to raise approximately $15 million for working capital and corporate purposes.
Use of Proceeds: The company plans to utilize the net proceeds from the offering for general corporate needs, with the offering expected to close on September 11, 2025, pending customary closing conditions.
Company Focus: Actuate Therapeutics is a clinical-stage biopharmaceutical company developing therapies for challenging cancers, with its lead drug, elraglusib, targeting pathways that promote tumor growth and resistance to conventional treatments.
Forward-Looking Statements: The press release includes forward-looking statements regarding the offering's timing and completion, emphasizing the inherent risks and uncertainties that could affect actual results.
Actuate Therapeutics Analyst Starts Coverage Positively; Check Out Tuesday's Top 3 Initiations
Analyst Ratings Updates: Top Wall Street analysts have revised their outlooks on several companies, with a focus on upgrades and new coverage initiations.
Actuate Therapeutics Coverage: B. Riley Securities analyst Mayank Mamtani initiated coverage on Actuate Therapeutics (ACTU) with a Buy rating and a price target of $20, while the stock closed at $7.98.
Gyre Therapeutics Coverage: HC Wainwright & Co. analyst Matthew Keller also initiated coverage on Gyre Therapeutics (GYRE) with a Buy rating and a price target of $18, closing at $8.18.
CareDx Coverage: William Blair analyst Andrew Brackmann started coverage on CareDx (CDNA) with a Market Perform rating, with shares closing at $12.75.
B. Riley Securities Begins Coverage of Actuate Therapeutics with a Buy Rating and Sets Price Target at $20
Real-time Intelligence: Benzinga Pro offers the fastest news alerts for traders to stay updated on market movements.
Exclusive Content: The platform provides exclusive stories and insights generated by Benzinga reporters.
Community Engagement: Over 10,000 serious traders are part of the Benzinga Pro community, sharing strategies and intelligence.
Market Winning Tool: Traders utilize Benzinga Pro's resources to enhance their trading success in the stock market.
Actuate Therapeutics To Collaborate with Incyte Corporation and the University of Pittsburgh on Clinical Trial of Elraglusib in Combination with Retifanlimab and mFOLFIRINOX in Patients with Advanced Pancreatic Cancer
Clinical Trial Announcement: Actuate Therapeutics has initiated a Phase 1b clinical trial at UPMC Hillman Cancer Center to evaluate the combination of elraglusib, retifanlimab, and modified FOLFIRINOX as a frontline therapy for advanced pancreatic adenocarcinoma, aiming to determine the recommended phase 2 dose and assess efficacy and safety.
Potential Benefits of Elraglusib: Previous studies have shown that elraglusib can enhance immune responses in cancer treatment, demonstrating significant improvements in overall survival rates when combined with other therapies, suggesting its potential as a novel approach in treating difficult cancers like pancreatic adenocarcinoma.
