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CHICAGO and FORT WORTH, Texas - Actuate Therapeutics, Inc. (NASDAQ: ACTU), a clinical-stage biopharmaceutical company with a market capitalization of $152 million, has announced the completion of patient enrollment for a Phase 2 trial of elraglusib in combination with FOLFIRINOX and losartan, targeting untreated metastatic pancreatic ductal adenocarcinoma (mPDAC). According to InvestingPro data, the company maintains a strong financial position with more cash than debt on its balance sheet, though analysts do not expect profitability this year. This trial is conducted under the leadership of Colin Weekes MD, PhD, at Massachusetts General Hospital with support from the Lustgarten Foundation.
The study, which enrolled 56 treatment-naïve mPDAC patients, aims to evaluate the safety, tolerability, and progression-free survival of the drug combination. Initial data presented at the AACR Special Conference on Advances in Pancreatic Cancer Research in September 2024 indicated early evidence of increased clinical activity from this combination in mPDAC patients. The stock, currently trading at $7.34, has seen its price decline about 15% over the past year, though analysts maintain a strong buy rating with a $20 price target.
Daniel Schmitt, President & CEO of Actuate, remarked on the milestone, emphasizing the company’s commitment to advancing elraglusib for advanced cancer treatment. Schmitt also mentioned interim Phase 2 data of elraglusib paired with gemcitabine/nab-paclitaxel, which showed statistically significant improvements in 1-year and median overall survival in mPDAC treatment.
Dr. Weekes expressed optimism about the trial’s potential to enhance treatment options for metastatic pancreatic cancer, with final results expected in 2026.
Actuate focuses on developing therapies for high-impact, hard-to-treat cancers by inhibiting glycogen synthase kinase-3 beta (GSK-3β). Elraglusib, their lead investigational drug, targets cancer pathways involved in tumor growth and resistance to conventional drugs, including DNA Damage Response ( DDR (NYSE:SITC)) pathways, and mediates anti-tumor immunity by inhibiting nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB).
This news is based on a press release statement from Actuate Therapeutics. The company advises that forward-looking statements in the release involve risks and uncertainties, and actual results may differ materially from those projected. Actuate does not undertake any obligation to update these forward-looking statements unless legally required. For deeper insights into Actuate’s financial health, growth prospects, and additional investment metrics, InvestingPro subscribers have access to over 30 financial indicators and exclusive analysis tools.
In other recent news, Actuate Therapeutics, Inc. has announced significant developments in its ongoing efforts to combat pancreatic cancer. The company reported that its Phase 2 trial of the drug elraglusib, in combination with chemotherapy, has met its primary endpoints, showing a substantial improvement in survival rates for patients with metastatic pancreatic cancer. The trial results revealed a doubling of the one-year survival rate to 43.6% when elraglusib was added to the standard chemotherapy regimen. Additionally, the median overall survival increased by two months compared to chemotherapy alone.
The European Medicines Agency has granted Orphan Medicinal Product Designation to elraglusib for the treatment of pancreatic ductal adenocarcinoma, a designation that could expedite the drug’s development and market exclusivity in the EU. Actuate’s President & CEO, Daniel Schmitt, expressed optimism about the potential of elraglusib, noting its favorable risk-benefit profile and the possibility of improved outcomes for patients. The company plans to engage with the FDA regarding the trial’s topline data and potential for a Phase 3 registration trial in 2025.
Actuate Therapeutics has also scheduled its first Annual Meeting of Stockholders for May 22, 2025, to be held virtually. The meeting will address various topics, with further details provided in the upcoming proxy statement. Stockholders have been invited to submit proposals by February 21, 2025, in accordance with the company’s bylaws and relevant regulations. These recent developments reflect Actuate’s ongoing commitment to advancing its cancer treatment pipeline.
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