Core Insights - EXACT Therapeutics has initiated its ENACT trial, marking the first patient dosed in a Phase 2 clinical trial for Acoustic Cluster Therapy (ACT) in pancreatic cancer patients [1][2] - The trial aims to address the significant unmet medical need in treating pancreatic cancer, which has over 500,000 new diagnoses globally each year and is known for its high mortality rate [2] - The Phase 2 trial will enroll up to 25 patients across the U.S., U.K., and Europe, following positive results from a Phase 1 trial involving patients with liver metastases of colorectal origin [3] Company Overview - EXACT Therapeutics is a clinical-stage precision medicine company focused on utilizing ultrasound and microbubbles for targeted drug delivery in oncology [4] - The company’s Acoustic Cluster Therapy (ACT) represents a novel approach that may be applicable to various therapeutic agents in oncology and other medical indications, including brain diseases [4] - Shares of EXACT Therapeutics are traded on Euronext Growth Oslo under the ticker EXTX [4]

Core Insights - EXACT Therapeutics announced positive final data from its Phase 1 ACTIVATE trial, demonstrating the efficacy of its Acoustic Cluster Therapy (ACT) combined with chemotherapy for patients with liver metastases of colorectal origin [1][3][8] - The results support the initiation of the ENACT Phase 2 study in pancreatic cancer, addressing a significant unmet medical need [1][8] Group 1: Trial Results - The ACTIVATE trial showed that tumor shrinkage was significantly greater with ACT and chemotherapy compared to chemotherapy alone, with a reduction of -29% versus -7% among responding patients (p<0.05) [3][8] - A clear dose-response relationship was observed with the proprietary agent PS101, where 3 out of 4 patients receiving 40 µl/kg PS101 showed tumor shrinkage of more than 30% in diameter [4][8] - The trial enrolled 11 patients, with 9 being evaluable, and was conducted at sites in the United Kingdom [9] Group 2: Safety and Efficacy - PS101 was found to be safe and well-tolerated when administered with chemotherapy, mirroring the excellent safety profile seen in interim results [4][8] - The trial's design allowed each patient to serve as their own control, enhancing the reliability of the anti-tumor activity assessment [7] Group 3: Future Plans - The company plans to present detailed data from the ACTIVATE trial at a future scientific publication and medical conference [5] - The CEO expressed excitement about the upcoming ENACT trial, which will focus on locally advanced pancreatic cancer [2][8] Group 4: Technology Overview - Acoustic Cluster Therapy (ACT) involves the intravenous administration of PS101, which is insonated over target tissue using ultrasound to enhance drug delivery [10][11] - The technology utilizes microclusters of perfluorobutane microbubbles and perfluoromethylcyclopentane microdroplets to improve the efficacy of concurrent chemotherapy [10][11]