EXACT Therapeutics announces positive final results in Phase 1 ACTIVATE trial in liver metastases from colorectal cancer

• These results indicate that EXACT Therapeutics’ Acoustic Cluster Therapy (ACT) significantly enhances the local effect of chemotherapy
  
  
• In the patients who had a response to chemotherapy, ACT-treated tumours showed a significantly greater reduction in diameter compared to control tumours (-29% vs. -7%, p<0.05)
  
  
• Final analysis mirrors the excellent safety profile of PS101 seen in the interim read-out and suggests a dose-response relationship
  
  
• The data supports the company’s plans for its Phase 2 trial (ENACT) in patients with locally advanced or borderline resectable pancreatic cancer
  

OSLO, Norway, May 20, 2025 (GLOBE NEWSWIRE) -- EXACT Therapeutics (Euronext Growth: EXTX), a clinical-stage precision medicine company, is pleased to announce the final and positive data set from its Phase 1 ACTIVATE trial. The trial investigated the use of EXACT’s proprietary Acoustic Cluster Therapy with chemotherapy in hard-to-treat patients with liver metastases of colorectal origin. These encouraging clinical data provide proof of principle for the clinical application of ACT technology and offer strong support for initiating the ENACT Phase 2 study in pancreatic cancer, a disease with a high unmet medical need.

"I am excited about the data from the ACTIVATE trial, which yet again underscore the attractive therapeutic proposition from our proprietary ACT technology. The strength of the response to treatment, the safety profile and its non-invasive nature points to a unique and highly differentiated therapeutic regimen. We continue our efforts to bring ACT to cancer patients as fast as possible. Building on the momentum of the ACTIVATE study, we are excited to be approaching the first patient dosing in our Phase 2 ENACT trial in locally advanced pancreatic cancer." said Per Walday, CEO of EXACT Therapeutics.

The final results affirm the previously reported positive ACTIVATE outcomes and indicate the significant added efficacy of ACT with chemotherapy compared with chemotherapy alone. Among patients who responded to chemotherapy, tumor shrinkage was significantly greater with ACT and chemotherapy compared to chemotherapy alone in the same individuals (−29% vs. −7%, p<0.05).

ACT treatment with EXACT’s proprietary agent PS101 had a clear dose-response relationship. Shrinkage of tumour lesions was significantly greater in patients who received 40 µl/kg PS101 compared with 20 µl/kg PS101. In the group of patients who showed a response to chemotherapy in the control lesions, 3 out of 4 patients who received 40 µl/kg PS101 showed tumour shrinkage of more than 30% in diameter. Tumour shrinkage was seen in 6 out of 9 patients who received ACT with chemotherapy. PS101 was safe and well tolerated when given with chemotherapy.