First patient dosed in Europe in Phase 2 trial in patients with locally advanced pancreatic cancer
Oslo, Norway, 3 March 2026. EXACT Therapeutics (the “Company”, Euronext Growth ticker: EXTX), a clinical-stage precision medicine company, today announced that the first patient has been dosed in Europe in its Phase 2 ENACT trial. The recruitment takes place at three hospital sites in Europe, in addition to seven sites in the U.S. All sites are now active.
The trial is a multi-centre, open-label Phase 2 clinical trial testing the safety and efficacy of PS101 in combination with standard of care (modified FOLFIRINOX chemotherapy) in first line patients with borderline resectable or unresectable locally advanced pancreatic cancer. On 27 January, the Company published a positive safety read-out and early, encouraging tumour shrinkage, and significant decrease in tumour biomarker CA 19-9 (>85% decrease, unaudited data) from the first safety cohort (40 µl/kg of PS101).
“We are delighted to see the Phase 2 ENACT trial progress to treating its first patient in Europe at Hammersmith Hospital, Imperial College London. This represents an important step in a study addressing a significant unmet medical need in pancreatic cancer, and we look forward to contributing to the generation of robust clinical data.” said the Coordinating Investigator of the ENACT trial, Professor Harpreet Wasan, leading the pancreatic cancer team at Hammersmith.
“The first pancreatic cancer patient treated with PS101 in Europe is an important execution milestone for the ENACT trial. With full site activation across the U.S. and Europe, enrolment and execution are progressing as planned. We remain focused on disciplined trial execution as we advance the trial toward interim read-out expected mid-2026.” said Per Walday, Chief Executive Officer of EXACT Therapeutics.
The Phase 2 trial will enrol approximately 28 patients in the U.S. and Europe and has the ClinicalTrials.gov Identifier: NCT06850623.
About EXACT Therapeutics:
EXACT Therapeutics is a clinical-stage precision medicine company utilizing the power of ultrasound to activate the proprietary drug PS101 and unlock targeted oncology therapies. PS101 has a unique mode of action and may be combined with a wide range of therapeutic agents within oncology and across a multitude of other indications, including brain diseases. EXACT Therapeutics’ shares are traded on Euronext Growth Oslo (EXTX).
Further information may be found here: www.exact-tx.com
For further information, please contact:
Per Walday
CEO EXACT Therapeutics
Email: per.walday@exact-tx.com
Forward looking statements:
This announcement and any materials distributed in connection with this announcement may contain certain forward-looking statements. By their nature, forward-looking statements involve risk and uncertainty because they reflect the Company's current expectations and assumptions as to future events and circumstances that may not prove accurate. A number of material factors could cause actual results and developments to differ materially from those expressed or implied by this forward-looking statement