EXACT Therapeutics: Positive second safety read-out from the Phase 2 ENACT trial in pancreatic cancer
2026-06-26 08:10:06
o Trial Monitoring Committee has issued a positive conclusion for the
pre-planned safety read-out for the increased dose (60 µl/kg), and the trial
proceeds with the increased dose.
o This safety read-out triggers opening of the full enrolment at all sites.
o Interim efficacy read-out is expected around end-2026.
Oslo, Norway, 26 June 2026. Reference is made to the private placement of EXACT
Therapeutics AS ("EXACT-Tx" or the "Company", Euronext Growth ticker: EXTX), a
clinical-stage precision medicine company, is pleased to announce that the Trial
Monitoring Committee ("TMC") for the Phase 2 ENACT trial in first line locally
advanced pancreatic cancer (NCT06850623) has unanimously issued a positive
conclusion for the safety read-out following the per-protocol review of the
second safety cohort enrolled in the trial and recommended to proceed with the
trial using the 60 µl/kg dose.
The TMC has reviewed the safety data from the second safety cohort with three
subjects with locally advanced pancreatic cancer treated with the Company's
proprietary PS101 drug candidate at a dose of 60 µl/kg body weight in
combination with modified FOLFIRINOX and completing the 28-day safety window.
Based on the second safety cohort data, TMC recommends proceeding with the trial
at a PS101 dose of 60 µl/kg and the ENACT trial is now open for unrestricted
patient enrolment.
All ten hospital sites are open for enrolment, and the interim efficacy read-out
is expected around end-2026.
Information in this announcement is considered inside information pursuant to EU
Market Abuse Regulation (MAR) and subject to the disclosure requirements
pursuant to MAR Article 17 and Section 5-12 of the Norwegian Securities Trading
Act. This stock exchange announcement was published by John M. Edminson, CFO, on
08:10 (CET) 26 June 2026.
About EXACT Therapeutics:
EXACT Therapeutics is a clinical-stage precision medicine company utilizing the
power of ultrasound to activate the proprietary drug PS101 and enhance the
clinical benefit of 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.
from those expressed\
or implied by this forward-looking statement.\