EXACT Therapeutics Announces FDA Clearance of IND for ENACT, a Phase 2 Trial in Pancreatic Cancer

16 Dec 2024 08:00 CET

• FDA clearance of the IND application for Phase 2 ENACT trial
• Single-arm trial of ACT® with modified FOLFIRINOX treatment in first line
locally advanced pancreatic
cancer
• On track to announce initial safety review mid-2025


Oslo, Norway; 16 December, 2024. EXACT Therapeutics (Euronext Growth: EXTX), a
clinical stage precision medicine company utilizing the power of ultrasound to
enable targeted drug delivery in oncology, today announced U.S. clearance by the
Food and Drug Administration (FDA) of its investigational new drug (IND)
application for the Phase 2 clinical trial. The trial is designed to evaluate
Acoustic Cluster Therapy (ACT®), the Company’s wholly owned ultrasound- and
microbubble-mediated therapy, with modified FOLFIRINOX in first line treatment
of patients with locally advanced or borderline resectable pancreatic cancer.
The trial is on track to announce initial safety review mid-2025.

“We are excited to announce the opening of the IND for our Phase 2 ENACT trial,
marking a significant milestone in advancing our strategic goals and bringing us
closer to dosing pancreatic cancer patients,” said Per Walday, CEO of EXACT
Therapeutics. “The ENACT trial builds on the encouraging data from the Phase 1
ACTIVATE trial in patients with liver metastases, and the regulatory clearance
by the FDA further adds to the strong momentum following our successful private
placement. We look forward to sharing further updates at a Capital Markets Day
in spring 2025.”

About EXACT Therapeutics:
EXACT Therapeutics is a clinical-stage precision medicine company utilizing the
power of ultrasound and microbubbles to enable targeted drug delivery in
oncology. Acoustic Cluster Therapy (ACT®) follows a unique approach and may be
applied to a wide range of therapeutic agents within oncology and across a
multitude of other indications including brain diseases. www.exact-tx.com

For further information, please contact:
Per Walday
CEO EXACT Therapeutics
Email: per.walday@exact-tx.com

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