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