EXACT Therapeutics Receives FDA Clearance for Phase 2 Pancreatic Cancer Trial
Key Insights
EXACT Therapeutics (search) received FDA clearance for its IND application for the Phase 2 ENACT trial, evaluating Acoustic Cluster Therapy (search) (ACT®) in pancreatic cancer (search).
The ENACT trial will assess ACT® combined with modified FOLFIRINOX as a first-line treatment for locally advanced or borderline resectable pancreatic cancer (search).
This single-arm trial is set to begin dosing patients, with an initial safety review expected to be announced in mid-2025.
EXACT Therapeutics (search) has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for the Phase 2 ENACT clinical trial. This trial will evaluate Acoustic Cluster Therapy (search) (ACT®) in combination with modified FOLFIRINOX for the first-line treatment of patients with locally advanced or borderline resectable pancreatic cancer (search).
The Phase 2 ENACT trial is designed as a single-arm study to assess the safety and efficacy of ACT®, EXACT Therapeutics (search)' proprietary ultrasound- and microbubble-mediated therapy, when used with a modified FOLFIRINOX regimen. The patient population will consist of individuals diagnosed with locally advanced or borderline resectable pancreatic cancer (search) who have not previously received treatment.
Strategic Milestone
"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 (search) patients," said Per Walday, CEO of EXACT Therapeutics (search). The company anticipates announcing an initial safety review from the trial in mid-2025.
Leveraging Prior Data
The ENACT trial builds upon encouraging data obtained from the Phase 1 ACTIVATE trial, which evaluated ACT® in patients with liver metastases. The positive outcomes from the ACTIVATE trial provided a foundation for further investigation into the potential of ACT® in treating other forms of cancer.
About Acoustic Cluster Therapy (ACT®)
Acoustic Cluster Therapy (search) (ACT®) is a unique approach that uses ultrasound and microbubbles to enhance targeted drug delivery in oncology. This method has the potential to be applied with a wide range of therapeutic agents across various oncology indications and other diseases, including brain disorders. EXACT Therapeutics (search) is focused on leveraging ACT® to improve treatment outcomes for patients with difficult-to-treat cancers.