• EXACT has reported positive early efficacy and safety interim data from its Phase 1 ACTIVATE trial in in cancer patients with liver metastases of colorectal origin.
• Valuable guidance has been received from the FDA in a Pre-IND meeting for the Phase 2 ENACT trial in pancreatic cancer.
• With FDA’s guidance, the Company will now focus on the ENACT trial and stop recruitment into the ACTIVATE trial.
• The planned follow-up of the recruited patients will continue. So far, there has been no change to the previously reported excellent safety profile of PS101.
Oslo, Norway, August 6, 2024 – EXACT Therapeutics AS (Euronext Growth: EXTX), a clinical stage precision medicine company utilizing the power of ultrasound to enable targeted drug delivery in oncology, announces that it will now be focusing all clinical efforts on the upcoming Phase 2 ENACT trial in locally advanced pancreatic cancer and is stopping recruitment in the Phase 1 ACTIVATE clinical trial in cancer patients with liver metastases of colorectal origin.
Previously, the Phase 1 ACTIVATE trial reported positive interim efficacy and safety data. The enrolled patients will be followed through the planned follow-up. The final results from the ACTIVATE Phase 1 trial (11 patients) will be reported after completion of independent blinded review, expected early 2025. So far, there has been no change to the previously reported excellent safety profile of PS101 in the ACTIVATE trial.
Dr Per Walday, CEO of EXACT Therapeutics commented: “EXACT will now focus its full resources on the ENACT Phase 2 trial in locally advanced pancreatic cancer; our first development indication for the versatile ACT® technology pipeline. Our interactions with the FDA have provided important guidance for the ENACT trial and the development of ACT® in pancreatic cancer, a disease that has seen no significant survival improvements over the years. EXACT has demonstrated very promising preclinical data with its proprietary ACT® treatment in pancreatic cancer models and we look forward to initiating the planned clinical development in this high unmet need indication.”
Dr Amir Snapir, CMO of EXACT Therapeutics added: ”The results achieved so far from the ACTIVATE study suggest excellent safety and support the efficacy of the ACT® technology in patients. We are grateful for the support from our clinical investigators, patients and collaborators, that made these first positive clinical results possible.”
Pancreatic cancer has the 10th highest cancer incidence in the US (SEER), a high unmet medical need, and a growing patient population.
For further information, please contact:
Per Walday
CEO EXACT Therapeutics
Email: per.walday@exact-tx.com
About EXACT-Tx
EXACT-Tx is a clinical-stage Norwegian precision health company developing a technology platform for targeted therapeutic enhancement – Acoustic Cluster Therapy (ACT®). ACT® follows a unique approach to ultrasound-mediated, targeted drug enhancement – with the potential to enable or significantly amplify the clinical utility of a wide range of therapeutic agents across a multitude of indications including within oncology (chemotherapy, immunotherapy) and brain diseases. www.exact-tx.com
About ACT®
• ACT is a proprietary formulation consisting of microbubbles and microdroplets that are activated through the application of ultrasound with the consequent increase in targeted delivery of a co-administered therapeutic agent.
• ACT is being tested in the clinic and has released positive interim data. It is supported by a strong and broad preclinical package demonstrating therapeutic enhancement in multiple oncology models (pancreatic, breast, colon, prostate) as well as blood-brain barrier penetration.
• Initial focus of the Company is oncology. The ACT platform has potential across many therapeutic areas (including CNS, immunotherapy) and product classes.
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.