EXACT Therapeutics raises NOK 145 million

Clinical-stage biopharmaceutical company EXACT Therapeutics closes the latest fundraising round at NOK 145 million, including a NOK 77 million investment from GE Healthcare in a new strategic collaboration. The funds will go to the ENACT phase II study in locally advanced pancreatic cancer.

“This is planned as a one-arm study, where the company wants to investigate the efficacy and safety of Acoustic Cluster Therapy (ACT®) in combination with Standard of Care treatment in first line locally advanced/regional or borderline resectable pancreatic cancer patients. We have planned for 25 patients, where the first three are a safety run-in (expected results mid-2025). We expect to have an interim read-out in first half of 2026, and final results first half of 2027,” commented Per Walday, CEO of EXACT Therapeutics.

Collaboration with GE Healthcare

GE Healthcare is both a cornerstone investor in the recent private placement and a strategic collaboration partner for EXACT’s upcoming clinical studies.

“We will work together with GE Healthcare to develop the ultrasound equipment and software needed for the next clinical studies within abdominal cancers, and, ultimately, commercialisation of ACT. GE Healthcare is a global market leader in ultrasound equipment, which means that their equipment is to be found in hospitals all over the world,” said Walday.

Microbubbles for drug delivery

ACT is a non-invasive technology consisting of EXACT Therapeutics’ patented PS101-formulation for intravenous injection and ultrasound. ACT treatment is given together with the established standard of care treatment to cancer patients.

“The tumours we want to treat are first located with ultrasound, and an i.v. injection of PS101 is thereafter provided at the same time as standard of care. PS101 consists of small microbubbles and microdroplets that form larger bubbles when activated with ultrasound at the target lesion. These larger bubbles get trapped in the capillary vessels, and we then use ultrasound at a lower frequency to make these bubbles oscillate.

“These oscillating movements produce waves and shear forces, and stretches and opens the capillary walls, thereby significantly enhancing the delivery of medication to the ultrasound targeted tumour. After about 10-15 minutes, the larger bubbles shrink and are released from the capillaries,” explained Walday.

From Norwegian ultrasound research

The history of ACT goes back longer than the company EXACT, which was spun out from GE Healthcare in 2012. The therapy was developed based on initial work conducted at GE Healthcare as part of a programme to develop a new ultrasound agent.

“EXACT was then formed with the objective to build on this initial work and develop an innovative and effective therapeutic targeting platform using a patented microbubble-microdroplet formulation and ultrasound. Following refinement and development of ACT for treatment applications, the first clinical study was started in 2019 with the ACTIVATE study. This study targeted liver metastases of colorectal origin. The results from the first 6 patients were presented at the American Association of Cancer Research in April 2024, showing on average more than 10 times increase in percent shrinkage of the tumours treated with the ACT compared to standard of care alone,” commented Walday.

There is also a series of articles about the history of Norwegian ultrasound, describing the story from Liv Hatle’s pioneering work in ultrasound to how microbubbles may enhance the delivery of therapeutics.

Across multiple indications

EXACT Therapeutics has demonstrated the effect of ACT in several different preclinical cancer models with different kinds of drugs.

“Our focus is on oncology, with the ENACT phase 2 study in pancreatic cancer as main priority. We also see a potential for ACT within the immuno-oncology (IO) space, and we have established collaboration with Agenus, a US-based clinical-stage biotech company. In addition, we have an ongoing research programme within IO together with NTNU, ICR and TGen. This programme is supported by a grant from the Norwegian Research council,” commented Walday.

Brain indications represent a third area, where the company has published proof-of-concept for targeted opening of the blood-brain-barrier in animal models. EXACT also has an ongoing preclinical study in glioblastoma which is an aggressive type of brain cancer.