Exact Therapeutics AS
Plans to recommence enrolment in the ACTIVATE clinical trial and new trial in pancreatic cancer in the US
OSLO/LONDON: 18 NOVEMBER, 2021: Exact Therapeutics AS (“EXACT-Tx”, or “the Company” Euronext Growth: EXTX), a clinical-stage precision health company evaluating Acoustic Cluster Therapy (ACT®) across multiple therapeutic areas, today announces a number of strategic, operational and scientific developments.
As reported in May 2021, EXACT-Tx plans to file a protocol amendment regarding its ACTIVATE phase 1 clinical trial with the UK MHRA. Following approval, the Company plans to recommence enrolment in the trial at the Royal Marsden Hospital London / Institute of Cancer Research with the recruitment of patients in the part 1 cohort planned to be completed by mid 2022. The study aims to evaluate the combination of PS101 ACT® with standard of care chemotherapy for treatment of liver metastases in patients with metastatic colorectal cancer A number of valuable and encouraging insights have been gained from this first cohort of treated patients particularly with respect to the application of ultrasound.
The Company also announces that it aims to start its first clinical trial in the USA to evaluate ACT® in pancreatic cancer patients. In the USA there are approximately 60,000 newly diagnosed cases of pancreatic cancer and approx. 50,000 deaths per year. The Company expects to submit IND filing to the FDA by mid 2022 which, if approved, will be followed by the start of the clinical trial towards the end of 2022. Today, the 18th of November, is Pancreatic Cancer Awareness Day, and EXACT-Tx is commited to play it’s role in fighting this aggressive disease.
EXACT-Tx is pleased to announce that Co-Founder Dr Andrew (“Andy”) Healey has returned to the Company as Chief Scientific Officer. Andy brings over 20 years experience in the life sciences industry, primarily working with contrast agents and optical molecular imaging, physics, instrumentation, characterisation and clinical imaging systems & trials. The Company’s management team has been significantly strengthened this year with the appointments of Dr Hilary McElwaine-Johnn as Chief Medical Officer and Dominic Moreland as Chief Financial Officer and subsequently Interim Chief Executive Officer.
Strong preclinical data on ACT® were recently published in The Journal of Controlled Release which demonstrated that ACT® safely and temporarily increased the permeability of the Blood Brain Barrier (“BBB”) in animal models as well as increased the penetration and accumulation of co-administered compounds including nanoparticles with no treatment related tissue damage observed. The BBB remains a formidable challenge to the delivery of drugs into the brain. The published preclinical data demonstrates that ACT® could be a potential strategy to overcome this obstacle and promote efficient and specific crossing through BBB of therapeutically relevant agents, addressing a huge unmet medical need and further demonstrating the power of the ACT® platform. “We have demonstrated that ACT® has the ability to open the BBB in a pre-clinical model to deliver large molecules and nano particles with no observable damage to the brain. This approach is an exciting and evolving field that has the promise to deliver drug and to treat the central nervous system.” says Professor Catharina de Lange Davies, Dept. of Physics, Norwegian University of Science and Technology (NTNU), and co-author of the paper.
Dr Masha Strømme, Executive Chair of the Board, stated: “We have significantly strengthened our team over the last few months and are well positioned to maximise the value of our innovative Acoustic Cluster Therapy (ACT®) platform for ultrasound enhanced drug targeting which has the potential to significantly amplify the clinical utility of a wide range of therapeutic agents across most drug classes and improve upon standard of care. I am very pleased to welcome Andy whose technical expertise and industry know-how coupled with his longstanding commitment to EXACT-Tx is a very strong addition to the leadership team. I look forward to working with him again as we further investigate this exciting approach to ultrasound mediated therapeutic targeting.”
For more information, please contact:
Optimum Strategic Communications
Mary Clark/ Manel Mateus/ Vici Rabbets
Tel: +44 (0) 208 078 0457
EXACT-Tx is a clinical stage Norwegian biotech 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 significantly amplify the clinical utility of a wide range of therapeutic agents across a multitude of indications including within oncology (chemotherapy, immunotherapy), infectious diseases, and brain diseases. www.exact-tx.com
- 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 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 in oncology, however the ACT® platform has potential across therapeutic areas (infectious diseases, CNS, immunotherapy) and product classes.