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EXACT Therapeutics är verksamma inom medicinteknik. Bolaget är specialiserade inom utveckling av medicintekniska produkter. Produktportföljen är bred och inkluderar exempelvis tekniska plattformar för läkemedelstestning. Utöver huvudverksamheten erbjuds även tillhörande kringtjänster och mervärdesprodukter. Verksamheten drivs globalt med störst närvaro inom den nordiska marknaden. Bolaget gick tidigare under namnet Phoenix Solutions och har idag sitt huvudkontor i Oslo.
2021-11-18 07:00:00

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:

Dominic Moreland
EXACT Therapeutics
Email: dominic@exact-tx.com

Optimum Strategic Communications
Mary Clark/ Manel Mateus/ Vici Rabbets
Tel: +44 (0) 208 078 0457
Email: Exact@optimumcomms.com

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

About ACT®
oACT® 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.
oACT® 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.
oInitial focus of the company is in oncology, however the ACT® platform has
potential across therapeutic areas (infectious diseases, CNS, immunotherapy) and
product classes.