The work performed during the MicroCaT project centred around five main activities: First, to provide the basis for expanding the IndiTreat offering to Germany and the UK, 2cureX has established an operational 2CX Branch (100 % subsidiary of 2cureX A/S) in Hamburg, Germany. In parallel we have enabled a 2curex partner, the QEHB in the UK to perform IndiTreat® measurements.
Second, 2cureX has established a Quality Management System (QMS) and performed and documented all experiments necessary for the CE-marking of IndiTreat®. 2cureX filed a Declaration of Conformity with the Danish Medicines in October 2018. It enables 2cureX to market IndiTreat® as a CE-IVD product under the Directive 98/79/EC for in vitro diagnostic medical devices. A major investment in the third year was to get the ISO 13485 compliant QMS audited and to future-proof IndiTreat® such that it will also conform with the IVD-Regulation that all CE-IVD products need to comply with by May 2022.
Third, the clinical validation of IndiTreat® has been carried out together with the Lillebaelt Hospital Vejle (LHV) Denmark. This interventional trial is aimed at demonstrating the ability to generate tumoroids from needle biopsies of the patient’s liver metastasis and to perform IndiTreat® measurements guiding drug therapy in patients suffering from metastatic colorectal cancer. The first patient was registered in the study in October 2017, and in December 2020, the last patient received IndiTreat-guided treatment. It now has been shown that 50 percent of the patients receiving IndiTreat® guided therapy did not experience any growth (progression-free survival or Progression-Free-Survival, PFS) of their liver metastases after eight weeks of treatment. The standard of care (SOC) for these difficult-to-treat patients gives a PFS value of 20 percent. On Mai 19th, 2021 ASCO published the outcome of the clinical trial in the ASCO meeting library (
https://meetinglibrary.asco.org/record/198560/abstract(si apre in una nuova finestra)). It demonstrates that the primary endpoint of the trial was met.
Fourth, after the IPO at the Nasdaq First North in November 2017, 2cureX has executed a very comprehensive dissemination and communication program comprising > 50 Press Releases, 40 non-scientific and non-peer reviewed publications, 15 Investor Presentations. 2cureX actively participated in 10 conferences. This has been flanked by social media activities on Twitter and LinkedIn. Finally, to prepare for market replication we have met and conducted interviews with target customers and added their input into a revised business plan. IndiTreat® was officially launched at the virtual ESMO (European Society of Medical Oncology) conference in September 2020. We have completed all pre-commercialisation activities and are now offering IndiTreat® testing in several regions throughout Europe.
Fifth, together with a consulting company specializing in market access we have reviewed the launch readiness of IndiTreat® and closed gaps. We have conducted multiple pre-commercialisation activities to establish logistics e.g. transportation of fresh tissue, defined treatment regimens, and reporting requirements for different European regions. Together with an external partner we developed a health economic model that will be used in in preparing the HTA dossiers for GE, UK and other European markets. The material is also helpful for negotiating contracts with IndiTreat® customer hospitals and local distribution partners. Finally, we have started to adapt and optimize IndiTreat® so that it is compatible with 3D microtumors derived from pancreas cancer patients.
