Questions and Answers
2cureX is happy to receive a number of questions and comments from our present and from potential future shareholders. With the present Questions & Answers (Q&A) section, we would like to make these questions and their answers publicly available.
Additional questions/comments should be mailed to email@example.com.
An IVD product that is placed on the European market must comply with the CE-IVD directive and carry the CE mark, in case the product lacks the CE-IVD label it will need to be registered as an RUO (Research Only) device and by definition is intended for research use only, and can’t be used for clinical use by physicians. This will impede market barriers in terms of market access and product reimbursement.
The CE-IVD marking is a major milestone for 2cureX as it is required for the IndiTreat market preparation and the subsequent market launch.
In detail there are 4 reasons why the CE-Certificate for IndiTreat is such a critical milestone:
a. Med-Tech products in the field of IVD (In Vitro Diagnostics) need to adhere to the CE IVD Directive 98/79/EC, it grants IndiTreat® a CE-IVD certificate that serves as a trade passport for the European marketplace and will allow 2cureX to freely circulate its product throughout the 30 countries of the European Economic Area (EEA).
b. The CE-IVD label serves for med-tech products as a quality stamp, as it means that the organization has processes in place that ensures customers that the product delivers on its product-claims within the Intention for use.
c. The CE-IVD is a pre-requisite for market-access and reimbursement within the EU as well as certain major markets outside the EEA.
d. The CE-IVD certificate for IndiTreat® provides efficiency for launching products in other Tumor entities as there is now only one set of requirements and procedures to comply in terms of designing and manufacturing a product for the entire EEA.
2cureX is a commercial market leader focused on the clinical application of 3D drug-response testing of cancer patients. 2cureX builds on an experience with the technology in more than 1000 patients and is currently engaged in two Multinational Clinical Trials that will further strengthen the IndiTreat® competitive profile. With a CE-mark filing in 2018 and strong clinical evidence, 2cureX is aiming to be the leading company within functional drug-response testing.
3D drug-response testing is getting traction in Academia, supporting the value of the technology to identify Individual treatment strategies for cancer patients. 2cureX considers the increased interest by researchers for the use of 3D-cell cultures in cancer therapy design a market driver that will greatly support the commercial success of IndiTreat®.
2cureX has a strong patent portfolio on the method of applying 3D micro-tumors to the design of cancer treatment for the individual patient. The initial generation of 3D micro-tumors from patient tissue is not protected and is conducted by several academic researchers. The more clinical information they create the better it is for 2cureX.
IndiTreat® is being clinical validated in two solid cancers: colorectal and ovarian cancer. It is important to 2cureX that clinical trials are conducted within the different cancer entities where we are launching the product initially. However, we have shown that the technology is applicable to other solid cancers.
Thank you for pointing out this issue to our attention. We have been in contact with Nordnet and our news distributor (Cision). It turns out that there has been an error in the distribution algorithm. This is very unfortunate. The error is now corrected. So, in the future, you will see the important press releases from 2cureX on Nordnet’s website.
The IndiTreat technology is easy to scale, and one person can run a large number of test in parallel. Setting up the test facility is relatively easy done – it requires access to the 2cureX know-how and patent rights; but is not demanding staff wise. With regard to the setup of test-sites, we have strategically decided that we want to have a presence in all countries where we operate. This will have a very positive effect on the general uptake of the test in the individual countries.
We were very successful with our EU application and received EURO 3 Mill in funding. The funds will be used to support our clinical studies and commercialization of the IndiTreat® test. The funds will directly support the business plan of 2cureX.
Yes, the first patients were enrolled end of October 2017. In February 2018 we had successfully enrolled the first 10 patients.
We will release information from the clinical trial before its finalization – we expect to inform the market about the status of the trial in the summer of 2018.
None of the mentioned competitors are running clinical trials in colon cancer.
As mentioned above it is not the accuracy of the IndiTreat® test that is 58%, it is its ability, in the tested patient population, to identify an effective treatment. The reasons for it not being higher is that some patients will show resistance or low sensitivity towards all the treatments tested. It is likely that the percentage will go up when we include other types of cancer drugs in the test panel.
This is true for colon cancer on average for the different stages of the disease. For late stage (IV), where the disease has spread to distant organs, most often the liver, the response is significantly lower.