2cureX are known for their patented IndiTreattechnology – a test used to match an individual cancer patient with the most effective treatment for that individual. The technology is at the forefront of the increasingly hot field of Functional Precision Medicine (FPM), a field that research suggests is a useful complement to the more classic, but less clear, form of precision medicine, Genomic Precision Medicine (GPM).
Read more about how 2cureX has positioned itself as a pioneer in FPM here.
IndiTreat gives immuno-oncology a breath of fresh air
The fact that traditional cancer treatments such as chemotherapy and radiation do not always achieve optimal treatment outcomes has opened up the field for the new therapeutic area of immuno-oncology (IO). IO is broadly about developing antibodies or other types of immune molecules that can counteract the harmful effects of cancer cells. Many studies have shown that IO therapy can be very effective, not least when used in an individualized treatment, as it can help the patient's immune system attack cancer tumors more effectively.
According to a new market report The global IO market is expected to be worth over USD 157 billion by 2027. Both pharmaceutical and biotech companies have invested heavily in IO and its potential to improve the treatment of cancer patients, but despite clear study results, progress in terms of real-world treatment outcomes has been slow to materialize. This is where IndiTreat can make a difference. The FPM test has the ability to predict which specific IO treatment, or combination of IO treatments, is best suited for each individual patient.
So far, it has been shown that the IndiTreat test not only reduces the burden on patients, who could otherwise suffer from side effects from unnecessary drugs or develop drug resistance, but also reduces the pressure on doctors who have had to come to terms with the fact that not all treatments work the same on every patient.
2cureX has ovarian cancer on the radar
IndiTreat is currently undergoing clinical validation for use in metastatic colorectal cancer, and a full launch of the FPM test in this indication is planned for the second half of this year. However, 2cureX is confident that the test can also perform well in other cancer indications.
One such indication is ovarian cancer, which in Europe alone claims more than 40 000 women's lives every year, in many cases due to the lack of effective and long-lasting treatment regimens. Drug resistance is a common phenomenon among patients with ovarian cancer. Almost all patients develop resistance to their first treatment and more than half die within five years of diagnosis.
Currently, there are no approved IO therapies for the treatment of ovarian cancer, but several candidates are in late-stage clinical trials. With proven FPM technology such as IndiTreat, which can predict the effect of both existing and new IO therapies as monotherapies or in combination with other cancer drugs, the prognostic outcome for ovarian cancer could be significantly improved. This by predicting how each patient will respond to each drug option and thereby helping to accelerate the development of new IO therapies.
German authorities see great potential in IndiTreat
The German Ministry of Education and Research (Federal Ministry of Education and Research, BMBF) were early to see the potential of IndiTreat. Already in 2017, they awarded 2cureX German subsidiaries, 2cureX GmbH, and its clinical partners University Hospital Hamburg-Eppendorf (UKE) 810,216 euros for a project evaluating IndiTreat in patients with ovarian cancer.
Following the project's good progress, the BMBF decided earlier this week to award it an additional grant of €1, of which €322 will go directly to 520cureX GmbH. The grant is intended to create the conditions for IndiTreat to benefit patients as soon as possible.
»Receiving grants from BMBF is highly prestigious and is recognized as an endorsement of what we have already achieved and an expectation from BMBF that 2cureX, together with UKE, can make a huge difference for ovarian cancer patients. The grant will initially allow us to fully develop the IndiTreat IO test. In the latter stages of the project, we will initiate the clinical validation in patients« — Ole Thastrup, CEO 2cureX
BioStock contacted 2cureX CEO Ole Thastrup to find out more about the collaboration with UKE and the importance of being awarded the grant.
Ole Thastrup, as IndiTreat moves closer to full commercialization for use in colorectal cancer patients by being clinically validated in hospitals across Europe, how is this project in ovarian cancer patients different?
- The ovarian cancer project is in earlier stages compared to the colorectal cancer project, meaning that commercialization of an IndiTreat ovarian cancer test will happen subsequent to the one for colorectal cancer.
– The ovarian cancer endeavor is supported by active clinical collaborations with Rigshospitalet in Copenhagen and our long-term partner UKE in Hamburg. In Hamburg, we concentrate on developing an IndiTreat test that can measure the direct interaction between the patient's immune system and the patient's tumor. Such test will address the fastest growing market segment within oncology: immuno-oncology.
As a follow-up, how confident are you that IndiTreat will work in ovarian cancer, as it does in colorectal cancer?
- As a young innovative company, we are obviously convinced that it will work, but you will get a more neutral judgment from the involved, highly recognized hospitals. They will only spend resources and credibility in such a project, if they really believe in it.
For what stage(s) of ovarian cancer would IndiTreat be most suitable?
- We are concentrating on ovarian cancer patients in the later stages (III and IV).
The project in ovarian cancer is focused on Immuno-oncology and predicting which IO therapies would be most effective in patients. How would this work even though no known IO therapies have yet been approved for treating ovarian cancer?
- You can say that we are out early; but it is globally expected that some of the large number of ongoing clinical trials with IO drugs in late stage ovarian cancer will turn out positive. 2cureX wants to be ready when that happens with an indispensable tool for stratifying those patients into responders and non-responders.
One of the goals with this project to help speed up the clinical studies with new IO therapies. How much of an impact do you believe IndiTreat could have here?
- There is a clear trend in clinical trial execution to include biomarker tools for selecting drug-sensitive patients before they are enrolled in specific clinical trials. IndiTreat IO will be uniquely positioned to provide such stratification within immuno-oncology. An effective stratification will save resources and time, thus helping in getting successful drugs faster to the market.
The collaboration with UKE began a few years back. Has it been as fruitful as you had expected so far and what are your expectations moving forward?
- Indeed, we have had a long-term collaborative interaction with UKE. UKE is highly recognized internationally within all aspects of cancer treatment. Initially, the collaboration was scientifically driven; now the collaboration has shifted to provide clinical benefits to the patients.
How important is this newly received grant for the ovarian cancer project, and how far do you believe it will bring you?
– Receiving grants from BMBF is highly prestigious and is recognized as an endorsement of what we have already achieved and an expectation from BMBF that 2cureX, together with UKE, can make a huge difference for ovarian cancer patients. The grant will initially allow us to fully develop the IndiTreat IO test. In the latter stages of the project, we will initiate the clinical validation in patients.
You are currently running an Early Access Program with IndiTreat across European clinics so that it can already be used in colorectal cancer patients. Can we expect a similar program down the line for ovarian cancer?
– We will have early access activities also for ovarian cancer; but it will not be constructed exactly as the current one for colorectal cancer, as there is a number of aspects of the current program that can be used directly in the subsequent commercialization of the IndiTreat IO test.
Will the current commercialization process affect the ovarian cancer project at all, and, if so, how?
- It will. The current commercialization process is providing 2cureX organization readiness to commercialize. This includes, for example, logistics, reimbursement/market access practices and clinical guidelines. Information that will be applicable also to the ovarian cancer project.
Finally, on a more general note, we know pancreatic cancer is another indication IndiTreat is expanding to. Do you expect further expansion to more cancer indications later on?
- We are receiving requests from clinical institutions for going into other solid cancers. For now, our focus remains on moving IndiTreat to the market for colorectal, ovarian and pancreatic cancers.
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