As we approach the summer holiday, there is growing interest in this winter’s upcoming results from WntResearch’s phase II study NeoFox. The company recently announced that it has achieved the recruitment target of a total of 120 patients for the interim analysis. At the same time, WnResearch has initiated a research collaboration to further supplement the Brazilian preclinical findings regarding Foxy-5’s potential as a treatment for acute myeloid leukemia. BioStock contacted the company’s newly appointed CEO Pernilla Sandwall to find out more.

When developing the drug candidate Foxy-5, cancer therapy company WntResearch targets the ability of tumour cells to spread. The candidate mimics the body’s own protein WNT5A which has been shown to inhibit the mobility of cancer cells. The company’s hypothesis is that with its similar properties Foxy-5 should be able to reduce the risk of spreading of cancer cells that can form metastases. The company is supported in this by preclinical data that indicates that they are on to something and that the candidate has a good ability to counteract tumour formation.

The pandemic disrupted recruitment

Following the phase I studies, the company is currently conducting the phase II study NeoFox to obtain clinical confirmation. In total, about 25 hospitals in Spain and Hungary are participating in the study and the goal is to conduct an interim analysis of patient data on 120 patients in December.

Along the way, WntResearch has struggled with the effects of the Covid-19 pandemic, which have periodically settled like a wet blanket over the recruitment of patients to the study. The company has worked hard to counteract these effects to ensure that it reaches the recruitment target, and during spring it has added new study centres in Spain.

The goal is to conduct interim analysis in December

By the end of the first quarter, 112 patients had been randomised and the company can now announce that a total of 120 patients have been recruited. The company confirms that the goal of conducting the important interim analysis in December remains.

The aim of the analysis is to get an early indication of whether Foxy-5 has the potential for disease prevention that is hoped for. It will also guide the company in how many patients it will need to recruit in total and show whether the study can proceed as planned.

Seeking further confirmation of the potential in leukemia

It is not just in colon cancer that Foxy-5 has shown signs of efficacy. At the turn of the year, a Brazilian research group presented results that indicated that the drug candidate may also have a role to play in the treatment of acute myeloid leukemia (AML). In order to get more information regarding this, a research collaboration has been initiated with a research group at the University of Helsinki led by Research Director Caroline Heckman. In the collaboration, WntResearch will contribute drug substance and funding to the planned preclinical study.

In a comment, Caroline Heckman writes about the collaboration:

“Although my group is focused on understanding pathogenic causes and mechanisms of drug resistance in hematological malignancies, we are particularly interested in identifying new ways to treat patients who no longer respond to conventional therapy, and in identifying the patients who would benefit most from these new treatments. In close collaboration with WntResearch, we can combine our resources to promote the development of the drug candidate Foxy-5 for patients with blood cancer. The study of Foxy-5 will not only be exciting as it will broaden our understanding of a biological relationship and its role in leukemia, but we also hope that this will lead to clinical investigations and eventually a new treatment option for blood cancer patients.”

Comments from the CEO

BioStock contacted Pernilla Sandwall, the newly appointed CEO of WntResearch, to find out more.

First of all, Pernilla, what do you think about the fact that you have now achieved full recruitment for the interim results?

– We have now achieved our goal of recruiting 120 patients for the interim analysis and it feels good. This is an important milestone for the company with regards to our aim of carrying out the interim analysis as planned in December. The analysis itself is important to be able to see if we are on the right track with the study and to see if there is anything in the study we will need to adjust. We will not receive any definitive impact data in December, but we should be able to see a trend that in turn is important when it comes to pointing us in the right direction for the future.

Now that the effects of the pandemic have begun to wear off, how has it affected your ability to treat and follow up on the patients included in the study?

– During the pandemic, we had problems with some patients being too scared and simply not daring to go into the clinics for treatment and follow-up. At the same time, some hospitals had problems with human resources. Both of these factors made the work more difficult.

– Another effect is that we are also now beginning to understand how many patients the clinics will be able to take in, which is important when we lay down our plan for the continued work on the study.

You recently began a new collaboration to dig deeper into Foxy-5‘s potential in AML. Why is this being done?

– We do this to complement the results presented by the research team in Brazil. In drug development, it is important to confirm results and ensure that the results are not just a case of chance.

Why did you choose Caroline Heckman and her research team?

– Caroline Heckman and her team are very prominent and have excelled internationally. They have built up a large library of tissue from many different types of tumours and have established methods to analyse them. They are a very competent group who are used to fast processes.

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