WntResearch’s new CEO comments on his first month in the position
Development company WntResearch recently recruited the first patient for the expansion part of the ongoing phase II study, NeoFox. This coincided with Per Norlén’s first days at the helm of the company. BioStock contacted him to find out how he sees the potential of Foxy-5, and how he, with a long career as CEO of several biotech companies, wants to contribute to advancing the positions of the project.
Foxy-5 is a peptide-based drug candidate that has been developed to mimic WNT5A, an endogenous protein that counteracts cancer. Among other things, WNT5A has been shown to prevent the spread of cancer, both by reducing the ability of cancer cells to detach from parent tumours, and by counteracting their ability to establish themselves in healthy tissue. With Foxy-5, WntResearch wants to use this effect to offer a new kind of treatment for patients suffering from colon cancer.
The company received a lot of attention in 2022, after ad hoc observations from a phase II study that pointed to an inhibitory effect on local tumour spread after just three weeks of treatment. This led to a pause in recruitment to redesign the study in order to optimise the possibilities of demonstrating this particular effect. The trial was re-started shortly thereafter.
First patient recruited
Recently, the company announced the completion of the first dose-finding part of the study. After receiving support to proceed with a significantly higher dose, the first patient in the subsequent expansion part has been enrolled. The plan is to recruit a total of 80 patients, half of whom are on active treatment, and to conduct an initial efficacy analysis once a sufficient number of patients have been treated. This analysis is expected to take place by the end of 2024.
Per Norlén takes over as CEO
WntResearch is not only recruiting patients. Heading the company during this exciting period will be Per Norlén, who took over as the new CEO from Pernilla Sandwall at the beginning of March. Per brings solid experience in drug development, heading companies like Alligator Bioscience, Targinta and Evaxion Biotech.
BioStock reached out to Norlén to find out more about his background, how he views the project with Foxy-5, and to get his impressions of BIO-Europe Spring, which recently took place in Barcelona.
First of all, Per, for those who don’t already know you, can you start by telling us a little about your background?
– Over the past 10 years, I have been the CEO of several different biotech companies, including Alligator Bioscience, which I brought to Nasdaq Midcap in 2016, but later also at Targinta and Evaxion Biotech. I am a medical doctor, board certified specialist in clinical pharmacology, and have an associate professorship in pharmacology. For the past 20 years, I have been involved in clinical drug development, within the healthcare system, at big pharma, and for the past almost 15 years in biotech.
What do you see as your main strengths, and how can they best be used where WntResearch stands right now?
– I believe that the combination of solid scientific and clinical expertise, and broad experience in IR and business development, can create value for WntResearch. The company is in a critical phase where the ongoing study will determine the future and where the goal is to obtain positive data that will lead to a major partnership.
– I believe that my experience of entering into significant partnerships with both big pharma and biotech companies will be positive in this regard.
If we turn our attention to the Foxy-5 project – what do you think about it?
– The most crucial thing about Foxy-5 is that the pre-clinical findings are now strengthened by clinical data showing a clear effect on local spread of colon cancer. The effect is both clinically meaningful and statistically significant, and based on a sample of 110 patients in a randomised controlled study.
– The previous study was unfortunately not fully sized to demonstrate an effect on clinical outcomes such as disease-free survival. The main reason for this was that there were fewer patients who relapsed than expected. This is probably due to improved diagnostics, surgery and post-surgery treatment in recent years. But instead, powerful effects on local spread were seen, already after three weeks of treatment before surgery, indicating that Foxy-5 has great potential in colon cancer.
– In the ongoing study, our hope is to show that this positive effect is of such a magnitude that Foxy-5 can become a truly value-creating drug.
The company is at a very important stage. What are your thoughts on the ongoing phase II study?
– It is important to understand the context in which Foxy-5 is being developed. The drug candidate is given to patients with localised colon cancer immediately after diagnosis. Thus, these patients do not yet have metastatic disease, as far as can be assessed with today’s diagnostic methods. The treatment then continues until the tumour is surgically removed, which normally occurs within 3 – 5 weeks. However, about 20 per cent of these patients will have a relapse with metastatic disease within a couple of years, and then the prognosis is extremely poor.
– The purpose of Foxy-5 is to reduce the number of patients who relapse after initial surgery. This clinical outcome is however not studied in the current study, where we focus entirely on showing that Foxy-5 reduces local spreading during the short treatment period up to surgery. We can analyse this very precisely through histological assessment of the surgically removed material, and compare effects between treated and untreated patients.
– In the previous study, we observed a clear reduction in local spread, despite the fact that the patients had received only part of the total treatment at that time. In the new design, the treatment is intensified during the first three weeks, where we increase both the dose and the number of doses, so that the total exposure to the drug candidate increases more than seven times. This could further enhance the effect.
You recently raised SEK 31.4 million in your rights issue. How does this affect your plans going forward?
– This was done in order to be able to continue the ongoing study which is essential in order to document the effects of Foxy-5 in colon cancer. The observations we have seen so far are very promising but need to be confirmed if we are to enter into a larger partnership. The current study is thus extremely important for the company, and we hope to be able to present initial efficacy data from the recruited patients already towards the end of the year.
You participated in BIO-Europe Spring. What impressions did you take with you from there and how would you describe the interest in your project?
– Building long-term relationships with potential partners is instrumental for successful business development, and BIO-Europe Spring is one of the many events that we participate in for this very purpose. Preparing for partnering is a continuous effort where you try to get as many stakeholders as possible to be aware of the company and the product candidate, so that they are interested in evaluating the clinical data as soon as we can share it.
– Due to our positive ad hoc observations, a lot of people want to talk to us, and most are interested in moving forward in these discussions as soon as we can confirm our previous findings.
The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.
