Foxy-5 is a peptide-based drug candidate that has been developed to mimic WNT5A, a natural protein that fights cancer. Among other things, WNT5A has been shown to inhibit the spread of cancer, both by reducing the ability of cancer cells to detach from parent tumors, and by counteracting their ability to establish themselves in healthy tissue. WntResearch wants to recreate this effect with Foxy-5, in order to offer a new type 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 indicated an inhibitory effect on local spread after just three weeks of treatment. After this, the study was paused and redesigned to optimize the possibilities of studying this particular effect, after which the study was restarted.
Recruited first patient
The company recently announced that the first dose-finding part of the study has been completed, that it has received support to proceed with a significantly higher dose, and shortly afterwards that the first patient in the subsequent expansion part has been recruited. The plan is to recruit a total of 80 patients, half of whom will be on active treatment, and to conduct a first efficacy analysis when a sufficient number of patients have been treated, which is expected to happen by the end of 2024.
Per Norlén takes over as CEO
It is not only in the patient level that the company has recruited. At the helm during this exciting period, WntResearch will have Per Norlen, who took over as new CEO after Pernilla Sandwall at the beginning of March. Per brings with him to the company a wealth of experience in pharmaceutical development, including as CEO of Alligator Bioscience, Targinta and Evaxion BiotechBioStock contacted Norlén to find out more about his background, how he views the Foxy-5 project, and to get his impressions of BIO-Europe Spring which recently took place in Barcelona.
First of all, Per, for those who don't know you before, can you start by telling us a little about your background?
– Over the past 10 years, I have been CEO of several different biotechnology companies, including Alligator Bioscience, which I took to Nasdaq Midcap in 2016, but later also at Targinta and Evaxion Biotech. I am a doctor by training, with a specialist degree in clinical pharmacology and an associate professorship in pharmacology. Over the past 20 years, I have been involved in clinical drug development, within county councils, big pharma, and for the past almost 15 years within biotech.
What do you see as your main strengths and how can they be best used where WntResearch stands right now?
– I believe that the combination of solid scientific and clinical expertise, and a broad experience from IR and business development can create value for WntResearch. The company is in a critical phase where the ongoing study will decide everything and where the goal is for positive data to lead to a decisive 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 – how do you view 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 tangible and statistically verified in a randomized controlled trial, based on a data set of 110 patients.
– The previous study was underpowered to show an effect on clinical outcomes such as disease-free survival. The main reason for this was that fewer patients relapsed than expected. This is probably due to improvements in diagnostics, surgery and treatment in recent years. However, at the same time, powerful effects on local spread were seen, already after 3 weeks of treatment before surgery, indicating that Foxy-5 has great potential in colon cancer.
– Now the ongoing study aims to show that this positive effect is so great 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 localized colon cancer immediately after diagnosis. These patients therefore do not yet have disseminated disease, as far as can be assessed with today's diagnostic methods. Treatment then continues until the tumor is surgically removed, which normally takes place within 3 – 5 weeks. However, approximately 20 percent of these patients will relapse with disseminated cancer within a couple of years, and then the prognosis is extremely poor.
– The aim of Foxy-5 is to reduce the number of patients who relapse after initial surgery. However, disease relapse is not studied in the current study, but rather we focus entirely on showing that Foxy-5 reduces local spread during the short treatment period prior to surgery. We can do this very precisely because we perform tissue analysis on the material that is surgically removed and compare between treated and untreated patients.
– In the previous study, we observed a clear reduction in local spread, even though the patients only received part of the total treatment at that time. In the new design, the treatment is intensified during the first 3 weeks, where we have both increased the dose and increased the number of doses, so that the total exposure to the drug candidate increases by more than 7 times. The hope is of course that this will 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 to be able to carry out the ongoing study, and is absolutely crucial for us to be able to document the effects of Foxy-5 in colon cancer. The observations we have seen earlier are very promising, but need to be confirmed in order to be able to enter into a larger partnership. The current study is therefore absolutely crucial for the company, and we hope to be able to present initial efficacy data from the included patients already towards the end of the year.
You participated in BIO-Europe Spring. What impressions did you take away from there and how would you describe the interest in your project?
– It is absolutely crucial for successful business development to build long-term relationships with the companies we hope to partner with, and BIO-Europe Spring is one of the many events we participate in for this very purpose. Preparing for partnerships is an ongoing effort that aims to get as many stakeholders as possible to get to know the company and our product candidate, so that they want to evaluate our clinical data as soon as we can share it.
– Our positive ad hoc observations have made many 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.