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For WntResearch, 2020 has been characterised by work on the phase II study with the company’s main candidate Foxy-5, developed to prevent cancer metastases. Another important event was the oversubscribed share issue that was carried out during the spring. BioStock talked to CEO Peter Morsing to hear more about the past six months and what the rest of 2020 has to offer WntResearch.

Malmö-based WntResearch aims to develop a treatment that inhibits cancer from becoming metastatic. Although metastases are behind a majority of cancer-related deaths, there are still no effective treatments that inhibit metastasis formation.

WntResearch’s primary candidate Foxy-5 is a synthetic copy of a portion of the WNT5A protein that has been shown to inhibit cancer cell mobility. Studies have found a clear link between low levels of WNT5A and a higher risk of tumours spreading. By adding Foxy-5, a peptide that mimics a specific part of WNT5A, the aim is to reduce the ability of cancer cells to break away from the main tumour and form metastases in the body.

Phase II studies with Foxy-5

WntResearch’s phase II study with Foxy-5, Neofox, is being conducted in patients with colon cancer and will examine the candidate’s ability to reduce the risk of metastasis and relapse in this patient group. During autumn 2019, Neofox was initiated in Spain and in early 2020 the company announced the good news that it had obtained study approval in Hungary as well, thus increasing the pace of the study.

But, just like the entire life science sector, WntResearch was affected by the Covid-19 pandemic. At the end of March, the decision was made, in line with the advice of the national health authorities, to pause patient recruitment in both Spain and Hungary.

Restarting Neofox

At the end of June, the company could yet again announce good news when the Hungarian health authorities judged Covid-19 to be under control meaning that the Hungarian hospitals could resume functioning as normal. As a result, WntResearch, in consultation with its partners Cato/SMS and Optimapharm, decided to restart Neofox in Hungary.

With regard to the Spanish part of the study, WntResearch expects to resume this soon too, probably during September. The assessment is based on the heavy burden that the most intensive Covid-19 period meant for the Spanish healthcare system in combination with the low patient recruitment the company saw in Spain last August.

A first evaluation

In connection with the restart of the study, WntResearch also announced that an initial evaluation of the already included patient group regarding their risk of relapse was performed. A satisfactory statistical calculation presupposes an accuracy in the patients’ preliminary diagnosis of 70 per cent – a parameter that currently measures 68 per cent among the study’s evaluable patients, and which appears to be increasing. Based on previously published WNT5A expression data in this patient group, 8 patients in each group are estimated to be evaluable according to the study’s inclusion criteria.

Oversubscribed rights issue

It is worth noting that 2020 has also meant strengthened finances for WntResearch. At the end of April and early May, the company completed a rights issue of approximately 38 million SEK. When the rights issue was concluded, it had been subscribed to as much as 128.4 per cent, which indicates that the market has a great interest in the company.

BioStock has spoken with CEO Peter Morsing about the resumed study, how the year has been so far and what he expects from the rest of 2020.

Peter Morsing, CEO, WntResearch

Peter, what would you say has been the most important event for WntResearch during 2020?

-In the middle of the first quarter, we saw that all the measures we took during the study were starting to produce results regarding the recruitment of patients to the study. The number of patients included in Spain increased significantly and the goals we had set at the start of the study were clearly within reach.

– At the same time, being given the go-ahead to start the study in Hungary a little earlier than expected was a big advantage. Of course, the fact that society then was hit with full force by Covid-19 overshadows everything else and left the study in a difficult situation.

Regarding Neofox, how far had you come in the study when you chose to pause patient recruitment?

-The low recruitment rate in the study during 2019 had placed us in a difficult situation, but the acceleration we saw at the beginning of 2020 gave us the opportunity to meet the goals we had set, i.e. more than a third of the patients would have been recruited in the summer of 2020. In addition to the fact that recruitment completely stopped after the Covid-19 outbreak, however, we also lost some patients. This means that it will take a little more time until we have enough patients to see the trend in treatment effect that we expect if our theory is correct.

While you have been forced to put the study on pause temporarily, you still managed to perform an initial, evaluation of the existing patient group. Can you tell us more about what this evaluation shows and what it means for the continuation of the study?

– The Neofox study breaks new ground in cancer treatment, and in order to maximise the full potential for treatment effect with Foxy-5, we have made a number of assumptions based on the history of the patient category we have chosen to study.

– An important parameter is the skill of the treating surgeons and the radiologists to be able to make a correct assessment of the stage of the primary tumour at the time of diagnosis, before the start of treatment.

– In order to be able to carry out a phase II study with a reasonably limited patient base and within a reasonable period of time, we have selected a patient group that historically has a high risk of relapse and that does not already have established metastases, which our treatment is to prevent. Large studies have shown that the accuracy of the preliminary diagnosis is somewhere between 70-90 per cent depending on the treatment regimen available in the country. In our assumptions, we have used the lower percentage and the analysis we have now conducted shows that we are close to this number, and we are pleased to note that the precision has increased as the study progressed. An interesting difference between Hungary and Spain is that in Hungary, the cancer stage is routinely used very early on to plan the care of the patients, while in Spain one tends to wait for the pathological evaluation and then plan the care.

– Other analyses that have not yet been performed are circulating tumour DNA where we wait until we have more patient material available and the expression of WNT5A in the primary tumour.

When can the first evaluation be carried out?

– We have calculated that we should achieve a satisfactory statistical calculation with an accuracy of 70 per cent in the patients’ preliminary diagnosis – a parameter that currently reaches 68 percent among the study’s evaluable patients, and this appears to be increasing. Based on previously published WNT5A expression data in this patient group, 8 patients in each control and treatment group are estimated to be evaluable according to the study’s inclusion criteria.

– One analysis that has yet to be performed concerns circulating tumour DNA where we will wait until we have a larger patient material available. We will also investigate the expression of WNT5A in the primary tumour. The patients who are now starting their treatment must first be treated and then have their first follow-up period, so we expect the first analysis of circulating tumour DNA to be conducted at the turn of the year.

What do you expect now that the study restarts in Hungary?

– Our contacts with the Hungarian clinics have been very positive. We expect that the experience we gained during the study’s start in Spain, together with the highly experienced test leaders who have been contracted, will lead to a rapid start of study and high precision in the work.

As for the Spanish part of the study, you expect to be able to resume it in September. Do you see any factors that could make this more difficult and, if so, what does your strategy look like for addressing these?

– The single most important factor that can make restarting difficult is a second wave of Covid-19 infection that cannot be controlled. The fact that we can now start in Hungary sooner than we had planned means that our patient recruitment margin, dependent on a later study start in Spain, will increase. We will be vigilant and monitor the development in both Spain and Hungary to assess whether further action needs to be taken to achieve our goal of including patients within a reasonable time period.

With the study once again underway in Hungary, and assuming it also starts in Spain in September, when do you expect to be able to complete the phase II study and when can the market expect the data?

– As we restart the study,there are really two goals that are important for us. One is that we get enough patient material to be able to analyse in order to see a trend in treatment effect. The second goal is to include all the patients needed for a statistically reliable assessment of treatment efficacy.

– We now expect to be able to achieve the first goal around the turn of the year, and we will hold off on this analysis as long as possible before our next important milestone for funding in February 2021. We expect to reach the second goal of having included 60 evaluable patients in the study by the end of Q2, 2021.

During spring, you carried out a very successful rights issue. What does the company’s financial position look like today and how long do you expect your existing cash to last?

– The financial position is good and we have good control over the costs. We have had to cut down on activities that do not directly affect the study, but we are carrying out some programs that move the company forward. With that said, we have set our sights on being an attractive company at the time of the warrants in February 2021.

If we look ahead, what milestones do you expect WntResearch to reach within 3 years?

– The single most important milestone is to be able to announce that the effects we see from Foxy-5 in preclinical trials can be translated into patients, initially by demonstrating a trend in reduced risk of relapse.

– Another milestone, provided that we achieve the first one, is of course to find a route for taking Foxy-5 all the way to being an effective and registered therapy.

 

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.

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