Reporting its third quarter, WntResearch is focusing on the restart of the NeoFox study with Foxy-5. The first patient was recently enrolled in the redesigned study, where the next milestone will be a first readout when half of the patients have been treated. BioStock reached out to CEO Pernilla Sandwall to get her thoughts on the development during the quarter.
WntResearch focuses its development on the endogenous protein WNT5A, which plays a critical role in the proliferation of tumour cells. The lead candidate Foxy-5 is a peptide designed to mimic the function of WNT5A, with the aim of preventing cancer cell motility and reducing the risk of metastasis.
During the past year, WntResearch has changed the design of its phase II study NeoFox, which aims to evaluate the efficacy of Foxy-5. After observing early and positive effects of the treatment on patients with colon cancer, the company decided to modify the study design.
The new plan means that patients are now only treated with Foxy-5 for at least three weeks until their surgery when the effect is measured, instead of the previous model that involved efficacy evaluation two years after surgery. The study also has a control group of patients who do not receive any study drug and the patients are randomised to each group.
First patient recruited
NeoFox has now officially been restarted and the first patient was recruited in October. The study is divided into two stages. The main purpose of the first stage is to evaluate higher doses than those previously studied and then, hopefully in the spring, choose the dose to use in the second stage of the study. In the second stage, 80 patients are planned to be included and the top-line results are expected to be presented sometime in 2025.
Aiming for the first efficacy readout in the near future
However, the company expects to receive indications of efficacy earlier than that. The next important goal is an initial efficacy readout when half of the patients have undergone treatment. WntResearch recently signed an agreement with Stockholm-based healthtech company Collective Minds Radiology (CMRAD), which will be responsible for the readout of the CT scans in the study.
By centralising the imaging diagnostics, WntResearch strives to reduce the variation in the readouts, ensuring the precision and thus the reliability of the study.
“Based on the outcome of that analysis, we will determine whether the data volume is sufficient and whether or not to include the remaining patients,” CEO Pernilla Sandwall writes in her statement in the Q3 report.
Aiming for capital raise in early 2024
WntResearch announced on Monday morning that it intends to carry out a capital raise at the beginning of next year, to finance the work on the restarted study. The company aims to carry out a rights issue of units, with an initial target of raising approximately 56 MSEK.
Comments from the CEO
In addition to the restart of the study and the capital raise, the company has also announced that Pernilla Sandwall will leave her position as CEO of the company. In connection with the BioStock Life Science Summit, BioStock took the opportunity to talk to her together with Chairman Christer Nordstedt to get an update.
We also contacted Pernilla Sandwall in connection with the Q3 report, to get her view of the company’s development during the autumn.
First of all, Pernilla, how would you describe the period since the release of the Q2 report?
– I would like to sum it up by saying that we have taken some really important steps forward in our development project. My assessment is that we are now in a better position than ever.
– We delivered two really good pieces of news. First of all, we got the study approved in Spain without a single question from the authorities. We also announced that we recruited the first patient in October. Then we got a very good patent approved by the European Patent Office (EPO), which is valid until 2041.
– I am also very pleased that we will be working with CMRAD to assess the patients’ X-ray examinations. The fact that we also had a very good outcome in the warrant program in September resulted in a valuable addition to the cash position. We also see that as a clear sign of our shareholders’ confidence in the project.
You recently announced that you will do an initial efficacy readout from the study when 40 patients have undergone treatment. Why are you doing this so early?
– It is quite common to do this, to ensure that you’re on the right track and don’t treat patients in a study unnecessarily. It could be that 40 patients are enough to draw a conclusion. However, the most likely thing is that the readout will show that we have planned well and need 80 patients.
When do you expect to do that readout?
– We will choose a dose in the spring and the entire study is expected to be completed in 2025. We have different scenarios, depending on how quickly patients are included. The information we have now is based on the first part of the study, where we recruited patients during the covid pandemic and for a much longer study. When the clinics are up and running properly in the new part, we will be able to provide a better sense of the timeline. So, I don’t want to promise anything just yet.
This morning, you announced a rights issue of initially 56 MSEK. What are your thoughts here?
– It is an important sign of strength that we have been able to secure support from eight of our major shareholders ahead of this new share issue. The capital injection takes us at least to the initial analysis of the data, where we make an initial evaluation of the efficacy after 20 patients have been treated with Foxy-5. Depending on the outcome of the entire share issue, including the warrants, it may even take us to the end of the study.
You are about to leave your position as CEO of WntResearch. If you look back on your time as CEO, what do you take with you?
– It feels too early to look back; I’ll have to do that when the new CEO is in place. I now continue with full force and look forward to evaluating the dose escalation that is ongoing in the study and continuing the discussions with potential partners that intensified recently in connection with BIO-Europe.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.