WntResearch’s CEO: “Aiming for an agreement”
WntResearch is approaching the first readout from the expansion part of the phase II study with Foxy-5 in colon cancer. In parallel, the company is working on business development where several potential partners are interested in taking part in the upcoming results, which are absolutely crucial for the project and the company:
– We are getting closer to a decision for WntResearch and Foxy-5. It will definitely be an exciting autumn, CEO Per Norlén writes in the Q2 report.
WntResearch is developing the drug candidate Foxy-5, designed to reduce the mobility of tumour cells by imitating the protein WNT5A. This gives the drug the potential to counteract the spread of cancer and prevent metastases.
The company is currently conducting a phase II study, NeoFox, with Foxy-5 to demonstrate efficacy in patients with newly diagnosed colorectal cancer. The study was originally intended to cover a long treatment period and follow-up. However, based on positive ad hoc observations, the company decided to adjust the study plan and focus on the early effect on local metastasis. The hope is that the study results will confirm the previous ad hoc results that showed a tumour-inhibiting effect already after three weeks of treatment with Foxy-5.
Focus on patient recruitment
The plan is to present initial results in the autumn, provided that enough patients are included. The study is being conducted at several clinical trial centers in Spain and Hungary and will include a total of 80 patients, half of whom will be treated with Foxy-5.
According to the company’s Q2 report, patient recruitment in the study is progressing well. By the beginning of August, 19 patients had been enrolled in the study, in addition to the six patients previously dosed in the dose escalation phase. 15 patients have been treated with Foxy-5, three of which have a slightly lower dose, and ten patients have been randomized to the control group. The majority of patients have been recruited by trial centers in Spain, but recruitment has also started in Hungary.
Approaching crucial stage
On top of the study WntResearch is also focusing on business development. Provided that the results are positive in the first readout, the company plans to initiate in-depth contract discussions. If the results do not meet expectations, there is a risk that the Foxy-5 project may be shut down, according to a previous interview with CEO Per Norlén.
The results will thus have a major impact on the company’s future plans and could, in the best of worlds, lead to a deal as early as next year:
– In a desirable scenario, we see strong enough data already this autumn to enter into agreements before final study data is available, which is expected to be in the second half of 2025, but this naturally requires very convincing indications of effect, says CEO Per Norlén.
A more conservative scenario would be for the initial data to attract preparatory negotiations and in-depth evaluations, which could then make it possible to sign a partnership agreement after final study data is available.
Conference participation
During the year, the company has also presented at several conferences in both the US and Europe to spread knowledge about Foxy-5 and the ongoing study. Among other things, the company participated in the European Society for Medical Oncology, the Gastrointestinal Cancer Congress Munich and the BIO International Convention in San Diego, USA, during the summer.
– It was an intense week with several partnering meetings. All in all, there is great interest in our drug candidate both among medium-sized biotech companies and some of the largest pharmaceutical companies. We look forward to following up on these dialogues once we have received the initial results from the NeoFox study.
Comments from the CEO
BioStock contacted CEO Per Norlén to get a deeper insight into the ongoing study and discussions with potential partners.
First of all, how do you ensure efficient patient recruitment and smooth implementation of the NeoFox study?
– Our strategy is to maintain a close dialogue with our study doctors. The goal is that they have us top of mind when they find a new patient. There is fierce competition for patients between different studies, and it is easy to be forgotten if you do not maintain contact with clinical CROs.
– Most CROs are also active in this, but it doesn’t create a personal relationship with the study doctors in the same way as if we have direct contact. This creates greater commitment and makes them more interested in the success of the study. The strategy seems to have worked well so far and we are very pleased with the initial recruitment.
You also have ongoing discussions with potential partners who are interested in evaluating the upcoming results. What results are needed for you to be able to move forward in these discussions?
– We primarily hope that the initial analysis this autumn will generate interest for initiating in-depth discussions. Effects on a par with those we saw in the original study should be sufficient to make sure of this. However, these effects were not part of the pre-planned analysis, and the results therefore need to be repeated to be seen as reliable, which is what we hope to do in the ongoing study.
– In addition, we have added evaluation with CT scans before and after treatment. If we see similar effects here, I think there will be great interest based on our current conversations.
What kind of partner would be optimal for the continued development of Foxy-5?
– Our main goal is of course a larger player with global coverage, but we have chosen a much broader strategy for our business development to create interest among as many companies as possible. The best-case-scenario is to get a competitive situation where companies are forced to outbid each other.
According to the Q2 report, you had a cash flow of SEK -15.7 million and a cash position of SEK 24 million at the end of the period. However, you have two warrants, TO7 and TO 8, which can provide additional capital in 2024 and 2025. How far are you financed if both warrants are fully subscribed?
– The warrants could take us well into the fall of 2025, but we will need additional funding or partnerships next year to complete the study. Many companies will probably be reluctant to sign an agreement before the study is completed. In addition, we will also need funding for some time after the study is completed to have an optimal negotiation situation.
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.
