Things are starting to move again for WntResearch, the company recently got the green light for its new study plan for Foxy-5. The company looks forward to being able to resume recruitment in its phase II study with the drug candidate. BioStock contacted CEO Pernilla Sandwall in connection with the release of the company’s report for the second quarter.
The cancer therapy company WntResearch develops Foxy-5 for the treatment of colon cancer. The drug candidate is a peptide that mimics the endogenous protein WNT5A, with the hope of reducing the spread of cancer cells in the body. A clinical phase II study with Foxy-5 is currently underway, where the candidate is being evaluated in patients with stage II/III colon cancer.
New study plan approved
During the summer, the Spanish authorities approved the company’s revised study plan for the study. Among other things, it means that patients’ participation in the study will be shortened by almost two years. Now that the altered plan has been given the go-ahead by both the Medicines Agency and the Central Ethical Review Committee in Spain, recruitment of the first patient is expected to begin in September.
Will test higher doses of Foxy-5
Another new feature of the revised plan is to test the candidate in higher doses than previously planned. Behind this initiative is data on the candidate’s good safety profile and it is hoped that the higher doses will show even better efficacy than has been noted so far.
That part of the study will be conducted in Spain and is expected to take approximately six months. Once the dose has been determined, the company will also include patients in Hungary for the part of the study that will evaluate the effect of Foxy-5. WntResearch currently expects to be able to present final results in 2025.
WntResearch enters H2 with a strengthened team
It is not only in clinical development that the company has excelled this year. The report for the second quarter shows that Mats Lindskog has been elected as a new member of the board. Lindskog has extensive experience in business development and pharmaceutical sales. In addition, Joachim Gullbo, one of the founders of Oncopeptides, has once again been appointed scientific advisor to the company.
Looking at the financial side of the report, cash flow from operating activities amounted to approximately -8.3 MSEK. In September, WntResearch is raising capital with the exercise of the series TO6 warrants, which will strengthen the cash position.
The warrants are thus an important component in the upcoming work on the study. The market has so far shown its confidence in the company. So far this year, it has managed to raise a total of approximately 42 MSEK via issue and exercise of warrant TO5, before issue costs.
Comments from the CEO
BioStock contacted WntResearch’s CEO Pernilla Sandwall for a comment on the quarterly report and her thoughts on what lies ahead.
First of all, Pernilla, how would you describe the first half of 2023?
– I would like to summarise it as an intense, exciting and fun six months. We have had many interesting meetings when we have been to both partner and investor conferences. In addition, we were also invited to the scientific meeting on WNT signalling where Tommy Andersson (professor and co-founder of the company) and I presented Foxy-5 and our ongoing phase II study. This was done in an intense period during the spring as there are not as many such events during the summer.
– What was incredibly important was that we strengthened our finances with a capital injection totalling approximately 40 MSEK, which means that we can continue operating. Some owners were upset by the rights issue. I know and understand it in a way, but it was the only option. I was really pleased that both the rights issue and series TO 5 warrants were subscribed to over 90 per cent, which I see as a sign of great confidence.
You will now measure the effect of Foxy-5 already at surgery and investigate higher doses. Can you tell us a little more about the background to this and what the hopes are for the autumn?
– This was absolutely fantastic; to be approved by both the Agency and the Central Ethical Review Committee in Spain without any questions whatsoever. It is as unusual as it is gratifying, as I wrote in my CEO comment in the report. I really see it as proof that our change of the study is well thought out and justified, and also that we are an experienced group that knows drug development.
– The reason for the changes in the study plan was the positive observations with Foxy-5 that we have previously reported on. Now we will measure the effect directly on the primary tumour removed during surgery, instead of seeing how the patients are doing two years after surgery. We will also investigate treatment with higher doses, which is possible thanks to the data we have so far showing that Foxy-5 has a favourable safety profile.
– The hope is that we will see a great interest from both all study staff at the hospitals to resume the recruitment of patients, as well as from the patients themselves to participate in the study.
– I am also looking forward to the major European oncology congress ESMO. There we will be able to meet doctors and representatives from pharmaceutical companies to discuss Foxy-5 and the study. Hopefully it will be very rewarding days!
You have added Mats Lindskog and Joachim Gullbo to the team. Why are these two right for WntResearch and what do you hope they will contribute?
– It is so important to have a good team with expertise in everything related to drug development and future commercialisation. Both Mats and Joachim are very experienced and competent people, each in their own field, i.e. business and drug development.
– They have experience from both small and large companies, which is also an important aspect. In addition to the fact that I am convinced that we will get a lot of good advice from them, they also have large networks in the industry, which is quite important.
What important events do you see ahead of you in the coming months?
– I immediately think of a couple of things; recruitment start in the study, in-depth discussions with pharmaceutical companies and a large participation in exercising the TO6 warrants.
– The first patient should be included in September. This means that all preparations are in full swing. For example, all clinics’ contracts and various instructions must be updated, which is always done when a study is changed. When a patient starts the study, there are many frequent visits to the clinic and therefore the entire study team needs to be on site. It is holiday time in Spain now, but they will soon be back at work again.
– With our ad hoc observations and a new approved design of the study, I look forward to in-depth discussions with various pharmaceutical companies. This is done through individual meetings, but also at conferences such as ESMO, so there are many opportunities ahead. We prioritise these activities, as a partnership is extremely important to us.
– In the near future, we now have our series TO6 warrants. I hope many of our shareholders will subscribe, because a high subscription rate will mean a valuable capital injection.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.