WntResearch recently announced that the Spanish authorities have approved the revised study plan for the phase II study NeoFox with the drug candidate Foxy-5 in colon cancer. The company has introduced new endpoints on the primary tumour already at the patients’ surgery, which enables significantly earlier data readout and thus cost and time savings. BioStock talked to CEO Pernilla Sandwall about the benefits of the new study design.

Malmö based biotech company WntResearch develops new cancer therapies intended to inhibit the ability of tumour cells to spread in the body and form metastases.

The company’s drug candidate Foxy-5 mimics the function of the endogenous protein WNT5A which affects tumour cells’ ability to move and spread in the body. Foxy-5 is currently being evaluated in a clinical phase II study, NeoFox, in patients with stage II-III colon cancer.

Revised study plan following positive observations

At the end of 2022, WntResearch announced that they planned to revise the study plan for the NeoFox study. According to the company, they had observed unexpectedly early and positive clinical effects of Foxy-5 in colon cancer. Therefore, they chose to introduce new endpoints already at the time of surgery, instead of after two years as was the original plan. Patients will be treated with Foxy-5 for three weeks before the surgery.

The new study plan means that patients participate in the study two years shorter, which reduces the cost per patient. According to the company, the study will also investigate whether Foxy-5 can be given at higher doses.

First patient after the summer

The changes in the study plan are now approved by both The Spanish Agency for Medicines and Medical Devices and the Central Ethical Review Committee in Spain, where most of the participating clinics are located.

The approval of the revised study plan means that patient recruitment can start again. WntResearch expects to include the first patient according to the new study design in early September, when the holiday period ends in Spain. According to the company, Spain is the most important country for the study and Hungary will therefore come later in the process.

CEO Pernilla Sandwall on the new study design

BioStock contacted the company’s CEO Pernilla Sandwall to learn more about the changes in the study plan for NeoFox.

First of all, what are the main benefits of the new study design?

– To be able to measure the effect on the primary tumour after what is called neoadjuvant treatment, i.e. treatment before surgery. Each patient will be in the study for two months instead of over two years. We will thus be finished with the study relatively soon after the last patient has been enrolled, instead of waiting two years.

»Each patient will be in the study for two months instead of over two years. We will thus be finished with the study relatively soon after the last patient has been enrolled, instead of waiting two years.«

Why did you choose to change the study plan?

– For results to be used in drug development, they must be predetermined – i.e. that you must have described what you are to measure in advance in a study plan, which must be approved by authorities. Our ad hoc observations, which we reported on last autumn and which we are very happy about, were first noted by one of the doctors in Spain when he operated on a patient, and then we were able to observe the same thing in many patients.

– Previously, the efficacy endpoints were not measured at the surgery, but first two years later. The observations we have seen so far suggest an effect on the original tumour, which is extremely important to document in our clinical trial.

What happens next?

– We will include the first patient according to the new study plan after the summer; probably in September. We are now updating all hospital clinics’ contracts and some other things that we could only prepare, but not implement, until approval from the authorities was in place.

»We will include the first patient according to the new study plan after the summer; probably in September.«

Finally, how can Foxy-5 become a valuable addition to the colon cancer treatment regimen?

– Cancer treatment is usally not given directly after diagnosis, before surgery. With the favourable safety profile we see with Foxy-5, one could do so, which we investigate in the study. Several approaches are needed for the treatment of cancer, and we therefore assess that Foxy-5 has the potential to become a valuable addition to the treatment arsenal, not just for colon cancer.

»Cancer treatment is usally not given directly after diagnosis, before surgery. With the favourable safety profile we see with Foxy-5, one could do so, which we investigate in the study.«

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