WntResearch to focus on patient recruitment
The key take-away from the Q3 report of cancer therapy company WntResearch is that, so far, 93 patients have been randomised in the NeoFox study. Due to the pandemic, recruitment has been slower than expected, but the company is still aiming for an interim analysis covering 120 patients in December 2022.
WntResearch’s drug candidate Foxy-5 is being developed to prevent metastasis of cancerous tumours, initially focusing on colon cancer. Previous preclinical studies have shown that the candidate has an ability to counteract tumour formation and the ongoing phase II study NeoFox is evaluating whether Foxy-5 can counteract colon cancer recurrence after curative surgery.
Foxy-5 to prevent metastases
The high mortality rate from cancer is mainly due to the fact that the cancer metastasizes, meaning that it spreads to other parts of the body. Preventing metastases is thus of utmost importance to improve treatment outcomes and reducing cancer-related mortality. Today, however, no treatment with the specific aim to prevent metastases exists.
The research conducted by WntResearch revolves around WNT, a family of proteins that control various cellular processes and, e.g., impact the way that cells devide and migrate. One of the proteins in the group, WNT5A, naturally occurrs in many cells, however, increased or decreased levels of WNT5A indicate cancer formation. WntResearch has developed Foxy-5, a synthetic copy of a specific region of the WNT5A protein, with the goal of inhibiting the cancer cell’s ability to break away from the mother tumour and migrate to other tissues, and thus reduce the risk of metastases.
NeoFox study advances
In a first step, Foxy-5 is being developed for the treatment of colon cancer. Clinical studies have shown that the candidate possesses the ability to counteract tumour formation. Backed by this data, WntResearch is currently conducting the phase II study NeoFox together with its partners CATO/SMS and Optimapharm.
Earlier this year, once it became clear that the pandemic could be kept in check in Europe (thanks to the effective rollout of covid-19 vaccines), the company was able to return to full activity within the study. The report for the second quarter stated that 80 patients had been recruited, a group that had grown to 93 patients by the time of the Q3 report.
The Q3 report indicates that, while the NeoFox study has returned to full activity, patient recruitment has still been slower than expected. In order to get back on track, the company plans – together with participating doctors, nurses and partners – to take measures and carry out activities to further stimulate patient recruitment.
The company expects to see results from the action programme over the next three to six months. It also expects to launch several research collaborations and potential partnerships to strengthen a clear and feasible clinical development plan for market registration of Foxy-5. At the same time, the report confirms the company’s goal to communicate the results from an interim analysis in December 2022.
Additional Foxy-5 has been manufactured
Parallel to the study, WntResearch has manufactured additional Foxy-5 study material and estimates that approximately 3 000 new vials will be available by January 2022. This should ensure the completion of the NeoFox study in accordance with the current study protocols.
Moreover, the company has been working on a new and more cost-effective manufacturing method for Foxy-5. The goal is to improve the properties of the substance and develop a better formulation for future clinical development and a possible launch. The company has identified some alternatives for further up-scaling and expects to present the results before the end of the year.
WntResearch is also conducting additional preclinical studies with the primary purpose of evaluating an alternative dose frequency for Foxy-5. Results are expected in the first quarter of 2022.
In addition, the company has taken steps to improve its IP situation by protecting both the substance and the manufacturing method, thus broadening its patent portfolio.
The potential for more indications is being investigated
During the autumn, WntResearch has examined the clinical and commercial potential of Foxy-5 and is now evaluating potential research collaborations with internationally renowned research groups. Among other things, one goal for the company is to explore the opportunities to develop Foxy-5 in other indications besides colon cancer.
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