“Foxy-5 is well tolerated and early data indicates biological activity in treated patients. Our newly started Phase 2 study will provide the answer to the question of whether Foxy-5 also protects patients from metastasis. ”
Peter Morsing, CEO
Foxy-5 – a unique drug candidate with the potential to prevent metastases
Foxy-5 is a peptide that mimics the WNT5A protein and is expected to reduce the mobility of the cancer cells. Preclinical data support the theory and clinical phase 1 studies have defined appropriate doses and proven that the substance has a very high tolerability. An optimized phase 2 study has recently been initiated with the aim of demonstrating reduced risk of metastasis in patients with colon cancer.
The protein WNT5A is not suitable as a drug in its natural form. It is a complex molecule with properties that allow it to bind to the surface of all cells. This results in WNT5A getting a local restriction to the site where it is injected and thus the protein does not reach the cancer cells. WntResearch’s drug candidate, Foxy-5, is a synthetic copy of a specific portion of the WNT5A protein.
Foxy-5 mimics WNT5A
Through its specific similarity Foxy-5 mode of action mimics the naturally occurring WNT5A protein, without the undesirable property of binding to cell surfaces. As described, the metastasis in a variety of cancers, such as colon, prostate and breast cancer, is linked to low intracellular levels of WNT5A. Foxy-5 is intended to be delivered to cancer patients who are believed to have a low expression of WNT5A in the primary tumour. According to the hypothesis, the cells’ ability to break away from the primary tumour will then decrease and the metastasis will be made more difficult.
Foxy-5 is expected to increase survival in patients with low levels of WNT5A
WntResearch estimates that if Foxy-5 therapy is initiated early after tumour detection, the survival of low-cancer patients of WNT5A in their primary colon tumours will increase significantly. This includes about 40–50 percent of all patients with colon cancer. The hypothesis is enhanced by data from a retrospective study conducted by WntResearch, which shows that close to 70 percent of stage III patients have a low expression of WNT5A, compared to about 45 percent in patients with less advanced tumour stages. This supports the hypothesis that the WNT5A level significantly affects the course of the disease. Tumour stage III patients differ from stage II mainly by the presence of tumour cells in lymph nodes located near the primary tumour. This is associated with a faster disease progression.
Preclinical results show positive effects
Foxy-5 has been tested in a number of toxicological studies and has been shown to be very well tolerated. The doses tested in toxicological studies in rats have represented more than 45 times the expected human therapeutic dose level, providing a very satisfactory safety margin. Furthermore, a number of preclinical experiments show that Foxy-5 reduces the ability of the tumour cells to move and counteracts the onset of metastases. The effect of Foxy-5 on tumour metastases has been tested in vivo in a mouse model of breast cancer. The results showed that Foxy-5 reduced the incidence of metastases in the lungs and liver by 70-90 percent compared to untreated animals. The results have also been confirmed in a mouse model of prostate cancer where the metastasis was inhibited to the same extent.