Fas 2-Studien

Clinical Phase 2 study initiated

A recently initiated Phase 2 study with Foxy-5 is conducted in patients with colon cancer that are considered to have a high risk of relapse after their primary tumour has been surgically removed. To optimize the effect of Foxy-5 on tumour spread, treatment is initiated at the time of diagnosis. Having a good correlation to predict the stage of the tumour and the risk of metastasis are important criteria required in order for the patients to be included in the study.. At the start of treatment, it is not known whether patients have a high or low expression of WNT5A in their primary tumour. It is the levels of WNT5A in the surgically removed primary tumours that will determine whether or not the patients will be included in the statistical evaluation.

Patients are treated with Foxy-5 for 12 weeks

The treatment with Foxy-5 will continue for a maximum of 12 weeks, but ends earlier if a patient starts chemotherapy within this time period. The study will compare the effect of Foxy-5 with a control group without Foxy-5 treatment. Foxy-5-treated patients will also be monitored and analysed in two groups: a group of low and a group with high expression of WNT5A. Even those patients who have a high expression of WNT5A will complete the treatment and be analyzed as a stand-alone group, as it is important to study the safety and efficacy of Foxy-5 also in this group.

The objective is to demonstrate that Foxy-5 decreases metastasis and relapse risk in patients with colon cancer

Patients will be followed for a total of 24 months and will be continuously evaluated every three months post surgery. The primary purpose is to document how Foxy-5 impacts time for relapse and the number of patients who have relapsed in the form of metastases. This will be done by computer tomography or Magnetic Resonance Imaging and in addition through analysis of circulating tumour DNA (ctDNA). In addition to WntResearch’s own study results, published studies of ctDNA have been important for the design of the Phase 2 study, aiming to shorten the time to demonstrate an anti-metastatic effect of Foxy-5 as a proof-of-principle. There is scientific evidence that the analysis of ctDNA in blood provides much earlier information on relapse than other available methods. ctDNA has, therefore, been chosen as a surrogate marker for the effect of Foxy-5 in the Company’s Phase 2 study. The majority of all recurrences usually occur within 12-24 months after diagnosis in our study population. Since the Phase 2 study is an open study, each follow-up event after completion of treatment will provide continuous information on the frequency of recurrence in the different study groups.

Positive results open up great opportunities

A positive indication of effect would mean a significant milestone for the company and provide the basis for further development of Foxy-5 in other indications, such as breast and prostate cancer. Such indications will give WntResearch a strengthened position for discussing future collaborations with leading pharmaceutical companies for a large number of other cancer indications.

Combination options with other cancer drugs

Clinical studies have clearly shown that treatment with Foxy-5 does not result in any severe side effects. Therefore, Foxy-5 can be used in conjunction with those chemotherapy therapies that dominate today’s treatment of cancer patients. The idea is to reduce the tumour burden with the help of chemotherapy and at the same time counteract metastasis using Foxy-5. In addition, there may be opportunities for combination therapies with the immuno-oncological treatments, so called Check-Point inhibitors that are now rapidly gaining ground. WntResearch has initiated a collaboration with the Department of Immunology and Microbiology at the University of Copenhagen for further studies regarding Foxy-5 treatment on top of these new treatments. The results of these preclinical studies show that Foxy-5 can be given concurrently with immuno-oncological drugs without affecting their effect. These results broaden the treatment possibilities and thus the market for Foxy-5.

Cancer reseach being reported to professor Tommy Andersson. Lund University in Malmö


Partners:

SMS

WntResearch has entered into an agreement with SMS Oncology as a contract research company (CRO) for the implementation of the Phase 2 study with Foxy-5 – a drug candidate to counteract tumour spread. The company, with its head office in the Netherlands, is focused on conducting only clinical cancer studies and has a long-term establishment in Spain and a solid experience of carrying out studies in these two countries. SMS Oncology is a full-service CRO company focusing on the implementation of clinical oncology studies in Europe, with special expertise in early phase and immuno-oncology studies.

Biovica

WntResearch has entered into an agreement with Biovica International AB for the development of a biomarker for Foxy-5 for the Phase 2 study. The purpose of the research collaboration is in the development of a so-called companion diagnostic, a diagnostic test linked to Foxy-5. With this type of test, Biovica and WntResearch see the possibility of offering an accurate and individualized treatment with Foxy-5. The background to the collaboration lies in several studies that have shown that the enzyme thymidine kinase (TK) is strongly correlated to aggressive tumour disease. To investigate whether there is a connection between TK, Wnt-5a and recurrence of cancer, TK will be determined in the Phase 2 study in patients with colon cancer.

Saga Diagnostics

WntResearch has entered into an agreement with SAGA Diagnostics regarding the KROMA ™ technology for the detection and measurement of circulating tumour DNA (ctDNA) in the blood. High levels of ctDNA have been shown to be strongly linked to early relapse in cancer disease. By measuring ctDNA in blood samples, cancer can be monitored during treatment and relapses are observed as early as 36 months before metastases can be detected with current imaging technologies. Studies have shown that the KROMA technology is more robust and has higher precision compared to other assay methods for determining ctDNA. With ctDNA, the treatment success in clinical studies have been found significantly earlier than with imaging technologies such as computer tomography (CT scan) and magnetic resonance imaging (MR / MRI).