Clarification on the observations of the unexpected positive effects of Foxy-5 in colon cancer

As previously announced by the company, the ad hoc analysis has shown that Foxy-5 treated patients in the NeoFox study have statistically significant TNM downstaging compared to patients in the control arm. This press release intends to provide more details.

The ad hoc analysis shows a statistically significant difference between the control arm and Foxy-5 treated colon cancer patients with respect to three prognostic parameters at surgery i.e. after only three weeks of treatment.

The most important prognostic analysis in colon cancer is the so-called TNM grading (Staging according to the American Joint Committee on Cancer (AJCC), 8th edition 2017) which evaluates and grades the invasive growth of the primary tumour through the bowel wall (T), metastasis to regional lymph nodes (N) and distant metastasis (M). In a cohort of 118 patients, of which 110 patients were included in the analysis, there was a p value of 0.012 in favour of Foxy-5 for downgrading TNM at surgery. The result remains true even when controlling for baseline factors such as age, sex and clinical site at inclusion in the study. This suggests that patients treated with Foxy-5 have a better prognosis compared to those who are not treated.

The detailed TNM stages are divided into major groups to describe the progression of the cancer. This system often uses Roman numerals I, II, III and IV and 0 as designations. Generally, the lower the number, the less spread of the cancer. Analyses show that patients treated with Foxy-5 have a significant reduction in their stage group at surgery compared to when the patient was included in the study (p=0.0275). Ja bättre med plural

A second prognostic event studied is the spread of cancer cells to vessels (vascular invasion). Patients treated with Foxy-5 had less dissemination to surrounding vessels (p=0.0097), again suggesting that patients treated with Foxy-5 had a better prognosis than those in the control group.

A third prognostic parameter analysed was nerve invasion of cancer cells (perineural spread). Patients treated with Foxy-5 had less invasion along adjacent nerves (p=0.0088), again supporting the interpretation that Foxy-5 treated patients had a better prognosis than those in the control group.

Patients with colon cancer should have their tumour removed within one month, as is standard practice in many countries. If patients are to be treated with chemotherapy or other cancer therapies, this treatment is usually started only after surgery. In the NeoFox study, patients are divided into two groups by a process called randomisation. The ad hoc analysis shows that the two groups are balanced in terms of patient age, gender and clinical sites. Patients randomised to the active treatment group will receive a total of 9 doses of Foxy-5 for three weeks before their surgery. In contrast, patients in the control group receive no treatment at all for their cancer before surgery.

"The invasion and spread of a cancer to surrounding tissues is one of the first steps in the metastatic process that eventually results in the establishment of distal metastases. The fact that after only three weeks of treatment with Foxy-5 we clearly see reduced invasion and spread of cancer cells is remarkable and supports the notion that Foxy-5 has an anti-metastatic effect also in humans," says Professor Tommy Andersson, co-founder of the company.  

"In the ad hoc analysis that has been completed, we have for the first time in a patient population of 118 randomized patients, which is relatively large for a phase 2 study, been able to confirm that the preclinical data we have are also seen in patients with colon cancer. The data suggest a reduced risk of metastasis. The likelihood of Foxy-5 having an anti-metastatic effect also in humans is therefore greater than it has been in the past and this is an important and positive breakpoint or value inflection point as they say in this context. To my knowledge, this is an entirely unique mechanism of action that has no competition in the pursuit of WNT signalling therapeutics. I am really looking forward to the further development and hope we will also be able to start exploring other cancers more", says CEO Pernilla Sandwall.

For further information:

Pernilla Sandwall, CEO

E-mail: pernilla.sandwall@wntresearch.com

This information was submitted for publication, through the agency of the contact person set out above, on 8 November 2022 at 10.10 pm CET.

About Wntresearch AB

WntResearch is a biotech company in oncology that develops new therapies intended to prevent the metastatic process. The company's research is focused on studying the endogenous protein WNT5A, which in scientific studies has shown to affect tumour cells' ability to move and spread in the body. WntResearch drug candidate Foxy-5 is a peptide that mimics the function of WNT5A and is intended to reduce the mobility and spread of cancer cells thus preventing metastases from occurring. Although current cancer treatment has become more effective, there are no effective ways to prevent the onset of metastases that cause about 90 per cent of all cancer-related deaths. Foxy-5 has a unique mechanism of action and has shown a good safety profile with few side effects in two Phase I clinical trials. The safety and efficacy of Foxy-5 are now being evaluated in the ongoing Phase 2 clinical trial NeoFox, in patients with stage II-III colon cancer.

WntResearch is listed on the Spotlight Stock Market. For more information, please visit: www.wntresearch.com.

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