Interesting clinical observations lead to changed plans for WntResearch
In connection with an ongoing post hoc analysis of the NeoFox phase 2 study, a reduced tumour burden (in primary tumour and regional lymph nodes), so-called down staging, has been observed in the patients treated with Foxy-5 before surgery. This down staging is significantly associated with treatment with Foxy-5. In addition, in the same group, a decrease in perineural invasion (i.e., tumour cells spreading along nerves) and a strong trend towards reduced vascular invasion (i.e., spread to blood vessels) have been seen.
In an ongoing post hoc analysis of approximately 100 patients, a reduced tumour burden so-called down staging (in primary tumour and regional lymph nodes) has been observed in the group that received Foxy-5, compared to the control group. These observations are consistent with previous preclinical findings. Down staging means that the tumour burden has decreased at the time of surgery compared to when the patients entered the study. Furthermore, in the Foxy-5 group, there was also a decrease in perineural invasion (i.e., tumour cells spreading along nerves) and also a tendency to reduced vascular invasion (i.e., spread to blood vessels). This indicates that the tumour burden may decrease by treatment with Foxy-5 before surgery. Data from NeoFox, as well as previous phase 1 studies, have shown that Foxy-5 has a very favourable side effect profile, without the problems that normally occur with conventional chemotherapy.
The company therefore assesses that NeoFox should not be completed as originally planned because the study did not intend to study these observations and has therefore decided to pause further recruitment of patients to the study. Treatment and follow-up of already included patients continues as planned. We will evaluate the significance of these observations and try to ensure that the development of Foxy-5 is done in a fast and optimal way. Our findings will therefore be further studied by scientific and medical expertise in line with the planned interim analysis. The purpose of this is to develop a revised plan within six months to ensure that Foxy-5 can be developed to its full potential. The intention is also that the actual analysis of the study's observations should be presented in an appropriate scientific forum.
Based on these findings, WntResearch will intensify efforts to identify potential collaborators with a strong presence in oncology to develop Foxy-5.
In drug development - especially with a drug candidate that has new properties - it is important to be attentive as even the unexpected may occur. The fact that treatment with Foxy-5 could possibly have a tumour-reducing effect even before surgery - which is consistent with the reduced tumour spread shown in preclinical studies - strengthens the possibility for Foxy-5 to become a treatment option for patients affected by cancer of the colon. Foxy-5 has so far not shown any serious side effects, which makes it even more interesting to move forward. However, we would like to urge caution in the interpretation of these early clinical findings. If these observations can be attributed to Foxy-5 in clinical treatment, we are in a very exciting position.", says Pernilla Sandwall, CEO of WntResearch.
In connection with the publication of the half-year report on August 18, an interview with CEO Pernilla Sandwall conducted by Biostock will also be available on the company's website http://www.wntresearch.com
For further information:
Pernilla Sandwall, VD, WntResearch AB
e-post: pernilla.sandwall@wntresearch.com
This information is the kind of information that WntResearch AB is obliged to make public according to the EU's Market Abuse Regulation. The information was provided, through the care of the above contact person, for publication on August 16, 2022.
About WntResearch
WntResearch is a biotech company in oncology that develops new therapies intended to prevent the meta-static 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 mobili-ty and spread of cancer cells thus preventing metastases from occurring. Although current cancer treat-ment has become more effective, there are no effective ways to prevent the onset of metastases that cause about 90 percent 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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