An update of the NeoFox study plan has begun as the previous observations have been confirmed and expanded in an updated analysis
The positive findings reported on August 16, 2022, have now been confirmed and expanded. WntResearch will thus revise the study plan for the ongoing NeoFox phase 2 study with Foxy-5 to more quickly generate the information required to take the drug candidate to the next step towards becoming a valuable tool in the treatment of cancer.
WntResearch takes a very positive view of the statistically confirmed observations. After analyses of additional pathology reports from the NeoFox phase 2 study, reduced tumour burden (in primary tumour and regional lymph nodes), so-called down staging, as well as reduced spread along the nerves (perineural invasion) are confirmed. In addition, the expanded material now shows a definite reduced spread to blood vessels (vascular invasion). In total, pathology reports from 118 patients have been received.
Consequently, the observed effects are planned to be included as new endpoints in a revised study plan for the NeoFox study. The advantage is that these can be evaluated already during surgery after approximately three weeks of preoperative treatment with Foxy-5. According to the current study plan, the endpoints should not be read out until two years after surgery.
The changed endpoints thus mean that the previously planned interim analysis, which would have guided decisions on the total number of patients in the NeoFox study, will not be carried out. The number of patients needed going forward is now estimated to be about the same as originally planned, approximately 200 patients in total (including the 127 patients already recruited).
The revised study plan is expected to give WntResearch an opportunity to consolidate the proof of concept also in humans in a shorter time compared to before. In addition, previously generated data from the NeoFox study can be utilised, which contributes to time and cost efficiency.
The revision of the study plan has now begun, and it will be submitted for approval by the health authorities and ethical review boards where the study is conducted. The recruitment of patients will resume after the authorities’ approval, which is estimated to take place in the spring of 2023. In the meantime, the paused recruitment to the study will thus remain. The treatment and follow-up of already included patients will continue as planned.
The invasive behaviour of the cancer cells is the basis for their propensity to spread and give metastases. The significant effect on the parameters observed in the NeoFox study reflects the invasive properties of tumours. These findings in humans are fully in line with the preclinical findings that Foxy-5 has an anti-metastatic effect. The company will continue to analyse new and existing data. If new and additional findings are added, they will be reported to the market.
"It is extremely satisfying that the results we obtained in previous preclinical studies now also have been observed in the company’s clinical study. That an effect was observed already after three weeks of treatment is not only surprising but also very interesting," says Professor Tommy Andersson, founder and board member of WntResearch.
"It is very positive that based on these data, we can revise the ongoing NeoFox study and continue with it in a more optimal way. It is fantastic fun to work with such an experienced team who noticed this unexpected effect and realized early on what it could mean. It is very stimulating, to say the least, to participate in the development of a treatment option for patients affected by colon cancer.” says Pernilla Sandwall, CEO at WntResearch.
For further information:
Pernilla Sandwall, CEO WntResearch AB
e-mail: 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 October 17, 2022.
About WntResearch
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 tumor 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 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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