The completed Phase 1b study with Foxy-5 aimed at documenting the drug candidate's safety profile, pharmacokinetics and determining the dose for Phase 2. WntResearch is very pleased with the results of the study, which provide a good foundation for continuing the project into Phase 2.
The relevance of circulating tumor DNA
In addition to the phase 1b results, published studies on circulating tumor DNA (ctDNA) have been important for the planning of the upcoming Phase 2 study to document the anti-metastatic effect of Foxy-5. With the help of this biomarker, WntResearch now sees good opportunities to select those patients at the highest risk of relapse (metastases), and who are therefore suitable for inclusion in the Phase 2 study. This means that it is possible to avoid inclusion of patients with low risk of developing metastases, by identifying this group early on. In turn, this results in a lower cost of carrying out the study. Additionally, it is reasonable to assume that an analysis of ctDNA in blood samples from the patients included in the study may provide a faster diagnosis of relapse than other available methods.
Manufacturing of substance for the Phase 2 study secured
After a long and intensive work, WntResearch announced in the spring the successful completion of the process development and manufacturing of the drug formulation to be used in the continued clinical development of Foxy-5. The new formulation of Foxy-5 does not restrict preparation of the substance to hospital pharmacies, but allows making the drug ready for administration in the clinics treating the patients. This greatly simplifies logistics and reduces costs. Thus, another important improvement is in place before the start of the Phase 2 study.
The preliminary study design indicates that the cost of the Phase 2 study can be reduced
Based on the results of the Phase 1b study and on the interactions WntResearch has had with the regulatory authority so far, it is estimated that the Phase 2 study will be performed on significantly fewer patients than previously planned. The company estimates that approximately 70 patients will be included. Fewer patients, an opportunity for quicker relapse diagnosis and an open-label study that provides continuous monitoring of the effect of Foxy-5 treatment, results in a reduced cost.
The Phase 2 study is scheduled to start at the end of 2017/18 and will be performed on patients with colon cancer (stage III) whose tumors have been surgically removed. One of the patient groups will receive Foxy-5 in combination with FOLFOX chemotherapy, while the control group is only treated with FOLFOX. Foxy-5 will be administered three times a week for up to 24 weeks, after which the patients in both groups will be followed primarily for 12 months and thereafter for up to 24 months. The primary objective is to document how Foxy-5 affects the risk of relapse in the form of metastases. Foxy-5 has demonstrated a favorable safety profile in previous studies. For regulatory reasons the phase 2 study may be initiated with a limited dose-escalating phase, since the substance is now for the first time combined with FOLFOX.
Interim data allows for an efficient out-licensing process and a rich news flow
Owing to the open study design (the treatment is known by everyone), each follow-up (which occurs at three month intervals after completion of treatment) will provide continuous information on the effect of Foxy-5. This will of course be of great interest to potential partners as well as the Company's shareholders. The Board of WntResearch is still convinced that a partnership based on Phase 2 results would be an ideal time to provide maximum values for the Company's shareholders. Should the initial read-outs of efficacy and safety turn out favorably, the Company will keep the door open to intensify discussions with global pharmaceutical companies already during the study.
The forthcoming rights issue is expected to cover the cost of the entire Phase 2 study, provided that the warrants are exercised
The cost estimates made by the Company based on the preliminary study design indicate that the contribution from the forthcoming rights issue, together with the utilization of the warrants issued in connection with this, is sufficient to cover the study costs during the treatment and follow-up phase of the patients.
At full subscription to the rights issue, the Company will receive approximately SEK 64 million before issue costs. If all subscription options are exercised, the Company will receive an additional approximately SEK 24 million before issue costs.
For further information, please contact:
Ulf Björklund, acting CEO, WntResearch AB
Phone: +46 706 670440
This information is information that WntResearch AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on September 25, 2017.
WntResearch is developing a new type of cancer treatment based on pioneering research, which shows that the endogenous protein Wnt-5a plays a crucial role for tumor cells’ ability to relocate and spread in the body. Most patients that die of cancer do so not due to the primary tumor, but due to metastases. The need for a specific treatment to counteract metastasis is therefore in high demand.
WntResearch’s most advanced drug candidate Foxy-5 has in preclinical tests been shown to reduce tumor cells’ mobility and thereby counteract the occurrence of metastases. The results from a completed phase 1b study show a favorable safety and pharmacokinetic profile, as well as early indications of biological activity. WntResearch is a public company listed at AktieTorget in Stockholm, Sweden.
For further information: www.wntresearch.com