WntResearch plummets after results
The initial results from the NeoFox clinical phase II study have arrived. The safety seems to be good, but unfortunately, Foxy-5 appears to have limited treatment effects. The stock plummeted on the news. BioStock contacted Per Norlén, CEO of WntResearch, for a comment.
WntResearch is developing the drug candidate Foxy-5, which is thought to work by preventing cancer cells from spreading in the body. The peptide is designed to mimic the endogenous protein WNT5A, which has been shown to play an essential role in the motility and proliferation of tumor cells.
In the phase II study NeoFox, Foxy-5 has been tested in patients with newly diagnosed colon cancer. Specifically, the investigation focused on the candidate’s ability to impact tumors and reduce local spread before surgery. The hope was to demonstrate the treatment effect with CT scans.
Foxy-5 does not show sufficient efficacy
Since the study restarted, 27 patients have been recruited. 16 have been treated with Foxy-5, and 11 have formed a control group. The patients in the treatment group were treated for three weeks until surgery.
Initial study results have been published, and WntResearch announces that the candidate has a good safety profile but limited clinical effects. After analyzing tumors and lymph nodes with CT scans and tissue samples, signs of efficacy were seen in individual patients. Still, there were no clinically significant differences between the groups.
The stock plummets
In a BioStock interview, CEO Per Norlén discussed the company’s binary situation. Positive results could lead to in-depth discussions with potential partners, whereas a negative study outcome would force the company to close the project. After the disappointing results, WntResearch has now chosen to stop recruitment and terminate the phase II study.
The stock plummeted on the news and is quoted down over 90 percent since then.
Commenting on the decision to stop the study, Chairman of the Board Christer Nordstedt said:
– The level of efficacy observed so far is not considered sufficient for the treatment to be clinically relevant. A larger patient base could provide a clearer outcome of the effect, but additional financial resources are required to complete the study.
He also writes that the board and management are now charting a way forward “to safeguard our shareholders’ interests best.”
CEO comments
BioStock contacted CEO Per Norlén to comment on the announcement and find out what’s in store for the future.
First, what do you think about the results you have now shared?
– The results are, of course, very disappointing. Based on our previous ad hoc observations, there was reason to believe we could see an effect even with CT scans. Still, we did not observe any clinically significant difference before compared to after treatment with Foxy-5.
– The analysis is based on a relatively small part of the planned number of patients, but the results were clear enough to allow us to decide to terminate the study. We currently see no apparent opportunities to advance in colon cancer, which has to do with the fact that this study builds on the initial part of the NeoFox study, which also had to be stopped. In this case, the most important efficacy outcome, recurrence after surgery, was so rare in both groups that no conclusions could be drawn about the product’s efficacy.
– However, it was observed that significantly fewer patients had signs of local spread in the treatment group. These ad hoc findings created enthusiasm to continue evaluating Foxy-5 in patients with colon cancer even though the first part of the study did not meet the endpoints for which it was designed. The study was redesigned to focus on the early effects leading up to surgery, and the results we have now reported are from the patients who have entered the study so far. We are also now seeing some signs of effect in tissue analysis, but it does not warrant further evaluation at such limited effects.
The Chairman of the Board mentions that a larger patient base could provide a clearer effect outcome. How do you assess the conditions for conducting a larger study?
– We would have had more reliable data with more patients, but with the results that the initial analysis yielded, we do not see that it would be reasonable to ask for more money from our shareholders. Even though the data set is small, it is enough to say that it is unlikely that data from more patients could lead to a result that could convince potential partners or, by extension, regulatory authorities.
– Therefore, I don’t currently see a clear path forward in colon cancer, but we will, of course, thoroughly evaluate all options before deciding on the next step. There may still be opportunities that we haven’t yet considered.
What is happening in the company now, and how should shareholders relate to the situation?
– Our focus will now be identifying the best action to safeguard our investors’ interests. This, of course, includes the possibility of finding a partner interested in evaluating Foxy-5 in other indications, preclinically or clinically. We have a product that affects a signaling pathway that may also be important in other disease areas, has been safety tested in clinical studies, and is ready for clinical trials.
– In light of our current results, it is perhaps not likely that we would succeed in making a major out-licensing deal, but there may be the possibility of an agreement with a later upside. We are also looking at other options, including opportunities for reverse acquisition, which we have already seen a lot of interest in. We are actively evaluating all these options and hope to get back to our owners shortly with a direction forward.
The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.
