For Malmö-based WntResearch, the main focus during 2020 has been on the work with Neofox, the clinical phase II study with the candidate Foxy-5 which is being carried out in Spain and Hungary. The ongoing Covid-19 pandemic has had a significant impact on the life science sector, and for WntResearch it has meant that patient recruitment to the study was paused. The company has now published an update regarding Neofox and BioStock got the chance to talk to CEO Peter Morsing about the current situation.

The ongoing Covid-19 pandemic has had a significant impact on the life science sector and WntResearch is no exception. In March, the company decided to pause patient recruitment to Neofox in both Spain and Hungary, a decision that was in line with directives from the two study countries’ national health authorities.

BioStock has spoken with CEO Peter Morsing to hear more about the current situation in the phase II study and what the next step is.

Peter, in June you announced that you had resumed the study in Hungary and you hoped for a quick start. How has the work progressed since the resumption, and what is the status of the Hungarian part of the study now?

– When the news came in June that the Hungarian authorities judged the epidemic to be under control, we decided in consultation with our partners to resume Neofox in Hungary.

– However, Covid-19 still constitutes a significant burden on healthcare, and since the study resumed in Hungary, intensive work has been underway to complete the work that was stopped in March, which includes finalising contracts, activating clinics and providing them with student medicines. All this has worked well.

– What we cannot influence, however, is the patients’ willingness to participate in a study that involves a significant number of trips to receive medication in a society that strongly advises people in risk groups to stay at home. This is understandable, but of course has consequences for our recruitment to the study. We did not expect this to have such a large impact, but unfortunately, we can only note that Covid-19 continues to be a serious problem for conducting a clinical trial. The number of patients included since the start of the study is marginal and far from the calculations we made in June when the study was resumed.

What measures have you taken to speed up the recruitment of patients to the study?

– We have regular meetings with both our CRO, which is responsible for the study in general, but also with our Hungarian partner, Optimapharm, where we have a meeting with the people who are out at the clinics and talk to the doctors every week to get a direct insight into what happens in the ”field.”

– We work on a broad front to make it easier for patients to agree to participate in the study, including individual transport by taxi to and from the clinics. We have also looked at the possibilities for home visits to patients, but this has not been possible to implement for regulatory reasons. Ultimately, it is up to each patient to decide whether they want to participate in a clinical trial or not and this is not something that we as a company or a doctor can, is allowed to or want to influence. The Helsinki Declaration on clinical trials is very clear on this point.

Yesterday it was announced that you have now also resumed the phase II study in Spain. Now that the work is resuming, what tasks are first on the agenda?

– During the time that the study was paused, the staff at the clinics have had limited opportunities to collect blood samples for follow-up of patients in the study. This in turn means that a number of important blood samples have not been collected for the planned analysis of circulating tumour DNA.

– Now that we have started the study again, two equally important activities are prioritised; contacting the patients who have already been treated to collect blood samples for analysis according to the schedule that exists for each patient and ensuring that the recruitment of new patients for the study starts again.

Covid-19 cases are on the rise again, and in Spain a system of regional restrictions is now in place to prevent virus outbreaks. Is this something that affects your work and if so how?

– It is too early to say how this will affect the work in general. However, it is clear that one of the clinics in Madrid as the only clinic has chosen not to start the study again due to these restrictions.

– We see that ”the second wave” now affects several regions, but in principle all of our trial leaders have informed us about the measures taken to manage infection in hospitals and that patients who come for return visits due to their participation in a clinical trial kept separate from the ordinary activities. They therefore have a strong belief that the situation is different than when the pandemic struck and surprised everyone this spring. However, right now it is not possible to predict if we will see the same problems as we are seeing in Hungary.

The plan has been to perform an analysis of circulating tumour DNA from included patients. However, due to the pandemic, this analysis will now be postponed. Can you tell us more about this and what it means for the work with Neofox?

– In order to assess whether or not Foxy-5 has an effect, analyses must be carried out within the same time interval, i.e. a sample from a patient that has been treated taken e.g. after 6 months must be matched against a control patient’s sample taken at the same time after surgery. During the pause in the study, which lasted more than 6 months, very few samples were taken, which means that we lack samples from perhaps two of these quarterly planned samples.

– Since the study has been proceeding for a long time, and patients have entered the study continuously, the missed samples can be e.g. after 6 and 9 months, 9 and 12 months, etc. The consequence of this is that we do not have a sufficiently large number of patients in each group for a given time after surgery, and we can now see that we will not have this data available at the time we had expected. It is important to point out that an analysis of an insufficient number of samples is in most cases misleading. Therefore, there is every reason not to rush into analysis.

Finally, how does this delay affect the financing of the company?

– WntResearch currently has cash that lasts the second half of 2021. In addition, there are issued warrants that in February 2021 give the right to subscribe for a new share in the company for cash payment amounting to 70 per cent of the volume-weighted average price for the share during the period from starting on and including January 22, 2021 up to and including February 4, 2021 at a maximum of 3 SEK per share but a minimum of the share’s quota value.

– This means that we currently make the assessment that subscription payments will benefit WntResearch, but due to fluctuations in the share price, it is difficult to predict how large the amount will be. However, we currently feel confident that existing cash and additional option payments will take us past the point for analysis data.

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.

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