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VD-intervju - 2013-03-20

WntResearch genomför för närvarande en företrädesemission på 7,2 MSEK. Syftet är att komplettera tidigare erhållen finansiering för att därmed kunna starta och genomföra kliniska fas I-studier på människa inom Foxy-5-projektet. Främst tack vare stöd från ett europeiskt forskningsprogram (Eurostar) sjunker de egna utgifterna för fas I-studien betydligt; av de totala beräknade kostnaderna under 2013 på 18 MSEK finansieras drygt hälften med externa medel.

Vi har fått tillfälle att genomföra en intervju med bolagets VD Nils Brünner. För att minimera risken för missförstånd har intervjun genomförts på engelska vilket vi hoppas att ni läsare kan ha överseende med.

Nils, you have now been WntResearch´s CEO for a year. Could you tell us a little bit about your professional background?

WntResearch is a cancer oriented biotech company and as such I feel well equipped being educated as an MD with many years of clinical work at Departments of oncology in Greater Copenhagen. Back in 1987-1989, I went to the United States to work at the national cancer Centre at National Institutes of Health in Bethesda. I got here an extra education as molecular biologist. Thus I have a dual education within cancer research- an education in basic research and an education in clinical oncology. I feel that these educations make me competent to tackle the scientific tasks in WntResearch. I also have several courses in leadership and I have been Head of Section at University of Copenhagen for the last 10 years. Since 2009, I have served as Centre Director for Sino-Danish Breast Cancer Research Centre, where I am leading approximately 50 scientists. During these obligations I have learned a lot about leadership which I am using in my job as CEO of WntResearch.

I have also served as Medical Advisor and Board Member for several smaller Biotech companies both in Denmark and in Sweden. At present I serve as Member of the Board of Create Health at Lund University. These activities have given me insight into the commercial part of cancer research.

From 2003-2006 I served as Chairman for preclinical research at the European Organization for Research and Treatment of Cancer (EORTC) which also included membership of the Board of Directors of EORTC. I learned to deal with many different nationalities, to stimulate and motivate the different research groups to work together and how to reach a common goal.

What is your most important task as CEO for a small developing company like WntResearch?

The most important tasks in WntResearch are 1) to create an innovative and aggressive development plan for Foxy-5; 2) to deliver in accordance with this plan; 3) to improve our communication with the market; 4) to identify alternative sources of financing; and 5) negotiate an attractive out-license/exit for the investors upon successful completion of phase 2.

I am not able to fulfill all these tasks as CEO due to my background. However, I have made sure that we now have a team of people who complement each other and thereby secure that we will reach our goals.

What has happened in the company since the share issue last autumn?

We have worked in accordance to the plan we have communicated previously. Since the last emission we have finalized the pre-clinical GLP studies which conclude that Foxy-5 is well tolerated and has a favourable toxicology profile. Furthermore we have finalized the GMP production and the material has been released for clinical use. We are now aiming at filing the CTA this month in order to initiate phase 1 clinical trial in Q2, 2013.

Foxy-5 is potentially a completely novel and unique take on cancer treatment as it works against the metastatic process. Considering the benefits we are surprised that we can’t find other substances working towards the same goal. Why do you think that is?

This is due to the complexity and the lack of good model systems for metastasis.

The industry and the scientific community has obtained significant knowledge about the processes which leads to formation of cancer cell and tumour cell growth by studying the mechanism of actions in cancer cell lines in vitro and test the results in animal models. The metastasis process has proven to me much more difficult to model. Furthermore, the metastasis process comprises a lot of steps where the mechanisms are poorly understood. Cancer cells have to be released from the neighbouring cells and extracellular matrix, they have to navigate towards and invade the blood vessels and/or lymph system, they have to survive in circulation before they reinvade the extra-cellular matrix in another part of the body and form new colonies of cancer cells. None of these processes are fully understood. Moreover, it has proven to be very difficult to distinct the differences between a metastatic cancer cell and a cancer cell which is unable to form metastasis.

The following article in Nature Medicine addresses the same question: Cancer drugs: Remedy required (Nature Medicine, published online 07 March 2011). http://www.nature.com/nm/journal/v17/n3/full/nm0311-231.html

This also illustrates the importance of the work of Professor Tommy Andersson and his group in Lund, who has played a pivotal role in validating the role of Wnt5a in cancer metastasis. They have shown that expression of Wnt5a in tumours leads to a good prognosis in breast cancer, colon cancer and prostate cancer. They have shown that no or low expression of Wnt-5a results in shorter recurrent free survival due to increased metastasis. They have shown that no or low expression of Wnt5a lead to reduced overall survival. Tommy Andersson and his group have uncovered the mechanism of Wnt5a in formation of metastasis at the cellular level. This work explains how the lack of Wnt5A expression leads to the release of cancer cells from neighbouring tissue and the formation of so called filopodia, which enables the cancer cell to move. Tommy Anderson and his group have during the process invented the peptide, Foxy-5, which is able to reconstitute the Wnt5a signalling, and they have been able to provide proof of principle in animal models.

Excluding financing of the study, what other issues need to be sorted out before the study can start, and what do you view as the biggest risk in the phase I ?

We are confident that we will file the CTA this month. The objective of the Danish authorities is to process clinical trial applications within one month. In parallel hereto, the program needs approval from the local ethical committee. This means that we should be able to initiate recruitment within a few months from filing the CTA.

The objective with phase 1 is to establish safety and tolerability of Foxy-5. The generic risk with phase 1 is that the company is not able to recruit the number of required patients within a reasonable time frame and that the product proves to be toxic at dose which is lower than the therapeutic relevant dose.

We are performing the trial at Herlev University Hospital in Copenhagen and the inclusion criteria are relative broad. Therefore, we expect to be able to recruit the patients in time.

Foxy-5 proved to be well tolerated in the pre-clinical animal studies. We hope and expect that this also proves to be the case in humans. Furthermore, it is to be noted that Foxy-5 is a small peptide which is based on amino-acid sequence which is specific for Wnt-5a, a protein which is expressed and secreted by human cells.

You are stating that finding preliminary proof of anti metastatic activity is a secondary goal of the upcoming study. Could you please explain how you will be able to do this?

Many cancer cells will be in the blood stream before they reinvade extracellular matrix and form metastasis in other parts of the body. We will recruite patients with breast cancer, colorectal cancer and prostate cancer. Breast, colon and prostate cells belong to a group of cells, which are called epithelial cells. These cells are not found in the blood stream under normal conditions. There exist validated methods for measuring these cells in blood. Therefore, we are able to measure the number of circulating epithelial cells and thereby the number of cancer cells in the blood stream. It is known that most metastatic cancer patients have a very high number of cancer cells in the blood stream and that only a tiny fraction of them will succeed in forming new metastasis. Thus, most of the circulating cancer cells will die and not form new metastasis. It is going to be interesting to see whether the use of Foxy-5 will reduce the number of circulating cancer cells and thereby potentially reduce the likelihood of formation of new metastasis.

You intend , in parallel to the clinical study, to initiate a couple of pre clinical studies during 2013. What is the purpose of these studies?  

We have initiated animal experiments in colon cancer at Copenhagen University based on funds from the Eurostars program. In addition to this we are investigating the possibility to test Foxy-5 in animal models of ovarian cancer and additional models of breast cancer. The purpose is to broaden the potential clinical scope of Foxy-5, to improve the out-licensing package and to help us design the phase 2 trial.

You have stated that you plan to do the phase-II study on patients with colon cancer patients who has liver metastases. Given the fact that earlier plans focused on breast cancer, what makes colon cancer more interesting?

There is a significant unmet medical need in breast and colon cancer and both indications represent large markets. Therefore, the proposed study in colon cancer is not due to the commercial preferences. The motive for selection of colon cancer patients with liver metastasis is that this indication appears to offer an early proof of concept in humans with a clear endpoint, which can be proven in a small patient group within a relative short time frame.

Your goal is to licence Foxy-5 after a successful phase-II study. However, it is not unusual to see substances licenses at earlier stages. What do you think about this opportunity?

Early stage discovery collaborations look very promising from a financial perspective if you assume that your products are moved forward in accordance to the plans. However, many biotech companies have realized that the pharmaceutical partner did not move their programs forward as expected due to project delays and changes in strategies. Therefore, many biotech companies are getting their products back just to realize that it is too late.

This situation is much different when you have proof of concept in humans. The perceived value increase is significant. The pharmaceutical partner is fully committed to do the deal and to perform the subsequent phase 3 trial, which is the last step before marketing authorization. The pharmaceutical company has the necessary capital, the infrastructure and marketing expertise to perform the trials. Your product will get full attention because it is important for your partner, since it may be introduced to the market within the next 3-4 years. Therefore, the destiny of your product is less vulnerable to reorganization, mergers and changes in partner strategy. 

Having said that, early stage out-licensing is always a possibility - if the price and conditions are right.

Smallcap tackar Nils Brünner för intervjun och för intressanta och detaljerade svar på våra frågor.

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Fakta WntResearch
Ticker / kodWNT
Antal aktier15,5 miljoner
VDNils Brünner
StyrelseordförandePeter Buhl Jensen
Största ägareIngen över 10 %