Q&A

General

New member proposed for the Board of Directors

Modified

16.May 19

Q: I can see that you are proposing a new member of the Board of Directors. Can you tell us a more about his background and future role in the Board?

A: Scandion Oncology is very pleased that Peter Høngaard Andersen has accepted to be proposed as member of Scandion Oncology Board of Directors. Peter is one of the most experienced Danes within biotech and business development. Not only has he been involved in the upstart of several biotech companies, but he has also secured very valuable exits for the share owners (e.g. Prexton Therapeutics and Epitherapeutics). Until recently he has been the CEO of the Danish Innovation Fund, the largest public fund in Denmark, targeting all industries and research areas and the complete value chain from basic research to market.

Moreover, he has solid experience as Chair for Boards of biotech companies, a strong scientific background, deep insight and hands on experience in Public Private Partnerships in EU, US and DK, year-long experience in collaborations with biotech and academia, and a successful career in life science within R&D, IP, litigation, public affairs strategic development, business development and mergers and acquisitions

Peter will be a very important person to bring Scandion Oncology to the next level.

SCO-301

Modified

26.Apr 19

Q: Regarding the PR released on April 16, 2019, on SCO-301: Is it correct that SCO-301 has gone through phase I and perhaps phase II but is not a registered drug?

A: SCO-301 is a registered drug but it is registered for a non-cancer indication. Scandion Oncology wants to develop SCO-301 for cancer treatment. At the same time we develop, together with University of Copenhagen, novel analogs of this drug. We expect to develop analogs with even better anti-cancer effects. The new analogs will be patented.

Since SCO-301 is a registered drug it can be bought at the Pharmacy so we do not need any own production – it is ready for testing in cancer patients with drug resistant disease.

Collaboration with Solural Pharma and Cambrex

Modified

20.Mar 19

Q: Scandion Oncology announced on March 19 that a contract has been signed with Solural Pharma, Denmark, regarding formulation of SCO-101 in tablets for clinical test. Does that mean that Scandion Oncology is no longer working with Cambrex regarding the production of SCO-101?

A: Scandion Oncology is still working actively with Cambrex and expects them to deliver the raw SCO-101 material (API) in June 2019. The API will then be transported to Solural Pharma, Denmark, to make tablets for the clinical study. Cambrex, Sweden, does not offer to make tablets. So, everything is according to plans and we are very satisfied with the work being performed at Cambrex.

Could SCO-101 affect the toxin pumps in healthy cells, or does it only affect cancer cells?

Modified

15.Jan 19

Yes it is likely that the toxin pumps (which are also the P-gp and BCRP pumps) in healthy cells are effected as well . We circumvent this problem by introducing a SCO-101 treatment pause between chemotherapy treatment. There have been toxicity studies of SCO-101 (clinical phase I) showing that SCO-101 is well tolerated for prolonged use (14 days) at the dose that we intend to use as our starting dose.

When we combine SCO-101 with chemotherapy we do not expect additional  toxicity based on the published Tariquidar clinical data. Please see this recent review with relevant references (Robey et al., Nature Reviews Cancer (vol. 18, p.452–464 (2018)).

Is it the P-gp and BCRP drug efflux pumps that you are trying to block?

Modified

15.Jan 19

Yes, these efflux pumps are considered as the most important in anti-cancer drug resistance.

There is a general notion that cancer stem cells are more resistant to chemotherapy than normal cancer cells. Do you have any indication that SCO-101 and/or SCO-201 will work on cancer stem cells?

Modified

30.Dec 18

Cancer stem cells are characterized by surviving cancer treatment and hence be responsible for recurrence of the cancer. Cancer stem cells have high expression of the ABCG2 drug efflux pump and they most probably use this pump to avoid the effects of chemotherapy. The ABCG2 drug efflux pump is being inhibited by SCO-101. Thus, we expect to kill cancer stem cells by combining chemotherapy with SCO-101. We have yet not looked at this but it is definitely in our development plans for 2019.

Immunotherapy has become a growing part of cancer treatment. How well will the old chemotherapies, which SCO-101 and SCO-201 hopefully will enhance, compete with new immunotherapies?

Modified

30.Dec 18

This is a very interesting and timely question. Roche, the big pharma company, has recently published that their check point inhibitors (immuno-oncology) works better if it is combined with chemotherapy. They showed this by combining their check point inhibitor with the chemotherapeutic drug Abraxane. Abraxane is paclitaxel bound to albumin. SCO-101 enhances the effects of paclitaxel and reverses paclitaxel resistance. Since quite a few of these patients will have paclitaxel resistant cancer cells, SCO-101 should be part of this combination to ensure cancer cell kill in the tumor thereby recruiting the immune cells. Thus, SCO-101 could be a very important addition to current immuno-oncology treatment.

You are currently a very small organization, do you see any risk of overreaching by aiming to develop at least 3 different drugs concomitantly?

Modified

30.Dec 18

This is a very good comment. We are certainly aware of such a “positive” problem and we therefore have the clinical development of SCO-101 as our main focus. This also appears from our budget presented in the memorandum published in connection with the IPO. For the two other compounds, further development is related to securing economical support for these.

What sets your company apart from those within your industry?

Modified

26.Oct 18

As far as we are aware, we are the only company having a drug against drug resistance in cancer in clinical development. So our “X factor” is a unique and safe oral drug that targets the perhaps most important problem in today’s cancer treatment: Existing or acquired drug resistance leading to the death of millions every year.

During your time at Scandion Oncology what has been in your eyes your greatest achievement thus far?

Modified

26.Oct 18

To discover that SCO-101 could reverse drug resistance in cancer and to identify the mechanisms of actions for this effect.

Could you please share with us your favorite memory and or event since you joined the company?

Modified

26.Oct 18

The day we decided to spin-out Scandion Oncology from University of Copenhagen and Saniona. It was a dream that came through for us – to establish our own company based on our own cancer research. Only by taking SCO-101 through a commercialization process, we will be able to bring our many years of research out to the benefit of cancer patients.

Could you please give our viewers a brief history of your company.

Modified

26.Oct 18

In brief, SCO-101 was originally developed by the Danish biotech company Neurosearch A/S to treat patients with Sickle Cell Anemia, which is a non-cancer hemoglobin disease. However, they were not satisfied with their first results and further development was stopped.

Neurosearch A/S was acquired by Saniona AB, which is on First North in Stockholm. At that time Nils Brünner, CEO of Scandion Oncology was CEO for WntResearch and the CFO in WntResearch, Thomas Feldthus, was one of the founders of Saniona. He introduced Nils Brünner to the CEO of Saniona, Jørgen Drejer, and several conversations about drug development were initiated. At the same time, Nils Brünner together with Associate Professor Jan Stenvang, at the University of Copenhagen, established a novel drug screening platform consisting of pairs of drug sensitive and drug resistant cancer cell lines. Nils Brünner and CSO Jan Stenvang obtained SCO-101 from Saniona and tested it in the screenings platform. The studies showed that SCO-101 by itself has no anti-cancer effects but when combined with standard cancer treatments in drug resistant cancer cell lines, SCO-101 blocked important resistance mechanisms rendering the cancer cells sensitive to treatment again. SCO-101 had been tested in 92 humans already at the time of Neurosearch and is now ready for phase II in cancer. We established Scandion Oncology in May 2017 and money is currently being raised to continue the clinical development in patients with drug resistant cancer.

Pre-clinical

Can you tell more about your results within antibiotic resistance in bacteria?

Modified

21.Mar 19

Q: Your findings that your substances might prevent antibiotic resistance are very interesting and of course very important since resistant bacteria can become a big threat to mankind.

Can you tell us more in detail what you have done and what results you saw?

A: The reason for our studies in antibiotics and bacteria was an idea that cancer cells and bacteria might share common resistance mechanisms. That this is a possibility is supported by the many publications on drug efflux pumps being responsible for drug resistance in both cancer cells and in bacteria. Therefore, Scandion Oncology contacted researchers at University of Copenhagen, who work in the area of antibiotic resistance. They received our drugs under a Material Transfer Agreement securing that Scandion Oncology retains all rights to any new invention made regarding our drugs when used at the University of Copenhagen. Our colleagues then tested the drugs in their repository of antibiotic resistant bacteria. What they observed was that our drugs could kill several types of antibiotic resistant bacteria including some of the most common antibiotic resistant bacteria strains. Moreover, in some bacteria, our drugs showed additive effects in combination with antibiotics suggesting that our drugs improve the effects of antibiotics.

We now have the first indications of the mechanisms of action of our drugs when killing antibiotic resistant bacteria. We are presently continuing these studies to be able to select candidate drugs for in vivo testing. Importantly, it is not SCO-101 that is being developed for anti-biotic resistance. Scandion Oncology owns the invention and a patent application has been filed.

In one of your slides that you use for presentations, it says that you have identified a non-cancer indication for SCO-101. Can you tell us more about this other indication?

Modified

26.Oct 18

It is correct that we now have preclinical data on SCO-101 and a non-cancer indication. We are presently preparing for a new patent application for this. The only information I can give right now is that this other indication could be as big as the cancer indication. We will initiate screening of our approximately 800 SCO-101 analogs in order to select a candidate for this indication.

Clinical

A product called Tariquidar that inhibits drug efflux pumps was abandoned in phase III: Was this due to toxicology issues?

Modified

15.Jan 19

Yes, indeed Tariquidar was abandoned in Phase III clinical trials. We are well aware of these clinical studies. Based on the published literature on these clinical trial with Tariquidar it seems that there is not very much added toxicity when combining Tariquidar with chemotherapy (the phase I and II trials). However, it was observed that there were responders in patients with a favorable biomarker profile. Unfortunately, it is not totally clear how they selected patients for their trials. It seems unclear why they decided to terminate future development of Tariquidar and there seems not to be any publications describing unacceptable toxicities. We are of course looking closely into the Tariquidar papers when we plan our clinical studies. More information and references can be found in this review: Robey et al., Nature Reviews Cancer (vol. 18, p.452–464 (2018)

Has Scandion Oncology plans to collaborate with 2CureX or Oncology Venture in order to select the most relevant patients for the future clinical studies?

Modified

17.Dec 18

Scandion Oncology is currently investigating several possibilities to apply predictive biomarkers in order to personalize the treatment with SCO-101. These predictive biomarkers will eventually be used to select the patients who are most likely to respond to treatment with SCO-101.

Jag undrar lite om era fas 1 studier, då jag inte hittar så mycket information om dessa. Hur kommer det sig att det gjorts hela fyra fas 1 studier? Då man oftast vill söka effekt i fas 2.

Modified

13.Nov 18

When Scandion Oncology was established in 2017 we received all documentation on the four Phase I clinical trials from Saniona. These trials were conducted around 2002 and the data were not published. We plan to include some of these data in our coming publications. All studies were performed in healthy volunteers. The four studies comprised

  1. Single doses
  2. Escalation doses
  3. Females and males
  4. Food interaction (since SCO-101 is delivered in a capsule)

The original plans for SCO-101 were to use it to treat a disease named sickle cell anemia. This is an inherited blood disease where the erythrocytes (red blood cells) have a sickle shape and they are more fragile. However, SCO-101 caused a slight and reversible increase in serum bilirubin and was therefore found unsuitable for treatment of a disease that results in increased serum bilirubin by itself.

This I fortunately not considered a problem when combining with anti-cancer treatment.

Do you have any plans to initiate clinical studies with SCO-101 in other indications than breast cancer?

Modified

26.Oct 18

Yes, we plan to initiate clinical studies also in colorectal cancer and most probably also in pancreatic cancer but we will need more resources in order to do this.

When do you expect that breast cancer patients can receive your drug?

Modified

26.Oct 18

We plan to initiate in late 2019 the clinical phase II study with metastatic breast cancer patients and docetaxel/paclitaxel resistant disease. Please contact Nils Brünner CEO (nb@scandiononcology.com) for further information.

Financials

SME Instrument phase I grant from EU

Modified

26.Apr 19

Q: Congratulations for the 350,000 DKK SME Instrument phase I grant from EU. Given that you were awarded this grant, can it be estimated what will be the likelihood that Scandion Oncology will also receive a phase II grant? Can you also give an estimation of the amount you might get in phase II or at least a lower and upper limit?

A: We surely are very happy to have his EU grant awarded. Although it does not automatically leads to a SME Instruments Phase II grant, our chances to get such a grant have significantly improved by this award. The phase I grant will be used to optimize our success rate for the Phase II grant. Moreover, it will be used to initiate the regulatory process regarding our breast cancer taxane study. We also got awarded 3 days of training from an international expert.

The SME Instrument Phase II grants can amount to 2.5 million EURO.

Possibilities to attract funding for antibiotic resistance?

Modified

21.Mar 19

Q: There seems to be a big interest from several governments to solve this problem. Last week Germany gave 40 MEUR to research within the field. Can you comment on your chances to get funding for the project from EU (or elsewhere)?

A: Indeed, there is a big interest in this field from governmental levels around Europe. In Denmark, there is also a big interest for antibiotic resistance with the Novo Nordic Foundation having their REPAIR Fund and their BioInnovation Institute (BII) now having antibiotic resistance on its agenda. Importantly, Denmark is going to host an international antibiotic resistance knowledge center. Therefore, Scandion Oncology feels confident about having soft money awarded to proceed with the development of drugs that can kill antibiotic resistant bacteria.

Market potential in antibiotic resistance?

Modified

21.Mar 19

Q: Do you have any idea about your market potential in antibiotic resistance compared to cancer resistance?

A: It is difficult to compare but based on all the information Scandion Oncology has collected, these two markets could be at the same magnitude, which means reaching blockbuster levels (annual sales of at least $1 billion). In a recent report from the UK government, it has been forecasted that in 2050 there will be 10 million deaths attributable to antibiotic resistance. Among the marketed antibiotics since 2000, the most valuable antibiotics, linezolid from Pfizer and daptomycin from Merck, had a global peak sale of 1,000-1,353 million US$ and generated sales above 1,000 million US$ for seven years and three years, respectively.

Burn rate and cash position

Modified

22.Feb 19

Q: I noticed from the Q4 2018 report that the burn rate is quite high and that the cash position is lower than expected. Why is that?

A: Scandion Oncology has in Q4 2018 paid the majority of the total production cost including a pre-payment of 2019 production cost. Moreover, we also paid the expenses related to the IPO.

What are Scandion Oncology´s medium to long-term goals and have these goals been consistent for some time?

Modified

26.Oct 18

To successfully pass clinical phase II with SCO-101, thereby obtaining clinical proof-of-concept, and then find a partner or a licensee. Next step will be to take our second drug candidate, SCO-201 through preclinical and clinical development.

Do any of the staff and or management team hold any shares within the company?

Modified

26.Oct 18

We all do and we have all invested in the Scandion Oncology.

How many staff do you have currently on the team

Modified

26.Oct 18

We have a CEO (Nils Brünner), a CSO (Jan Stenvang), a CMO (Peter Michael Vestlev) and a CFO (Carit Andersen).

When does Scandion Oncology plan to have investor meetings in 2018?

Modified

26.Oct 18

There will be investor meetings at

Investerarträff Copenhagen, October 4, 2018

From 17:30-19:30

Radisson Royal Copenhagen,
Hammerichsgade 1,
1611 København V

Sedermeradagen Göteborg, October 11, 2018

From 11:00-18:00

Elite Park Avenue Hotel,
Kungsportsavenyen 36,
411 36 Göteborg

Investerarträff Stockholm, October 12, 2018

From 11:30-13:00

Scandic Klara,
Slöjdgatan 7,
111 57 Stockholm

Is it correct that we can now pre-invest in Scandion Oncology?

Modified

26.Oct 18

We have just finalized the presubscription period, which went extremely well. From October 4, it will be possible to subscribe to Scandion Oncology shares at Spotlight. Please contact Nils Brünner, CEO (NB@ScandionOncology.com) for further information.

Presentation

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