It is an exciting year for BerGenBio and its AXL inhibitor. Upcoming trial data will define their way forward towards a new approach to fighting cancer and improving the efficacy of cancer treatments.

The Norwegian clinical stage biopharmaceutical company BerGenBio, founded in 2007, is based on identification and understanding of the protein AXL kinase. This protein is increased in aggressive cancer, it allows the cancer cell to acquire resistance to drugs, to hide from the immune system, and to spread around the body. In order to make cancer treatment more effective, BerGenBio’s drug blocks and inhibits the AXL signal. The company is basen in Bergen, Norway and has a subsidiary in Oxford, UK. It is listed on the Oslo Stock Exchange. Nordic Life Science asked Richard Godfrey, its CEO, about BerGenBio’s business strategy and what results we can expect during 2020.

Your lead program, bemcentinib, is in several phase II programs, on its own but also in combination with other drugs. What’s new with these, what current results are you most excited about, and what opportunities do you have on the market for cancer treatments?

“Our focus is in acute myeloid leukaemia (AML) and advanced non-small-cell lung cancer (NSCLC), and we see both first-line (1L) and second-line (2L) opportunities where AXL inhibition with bemcentinib can modify progression of the disease and provide improved patient outcomes. Bemcentinib is very well tolerated and combines well with other drugs. In recent years both diseases have seen substantial improvement in 1L standard of care, leaving somewhat of a vacuum in 2L; which represents a significant unmet medical need and presents very attractive market opportunities. We have 2L phase II trials ongoing in both indications. Early results from both are very encouraging and additional data will read out in the coming months and will inform our registration strategy.”

Describe your business strategy? You said recently that you are committed to progressing bemcentinib through to regulatory approval. What happens after that?

“Clearly biotech is a science driven business and in our case we are focused on understanding the biology that drives aggressive cancer and developing AXL inhibitors to improve patient treatment outcomes – we are now defining our registration path and will pursue those clinical trials in the near future, and at the same time prepare for commercialization. Clearly that requires different skill sets that we can build, or indeed could access through partnerships, we are flexible and open to both possibilities. The AML market is substantially smaller than the NSCSL market and could more easily be accessed with a smaller in-house commercial team.”

“The AML market is substantially smaller than the NSCSL market and could more easily be accessed with a smaller in-house commercial team”

What lessons have you learned from your different strategic partnerships?

“Like all relationships they must be treated with respect and cared for. Communication is key, and it is important to understand each other’s priorities and work together, but sometimes these change and one must be flexible and open minded.”

Describe your developments in companion diagnostics?

“In our experience, approximately 50% of patients seem to have high levels of AXL in their cancer and we can identify this with our companion diagnostics (CDx). In parallel we are developing the CDx so that we can prospectively identify patients who will benefit from taking bemcentinib. In AML we can identify responding patients by measuring the levels of AXL in the blood. We call this ‘sAXL’, which is very convenient. In solid tumors we take a biopsy and stain for AXL and compute a predictive score we call ‘cAXL’, to identify the responding patients. In NSCLC we see 3x longer patient benefit in cAXL +ve patients and in AML almost half the patients are sAXL and they report a complete response.”

What’s next for BerGenBio and what results can we expect during 2020?

“We are in the process of taking scientific advice from the FDA and EMA. We will report 2L trial data from AML and NSCLC in 2020, and when combined these will inform our strategy and our ambition is to initiate randomized studies with the potential for conditional approval.”

Do you have any advice for Nordic life science companies, perhaps aiming for the stock exchange?

“There are pros and cons of both private and public ownership. Certainly you should not go to public market too early, the company must have robust assets and a clear development plan, and an organization that can support its strategy. Shareholder communication is very important and carefully managing investor relations is essential. Valuation is always important to shareholders and is best developed and defended by milestone delivery – but sometimes on the stock exchange external factors can impact your share price, over which you have no control.”

Advantages/disadvantages of being a Norwegian life science company?

“Norwegian life science companies certainly benefit from a local conscientious and skilled scientific talent pool, which is especially valuable in the early days of research and technology development. Moving into clinical development requires an industry knowledge and experience there is limited – but growing; clusters and long term government innovation initiatives have an important role here, and more could be done. There are very valuable and well managed sources of non-dilutive funding available that are extremely useful and offer win-win project funding, and we enjoy the benefits of several grant supported R&D projects and well-funded collaborations in clinical research. The investor base is supportive, access to capital is possible and the business environment is buoyant.”

“Norwegian life science companies certainly benefit from a local conscientious and skilled scientific talent pool, which is especially valuable in the early days of research and technology development”

Photo of Richard Godfrey: Nils Olav Mevatne