The Nordic biotech Coegin Pharma is responding to calls for new cancer therapeutics by offering a novel approach to cancer treatment through the inhibition of a unique and well- validated target, the cPLA2α enzyme. BioStock got in touch with CEO Tore Duvold to learn more about the company and its strategy for bringing new treatments to cancer patients.

While cancer therapy innovation has brought new treatments to the market over the last couple of decades, cancer remains one of the leading causes of death worldwide. According to a recent report from the World Health Organization (WHO), approximately 9.6 million people died of cancer in 2018, globally, and, while the overall mortality rate from cancer has decreased over the last 30 years, many cancers continue to lack proper treatments, adding a significant burden on suffering patients and the healthcare system. Thus, the need for novel treatments remains critical.

Actinic Keratosis – a hidden danger

Some pre-cancerous conditions are often overlooked. One of these conditions is actinic keratosis (AK) – a pre-cancerous condition of the skin that each year affects close to 60 million people in the US alone.

AK typically comes in the form of small, rough or scaly spots on the upper-most layers of the skin that represent chronic inflammation caused by too much exposure to the sun. And, while AK itself is usually not harmful, if left untreated, it can develop into more serious forms of cancer like squamous cell carcinoma (SCC) – a potentially life-threatening disease.

Despite being very common, the lack of awareness around AK leads to a heavy burden on patients who ignore these lesions until it is too late and become cancerous. Meanwhile, the most common treatment for the condition is cryotherapy – a freezing off of the lesion through liquid nitrogen that can lead to scarring, blisters, or other permanent changes to the skin. Therefore, as with chronic cancers, new innovative therapies are in high demand for pre-cancerous conditions like AK.

Coegin Pharma has novel target for cancer therapy

Fortunately, a biotech company leading the way in pursuit of such alternatives is Coegin Pharma. Based in both Sweden and Norway, and listed on the NGM Nordic SME market, Coegin Pharma is developing cancer treatments based on a novel target – an enzyme called cPLA₂α. This enzyme is well-known for its involvement in a variety of inflammatory diseases, including several cancers, as well as pre-cancerous conditions like AK.

Coegin Pharma’s ambition to develop new cancer therapies is based on more than 30 years of pioneering research led by Professor Berit Johansen at the Norwegian University of Science and Technology (NTNU). Professor Johansen was the first to identify the pro-inflammatory roles and signalling cascades of the cPLA2α enzyme, and her work has led the company to develop two distinct classes of highly potent and selective molecules able to inhibit cPLA2α, thus leading to remarkable attenuation of inflammatory processes often found in cancer.

From R&D to biopharma business

After obtaining proof-of-concept (PoC) with a topical formulation of one of its two classes of molecules in a combined phase I/II clinical study in psoriasis patients in 2015, Coegin’s research generated an opportunity to shift the company’s focus to cancer, where the demand for new treatments was, and still is, higher. Since then, Coegin Pharma has taken steps to translate its R&D capabilities into a business and thus putting together a strong team of leaders with extensive entrepreneurial experience within the life science arena.

Coegin Pharma brought onboard Tore Duvold as CEO – an executive with more than 20 years of experience as a leader in life science business, including top managerial experience for high-profile companies specialised in chronic inflammation. Professor Johansen remains the key expert as the company’s CSO.

Ready for the next phase of development

Now, with a team that includes vast scientific expertise as well as a strong business knowhow, Coegin Pharma is getting ready to enter into the next phase of development, initiating clinical studies for evaluating its therapeutic candidates in AK, at first, and then cancers like, basal cell carcinoma (BCC), triple negative breast cancer (TNBC) and leukaemia, as well as chronic kidney disease and other fibrotic diseases.

»We believe we have unique assets based on a strong scientific platform with the potential to become important tools in the treatment of several cancers and pre-cancerous conditions like actinic keratosis. We have proven the validity of the concept in a range of preclinical models and, more importantly, in patients suffering from psoriasis. Our vision is to offer safe, efficacious and convenient medicine adapted to patients in urgent need for better treatment options« — Tore Duvold, CEO at Coegin Pharma

The company is currently planning for a combined phase I/II clinical trial in AK this year to evaluate safety and efficacy. An announcement was made this week that the study will be run in collaboration with Studies & Me and Bispebjerg Hospital. For the study, patients with actinic keratosis will be recruited for topical treatment with Coegin Pharma’s top drug candidate AVX001 in different doses. The company plans to submit an application to the Ethics Committee and the Danish Medicines Agency in the spring of 2021 with the aim of starting clinical trials in August 2021.

CEO introduces Coegin Pharma’s vision

BioStock reached out to Coegin Pharma’s CEO Tore Duvold to learn more about the company and its plans moving forward.

Tore Duvold, could you tell us more about the company’s overall vision? 

– We believe we have unique assets based on a strong scientific platform with the potential to become important tools in the treatment of several cancers and pre-cancerous conditions like actinic keratosis. We have proven the validity of the concept in a range of preclinical models and, more importantly, in patients suffering from psoriasis. Our vision is to offer safe, efficacious and convenient medicine adapted to patients in urgent need for better treatment options.

You were recently appointed as CEO of the company. Could you tell us more about your background and how your past experiences match with Coegin Pharma’s ultimate goal?

– I am scientist by training with more than twenty years in the life science industry including executive roles in established pharma, biotech and funding of breakthrough science. My focus has always been on how to translate great science into new business opportunities with a clear benefit to people. Nothing is more meaningful than developing medicines that can help many people live a better life. I hope, and I believe, that Coegin Pharma, with our unique assets and agile operation, will be able to develop new medicines for patients in need for better treatment. Achieving our goals will obviously be rewarding for our investors who trust and believe in the company.

What triggered the shift from psoriasis to cancer once proof-of-concept was reached in psoriasis?

– We were very happy to see that one of our investigational drugs was both efficacious and remarkably safe in psoriasis patients. That was really an important milestone. No doubt, psoriasis is a serious disease affecting the quality of life of millions of people. Fortunately, psoriasis has been prioritised by several companies who now offer good medicine to great benefit for psoriasis patients. Therefore, we turned our eyes towards diseases where patients are in much greater need for new and better medicine. Taking actinic keratosis as an example, we know that millions of people go untreated or undergo repeated cryotherapy which can be painful, inconvenient, leaves scars and is not always that effective. We estimate that a topical treatment which is both safe, efficacious and convenient will be of great help to many people suffering from this common disease.

– Despite good progress in the cancer field in general, there is an urgent need for better and more convenient treatments with less side effects for several cancer indications, for example within leukaemia and breast cancer. I would also like to mention that we have some very interesting preclinical results related to fibrotic diseases, which makes it obvious to look into chronic kidney diseases where the need for new medicine is very large.

»We are ramping up to conduct our first clinical trial in AK this year and we are soon ready to submit the application to the ethics committee and the Danish Medicines Agency. The clinical trial will be conducted at Bispebjerg Hospital in Copenhagen, one of the major centres for skin diseases in Scandinavia. We expect to start the recruitment in August and complete the study by the end of 2021. The results can then be available at the beginning of 2022«

Why is the cPLA2α enzyme such a promising target and what distinguishes it from more common classes of cancer therapeutics like immunotherapy?

– The cPLA2α enzyme is a promising target for cancer treatment for many reasons. First, and in relation to immunotherapy or other cancer drugs, these only work in a subset of cancer patients. Furthermore, as the disease progresses, treatments fail, and patients have an unfavourable prognosis. Therefore, the need for new therapies remains extremely high.

– Second, cPLA2α is a novel anti-cancer target. Based on the medical need mentioned above, it is imperative that drugs targeting novel targets are being developed and used in the clinic alone or in combinations with other anti-cancer drugs.

– Third, a certain portion of tumours overexpresses this target and patients showing such overexpression have unfavourable disease prognosis. Thus, a cPLA2α targeting drug may have added benefits in this portion of patients.

– Finally, preclinical data in relevant in vitro and an in vivo model have already shown that inhibition of cPLA2α by Coegin’s compounds translates into therapeutic benefit. Importantly, these compounds are able to act synergistically with other classes of anti-cancer drugs providing a better combined benefit in these models.

You have received substantial grants and funding from the Research Council of Norway, and in May you were able to raise 20 Mkr from existing and new investors. Can you tell us more about the company from a financial perspective?

– We are grateful to the many investors who have followed the company for years and for the new investors who got onboard recently. The quality of the science has led to substantial funding from the Research Council of Norway. We were happy to raise 20 MSEK in May 2020 from existing and new investors, enabling us to move forward with our new strategy and get registered on NGM Nordic SME by means of a reverse takeover from Gold Blue AB. Our current development programme takes offset in an already established platform and investigational drugs, which have already been used in clinical trials. Our operational model is very cost effective, and we do not carry a large organization. We will constantly follow our capital need to secure a stable financial basis for developing our project pipeline.

Finally, what are some major milestones to look forward to for Coegin Pharma this year?

– We have several important milestones this year. We are ramping up to conduct our first clinical trial in AK this year and we are soon ready to submit the application to the ethics committee and the Danish Medicines Agency. The clinical trial will be conducted at Bispebjerg Hospital in Copenhagen, one of the major centres for skin diseases in Scandinavia. We expect to start the recruitment in August and complete the study by the end of 2021. The results can then be available at the beginning of 2022. I am very excited that we have entered into a strategic collaboration with Studies&Me, a contract research organisation established to set new standards for clinical research by means of digital tools to improve recruitment, support to the patients and continuous collection of data.

– This innovative approach is very patient-centric and data driven. We plan to expand the topical treatment to skin cancers like basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) in 2022. In parallel we aim to select the first systemic drug candidate this year and start the preclinical development programme required to initiate phase I clinical trials for cancer in 2022/2023. Here we are considering specific indications within leukaemia and breast cancer. We are also investigating the potential of our molecules for the treatment of chronic kidney disease which could become a very interesting opportunity.

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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