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Business Q&A: Herantis Pharma

We asked the CEO of Herantis Pharma, Pekka Simula, about what is in their pipeline right now, about their strategy to reach market and about patient-driven innovation.

Herantis Pharma was created by a merger of two pharma companies, Hermo Pharma and Laurantis Pharma. It has a broad product portfolio in various therapeutic areas and several projects in clinical phase already showing promising results. Their basis in academia has also paved the way for important scientific collaborations.

The company’s assets are based on research in CDNF for disease modification in neurodegenerative diseases, primarily Parkinson’s and ALS, and Lymfactin for breast cancer-associated lymphedema with potential also in other lymphedema.

Its shares are listed on NASDAQ OMX Helsinki First North Finland. It recently raised EUR 5.8 million from a positive outcome of a directed share issue, gaining additional support from long-term strategic institutional investors.

“With a better understanding for disease mechanisms, neurology including Parkinson’s disease is now “more ripe” for not only symptomatic treatment but truly disease modifying therapies,” says Mattias Häggblom, portfolio manager for Medica, Swedbank Robur’s global healthcare fund (Swedbank Robur was the lead investor in the directed share issue).

In 2017, the company was one of the three winners of the Nordic Star Awards at NLSDays.

When can we expect results from the Phase 2 and 3 clinical studies of CDNF and Lymfactin respectively?

“While we are beginning to prepare for those studies, we of course first need to wait for the unblinding of the ongoing Phase 1/2 study with CDNF in Parkinson’s disease, which is expected around the end of 2019, and the Phase 2 study with Lymfactin in breast cancer-associated lymphedema, which is expected at the end of 2020. The outcome of these studies will impact the design of the consecutive studies.”

And from the pre-clinical studies of non-invasive CDNF?

“We intend to select a lead molecule for our preclinical study in non-invasive CDNF by the end of this year. Our current positive challenge is that we have a wide selection of possibilities that all look very exciting!”

What is your strategy to reach the market with CDNF and Lymfactin?

“CDNF works via modulating Unfolded Protein Response (UPR) pathways and alleviating ER stress, which have been revealed as key mechanisms in neurodegenerative diseases. Based on this, these findings could mean an enormous opportunity for the improvement of the disease treatment. Our primary target alone, disease modification of Parkinson’s disease, would be a significant breakthrough and probably more than a small company could commercialize alone. As the mechanism suggests potential to expand into other neurodegenerative diseases, partnering is certainly something we will consider as we strive towards reaching the market. On the other hand, Lymfactin targets a well-defined group of patients: breast cancer-associated lymphedema patients who undergo lymph node transplantation surgery. Such market roll-out may be a more feasible endeavor for a small company and still a significant business opportunity for fighting an unmet clinical need.”

What opportunities are currently on the market for treatments of neurodegenerative diseases and breast cancer-associated lymphedema?

“Neurodegenerative diseases, in particular Parkinson’s disease, as well as lymphedema are indications with real unmet medical need. Currently available therapeutic options only treat symptoms, not the overall disease. Moving forward, our vision is to create therapies that would more specifically target each indication and not just mitigate symptoms as we have shown to be possible in the pre-clinical and clinical studies we have carried out to-date.”

How can the industry involve patients more in therapy and drug development?

“The best way to do this would be by collaborating with patient advocacy groups. They provide a direct link to patients and know what issues matter most to them. It is very important, especially in smaller indications such as lymphedema, to involve patients early on in the trial planning, to understand the patient’s needs and implement a smart and feasible trial-design. For example, we work closely with the European Parkinson’s Disease Association EPDA and with the Lymphatic Education & Research Network LE&RN. Both have been wonderful partners who really want us to succeed because that could make a huge difference for the patients they represent.”

What are your hopes and expectations for the future of Herantis Pharma?

“We believe in our science, our approach and our team. We will continue to look for scientific breakthroughs that could lead to exciting and innovative development programs and support our future growth. Of course, our ongoing development will also keep us busy with high hopes!”

About CDNF

As opposed to other treatment modalities for Parkinson ’s disease, CDNF represents an opportunity to modify the disease state by alleviating both motor and non-motor symptoms and stopping disease progression; effects that Herantis has demonstrated in non-human primates.

About Lymfactin

In Herantis’ second disease-modifying program for the treatment of lymphedema, stemming from Professor Kari Alitalo’s research, the company is advancing a gene therapy approach to increase the expression of VEGF-C locally in the damaged tissue to reconstitute the lymphatic vasculature and thereby repair the lymphatic system to reduce the progressive swelling.

Photo: Vessi Hamalainen