Targeting the root causes of inflammation and fibrosis

Published: 03 January 2024

Text: Newslab / Anne-Marie Korseberg Stokke

Photo: Angelique Culvin-Riccot / Arxx Therapeutics

Arxx Therapeutics is merging with Oxitope Pharma and securing 862 million NOK from investors to finance the development of a new treatment for systemic sclerosis. The merged company will be named Calluna Pharma.

Arxx Therapeutics was founded by entrepreneurs and physicians Rizwan Hussain and Jonas Hallén in 2019, after meeting as colleagues at the pharmaceutical company Novartis in Basel. Together with Arxx's third founder and inventor Jörg Klingelhöfer, the trio formed the company around Jörg's research and the academic group he worked with. From the headquarters in Forskningsparken and as part of the innovative biotech environment in ShareLab, the founders can immerse themselves.

"We both wanted to work in biotech and wanted to start something together. Then we came across exciting research about an antibody," explains Hussain.

The antibody AX-202 binds to a protein that functions as an alarm signal in the body.

"The protein is present in blood and tissue during inflammation. The antibody can inhibit the signal, stopping inflammation and preventing the formation of connective tissue," explains Jonas Hallén, who is currently the Chief Medical Officer at Calluna Pharma.

In order to acquire the right expertise, the doctors aimed internationally. "It is an international industry, and we have consciously worked to bring in consultants with experience. We have chosen those whom we believe are the best," explains Hussain (right).

From mouse to man

The transition from mouse to human for AX-202 was a complex process that took 3.5 years. After animal studies, experiments with human material, and production, the substance was approved for a clinical study in 2023.

"The goal of the study is primarily to uncover the side effect profile in healthy volunteers, but the study also includes patients. This will provide the first indication of whether AX-202 has a disease-modifying effect," explains Hallén.

Carefully planned

"To test patients in the target group for AX-202, we have to think far ahead, and we spend a lot of time planning it. We have to decide which clinical studies will follow after phase 1, which patient groups will be involved, what and how we will measure, what we want to find out, and which hospitals and doctors we will collaborate with.

Phase 2 is likely to be initiated towards the end of 2024, followed by at least one phase 3.

"For a small biotech company like us, it would be natural to find a larger partner to take it further, either in collaboration with us or alone all the way to the market," says Hallén.

The production process for AX-202 takes place in Germany, with a manufacturer who is also involved in producing the Pfizer vaccine. Consequently, there was some competition for resources when Covid was at its worst. "We have been fortunate; things have gone exactly according to plan and schedule," summarize the founders.

Engaging in this type of work is highly resource-intensive. A crucial task has therefore always been to secure enough funding to keep the project going. In the beginning, the Norwegian duo quickly started reaching out to investors.

During the first three years, they secured 150 million from investors, along with 30 million from various public funding programs.

In January 2024, the news broke that Arxx Therapeutics was merging with Oxitope Pharma, forming the new company Calluna Pharma. The largest shareholder is the Dutch fund Forbion. The fund is one of the leading life science venture investors in Europe, with around 30 billion kroner under management, according to Sveinung Hole, chairman of Arxx and managing partner at Sarsia.

"The funding round is one of the largest for an unlisted Norwegian early-stage biotech company ever. This is not only very strong by Arxx in a challenging capital market, but also a big day for Norwegian biotech," wrote Sveinung Hole in a press release.

Find a niche

Hussain stepped down as CEO of the company and is now CEO of Agiana, which is working on a drug under development for dangerous, irregular heartbeat.

"I am a founder at heart and driven by trying to turn research into medicine. My best entrepreneurial advice is to do a good job of creating a proper roadmap, identifying a medical need and a market where there is not too much competition."

"Find a niche with the best effect and where you have the best chance of success, with minimal competition."

Co-founder Jonas Hallén, on the other hand, continues the journey at Arxx Therapeutics, now Calluna Pharma, and loves the challenging work and varied days.

"Developing a new medicine for patients in need is both intellectually stimulating and demanding. There are many things to consider, and it's a fun day with new issues you have to have an opinion on. No day is the same. We are a small company, and there is a short distance from idea to decision. We are very flexible and can turn around quickly when needed."