At the beginning of 2023, Merck EUR 10 million to tackle autoimmune and inflammatory diseases together with Aqilion – a private Helsingborg-based biotechnology company. The agreement included up to EUR 950 million in milestone payments for the development of preclinical inhibitors of the transforming growth factor-β-activated kinase 1 protein (TAK1).
Interest in the TAK1 protein is driven by the lack of efficacy of current anti-inflammatory treatments, which target the tumor necrosis factor (TNF) signaling pathway – which is prominent in chronic inflammation. Antibodies that Remicade (infliximab) has improved the treatment of many autoimmune diseases, including rheumatoid arthritis, but some patients either do not respond at all or relapse after a period of treatment. TAK1 is a potential alternative for disrupting TNF, and Aqilion's preclinical work with its TAK1 inhibitors has shown great potential to overcome current treatment challenges.
A success story in biotechnology
The deal with Merck was widely seen as a success story in biotech and Aqilion's CEO Sarah Fredriksson talked about the importance of collaboration in a interview with BioStock:
– This deal inspires us as a team and will strengthen our financial ability to continue developing interesting drug development projects and strengthen our pipeline. Three years ago, we made an active decision to make Aqilion a biotech company and develop our own drug development programs in chronic inflammation, and you could say that this deal actually confirms that decision today.
Dark clouds over Helsingborg
Last week, however, Aqilion announced that it was terminating its agreement with Merck. According to the biotech company, “the data generated during the collaboration has changed the risk-benefit profile within the intended indications.”
Aqilion will oversee the transfer of all relevant data and materials and conduct an internal review to determine the future of the TAK1 program. The Company will explore further development opportunities in inflammation and other therapeutic areas.
– The license and collaboration agreement with Merck validated our business strategy to generate high-quality and innovative research projects. It is unfortunate, but not uncommon, to discover challenging aspects of new mechanisms in this early phase of drug development. We are now prioritizing our resources on the existing pipeline programs, outside of the TAK1 program, comments Sarah Fredriksson, CEO of Aqilion.
The way forward for Aqilion
Aqilion currently has four ongoing pipeline projects. The lead program includes a selective inhibitor of Janus Kinase 1 (JAK1), AQ280In August last year, Aqilion initiated a clinical phase I study with AQ280 as a treatment for eosinophilic esophagitis (EoE), an inflammatory condition of the esophagus. Positive results from the study was announced shortly thereafter.
In May this year, Aqilion announced a new drug development program targeting PKCtheta, which CEO Sarah Fredriksson explained more about. here.
The Helsingborg-based biotechnology company thus has a broad pipeline with the potential to make a significant difference for patients suffering from chronic inflammatory diseases.
CEO comments
BioStock contacted Sarah Fredriksson to find out more about the terminated collaboration with Merck and what awaits the company in the future.
Sarah, can you elaborate on the reasoning for terminating the agreement with Merck?
– During development, we have repeatedly seen very promising efficacy data in disease models, but we have also encountered challenges that change the risk/benefit profile of the program. In light of these findings, combined with the intended indications and strategic considerations, both parties have decided to terminate the joint development.
How big of a setback is this for Aqilion?
– It is of course unfortunate and we are disappointed because we were really hopeful given how promising the TAK1 biology was in our early trials. We remain proud of the agreement with Merck and for us it proved that it is worth continuing to invest in early innovative research projects that are noticed by large pharmaceutical companies.
– It was an early deal with a substantial upfront payment and a rewarding partnership. We will of course analyze whether we could have done things differently to reduce risk already in the discovery phase, but it is likely that this is simply the nature of many early drug development projects.
What's next for the TAK1 program?
- First, we will ensure that the materials and data are transferred back to Aqilion. Then, we will analyze other options for the program and evaluate whether or not there is a viable path forward. For now, we will primarily focus our resources on our other pipeline programs.
What will Aqilion need to do to adjust its financing and business development strategy?
– Our business development strategy remains the same. We are business-driven. Actively seeking potential partners to secure or verify significant interest in our programs is one of our most important strategic cornerstones. Funding the Phase II clinical trial in EoE is a priority and we never planned to use any upcoming milestone payment for that purpose.
– Owners and potential investors are of course as disappointed as we are. However, we believe we have three exciting programs in chronic inflammation and autoimmune diseases, from early detection to clinical development, and will continue to work on our next round of funding based on our pipeline and track record.
Overall, how does this affect Aqilion's other programs?
– All of our pipeline programs are independent of each other. With individual IP and development plans, they are not directly affected by events within the TAK1 program.
Finally, what milestones are you most looking forward to in the coming months?
“We look forward to presenting new promising data in AQ312 and following up on business development leads across our assets. The next milestone for the AQ280 program is a pre-IND meeting and completing API production and drug formulation in order to submit an IND application by the end of the year.”
