– The encouraging announcement from Eurostars makes it possible for us to carry out the project together with Age Labs, with the goal of enabling effective and personalized treatment, says CEO Ola Sandborgh.
Lipum is developing a new treatment for chronic inflammatory diseases, with a particular focus on rheumatoid arthritis (RA). The company's drug candidate SOL-116 is an antibody that blocks the novel target protein Bile Salt-Stimulated Lipase (BSSL), which is expected to enable effective and safe treatment.
To further improve treatment options, Lipum has initiated a project together with Age Labs, an Oslo-based life science company focused on the research and development of diagnostic tools and biomarkers. The company specializes in analyzing epigenetic changes in immune cells and building predictive algorithms to identify biomarkers for early disease detection and risk assessment.
Can facilitate patient selection
The collaboration between Lipum and Age Labs aims to establish new knowledge and technology for the diagnosis and treatment of rheumatoid arthritis (RA) with the drug candidate SOL-116. The goal is to develop a technology to predict which RA patients will respond to treatment, which can facilitate patient selection and provide clearer treatment results in future clinical trials.
In the longer term, the project may lead to the development of a diagnostic test that identifies patients most likely to benefit from SOL-116, to enable more personalized treatment of RA.
The final results from the project could potentially also be an important piece of the puzzle in upcoming registration activities and the subsequent commercialization of SOL-116, according to previous statements from Lipum's CEO Ola Sandborgh.
Financial contribution from Eurostars
The project, which will run for three years, has a total budget of approximately EUR 1,9 million. Approximately 50 percent of the costs are covered by financial support from Eurostars, through contributions from Vinnova and Research Council of NorwayEurostars is a funding programme supported by the EU through Horizon europe (previous Horizon 2020) and is designed to support innovative small and medium-sized companies that collaborate to develop innovative products.
Lipum and Age Labs submitted an application to Eurostar's call for proposals in 2024. The competition was tough as many applied for grants, but Lipum managed to obtain approval after a thorough review and evaluation of all applications.
– We are very pleased to receive support from Eurostars in tough competition. The funding and the continued collaboration with Age Labs will open up opportunities to select patients suitable for treatment with SOL-116, says Lipum's CEO Ola Sandborgh.
– This is considered to be valuable in upcoming clinical trials and could lead to a future offering of precision medicine with SOL-116 that can reach the market faster to the benefit of patients who lack good treatment options today.
Age Labs discusses the project
A key person in the project is Catherine Hadley, Head of Clinical Development at Age Labs since March 2020. She is a physician with extensive clinical experience in internal medicine and cardiology, and holds a PhD in emergency medicine. Cathrine also has experience in leading large multicenter clinical trials.
BioStock contacted Cathrine to find out more about Age Labs' operations and the collaboration project with Lipum.
Can you start by providing an overview of Age Labs' operations and the role epigenetics plays in the development of diagnostic tools?
– Age Labs specializes in bioinformatics and biomarker discovery. We use machine learning to analyze large epigenetic and proteomic data sets to develop diagnostic tests that enable earlier disease detection and guide treatment decisions. We collaborate with pharmaceutical companies, hospitals and research institutions, and our leading biomarker is used to detect RA at an earlier stage.
– Epigenetics reflects which genes are active and are influenced by both genetic predisposition and environmental factors. Since changes in epigenetic markers often occur before clinical symptoms appear, they are well suited to detecting diseases earlier than conventional tests.
“In oncology, the introduction of epigenetic testing has enabled personalized treatment, where doctors can choose therapies based on a patient’s biology rather than assumptions. We aim to bring the same personalized approach to patients with autoimmune diseases.”
| Epigenetik | Epigenetics explores gene activity. G Through chemical markers, such as DNA methylation, genes can be turned on or off – like a switch. These epigenetic modifications are influenced by environmental factors such as diet and stress and are reversible, and play a key role in the patient's health and disease state. |
| Proteomics | Proteomics studies proteins, i.e. active molecules that perform most vital functions in the body. Genes are the blueprint, epigenetics controls which proteins are produced, and proteomics shows which proteins are actually present and in what quantities. This provides important insights into disease mechanisms and the patient's health status. |
How will Age Labs' expertise in the field be applied in the collaboration with Lipum?
– Lipum and Age Labs bring complementary competencies to the project. Lipum has developed an innovative and promising drug candidate for RA, while Age Labs specializes in biomarker discovery and bioinformatics. Using our machine learning platform, we will analyze Lipum's data to identify and validate biomarkers that can predict response to SOL-116.
– Our experience with omics data across multiple disease areas makes us well-equipped to develop biomarkers for a companion diagnostics product – a test that enables personalized treatment decisions. Lipum’s commitment to innovation and precision medicine makes them an ideal partner for us.
What specific tasks will you focus on during the project with Lipum?
– Our primary role is to contribute data and analyze proteomic and epigenetic data to identify biomarkers that can predict treatment response to SOL-116. We will also validate these biomarkers on independent data and support the development of a cost-effective and scalable laboratory test for clinical use. Although we will lead the bioinformatic tasks, Lipum's deep expertise in the biological background will be crucial in guiding the process.
How can the project help drive the development of individualized treatment for rheumatoid arthritis?
– Today, RA treatment often follows a trial-and-error process, where patients have to try several drugs before one works. This delays effective treatment, increases healthcare costs and exposes patients to unnecessary side effects. By developing a diagnostic test that can predict treatment response in advance, we want to enable precision medicine in RA, so that patients receive the right medication from the start.
– The project has the potential to improve treatment outcomes, shorten the time to effective treatment and create a model for individualized care in autoimmune diseases. We see enormous potential in Lipum's innovative approach to RA treatment and are proud to contribute to bringing this promising treatment closer to patients.
CEO Ola Sandborgh talks about the project's interim goals
BioStock also contacted Lipum's CEO Ola Sandborgh to find out more about why they chose to initiate the project and what it could lead to.
What was the main driving force behind you choosing to start this project?
– We want to develop as good and complete a product as possible. Of course, our primary focus is the therapeutic antibody SOL-116, but there are more needs to be filled. A question that often arises in connection with the commercialization of a drug is “which patients can we treat and what is the likelihood that they will get satisfactory results?”.
– Based on this, a number of different Companion Diagnostic Tests (CDTs) have been developed. Today, there are about 200 CDTs approved by the US FDA. Each one concerns use in connection with a specific drug and an indication. If we can provide a CDT that is developed for SOL-116, our chances of successful registration and commercialization increase significantly. From a payer perspective, a CDT is important as it can support the choice of treatment where one can expect that the cost of treatment is met by a successful treatment outcome.
What specific milestones and timeframes have you set for the project?
– The project is divided into 6 different work packages (WP) and extends over 36 months. Each WP has its own milestones and primarily refers to the results that are generated and that are part of the overall goal of the project. These milestones come continuously from month 10 to 36. The most interesting milestone is of course the validation of the new biomarker that helps us predict the response to treatment with SOL-116. This milestone only appears in WP6 at the end of the project. As always, those who wait for something good…
What role does Eurostars play in ensuring the success of the project?
– Of course, the grant we received, which covers up to 50 percent of the project's cost, plays a very important role. But also the quality control that was carried out before the grant was granted, as well as the continuous reports that we have committed to share with Eurostars, play important roles in terms of quality of execution and progress.
How is Lipum's research on BSSL integrated into the project?
– We have a number of preclinical projects underway that concern BSSL and its role in various types of chronic inflammation. The knowledge we gain will also be directly linked to the project we are conducting together with Age Labs. The phase II study we plan to conduct is also significant as patients who will be treated with SOL-116 constitute an important data source for one of the subprojects.
Finally, how can the knowledge and technology developed within the project facilitate the clinical development and commercialization of SOL-116?
– I have already touched on the benefits of commercialization, but for the clinical development program, it also provides the opportunity to select patients for future studies that can contribute to valuable insights and results for the benefit of both registration documents and award and subsidy applications. In addition, the technology will have a prominent position in the introductory and communication materials we use to support commercialization.
