Lipum’s CEO summarizes the half-year – continued positive study data
Lipum’s report for the first half of 2024 highlights the positive interim results from the phase I study with SOL-116. The company has started preparations for phase II trials in rheumatoid arthritis, including initiating the collaboration with NorthX Biologics for the manufacturing of SOL-116. BioStock reached out to Lipum’s CEO Ola Sandborgh to learn more about this, as well as the audit report of the Horizon 2020 project, which may result in them being liable for repayment.
Lipum is a biopharmaceutical company specialised in development of treatments for chronic inflammatory diseases. The company’s lead candidate SOL-116 is an antibody targeting Bile Salt-Stimulated Lipase (BSSL), which is active in inflammation.
The company is now in the final stretch of a phase I study that aims to evaluate the drug candidate’s safety, as well as pharmacokinetics and exploratory endpoints. Lipum has also begun planning for phase II studies to demonstrate the treatment effect on patients with rheumatoid arthritis (RA).
Half-year report presents progress in study
The recently published report for the first half of 2024 indicates that development and results are in line with expectations. Among other things, Lipum has entered into a manufacturing agreement with NorthX Biologics for the manufacturing of SOL-116 for phase II trials.
In addition, the company has made progress in the ongoing phase I study, where both the multidose part and the single dose escalation part have been completed. The interim results from both parts of the study show that SOL-116 is safe and well tolerated, with few side effects and none of serious nature.
The study indicates that the drug candidate exhibits a favourable pharmacokinetic profile with a half-life of 20 days, and that the subjects do not develop antibodies to the drug. Data also show that SOL-116 effectively eliminates BSSL levels in the blood to non-measurable levels for up to 90 days.
The third and final part is underway, involving a group of RA patients who receive a dose of SOL-116. Only one patient remains to be recruited, which means that the study can likely be completed and reported this year.
Financed for study completion and manufacturing
The phase I programme will be completed with the capital raised in a rights issue that Lipum carried out in the spring and that provided the company with SEK 79.9 million. In addition, Lipum has received a loan commitment of SEK 20 million from Flerie Invest.
The capital injection also enables the initiation of preparations for the phase II programme. Lipum and NorthX Biologics have already taken the initial steps in the manufacturing of SOL-116. The entire process from start to finish will take about 18 months and cost about SEK 52 million. According to the interim report, the process includes cell cultivation, scaling up to the right volume and cell concentration, as well as purification, formulation and filling into ampoules. The goal is to complete production in autumn 2025.
Other significant events
During the first half of 2024, the company was also granted funding of SEK 2.8 million from Swelife for a project that evaluates precision medicine biomarkers to predict or assess the disease course in RA and optimize treatment. The project is conducted in collaboration with Karolinska Institutet and Linköping University.
Additionally, Lipum has strengthened the patent protection for SOL-116 with a patent application for inflammation-induced cancer. The application is supported by research showing elevated levels of BSSL in breast cancer tumour tissue, and that blocking BSSL inhibits the growth of cancer cells.
Furthermore, Ingemar Kihlström has taken over as chairman from Ulf Björklund, and Åsa Magnusson has been elected as a board member. Read BioStock’s interview with Åsa here.
Risk of repayment following audit report
While the company has made progress in the clinical development of SOL-116, there has been an ongoing revision of the previous work funded by Horizon 2020.
At the end of 2018, Lipum was granted approximately SEK 23 million from the European Commission’s innovation program Horizon 2020, which was used to optimize the design and establish a manufacturing method for SOL-116. The project was completed in 2021 and Lipum received its final payment in March 2021.
In 2022, Deloitte initiated an audit of the project, and Lipum has now received a preliminary audit report. According to the report, Lipum risks grant adjustments of EUR 400 000 together with a 25 per cent flat rate for the indirect costs.
That report also claims that, in its reporting of eligible costs, Lipum have incorrectly categorised consulting expenses. The company does not agree with the conclusions and plans to submit objections before August 31, 2024.
Interview with the CEO
The audit report was made public the day before the release of the company’s interim report, which CEO Ola Sandborgh presented in a live broadcast the same morning on August 9. During the presentation, Ola stated that he is proud of what the company’s employees and partners have achieved during the first half of 2024.
BioStock contacted Ola to gain deeper insight into the year’s developments, as well as the preliminary audit report for Horizon 2020.
Ola, you took over the role of Lipum’s CEO at the end of 2023 – how would you summarize your first six months in this role?
– Intense, fun, and progress in the project that makes me very pleased and proud!
What discoveries in the phase I study will be particularly valuable in planning for phase II?
– Primarily, we have a drug candidate that is safe and well-tolerated in different doses given both as a single and multiple doses. At the same time, the knowledge we have gained about pharmacokinetics as well as the effect on the target protein BSSL is significant when we design an upcoming phase II programme.
What was your first reaction to the audit report for the Horizon 2020 project?
– Finally, we got an answer; the audit has been going on for more than two years, and we must reach a conclusion. At the same time, I am clearly disappointed with the content of the preliminary report as we know that we used the grant for exactly what it was intended.
What do you think about the claim that consulting costs were misclassified, and how have you worked to ensure correct cost reporting?
– We are now aware that the reporting of consulting costs that we have submitted to the commission was misclassified. At the same time, the costs we reported are fully in line with the project’s orientation. We will share our views and objections to the preliminary report, and we hope that the European Commission, in its final decision, will conclude that the costs are to be considered approved. I think it is unfortunate that we may have to repay parts of the project, especially considering that the commission previously has highlighted the project as successful on its Cordis channel.
According to the interim report, the cash at the end of the second quarter amounted to SEK 20.131 million. How far will it go for your continued work?
– Together with VAT refunds and the loan commitment of SEK 20 million, we have secured financing until the next half-year.
Finally, what milestones can we look forward to in the coming year?
– The next milestone is the completion of the phase I study and the publication of the final report. We also expect the project together with KI to deliver results regarding the mechanism of action of SOL-116. In addition, biobank data on RA and other indications will be made available, and the the first phase II study is planned to start at the turn of the year 2025/26.
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.
