Lipum is an Umeå-based biopharmaceutical company developing a new treatment for chronic inflammatory diseases. The company's drug candidate SOL-116 is a humanized antibody that aims to offer a safer and more effective treatment than current treatment options by blocking a new target protein – Bile Salt-Stimulated Lipase (BSSL).
The company is currently evaluating SOL-116 in a Phase I clinical study, which has so far confirmed that the drug candidate has a good safety profile, expected pharmacokinetics and interacts with its target protein.
Rights issue to advance SOL-116 to Phase II
Based on these progress, the company intends to continue development in a Phase II clinical trial to study the effect of SOL-116 in patients with rheumatoid arthritis (RA). To enable this, additional capital is required and therefore the company has decided to conduct a rights issue with a subscription period of April 9-23, 2024.
The capital injection of up to SEK 187 million will be used to complete the ongoing clinical phase I study, new production of SOL-116, planning and implementation of clinical phase II studies, as well as preclinical studies on the mechanism of action and additional indications.
Lipum has also recently received Vinnova funding to make an application to the funding program. Eurostars, which can further strengthen the treasury with so-called "soft money".
Agreement with NorthX Biologics
Ahead of the upcoming Phase II study, relatively costly production and formulation of the antibody SOL-116 is required. In preparation for this, Lipum has chosen to change contract manufacturers and move the production of SOL-116 to Sweden. The company has entered into a framework agreement and a related project agreement with the Swedish NorthX Biologics for research, development and manufacturing of SOL-116 as an investigational drug for the phase II study.
NorthX Biologics develops and manufactures advanced biologics and has over 30 years of experience in GMP manufacturing. The company has facilities in both Matfors and Solna, which is significantly closer than Lipum's current manufacturing partner Abzena in San Diego. The collaboration with Abzena will continue until the Phase I program is completed, after which NorthX will take over manufacturing.
Lipum believes that the collaboration with NorthX Biologics can lead to cost savings and time savings, while the company can ensure high quality and delivery reliability by avoiding long transport times, time differences and currency effects.
Next step in the study: dosing of RA patients
In the near future, Lipum will primarily focus on the upcoming capital raising and the completion of the ongoing Phase I study. The first part of the study has been successfully completed, where 40 healthy volunteers received a single dose of SOL-116 or placebo. Interim results from the first part show that the candidate is well tolerated with few side effects, none of which were serious. In addition, SOL-116 was shown to reduce the amount of BSSL in plasma to undetectable levels for 90 days after dosing.
In the second part, all eight subjects have received all four doses of SOL-116, and follow-up and evaluation are now underway. At the same time, patient recruitment continues for the third and final part, where eight RA patients will each receive a dose of SOL-116 or placebo. Dosing is expected to begin shortly. Lipum expects to be able to present additional interim results and the final study report during the year.
In parallel, a collaboration is underway with Karolinska Institutet which is expected to result in more knowledge about the mechanism of action of SOL-116.
CEO comments on the latest news
BioStock contacted Lipum's CEO Ola Sandborgh to learn more about the company's progress, the share issue that will enable further development, and the new agreement with NorthX Biologics.
In the year-end report, you describe that Lipum has had a flying start on an exciting journey. What challenges may arise along the way and how do you plan to tackle them?
– There are always challenges, as well as opportunities. The main challenge that comes to mind when it comes to clinical drug development is how a study is designed and recruiting patients. For us, things have still gone relatively well and much of the reason for that is a well-designed study and an active CRO that has always been one step ahead when it comes to finding volunteers and patients. Another challenge for a company of our size and in the phase we are in is of course financing the business. An important part of that is the support from existing and new shareholders, but we are also continuously working to seek soft money from government agencies such as Vinnova as well as various opportunities for EU funding, for example from the EIC.
Why, in your opinion, should shareholders continue to follow Lipum's journey by participating in the upcoming rights issue?
– It is important to understand that Lipum is a long-term investment. At the same time, we have come a long way in our development as we are now in the clinical phase. Along the way, we have received the answers we need to confidently drive the development forward. Right now, we are again at a turning point where we have decided to take the step into phase II. That decision is based on the fantastic research results we have obtained and which help us design the next step.
»Along the way, we have received the answers we need to confidently drive the development forward. Right now, we are again at a turning point where we have decided to take the step into Phase II. That decision is based on the fantastic research results we have received and which are helping us design the next step.«
You have also announced that you have chosen to change contract manufacturer to Swedish NorthX Biologics. What prompted the decision to move manufacturing to Sweden instead of the US and what made you ultimately choose NorthX Biologics?
– I have chosen to pursue a change of contract manufacturer and bring production back to Sweden. The process involved taking in quotes from several potential manufacturers and then carrying out a selection process where NorthX Biologics emerged as the clear winner. With them as the manufacturer of SOL-116, we can see that it will lead to cost savings and time savings while maintaining the highest quality and delivery reliability. We get a partner at home that reduces the need for long transports and we are not affected by time differences or currency effects.
Flerie Invest and other major shareholders have committed to subscribe for shares in the issue. In addition, Flerie Invest has exceeded the mandatory bid threshold by acquiring additional shares. What does this support mean to you?
– I would say that it “means everything”. Having a stable, knowledgeable and supportive owner base is extremely important and we appreciate the support very much. Flerie Invest as a specialized investor in the life science area means a lot to other stakeholders as well. If a major owner continues to believe in the company and invests, then it tends to influence others to do the same. And our shareholders are an important prerequisite for Lipum’s continued operations.
Lipum's CEO Ola Sandborgh has also recently participated in BioStock's video podcast Health and Wealth - see the video here.