Lipum initiates GMP-production for clinical trials
Press release: Umeå, September 15, 2021. Production of Lipum's drug candidate SOL-116 for use in clinical trials has according to plan been initiated by the company's partner Abzena.
The drug candidate SOL-116 is an antibody and is thus a biological drug. In collaboration with Lipum's partner Abzena in San Diego, the development of a cell line and production method began in March 2019. Following a successful upscaling of the manufacturing method, production has now been initiated under the regulations that apply to Good Manufacturing Practice (GMP), which shall provide a product that can be administrated to humans in clinical trials. The production takes place in a volume of 500 liters and is expected to provide a sufficient amount of SOL-116 for carrying out planned clinical trials. The initial safety study on healthy volunteers (phase 1a) is intended to start next year.
"Biological drugs are generally both tricky and expensive to develop compared to small molecules, but the chance of reaching the market is significantly better. We have now reached a milestone and taken a decisive step for the start clinical trials according to plan” - says Einar Pontén, CEO.
Lipum AB (publ) is a biopharmaceutical company specialized in discovery and development of a novel treatment for chronic inflammatory diseases. The lead candidate SOL-116 is a humanized antibody designed to provide efficacious therapy by blocking a previously overlooked target molecule of the immune system (BSSL). SOL-116 is in late preclinical stage supported by solid data for the rare disease juvenile idiopathic arthritis and rheumatoid arthritis. Lipum also explores other inflammatory diseases with a high unmet medical need. The company is based in Umeå, an excellent life science cluster in Sweden. Lipum’s unique approach has attracted international attention, including a major European Commission Horizon 2020 grant. The company's share (LIPUM) is traded on the Nasdaq First North Growth Market. Certified Adviser is G&W Fondkommission, email: firstname.lastname@example.org, phone: +46 8 503 000 50.