A NOVEL MONOCLONAL ANTIBODY SOLUTION FOR LASSA FEVER - TRANSFORMING PROPHYLAXIS AND TREATMENT TO IMPROVE HEALTH SECURITY AND PANDEMIC RESILIENCE

MALASSA aims to develop, GMP-produce, and establish the safety, pharmacokinetics, and pre-clinical efficacy of a monoclonal antibody (mAb) therapy, oLAVA01, for the prophylaxis and treatment of Lassa fever. With a fatality rate of approximately 20% of diagnosed cases, no licensed vaccines, and current controversial off-license antiviral therapy use, there is a clear need for effective prophylactic and therapeutic agents against Lassa fever. This need will be answered by MALASSA. The project will (i) provide solid proof for cost-effective mAb optimisation leveraging innovative AI-based models to enhance antibody potency, breadth, and manufacturability of our lead candidate LAVA01, (ii) provide a novel, more cost-effective, and scalable lipid nanoparticle-based GMP production platform, (iii) develop a novel Lassa virus-targeting mAb with proven preclinical efficacy and clinical safety; latter utilising an innovative in silico trial design-informed, first-in-human phase 1 trial. Next to these technological and clinically-relevant breakthroughs, MALASSA will generate regulatory roadmaps and foster open science practices through a diverse consortium comprising 10 partners from 5 countries: leading academic institutions (AUMC, INSERM, UAVac, CEA), SMEs (MAbSilico, Polymun, NovoArc, IST), clinical partners (Penta), and research infrastructures (ERINHA). By combining expertise in antibody discovery, AI-based mAb modelling, GMP manufacturing, clinical research, in silico clinical trial design, and local endemic control and prophylaxis logistics, MALASSA will accelerate mAb development for Lassa fever applications and beyond, reduce mAb development and production costs in general, and thereby enhance Europe's preparedness for epidemic threats also beyond Lassa fever, while building capacity in endemic regions and supporting equitable access to advanced therapies.