FMB-3991

FMB-3991 is a lead candidate lipid nanoparticle (LNP) formulation developed by Mana Bio using a proprietary machine learning (ML) platform. It is designed for the passive-targeted, in-vivo delivery of mRNA to reprogram T-cells, offering a potential alternative to ex-vivo CAR-T cell therapies. The formulation was identified through iterative ML-driven screening of over 86,000 data points to optimize transfection efficiency, cell viability, and safety. In preclinical studies, FMB-3991 demonstrated significant T-cell transfection in humanized mice and non-human primates with a favorable safety profile, avoiding common LNP-associated toxicities such as liver inflammation or coagulation issues. It is primarily being developed for in-vivo CAR-T applications, specifically targeting CD19 for the treatment of B-cell malignancies.