Two IND clears advance CNS and rare-disease programs — Latus and Vectory move to clinic

The FDA cleared INDs for two early-stage programs: Latus Bio’s LTS-101 gene therapy to treat the CNS manifestations of late-infantile neuronal ceroid lipofuscinosis type 2 (CLN2) disease, and Vectory Therapeutics’ VTX-002, a vectorized antibody targeting TDP-43 pathology in amyotrophic lateral sclerosis (ALS). Latus also received orphan, rare pediatric disease and fast-track designations for LTS-101. Both clearances mark important translational steps for gene- and vectorized biologic modalities addressing severe neurological conditions. Sponsors will now initiate Phase I/II clinical studies, with regulatory designations intended to accelerate development timelines and support closer agency engagement on trial design and endpoints.