Tonix Pharmaceuticals Announces In-licensing Phase 2/3-Ready Monoclonal Antibody Designed for Seasonal Prevention of Lyme Disease (TNX-4800)

Core Insights - Tonix Pharmaceuticals has in-licensed worldwide rights to TNX-4800, a long-acting human monoclonal antibody targeting the outer surface protein A (OspA) of Borrelia burgdorferi, the causative agent of Lyme disease [2][3] - TNX-4800 is designed for annual seasonal use, with a single subcutaneous dose providing protection against Lyme disease for the entire tick season in the U.S. [2][3] - The company aims to advance TNX-4800 through additional clinical trials, with the goal of submitting a Biologics Licensing Application (BLA) [3][8] Company Overview - Tonix Pharmaceuticals is a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, focusing on central nervous system disorders, immunology, immuno-oncology, and infectious diseases [8] - The company recently received FDA approval for Tonmya, a non-opioid analgesic for fibromyalgia, marking the first approval for a new prescription medicine for this condition in over 15 years [8] - Tonix's infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, and TNX-4200, a broad-spectrum antiviral agent [8] Industry Context - Lyme disease is the most common vector-borne infection in the U.S., with its incidence increasing annually [3] - Approximately 70 million people in the U.S. live in areas where Lyme disease is endemic, highlighting the urgent public health need for effective prophylactic measures [2][3] - Current preventive measures for Lyme disease are limited, as there are no FDA-approved vaccines or prophylactics available [2][3]