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Tonix Pharmaceuticals Presented Data on Potential Mpox Vaccine TNX-801 at World Vaccine Congress Washington 2025

Core Viewpoint - TNX-801 is a promising single-dose live virus vaccine in development to protect against mpox and smallpox, demonstrating positive preclinical efficacy and tolerability, particularly in immunocompromised animals [1][2][3]. Group 1: Vaccine Efficacy and Safety - TNX-801 has shown the ability to protect immunocompromised animals from lethal challenges with both clade IIa monkeypox virus and rabbitpox, with a demonstrated six-month durability of protection [1][2]. - The vaccine is well tolerated, with no spreading to blood or tissues observed even at high doses in immunocompromised animals [1][2]. - After a single dose, TNX-801 prevented clinical disease and lesion formation in non-human primates, indicating effective mucosal immunity and potential to block forward transmission [3][4]. Group 2: Market Need and Regulatory Context - The ongoing clade IIb and clade Ib mpox epidemics, declared by the WHO as Public Health Emergencies of International Concern, underscore the urgent need for additional vaccine options, particularly single-dose vaccines [2][4]. - TNX-801 aligns with the WHO's preferred target product profile, which emphasizes single-dose administration, durable protection, and stability at ambient temperature [2][4]. Group 3: Company Overview and Development Plans - Tonix Pharmaceuticals is a fully integrated biopharmaceutical company focused on developing therapies for public health challenges, including TNX-801 for mpox and smallpox [5]. - The company has received feedback from the FDA regarding the development of TNX-801 and is collaborating with the Kenya Medical Research Institute to plan a Phase I clinical study [3][4]. - Tonix's broader portfolio includes other candidates for CNS disorders and infectious diseases, highlighting its commitment to addressing significant health challenges [5].