Core Points - Bavarian Nordic A/S has initiated two clinical trials for the MVA-BN mpox/smallpox vaccine targeting vulnerable populations, specifically infants under 2 years and pregnant or breastfeeding women [1][2] - The first study involves 344 infants aged 4-24 months, while the second study aims to enroll 359 women [1][2] - Both studies are conducted in the Democratic Republic of Congo, the epicenter of the ongoing mpox outbreak [1] - Bavarian Nordic is also sponsoring a trial for children aged 2-11 years, with topline results expected in Q3 2025 [3] Company Overview - Bavarian Nordic is a global vaccine company focused on improving health through innovative vaccines and is a preferred supplier of mpox and smallpox vaccines to governments [5] - The MVA-BN vaccine is the only non-replicating mpox vaccine approved in several countries, including the U.S., Canada, and the EU [4] - The vaccine was originally developed as a smallpox vaccine in collaboration with the U.S. government to ensure supply for the entire population, including immunocompromised individuals [4]

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].