live modified horsepox virus vaccine (TNX-1800) / Tonix, Southern Research - LARVOL DELTA

Immunogenicity and Efficacy of TNX-1800, A Live Virus Recombinant Poxvirus Vaccine Candidate, against SARS-CoV-2 Challenge in Nonhuman Primates. (PubMed, Vaccines (Basel)) - "Following challenge with SARS-CoV-2, African Green and Cynomolgus Macaques exhibited rapid clearance of virus in the upper and lower respiratory tract. Future studies will assess the efficacy of TNX-1800 against newly emerging variants and demonstrate its safety in humans."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG

Immunogenicity and Tolerability of a SARS-CoV-2 TNX-1800, a Live Recombinant Poxvirus Vaccine Candidate, in Syrian Hamsters and New Zealand White Rabbits. (PubMed, Viruses) - "Post-vaccination, all animals had anti-SARS-CoV-2 spike protein IgG specific antibody responses. These data demonstrate that TNX-1800 infection was limited, asymptomatic, and cleared by the end of this study, and a single dose was able to generate immune responses."

Journal • Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Tonix Pharmaceuticals Enrolls First Participant in the PRECISION Study, an Observational Study to Facilitate Development of Precision Medicine Techniques for COVID-19 Vaccines and Therapeutics (GlobeNewswire) - "Results from the PRECISION Study Expected in First Half of 2021; Tonix Pharmaceuticals Holding Corp....announced that the first participant was enrolled in the observational PRECISION study (TNX-C002), to examine the immune responses to COVID-19....The research encompasses two projects. The study led by Dr. Ilya Trakht, Ph.D....has the potential to lead to the isolation and characterization of therapeutically relevant fully human monoclonal antibodies to SARS-CoV-2. The study led by Dr. Sergei Rudchenko, Ph.D....is designed to generate DNA aptamer-based anti-idiotypes to selected monoclonal antibodies identified in Dr. Ilya Trakht’s study."

Enrollment status • Observational data • Infectious Disease • Novel Coronavirus Disease

Tonix Pharmaceuticals Enrolls First Patient in COV-LOGIC, an Observational Study to Assess Antibody and T Cell Responses to SARS-CoV-2, the Virus that Causes COVID-19 (GlobeNewswire) - "Tonix Pharmaceuticals Holding Corp....today announced that the first patient was enrolled in the observational COV-LOGIC study (TNX-C001)....The research is part of an ongoing and broader collaboration between Tonix and Southern Research to develop and conduct animal testing of Tonix’s TNX-1800....'This represents a significant milestone for the Company as the data we plan to collect...will help inform vaccine development on how to safely provide the same immune responses...'"

Trial status • Infectious Disease • Novel Coronavirus Disease

Tonix Pharmaceuticals and Southern Research Announce Expansion of COVID-19 Vaccine Collaboration (GlobeNewswire) - "Tonix Pharmaceuticals Holding Corp...announced today an expansion of its strategic collaboration with Southern Research to include a study of T cell immune responses to SARS-CoV-2 in volunteers who have recovered or remain asymptomatic after exposure to COVID-19. The research is part of an ongoing and broader collaboration between Tonix and Southern Research to develop and conduct animal testing of Tonix’s TNX-1800, which is a live replicating virus vaccine designed to protect against COVID-19."

Licensing / partnership • Infectious Disease • Novel Coronavirus Disease

Tonix Pharmaceuticals Announces FUJIFILM Diosynth Biotechnologies to be Manufacturing Partner for COVID-19 Vaccine Candidate TNX-1800 (GlobeNewswire, Tonix Pharmaceuticals Holding Corp.) - "Tonix Pharmaceuticals Holding Corp....today announced an agreement whereby FUJIFILM Diosynth Biotechnologies (FDB) will provide contract manufacturing and development services to support the manufacturing of Tonix’s COVID-19 vaccine candidate, TNX-1800, for clinical trial supply....FUJIFILM Diosynth Biotechnologies will develop a manufacturing process, manufacture, and stock a supply of TNX-1800..."

Commercial • Infectious Disease • Novel Coronavirus Disease

Tonix Pharmaceuticals Reports First Quarter 2020 Financial Results and Operational Highlights (GlobeNewswire, Tonix Pharmaceuticals Holding Corp.) - "Research and Development....TNX-1800, TNX-1810, TNX-1820 and TNX-1830 are in the pre-clinical, pre-Investigational New Drug (IND) application stage of development. The company expects preliminary data from animal experiments with TNX-1800 in the fourth quarter of 2020, but the COVID-19 pandemic may lead to a delay in this timeline."

IND • Preclinical • CNS Disorders • Infectious Disease • Inflammation • Musculoskeletal Diseases • Novel Coronavirus Disease