Type: Single dose intranasal anthrax vaccine candidate
Status: Altimmune said June 30 the first patient was dosed in the company’s Phase Ib clinical trial of NasoShield. The trial (NCT04415749) is expected to enroll 42 healthy subjects who will receive intranasally administered NasoShield or placebo and be followed for six months. The study’s estimated primary completion date is November 2020.
Primary outcome measures are reactogenicity to evaluate the safety of NasoShield for seven days after vaccination, and adverse events to evaluate the safety of NasoShield from day 1 to day 210. The primary immunogenicity readouts are the serum titers of antibody to protective antigen and toxin-neutralizing antibody 28 and 56 days after dosing. Stimulation of a mucosal IgA immune response in the nasal cavity will also be assessed as a potential additional benefit to serum antibody responses, Altimmune added.
NasoShield is being developed under a contract with the Biomedical Advanced Research and Development Authority (BARDA; (HHSO100201600008C), with a total potential value of $133.7 million if all options in the contract are exercised. At the conclusion of the Phase 1b trial, BARDA can enable Phase II development by exercising the remaining contract options, valued at approximately $105 million.
COVID-19: 200 Candidates and Counting
To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data.
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: