IBT-V02 is a multivalent toxoid vaccine indicated for prevention of recurrent skin and skin structure infections (SSSI) caused by Staphylococcus aureus. IBT-V02 is the only entirely toxoid vaccine for S. aureus currently under development. IBT-V02 is being developed under a grant from CARB-X and NIAID. The vaccine is scheduled to enter phase I safety and immunogenicity trial in 2020. IBT-V02 differentiates from other prior efforts for S. aureus vaccine in multiple ways.
- Differentiator- Mechanism of Action:The toxoid vaccine is unique as it circumvents the problems that have plagued previous S. aureus vaccine candidates, all of which targeted the surface of S. aureus. Animal studies and evidence from clinic indicate that targeting the surface of S. aureus can lead to a deleterious immune response while toxoid vaccines are protective.
- Differentiator- Supported by clinical and epidemiological evidence: IBT-V02 is the only S. aureus vaccine candidate heavily supported by clinical and epidemiological evidence. Previous vaccine efforts relied on very limited efficacy studies in mice.
- Differentiator- Animal efficacy: IBT-V02 has demonstrated remarkable efficacy in eight different animal models in mice and rabbits.
- Differentiator- Clinical strategy: Unlike the previous efforts (Merck, Pfizer, Nabi) IBT seeks prevention of S. aureus skin and skin structure infections (SA-SSSI) and recurrence for market entry. The target population for clinical trial will be people with recent bout of SA-SSSI. This population has 50-70% risk of recurrence within a year.