Tonix Pharmaceuticals (NASDAQ:TNXP) has added ~5.3% in the pre-market after the company said it received an official written response from the FDA following a Type B pre-Investigational New Drug (IND) meeting for potential COVID-19 vaccine TNX-1800.
The company said it believes the response as indicating a “path to agreements” on the design of a Phase 1 trial and the overall development plan for TNX-1800 as a vaccine targeted at COVID-19.
Designed for percutaneous administration and to elicit a T cell response mainly, TNX-1800 is a live modified horsepox virus vaccine expressing SARS-CoV-2 Spike protein.
“The pre-IND meeting written response marks an important milestone in the development of TNX-1800,” Seth Lederman, CEO of Tonix, said.
“We have obtained FDA concurrence and clear guidance on the proposed manufacturing, nonclinical pharmacology and toxicology studies, and the Phase 1 clinical design,” he added.
The company remains on track to start the Phase 1 trial in H1 2022, as previously announced in early August.