Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) has received an official written response from the US FDA regarding its Type B Pre-IND meeting to develop TNX-1800 as a possible COVID-19 vaccine.
Response clears a pathway for the development of TNX-1800
The company is optimistic that the written response will pave the way for approval on the first phase study design and the clinical development strategy for TNX-1800 to be qualified as a COVID-19 vaccine. Tonix aims to start a Phase 1 trial in 1H 2022, based on the response.
Notably, TNX-1800 is a live virus vaccine based on the horsepox viral vector platform expressing the SARS-CoV-2 spike protein. The vaccine candidate protects against COVID-19 by inducing a T cell response. In the first quarter of 2021, Tonix released positive efficacy data from TNX-1800 animal tests. The horsepox virus correlates to Dr. Edward Jenner’s smallpox vaccine, which was produced over 200 years ago for smallpox eradication.
CEO Seth Lederman said, “The pre-IND meeting written response marks an important milestone in the development of TNX-1800. We have obtained FDA concurrence and clear guidance on the proposed manufacturing, nonclinical pharmacology and toxicology studies, and the Phase 1 clinical design.” Dr. Lederman continued, “Operation Warp Speed (OWS) vaccines were available very rapidly and have made a huge contribution to the health of the U.S. population, but they have limitations, particularly in terms of the short duration of protection and the likely requirement for boosters.
Tonix reported positive TNX-1800 results in animal models.
Tonix’s EVP strategic development Anthony Macaluso said, “We previously reported the positive results of TNX-1800 in animals after a live SARS-CoV-2 challenge. Animals vaccinated with TNX-1800 had undetectable SARS-CoV-2 in their upper and lower airways six days after challenge with SARS-CoV-2. Animals vaccinated with TNX-1800 manifested both neutralizing antibodies and a ‘take’, which is a skin reaction to horsepox vaccination that also serves as a validated biomarker of functional T cell immunity.”