Benzinga | Mar 17, 2021 09:35AM EDT

Tonix Pharma's COVID-19 Vaccine Candidate Shows Encouraging Efficacy In Animal Studies

Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) jumps in premarket trading after announcing positive preliminary results following vaccination of non-human primates with TNX-1800, its COVID-19 vaccine candidate.

* TNX-1800 is a modified horsepox virus encoding CoV-2 spike protein.

* Immunogenicity and protective efficacy of single-dose TNX-1800 were assessed at two dose levels (n=4 per group).

* On Day 41, after the vaccination, animals were challenged with live SARS-CoV-2. Protection was assessed at day 47, six days after the challenge.

* All eight animals vaccinated with TNX-1800 had undetectable SARS-CoV-2 in their upper and lower airways six days after challenge with SARS-CoV-2.

* Last year, the company reportedthat the vaccination was associated with neutralizing antibodies.

* All eight of the animals vaccinated manifested a skin reaction to the vaccination, a validated biomarker of functional T cell immunity.

* The current data shows that on day 14, after a single vaccination, all eight of the TNX-1800 vaccinated animals made anti-CoV-2 neutralizing antibodies against none in the control arm (TNX-801, horsepox virus, live vaccine) and placebo group.

* The level of neutralizing anti-CoV-2 antibody production was similar between the low and high doses TNX-1800 groups.

* TNX-1800 and TNX-801 were well tolerated at both doses.

* These results support the expectation that TNX-1800 at the low dose of 1 x 106 PFU is an appropriate dose for a one-shot vaccine in humans and indicate that 100 doses per vial are the target format for commercialization.

* Phase 1 human study is expected to start in the second half of 2021.

* Price Action: TNXP shares were trading at 8.7% higher at $1.38 in premarket on the last check Wednesday.