Tonix Pharmaceuticals CEO Believes That Additional COVID-19 Vaccine Research Is Still Needed
Tonix Pharmaceuticals was one of the sponsors for the Benzinga Global Small Cap Conference that took place on December 8-9, 2020. The information contained in this article in no way represents investment advice or opinion on the part of Benzinga or its writers and is intended for informational purposes only.
On November 16, 2020, Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) announced preliminary results of its leading COVID-19 vaccine, TNX-1800. TNX-1800 is a live, modified horsepox virus designed to elicit a T cell response to the SARS-CoV-2 spike protein.
The study conducted in collaboration with Southern Research Institute demonstrated a positive immune response in all non-human primates that were vaccinated with TNX-1800.
“We had good tolerability in the non-human primates and the dose that was required to induce the immunity is low and that’s promising because we believe that we’ll be able to present this as a product with 100 doses in each glass vial,” said Dr. Seth Lederman, CEO of Tonix Pharmaceuticals. “That glass sparing property is very important in dealing with a pandemic.”
This compelling development comes during the height of COVID-19 vaccine news, as vaccines are currently being rolled out and administered across the U.S.
“There are over 150 COVID-19 vaccines in development, and we believe that more than one vaccine will be approved. We believe different vaccines will have different attributes,” said Dr. Lederman. “Our lead vaccine is one of only a very few that is based on live attenuated viruses.”
At the recent Benzinga Global Small Cap Conference, Dr. Lederman joined the event to discuss some of the attributes and developments of Tonix’s COVID-19 vaccine, TNX-1800. Benzinga also had the opportunity to speak one-on-one with Dr. Lederman to discuss why he believes additional vaccine research needs to be conducted regardless of current emergency use authorizations.
Engineered For Long-Term Immunity
As previously mentioned, Tonix is one of a small number of companies that are currently using live attenuated viruses for their COVID-19 vaccine. The two vaccines Tonix is currently working on are TNX-1800 (live attenuated vaccine based on the horsepox viral vector platform) and TNX-2300 (live attenuated vaccine based on the bovine parainfluenza viral vector platform).
Typically, live attenuated viruses are used for vaccines due to their ability to elicit a strong T cell immune response. Some of the potential benefits of this type of vaccine include long-term durable immunity, single-dose administration, scalable manufacturing, and the prospect of blocking forward transmission which limits a virus’s ability to be contagious.
Tonix is the only company utilizing a horsepox vector. The company chose the horsepox platform for its leading TNX-1800 vaccine for a multitude of reasons.
“Horsepox can be engineered to express a number of different antigens. It does not integrate into the host genome, elicits a very strong T cell immune response, and is manufacturable at scale. Finally, because horsepox is an attenuated, live vaccine, it stimulates the immune system in a relatively unique way,” said Lederman.
In addition to its unique choice of vector, TNX-1800 is related to a vaccine that was developed more than 200 years ago by Dr. Edward Jenner called “vaccinia.”
“Jenner’s vaccinia vaccine is the most successful vaccine ever. It led to the eradication of smallpox. Smallpox is the only disease ever to have been eradicated,” said Dr. Lederman. “The vaccinia smallpox vaccine was developed and used before the molecular era, it is known to be manufacturable at scale, has minimal cold chain issues, and can be packaged in a vial with many doses.”
In the company’s recent study conducted on non-human primates for TNX-1800, in addition to a positive immune response, the study showed that each animal that was vaccinated with TNX-1800 developed ‘takes’ — a skin reaction that measures T cell immunity. According to Dr. Lederman, smallpox was eradicated using the “take” as a biomarker for successful vaccination.
Recently, genomic scientists found that the horsepox vector Tonix is using as its vaccine is very similar to an 1860 United States smallpox vaccine. “This new finding tells a very compelling story about the evolution of smallpox vaccines and strengthens the case that horsepox is closely related to the vaccine that Edward Jenner used,” said Dr. Lederman.
Why Continue Vaccine Research?
According to recent numbers, approximately 31.8 million shots of the COVID-19 vaccine have been administered across the country. Although even with the widespread distribution of vaccines, Dr. Lederman told Benzinga that the need for continued research is vital.
“I fear that many people believe the vaccine quest is over and wonder why we are still working on a vaccine,” he began.
Dr. Lederman went on to explain that while efficacy rates are high for both the Pfizer Inc. (NYSE: PFE) and Moderna Inc (NASDAQ: MRNA) vaccines, there are still concerns that need to be addressed.
According to Dr. Lederman, the highly contagious nature of CoV-2 has been a major problem driving the pandemic, yet we do not know if the currently authorized vaccines protect against forward transmission — the ability of one person to spread it to another.
“Some vaccines, like Jenner’s vaccinia, protect against forward transmission of other viral diseases, but it’s not known if the mRNA vaccines provide that protection against spreading COVID-19,” he said.
Is it also unknown whether those who receive the mRNA vaccines will be protected one year after vaccination. Dr. Lederman said the current data were limited to events within two or three months after vaccination. There are also concerns surrounding the safety of the mRNA vaccines, particularly since the benefit and risks for different age groups vary. For example, young people have a lower risk of serious disease, so vaccines should be exceptionally safe in this group, unless they are shown to have other benefits, such as limiting transmission.
Dr. Lederman emphasized that while the current mRNA vaccines may indeed have these properties, it is still unknown. He believes that until more is known, it is important to not be complacent and continue to conduct research on new vaccines. If we learn that we need better COVID-19 vaccines in a year or two, after more is known about the mRNA vaccines, then the new potential vaccines may be further along in development.
“The Moderna and Pfizer vaccines so far have reported data on people two or three months after they’ve been vaccinated. For vaccines, we would ideally want data a year after people have been vaccinated. I fear that there’s been a big shift towards an idea that the vaccine quest is over since two vaccines have Emergency Use Authorization or EUA,” said Dr. Lederman. “We think it’s too early to be complacent. Everyone has a lot to learn about the durability of protection with the two EUA vaccines and whether they protect against death from COVID-19.”
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