Tonix Pharmaceuticals is a name that we covered last month before its run to $2.50, which you can read here. What attracted us to Tonix is the more we keep researching COVID-19, the more we discover about T-cells. This new info causes us to dive deep and look for the best T-cell plays for our readers and subscribers. We’ve circled back around to Tonix Pharmaceuticals as the stock has backed off the recent highs and now trades around the $1 level. In this article, we take a look at why we believe Tonix Pharmaceuticals is a smart bet and that a bull run is coming in TNXP.
First up, here’s a little background info for those not familiar with Tonix Pharmaceuticals. The key to understanding Tonix is realizing that this is a company with a lot of irons in the fire beyond COVID-19.
Tonix’s portfolio is primarily composed of the central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric, and addiction conditions.
Tonix’s lead vaccine candidate, TNX-1800*, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix expects data from animal studies of TNX-1800 in the fourth quarter of this year.
TNX-801*, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox and serves as the vector platform on which TNX-1800 is based.
Tonix is also developing TNX-2300*, a second live replicating vaccine candidate for the prevention of COVID-19 which employs the bovine parainfluenza virus as the vector.
Tonix’s lead CNS candidate, TNX-102 SL**, is in Phase 3 development for the management of fibromyalgia. The Company expects results from an interim analysis in September 2020 and topline data in the fourth quarter of 2020. TNX-102 SL is also in development for agitation in Alzheimer’s disease and alcohol use disorder (AUD). The agitation in Alzheimer’s disease program is Phase 2 ready with FDA Fast Track designation, and the development program for AUD is also Phase 2 ready.
Tonix‘s programs for treating addiction conditions also include TNX-1300* (T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution), which is in Phase 2 development for the treatment of life-threatening cocaine intoxication and has FDA Breakthrough Therapy designation.
TNX-601 CR** (tianeptine oxalate controlled-release tablets) is another CNS program, currently in Phase 1 development as a daytime treatment for depression while TNX-1900**, intranasal oxytocin, is in development as a non-addictive treatment for migraine and craniofacial pain.
Tonix’s preclinical pipeline includes TNX-1600** (triple reuptake inhibitor), a new molecular entity being developed as a treatment for PTSD; TNX-1500* (anti-CD154), a monoclonal antibody being developed to prevent and treat organ transplant rejection and autoimmune conditions; and TNX-1700* (rTFF2), a biologic being developed to treat gastric and pancreatic cancers.
T-Cells vs Antibodies
COVID-19 is part of the same coronavirus family as SARS. An epidemic of SARS affected 26 countries and resulted in more than 8000 cases in 2003. While not as potent as COVID-19, it’s the closest outbreak that can be studied to determine how best to treat and develop a vaccine.
Last month, a study looked for T cells in blood samples from 23 people who survived SARS. Sure enough, those survivors still had SARS-specific memory T cells 17 years after getting sick. Those same T cells could recognize the new coronavirus, too.
This medical breakthrough has scientists looking at T-cells rather than antibodies. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, called T-cell studies like this one “good news.”
“There’s a lot of hot stuff going on right now” in T-cell research, Fauci said during a NIAID Facebook Live interview on Thursday, adding, “People who don’t seem to have high titers of antibodies, but who are infected or have been infected, have good T-cell responses.”
Early research suggested that coronavirus antibodies — blood proteins that protect the body from subsequent infections — could fade within months.
A study published Friday in the journal Cell suggests that everyone who gets COVID-19 — even people with mild or asymptomatic cases — develops T cells that can hunt down the coronavirus if they get exposed again later. Memory T-cells stick around for years while antibodies drop after an infection.
The authors of the new study examined blood from 206 people in Sweden who had COVID-19 with varying degrees of severity. They found that regardless of whether a person had recovered from a mild or severe case, they still developed a robust T-cell response. Even coronavirus patients who did not test positive for antibodies developed memory T cells, the results showed.
Reasons To Be Bullish On Tonix Pharmaceuticals
There are many reasons to like Tonix Pharmaceuticals stock. These are just a few of the main ones.
- Tonix expects to have the first data from animal studies of its lead COVID-19 vaccine candidate, TNX-1800, in the fourth quarter of this year.
- In the Phase 3 RELIEF study of TNX-102 SL for fibromyalgia, Tonix expects interim data in September and topline results from the RELIEF study by the end of this year.
- Tonix has an agreement with FUJIFILM Diosynth Biotechnologies to provide contract manufacturing and development services to support the manufacturing of TNX-1800 for clinical trial supply.
- Tonix has four collaborations when it comes to a COVID-19 vaccine – Southern Research, Columbia University, Kansas State University, and University of Alberta.
- Tonix and Southern Research have just expanded their collaboration focusing specifically on T cell immune responses to SARS-CoV-2 in volunteers who have recovered from the disease or who remain asymptomatic after exposure to COVID-19. Raj Kalkeri, Ph.D., MBA, a senior scientist in Southern Research’s Infectious Disease Research Group, said the study’s findings will shed new light on the role that T cells – a central part of the immune system – may play in the development of a vaccine against the novel coronavirus.
- Tonix initiated a second potentially pivotal Phase 3 trial, F306, or the RALLY study, to study TNX-102 SL for the management of fibromyalgia. Enrollment began on September 3rd. The trial design will be very similar to the ongoing Phase 3 RELIEF study. The two-arm trial is expected to enroll ~470 patients. The primary endpoint is daily diary pain severity score change (TNX-102 SL 5.6 mg vs. placebo) from baseline, analyzed by mixed model repeated measures with multiple imputations. If the RALLY study maintains current enrollment timelines and objectives, it is expected to report topline data in H2 2021.
- Tonix has received FDA clearance of its IND for TNX-102 SL for the treatment of alcohol use disorder. This clearance supports the initiation of a Phase 2 proof-of-concept study.
- On June 30, 2020, Tonix had $55.0 million of cash and cash equivalents, compared to $11.2 million as of December 31, 2019.
- Tonix Pharmaceuticals has a current market cap of just $142 million.
The recent news on T-cells is huge news for Tonix Pharmaceuticals. TNX-1800, the firm’s leading COVID-19 vaccine candidate, is designed to elicit a predominant T cell response, along with some antibody response. Three other early candidates in the company’s vaccine portfolio are designed to elicit an almost pure T cell response. More impressive is the fact that Dr. Anthony Fauci has taken notice of the importance of T-cells.
Who is in charge of the U.S. government’s efforts for a COVID-19 vaccine?
Dr. Anthony Fauci
Who can get Tonix Pharmaceuticals funding from Operation Warp Speed?
Dr. Anthony Fauci
Who needs a COVID-19 vaccine to win re-election?
Dr. Anthony Fauci’s boss President Trump
No doubt Moderna has also taken notice of the importance of T-cells.
Which company has a $25 billion market cap and no FDA approved drugs or vaccines?
Which company has tens of billions of dollars to potentially hundreds of billions of dollars at stake?
Which company should buy Tonix Pharmaceuticals?
No matter how you look at things, Tonix Pharmaceuticals is a buy.
As always, good luck to all (except the shorts)!
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Disclosure: We have no position in NASDAQ:TNXP or any of the securities mentioned. We wrote this article ourselves and it expresses our own opinions. We are not receiving compensation for it. We have no business relationship with any company whose stock is mentioned in this article. Insider Financial is not an investment advisor and does not provide investment advice. Always do your own research and make your own investment decisions. This article is not a solicitation or recommendation to buy, sell, or hold securities. This article is meant for informational and educational purposes only and does not provide investment advice.