Benzinga | Sep 13, 2021 08:03AM EDT

Tonix Pharmaceuticals Announces Results Of Pre-IND Meeting With FDA For TNX-1800 As A Potential Vaccine To Prevent COVID-19; Says Phase 1 Trial Expected To Start In 1H Of 2022

TNX-1800 is a Live Virus Vaccine Designed to Elicit Durable T cell Immunity



TNX-1800 is a Modified Version of Dr. Edward Jenner's Vaccine that Eradicated Smallpox, Engineered to Express SARS-CoV-2 Spike Protein

In Animal Testing, TNX-1800 Protected Upper and Lower Airways After Challenge with SARS-CoV-2, Suggesting an Ability to Block Forward Transmission

Phase 1 Trial of TNX-1800 for the Prevention of COVID-19 Expected to Start in the First Half of 2022

CHATHAM, N.J., Sept. 13, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced it received the official written response from a Type B pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA) to develop TNX-18001 (recombinant horsepox virus, live vaccine) as a potential SARS-CoV-2 vaccine to protect against COVID-19.

Tonix believes the written response provides a path to agreements on the design of a Phase 1 study and the overall clinical development plan to qualify TNX-1800 as a vaccine to prevent COVID-19. Based on the response, the Company expects to begin a Phase 1 study in the first half of 2022.

TNX-1800 is a live virus vaccine based on the horsepox viral vector platform designed to express the SARS-CoV-2 spike protein and to protect against COVID-19, primarily by eliciting a T cell response. Tonix reported positive efficacy data from animal studies of TNX-1800 in the first quarter of 2021. The horsepox virus is closely related to the vaccine developed by Dr. Edward Jenner more than 200 years ago that led to the eradication of smallpox.

Seth Lederman, M.D., President and Chief Executive Officer of Tonix, stated, "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. Concerns about durability of protection have led Pfizer and Moderna, the innovators of the two most widely used COVID-19 vaccines in U.S., to file or plan to file for approval of booster shots within eight months after the administration of each vaccine's second dose."

"It's taken longer to develop live virus vaccines relative to the OWS vaccines," Dr. Lederman added, "but live virus vaccines for other viruses have proven to induce durable T cell immunity, prevent serious illness after infection and block forward transmission. These properties have been demonstrated with vaccines against smallpox, chickenpox, mumps, measles, and rubella, among others. We designed TNX-1800 as a potential single dose vaccine using a virus that is closely related to Dr. Jenner's vaccine, which provided long term, even lifetime T cell immunity to smallpox, prevented forward transmission of the smallpox virus, and eradicated that disease."

Dr. Lederman continued, "Unlike smallpox, we do not expect COVID-19 to be eradicated because there are asymptomatic spreaders, a relatively long period when people are infectious before they become symptomatic and numerous animal reservoirs. Like Jenner's smallpox vaccine, we expect TNX-1800 can potentially be scaled up for manufacturing and will not require a costly and cumbersome cold chain for distribution and storage. We expect it will also be glass-sparing, with 100 doses filled per vial."

"Many believe that after the COVID pandemic passes COVID will become endemic, and it will likely remain a long-term concern," Dr. Lederman added. "Because of this, we believe the need for new vaccine technologies will be ongoing and may lead to vaccines that are tailored to each person's health, genetics or age using precision medicine. Ultimately, a childhood vaccination like the MMR for measles, mumps and rubella with long lasting protection may be what's needed to control COVID in the future. Together with an expected strong and durable immune response, ability to manufacture at scale, store and ship in standard refrigeration, a live virus vaccine like TNX-1800 could become a global product."

Anthony Macaluso, Ph.D., Executive Vice President of Strategic Development of Tonix, commented, "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."

Dr. Macaluso continued, "The 'take' is considered important because it is otherwise difficult and costly to measure the T cell response to a vaccine. Vaccines that elicit a strong T cell response, like horsepox and closely related vaccinia virus vaccine, have been established to provide long-term, durable immunity and to block forward transmission. In the successful campaign to eradicate smallpox, which was also spread by the respiratory route like COVID-19, the 'take' was used as a biomarker for protective immunity. We believe the absence of detectable CoV-2 in the upper airways shows the potential for TNX-1800 to decrease shedding of virus and is consistent with decreased forward transmission."

Dr. Lederman added, "The reliable durability of vaccine protection from the OWS vaccines is under review1, leading the makers of the two mRNA vaccines to take steps towards seeking approval of booster shots and setting up the possible need for boosters on a regular basis in the future. The U.S. government has pledged to make available booster shots for the mRNA vaccines available starting on September 20, pending FDA approval. The prospect of boosters poses a challenging and expensive public health policy implementation in the U.S. In contrast to the short duration of protection of the OWS COVID-19 vaccines, live virus vaccines typically provide decades or life-long protective immunity against those diseases. Live virus vaccines activate the immune system in ways that scientists do not completely understand and have not yet been able to recreate with other technologies."