Monkeypox Vaccine In The Works By Chatham-Based Pharma Company

CHATHAM, NJ — Tonix Pharmaceuticals Holding Corp., a Chatham-based clinical-stage biopharmaceutical company, announced a partnership with the Kenya Medical Research Institute (KEMRI) to plan, seek regulatory approval for, and develop TNX-8011 as a vaccine to protect against monkeypox and smallpox.

The study, which will conduct a Phase 1 clinical trial in Kenya, is scheduled to begin in the first half of 2023, officials said.

“Since ending routine vaccination for smallpox in the 1960s, monkeypox has emerged as a growing problem among people in West and Central Africa. People who received the live virus vaccine for smallpox prior to eradication appear to maintain durable protective immunity against monkeypox,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals.

Monkeypox, previously only known as an obscure African virus, has evolved into a global threat, infecting over 20,000 people in 75 countries and prompting the World Health Organization to declare a global health emergency.

“The recent global outbreak of monkeypox has exemplified the need to be prepared with a vaccine that is efficacious, that provides for durable immunity, and that blocks forward transmission. Tonix’s live virus vaccine technology is designed to achieve these outcomes,” said Professor Matilu Mwau, Ph.D., of KEMRI. “The West African strain which has recently spread outside of Africa has a low fatality rate, but the Central African strain is reportedly fatal in approximately 10 percent of infected individuals.”

There is currently only one company with an approved monkeypox vaccine.

The JYNNEOS vaccine is manufactured by Bavarian Nordic, a small Danish company. As the virus continues to spread, supplies have been severely depleted, and the Biden administration moved slowly to acquire additional doses.

“People who received the live virus vaccine for smallpox prior to eradication appear to maintain durable protective immunity against monkeypox. TNX-801 is a live virus vaccine that we believe is closer to the smallpox vaccines used in the U.S. and Europe before 1900 than the modern smallpox vaccines. TNX-801 has reduced virulence in animals, and we believe it has the potential for widespread use to protect against monkeypox,” Lederman said.

According to the CDC, the state has 155 monkeypox cases as of Monday, Aug. 1. This is a small number in comparison to Covid-19, for which the state has confirmed nearly 2.2 million cases since the pandemic began.

However, the number of cases has risen rapidly in recent weeks. New Jersey's first probable case was reported on June 18, and the state health department had only four cases at the end of June.

According to the New York City Department of Health, the virus is most commonly transmitted through direct contact with a monkeypox rash or sore. It can also spread through contact with bedding, clothing, and other items used by a person infected with monkeypox.

Transmission can occur during sex and other intimate activities due to close contact, according to New York City health officials, but it is unknown whether monkeypox can spread through saliva, sperm, or vaginal fluids.

“KEMRI is excited to plan this clinical trial with Tonix, and ultimately to lead the trial,” said Professor Samuel Kariuki, Director General and CEO of KEMRI. “Monkeypox has spread in Central and West Africa, and there’s a concern that we could begin seeing cases in Eastern and Central Africa or from foreign travelers. Recently, monkeypox has been reported in over 30 countries outside of Africa that were not endemic for the monkeypox virus. We are grateful that Tonix is committed to sponsoring clinical studies and making TNX-801 available for this important problem.”