Tevogen Plans Novel T-cell Therapies Aimed at EBV in MS, Cancer
Similar therapy for COVID-19 virus shows positive safety data in trial
The decision comes on the heels of positive safety data from a proof-of-concept Phase 1 Tevogen trial that tested a similar T-cell therapy in people infected with SARS-CoV-2, the virus that causes COVID-19.
The novel genetically unmodified T-cell therapies against EBV will be developed as potential treatments for conditions with a known connection to the virus, including MS and certain cancers.
“With nearly 1 million patients living with multiple sclerosis in the United States alone, we hope to bring additional arsenal to help treat this debilitating disease, which impacts patients in their most productive years,” Sadiq Khan, Tevogen’s chief commercial officer, said in a company press release.
Tevogen plans to make use of its proprietary T-cell platform in developing the T-cell therapies.
Developing T-cell therapies against EBV
In MS, the body mistakenly attacks the myelin sheath, a fatty layer that surrounds and protects nerve cell fibers. This protective covering also serves to increase the speed of communication between nerve cells.
EBV is a common virus, mainly transmitted through saliva, but also through other body fluids such as blood and semen. The virus is the leading cause of infectious mononucleosis, commonly known as mono, or the “kissing disease.”
It works by infecting B-cells, a type of immune cells involved in MS that are responsible for producing antibodies. After an infection, EBV remains in the body, where it lies dormant inside B-cells for an individual’s entire life.
A pivotal study published earlier this year showed that EBV infection may be the leading cause of MS, increasing its risk by 32 times. According to another study, the structural resemblance of EBV and a brain protein called GlialCAM — found on myelin-producing cells — may lead to B-cells wrongly attacking the myelin sheath, leading to myelin loss and nerve damage.
The virus also is strongly linked with certain lymphomas and nasopharyngeal cancer.
“Recent studies on MS have suggested a probable link between infection with EBV and later onset of the inflammation that degrades the myelin sheath and causes MS,” said Neal Flomenberg, MD, Tevogen’s chief scientific officer.
Tevogen’s T-cell platform uses cytotoxic T-cells, also known as CD8-positive T-cells or killer T-cells. These immune cells have the capacity to kill other cells considered damaged or dangerous, such as those infected with certain viruses and cancer cells.
In MS, cells are collected from a healthy donor and those that target EBV proteins of interest are expanded to millions. After a quick patient-donor match, the EBV-specific cells are infused into the patient’s bloodstream, where they are expected to fight EBV-infected cells.
The technology is expected to work on two fronts: preventing MS or possibly slowing its progression.
One aim is to prevent the disease’s development in people already at risk for MS due to EBV infection. For patients who already have MS, the goal is to mitigate the immune attacks that destroy the myelin sheath, potentially slowing disease progression.
“We believe that cell therapies are expected to be the norm, not the exception,” said Ryan Saadi, MD, Tevogen’s CEO.
Tevogen now is assessing the safety and efficacy of its investigational T-cell therapy against SARS-CoV-2. That therapy, called TVGN-489, is designed to detect and kill cells infected by the virus that causes COVID-19. It’s been tested in a Phase 1 clinical trial (NCT04765449) involving 3o participants — that’s expected to wrap up in early 2023.
In the trial, cytotoxic T-cells were collected from healthy volunteers who recovered from COVID-19, and then administered to people newly diagnosed with the virus who were at higher risk for infection-related complications.
No side effects were observed during treatment with TVGN-489 in any patient at any dose level, according to Tevogen.
“We look to apply our significant expertise in off-the-shelf allogeneic SARS-CoV-2 specific CD8+ cytotoxic T lymphocytes to explore EBV specific [cytotoxic T-cell] therapy as a possible means of addressing the unmet needs of MS patients and certain cancer patients,” Flomenberg said.
Added Saadi: “Tevogen aspires and is designed to be the very first biotech to achieve commercial success and patient affordability through advanced science and efficient business models.”