Tevogen Bio Announces its Investigational SARS-CoV-2 Specific T cell Therapy, TVGN-489, Is Not Affected by Omicron Variant Following Research Team Review of all Reported Mutations

METUCHEN, N.J.--()--Tevogen Bio today announced TVGN-489, its lead investigational allogeneic SARS-CoV-2 specific Cytotoxic CD8+ T lymphocytes (CTL) immunotherapy for treatment of COVID-19 in high-risk patients, is expected to retain activity against the B.1.1.529, or Omicron variant. A comprehensive review, completed by its preeminent research team, finds the targets of TVGN-489 are not impacted by known Omicron mutations. TVGN-489 is currently undergoing proof of concept clinical trial at Thomas Jefferson University in Philadelphia.

Dr. Neal Flomenberg, M.D., Professor and Chair of the Department of Medical Oncology at Thomas Jefferson University has led the efforts for the development of TVGN-489. “We are deeply concerned about the recently reported Omicron variant’s worrisome immune escape potential and transmissibility. Our research team has reviewed all the mutations present in the Omicron variant and ascertained that TVGN-489’s targets have not been affected. TVGN-489 CTLs are sensitized to multiple targets across the entire viral genome and not simply focused on the spike protein, which, as we’ve unfortunately witnessed, is very susceptible to mutation,” Flomenberg said.

“We performed a similar analysis of the Delta variant when it first appeared. Our targets appeared to be similarly preserved in Delta in that analysis,” Flomenberg continued. “Now, with more than 3400 Delta isolates having been sequenced and added to the NIH/NCBI database, we have seen that TVGN-489’s targets are indeed retained in 98.8% to 100% of these 3400+ isolates. This experience with the Delta variant makes us confident that our analysis of the targets in the Omicron variant will similarly hold up over time," he added.

“We hope to provide a meaningful tool in the fight against COVID-19, particularly for those high-risk patients who may be susceptible to reduced neutralization activity of both vaccine-induced and monoclonal antibody conveyed immunity in Omicron, Delta, and other current variants,” said Tevogen CEO Ryan Saadi, M.D., M.P.H. “While SARS-COV-2 variants have demonstrated how this virus is able to escape our immune system by mutating immunodominant epitopes, the proprietary approach to manufacturing TVGN-489 allows us to monitor the sequences of emerging variants and, if necessary, be able to adjust or fine ‘tune’ our products to ensure that they continue to recognize and treat current and future variants of this and other viruses.”

About TVGN-489

TVGN-489 is a highly purified SARS-CoV-2 specific cytotoxic CD8+ T lymphocyte product which detects targets spread across the entire viral genome. These targeted CTLs are expected to recognize and kill off virally infected cells, allowing the body to replace them with healthy uninfected cells. TVGN-489 has demonstrated strong antiviral activity against SARS-CoV-2 in preclinical studies.

About Tevogen Bio

Tevogen Bio is driven by a team of distinguished scientists and highly experienced biopharmaceutical leaders who have successfully developed and commercialized multiple franchises. In collaboration with key strategic partners, the company moved its lead product from discovery to clinical phase within 12 months of inception, shaving years off the industry’s standard for drug development timelines.

Tevogen leadership believes that affordable personalized immunotherapies are the next frontier of medicine and disruptive business models are required to sustain medical innovation in the post pandemic world. The company’s breakthrough technology overcomes traditional barriers to the broad application of targeted T cell therapies through revolutionary advances in speed to patient and product purity. Tevogen’s focus on organizational and manufacturing efficiency is core to its highly successful biopharma business model and goal to make personalized immunotherapies accessible to the masses for the first time. Tevogen Bio’s research pipeline includes targeted CD8+ T Lymphocyte therapeutics for the treatment of common cancers (NSCLC, Cervical Cancer) and difficult to eradicate serious viral infections (Hepatitis B).

Forward Looking Statements

This press release contains certain forward-looking statements relating to Tevogen Bio™ Inc.’s (the “Company”) development and patient access of its innovations in infectious diseases and oncology. These statements are based on management’s current expectations and beliefs as of the date of this release and are subject to a number of factors which involve known and unknown risks, delays, uncertainties and other factors not under the company’s control which may cause actual results, performance or achievements of the company to be materially different from the results, performance or other expectations implied by these forward-looking statements. In any forward-looking statement in which the Company expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These factors include results of current or pending clinical trials, risks associated with intellectual property protection, financial projections, sales, pricing and actions by the FDA/EMA. The Company undertakes no obligation to update the forward-looking statements or any of the information in this release, or provide additional information, and expressly disclaims any and all liability and make no representations or warranties in connection herewith or with respect to any omissions herefrom.


Katelyn Joyce: Katelyn.joyce@tevogen.com

Release Summary

Tevogen Bio's investigational SARS-CoV-2 specific T cell therapy, TVGN-489, is not affected by Omicron variant following review of reported mutations.

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Katelyn Joyce: Katelyn.joyce@tevogen.com