Tevogen Bio announced the completion of technology transfer of its investigational COVID-19 therapy TVGN-489 to BioCentriq, Tevogen’s clinical manufacturing partner, representing a major milestone in achieving commercial manufacturing readiness. TVGN-489 consists of Allogeneic COVID-19 Specific Cytotoxic CD8+ T Lymphocytes (CTLs), which are specifically designed for the treatment of high-risk patients who are at-risk of breakthrough infections and progressing to severe COVID-19.
“The troubling emergence of breakthrough cases and new variants highlights that the fight against this virus is not over,” said Ryan Saadi, MD, MPH, and CEO of Tevogen Bio. “We have spent significant resources and time identifying the TVGN-489 targets across the viral genome which are less likely to mutate under evolutionary pressure. With the completion of technology transfer and the initiation of the clinical trial, Tevogen is one step closer to realizing the potential of this breakthrough innovation becoming a vital tool in the fight against COVID-19.”
BioCentriq’s experience in cell and gene therapy manufacturing will help expedite the process of making Tevogen’s disruptive innovations accessible to patients. “The milestone represents the commitment of both entities to expedite patient access to Tevogen’s proprietary investigational SARS-CoV-2 specific T cell therapy. The team at BioCentriq is uniquely equipped to help us meet our goal of delivering personalized immunotherapies to large patient populations for the first time ever,” Saadi stated.
The POC trial of TVGN-489 is now underway to evaluate the safety and optimal dosage of the therapy for the treatment of high-risk COVID-19 patients. TVGN-489 has demonstrated strong antiviral activity against SARS-CoV-2 in preclinical studies.
TVGN-489 is highly purified SARS-CoV-2 specific cytotoxic CD8+ T lymphocytes programmed to detect targets spread across the entire viral genome. These targeted CTLs are expected to recognize and kill off virus infected cells, allowing the body to replace them with healthy uninfected cells.
Dr. Neal Flomenberg, Chairman of Tevogen’s Scientific Advisory Board, said, “CTLs are the tools normally used by our bodies to eliminate viral infections. Current COVID-19 treatments attempt to slow the virus until our own CTLs can develop in adequate numbers to eliminate the infection. In contrast, TVGN-489 provides substantial numbers of highly enriched, highly potent SARS-CoV-2 specific CTLs directly to the patients. It is because we are using nature’s own tools that we are optimistic that this approach will prove both safe and effective.”
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). www.tevogen.com
BioCentriq™ is a full service CDMO for cell and gene therapy process development and clinical manufacturing with a GMP clinical manufacturing facility in Newark, NJ, and a pilot plant in South Brunswick, NJ. The company develops and manufactures autologous and allogeneic cell therapies, gene therapies, and specializes in viral vectors, cell and viral banking, and upstream and downstream processing. BioCentriq also manufactures immunotherapies, including monoclonal antibodies and proteins, vaccines, and offers workforce development programs. www.biocentriq.com
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.