From The Editor | March 23, 2021

Tevogen Bio, BioCentriq Team Up To Manufacture T-Cell Therapy For COVID-19


By Erin Harris, Editor-In-Chief, Cell & Gene
Follow Me On Twitter @ErinHarris_1

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Tevogen Bio recently announced its partnership with BioCentriq, a New Jersey-based cell and gene therapy development and manufacturing center, to support clinical manufacturing of Tevogen’s investigational COVID-19 treatment. Experts from both companies will collaborate at BioCentriq’s GMP facilities to produce Tevogen’s proprietary COVID-19 targeted T-cells. The teams will use the processes and technology required to ensure that all quality standards are met in the large-scale manufacturing of Tevogen’s clinical grade, allogeneic T-cell therapy.

According to Ryan Saadi, M.D., MPH, Chairman and Chief Executive Officer at Tevogen Bio, the immune response to viral infections in complex and multifaceted. “However, the key component in eradicating these infections is the development of cytotoxic T lymphocytes (CTLs), which recognize and kill off virus infected cells, allowing the body to replace them with healthy uninfected cells, explains Saadi. “In the setting of COVID-19, the immune response is often too slow, and the backup pathways in the body which then come into play sometimes are more harmful than helpful.”

Saddi explains that TVGN-489 is an anti-COVID-19 therapy containing highly purified cytotoxic CD8+ T lymphocytes designed to detect and kill SARS-CoV-2 infected cells. These allogeneic CTLs are expanded in the lab and are not modified or genetically engineered. TVGN-489 cells are trained to detect proteins from the entire genome of SARS-CoV-2, instead of a single target such as spike proteins. “This is important because COVID-19 is a mutation prone RNA virus, and we are already experiencing variants with worrisome immune escape potential-particularly to the spike region,” says Saadi. “We have spent significant resources and time to identify the TVGN-489-targets which are less likely to mutate under the evolutionary pressure.”

Cell donation from thoroughly screened volunteers is obviously the starting point. “The breakthrough nature of our technology is that we can overcome two main barriers in off the shelf T cell therapy for large patient populations — “purity” and “quantity,” he says. “Tevogen’s proprietary approach to generating CTLs produces levels of purity and potency that have not been previously reported. The percentage of TVGN 489 CTLs responding to COVID-19 has consistently been approximately 20-fold higher than that of other CTL therapies reported in the literature. Even at low numbers, TVGN 489 CTLs have demonstrated potent cytotoxicity against COVID-19 targets. Depending on successful completion of our dose finding trial, we anticipate producing thousands of doses from a single donor and making this advanced therapy affordable. Our preclinical work has demonstrated that TVGN 489 is highly specific to COVID-19 and does not contain other potentially harmful cell types. We expect to confirm our findings in an upcoming phase I/IIa clinical trial. The preclinical data will be presented in one of the upcoming major scientific conferences in early May.”

T-Cell Therapy a Game Changer for COVID-19

Saadi states that effective control of a pandemic depends on three factors — suppression, prevention, and curative therapeutics. While current public health measures and vaccines have reduced the rate of infection, the mutational evolution of the virus, vaccine hesitancy and significant portion of population who traditionally do not benefit from vaccines, (e.g. immunocompromised) suggest that suppression and vaccinations alone will not completely control COVID-19 and related infections. Individuals will continue to be infected with COVID-19, necessitating the development of curative therapies. “Currently, there is “no cure” for COVID-19 infection,” explains Saadi. “CTLs are a game changer for COVID-19 treatment for three reasons. First and most important, they have the potential to cure the infection as these types of cells are highly potent and highly specific to COVID-19 viral proteins. Second, TVGN-489 CTLs have been sensitized to multiple targets in the COVID-19 genome reducing the ability of the COVID-19 virus to escape the CTLs through mutation. Finally, CTL therapy can be adapted to treat COVID-like and other types of viruses. TVGN-489 showed efficacy against SARS and MERS in our lab.”

Why Tevogen Bio Partnered with BioCentriq

Tevogen Bio has teamed up with BioCentriq’s GMP facilities to produce Tevogen's COVID-19’s targeted T-cells. Tevogen Bio scientists have developed the manufacturing process to generate this disruptive therapy. BioCentriq will add the commercial efficiency to Tevogen’s current process. The relationship is designed to be bidirectional in that both Tevogen Bio and BioCentriq experts will work together at BioCentriq’s state-of-the-art GMP facilities to enhance the clinical manufacturing process and expand the treatment to as many patients as possible. “BioCentriq will also assist Tevogen to generate CTLs to treat other viral infections and both solid and hematologic malignancies in the future,” says Saadi. “Tevogen’s primary mission is to develop affordable lifesaving therapies and further enhancement of our manufacturing capacity will take us one step closer to that goal.”