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Reaches commercial manufacturing readiness milestone for its investigational COVID-19 therapy TVGN-489.
September 16, 2021
By: Tim Wright
Editor-in-Chief, Contract Pharma
Tevogen Bio has completed the technology transfer of its investigational COVID-19 therapy TVGN-489 to BioCentriq, its 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, CEO, 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,” said Saadi. “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.” 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.
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