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Tevogen Bio Announces Publication of Positive Phase I Clinical Trial Results for TVGN 489 in Blood Advances
WARREN, N.J., June 25, 2024 (GLOBE NEWSWIRE) -- Tevogen Bio Holdings Inc. (“Tevogen” or “Tevogen Bio”) (Nasdaq: TVGN), a clinical-stage specialty
About this update from Tevogen Bio Holdings Inc.
[{"type":"text","content":"WARREN, N.J., June 25, 2024 (GLOBE NEWSWIRE) -- Tevogen Bio Holdings Inc. (“Tevogen” or “Tevogen Bio”) (Nasdaq: TVGN), a clinical-stage specialty immunotherapy biotech pioneer developing off-the-shelf, genetically unmodified T cell therapeutics in oncology, neurology, and virology, reports publication of its phase I clinical trial data of TVGN 489, its investigational allogeneic SARS-CoV-2 specific Cytotoxic CD8+ T lymphocytes (CTLs) immunotherapy by the journal Blood Advances. Key Observations: Interventional arm patients, totaling twelve high-risk individuals, 50% of whom were immunocompromised, and 40% of whom were immunocompromised due to preexisting cancers, received a single infusion of one of four escalating doses of TVGN 489, a product containing 68.5% SARS-CoV-2-specific CD8+ CTLs/total cells.Symptom improvement and resolution in treatment arm patients were compared to an observational group of eighteen patients who received standard care, making a total of 30 study participants.TVGN 489 was well-tolerated at all four doses tested.Nasal swab PCR data showed 88% or greater viral elimination in 92% of patients by day +4 and > 99% viral elimination in all patients by day +14.No progression of disease or the development of Long COVID was observed in the treatment group, despite the prevalence of immunocompromised patients.TVGN 489 did not interfere with the development of endogenous anti-SARS-CoV-2 humoral or cellular responses.T-cell receptor beta (TCRβ) analysis comparing TVGN 489 responses derived from the CTL donor versus recipients showed persistence of donor-derived CTLs through the end of the 6-month follow-up period. An unanticipated finding was the persistence of the TVG-489 CTLs in all patients tested through the end of the 6-month follow-up period. “Due to the high degree of immune mismatch between the treated patients and the CTL donor, we suspected that after an initial reaction against the SARS-CoV-2 virus, the CTLs would have been quickly eliminated by the patients. Persistence of allogeneic T-cells has been associated with disease control in many settings, therefore, the further exploration of the reason for the persistence and the potential implications is important,” said Neal Flomenberg, Tevogen’s Chief Scientific Officer. “We are excited by the outcomes of the phase I trial and are looking forward to bot...