Tevogen Bio Holdings Inc. (Nasdaq: TVGN) announced a risk-adjusted net present value estimate of $9 billion to $11 billion for TVGN-489, marking a significant milestone for the company's first clinical-stage allogeneic precision T cell therapy. The treatment, developed using Tevogen's proprietary ExacTcell platform, targets SARS-CoV-2 infection in high-risk vulnerable patients and Long-COVID in patients with evidence of persistent viral reservoirs.
Phase I Trial Demonstrates Strong Efficacy and Safety Profile
The Phase I proof-of-concept clinical trial, published in Blood Advances, enrolled high-risk ambulatory patients, with 50% being immunocompromised. Patients received a single infusion of TVGN-489 across four escalating dose levels, demonstrating exceptional tolerability with no dose-limiting toxicities, infusion reactions, cytokine release syndrome, or graft-versus-host disease observed.
Treatment outcomes showed significant viral clearance rates, with nasal PCR testing revealing ≥88% viral elimination by Day 4 in 92% of patients, escalating to >99% elimination in 100% of patients by Day 14. Notably, no disease progression, recurrent COVID-19, or cases of Long-COVID were observed in the treatment arm during six months of follow-up.
Breakthrough Results in Immunocompromised Cancer Patients
The therapy's efficacy was particularly striking in cancer patients requiring stem cell transplantation. According to Neal Flomenberg, M.D., Chief Scientific Officer of Tevogen Bio, "Two cancer patients were able to proceed to stem cell transplant just 15 and 28 days after receiving TVGN-489, a procedure that effectively eliminates the patient's immune system and requires months for recovery. Remarkably, neither patient experienced reactivation or any complications from COVID-19 during or after transplant."
These results suggest that TVGN-489 achieves complete viral eradication without evidence of rebound, a critical finding for immunocompromised populations who face heightened risks from COVID-19 infections.
Durable Immune Response and Variant Resistance
The clinical data revealed that TVGN-489 did not impair patients' endogenous humoral or cellular immune responses, while TVGN-489 cytotoxic T lymphocytes (CTLs) were detected in patients through six months, supporting the therapy's persistence and durability. Importantly, TVGN-489's target epitopes remain unaffected by viral mutations, including the current XFG SARS-CoV-2 variant, suggesting broad applicability across viral strains.
Commercial Valuation and Market Potential
The $9-11 billion risk-adjusted net present value reflects US-only revenue potential for TVGN-489 and does not encompass the broader value of the ExacTcell technology platform. This valuation, initially shared in October 2024, represents cumulative revenue projections over five years from Tevogen's oncology and specialty care units.
Treatment arm patients demonstrated faster and more consistent symptom improvement and earlier resolution compared to observational arm patients, positioning TVGN-489 as a potentially transformative therapy for high-risk COVID-19 patients and those suffering from Long-COVID with persistent viral reservoirs.
Tevogen intends to continue providing valuation updates on its internally developed assets, including its expanding product pipeline and other platform-derived therapeutics.
