TVGN-489 / Tevogen - LARVOL DELTA

Tevogen Bio Announces Unique T Cell Vaccine Under Development and Files Patent with the USPTO (GlobeNewswire) - "Tevogen Bio...announced the filing of a new patent with the U.S. Patent and Trademark Office (USPTO) for its under-development T cell vaccine. Unlike many vaccines that primarily induce a B cell response, Tevogen Bio’s design aims to leverage the Company’s proprietary Tevogen.AI-powered PredicTcell technology to identify peptides which stimulate a T cell response....A key differentiator of this vaccine is its ability to target the entire viral genome, much like the Company’s lead product candidate, TVGN 489. This strategy helps mitigate the risk posed by mutations that might otherwise evade immune detection when only one protein or segment of the virus is targeted."

Patent • Infectious Disease

Tevogen Bio Oncology Reports Top-Line Revenue Forecast of $1 Billion in Launch Year and Cumulative 5-Year Estimate Between $10 Billion and $14 Billion; Forecasts for Non-Oncology Therapeutic Areas to Follow (GlobeNewswire) - "Treatment of SARS-CoV-2 infection in solid and hematologic cancer patients under active treatment...'With compelling evidence that SARS-CoV-2 remains a serious threat to those undergoing immunosuppressive treatments and chemotherapy, our first pivotal study with TVGN 489 is being designed specifically to help these vulnerable patients combat the infection.'....Pipeline: TVGN 920: Cervical cancer prevention; TVGN 930: EBV-associated lymphomas; TVGN 960: Mouth and throat cancer; TVGN 601: Multiple sclerosis."

Commercial • Cervical Cancer • Gynecologic Cancers • Head and Neck Cancer • Hematological Malignancies • Immunology • Lymphoma • Multiple Sclerosis • Novel Coronavirus Disease • Oncology • Oral Cancer • Solid Tumor

Transfer of Infection Fighting Immune Cells Generated in the Laboratory to High Risk Patients With COVID-19 Infection (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: Thomas Jefferson University | Active, not recruiting ➔ Completed

Immune cell • Trial completion • Infectious Disease • Novel Coronavirus Disease

Transfer of Infection Fighting Immune Cells Generated in the Laboratory to High Risk Patients With COVID-19 Infection (clinicaltrials.gov) - P1 | N=30 | Active, not recruiting | Sponsor: Thomas Jefferson University | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2022 ➔ Jan 2023

Enrollment closed • Trial completion date • Infectious Disease • Novel Coronavirus Disease

Tevogen Bio Initiates Final Dose Level in Proof-of-Concept Clinical Trial of its Investigational T cell Therapy for High-Risk COVID-19 Patients (Businesswire) - "Tevogen Bio, a late-stage biotechnology company specializing in developing cell and gene therapies in oncology, neurology, and virology, today announced it has initiated the fourth and final dose level of its investigational T cell therapy for high-risk COVID-19 patients....Each patient in the third cohort received a single infusion (1 x 106cells/kg) of TVGN-489, a higher dosing level than the first (1 x 105cells/kg) and second cohorts (3 x 105 cells/kg)."

Trial status • Novel Coronavirus Disease

Loss of an Immunodominant HLA-Α *01:01 Restricted Epitope for CD8+ Cytotoxic T Lymphocytes (CTLs) in the Delta Variant of COVID-19: An Example of Immunologic Escape and Implications for Immunologic Treatment (ASH 2021) - "TVGN-489 is a clinical grade product consisting of highly enriched, highly potent CD8+ CTLs recognizing peptides derived from COVID-19 gene/ORF products in an HLA restricted manner...These data are consistent with the hypothesis that immunodominant epitopes will be preferentially eliminated as the virus continues to evolve. They further illustrate the need to monitor viral sequences and to tune the production of CTLs in order to ensure that they can continue to recognize and effectively treat newly emerging variants of COVID-19."

Immunology • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD8 • HLA-A • KEAP1

[VIRTUAL] TVGN-489: A novel approach for the production of SARS-CoV-2-specific cytotoxic T lymphocytes to treat COVID-19 (IMMUNOLOGY 2021) - "This preclinical effort produced CTLs of high purity (>95% CD3+/CD8+, >60% positive by tetramer staining) and potency (60% lysis of peptide pulsed targets at an effector to target ratio of 3:1) in sufficient quantities for clinical application. Trials using these TVGN-489 CTLs and those produced with other SARS-COV-2 peptides and HLA restriction elements will hopefully be launched shortly."

Bone Marrow Transplantation • Infectious Disease • Novel Coronavirus Disease • Transplantation • CD8

[VIRTUAL] TVGN-489: A novel approach for the production of SARS-CoV-2-specific cytotoxic T lymphocytes to treat COVID-19 (IMMUNOLOGY 2021) - "This preclinical effort produced CTLs of high purity (>95% CD3+/CD8+, >60% positive by tetramer staining) and potency (60% lysis of peptide pulsed targets at an effector to target ratio of 3:1) in sufficient quantities for clinical application. Trials using these TVGN-489 CTLs and those produced with other SARS-COV-2 peptides and HLA restriction elements will hopefully be launched shortly."

Bone Marrow Transplantation • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Transplantation • CD8

Transfer of Infection Fighting Immune Cells Generated in the Laboratory to High Risk Patients With COVID-19 Infection (clinicaltrials.gov) - P1; N=24; Not yet recruiting; Sponsor: Thomas Jefferson University

Clinical • New P1 trial • Infectious Disease • Novel Coronavirus Disease

Tevogen Bio Announces Partnership With BioCentriq, New Jersey Innovation Institute’s Pioneering Cell and Gene Therapy Center, to Enhance Tevogen’s Development Capacity of Its Proprietary Targeted T Cell Therapy For COVID-19 (Businesswire) - "Tevogen Bio announces partnership with BioCentriq...to support clinical manufacturing of Tevogen’s investigational COVID-19 treatment....Experts from both entities will collaborate at BioCentriq’s state-of-the art GMP facilities to produce Tevogen’s proprietary COVID-19 targeted T cells....Tevogen will study its highly enriched COVID-19 specific CD8+ T cells, TVGN-489, for the drug’s safety and ability to recognize and eliminate COVID-19 infected cells..."

Commercial • Infectious Disease • Novel Coronavirus Disease

Tevogen Bio Announces IND Submitted to FDA for Clinical Trials of T Cell Treatment for COVID-19 (PRNewswire) - "Tevogen Bio, today announced that its Investigational New Drug (IND) application to develop a COVID-19 treatment using proprietary antigen specific T cell technology has been submitted to the US Food and Drug Administration (FDA). Tevogen is partnering with renowned bone marrow transplant expert, Dr. Neal Flomenberg...with the intent to evaluate Tevogen's T cell technology to treat hospitalized COVID-19 patients....'We expect our upcoming Phase I trial to generate data that will hopefully demonstrate the safety of these T cells, the optimal dose of cells we should administer, and how we should best combine them with current COVID-19 standards of care.'"

IND • Infectious Disease • Novel Coronavirus Disease