VRON-0200 / Virion Therap - LARVOL DELTA

HBSAG DECLINES OBSERVED WITH VRON-0200 ALONE ARE RAPIDLY ENHANCED WITH THE ADDITION OF COMBINATION ANTIVIRAL THERAPIES: RESULTS: FROM A PHASE 1B STUDY FOR FUNCTIONAL CURE IN CHRONICALLY HBV-INFECTED PATIENTS (AASLD 2025) - "VRON-0200 alone, or in combination, had no observed safety concerns, and was well tolerated. Despite not targeting HBsAg, a single VRON-0200 dose was able to lower S-antigen in ~25% of pts. The combination of VRON-0200 with elebsiran and tobevibart rapidly and profoundly enhanced VRON-0200 HBsAg declines within 7 days in all pts, with further declines being observed with additional doses."

Clinical • P1 data • Hepatitis B • CD8 • IFNG

Dose-Escalation Prime/Boost Therapeutic Vaccination Study Of 2 Chimp Adenoviral Vectors in Adults With Chronic HBV On Nucleos(t)Ide Therapy (clinicaltrials.gov) - P1 | N=56 | Active, not recruiting | Sponsor: Virion Therapeutics | Recruiting ➔ Active, not recruiting | Trial completion date: Nov 2025 ➔ Mar 2026 | Trial primary completion date: Nov 2025 ➔ Mar 2026

Enrollment closed • Trial completion date • Trial primary completion date • Hepatitis B • Infectious Disease • Inflammation

Rapid HBsAg declines and HBsAb seroconversion observed with a single dose of VRON-0200 plus Tobevibart and Elebsiran: preliminary results of a VRON-0200 combination treatment from a phase 1b study for functional cure in chronically HBV-infected patients (EASL 2025) - "These initial data of the combination of a single i.m. VRON-0200 dose plus Tobevibart and Elebsiran had no observed safety concerns, was well tolerated, and displayed rapid (within 7 days of the addition of Tobevibart and Elebsiran) HBsAg declines and HBsAb seroconversions in all 4 (100%) patients. These initial responses appear promising, compared to investigational combin- ation regimens, reported to date, including those containing PEG-IFN. These data, coupled with VRON-0200's safety, tolerability and ease of administration, may eventually support its use as an IFN-sparing immunotherapy, with the potential for shorter duration combination treatments for HBV functional cure."

Clinical • Late-breaking abstract • P1 data • Hepatitis B • CD8

HBsAg declines, and T cell increases, observed in CHB patients: Interim results from P1b trial of VRON-0200, a novel checkpoint modifier, following prime only, and prime and boost dosing (EASL 2025) - "In a CHB pt population with limited preexisting HBV immunity, VRON-0200 was safe, well tolerated, and significantly increased T cell responses and reduced HBsAg levels in >20% of patients, reflecting restored broad HBV-specific immune responses (vaccine does not contain S). VRON-0200 is a potential simple, easy-to administer, IFN-sparing immunotherapy, alone or in combination, for HBV functional cure. Immunologic, clinical, and safety analyses are ongoing."

Clinical • Hepatitis B • CD8

HBsAg Declines and Immune Responses Following a Single Dose of VRON-0200: Interim Results from a Phase1B Study for HBV Functional Cure in Chronic HBV-Infected Patients (APASL 2025) - "A single i.m. dose of VRON-0200 was safe, well tolerated, and significantly increased T cell responses. At D91, HBsAg declines occurred in several pts even though VRON-0200 does not target S. VRON-0200 is a potential simple, easy-to administer, IFN-sparing immunotherapy, alone or in combination, for HBV functional cure. Immunologic, clinical, and safety analyses are ongoing."

Clinical • P1 data • Hepatitis B • CD8

Virion Therapeutics Completes Enrollment of First 2 Cohorts of Phase 1b Chronic Hepatitis B Trial of VRON-0200 For HBV Functional Cure (PRNewswire) - "Virion Therapeutics...announced that its Phase 1b clinical trial, evaluating VRON-0200 for HBV Functional Cure has completed enrollment in its first two cohorts. Specifically, 27 chronically HBV-infected patients on nucleos(t)ide antiviral therapy, have now received a single (Prime), or Prime and Boost, i.m. injection of VRON-0200....Additionally, a third Cohort, the first to investigate VRON-0200 in combination with several investigational anti-HBV agents, is now underway....'We look forward to sharing more VRON-0200 clinical data in 2025'..."

P1 data • Trial status • Hepatitis B • Infectious Disease

Dose-Escalation Prime/Boost Therapeutic Vaccination Study of 2 Chimp Adenoviral Vectors in Adults with Chronic HBV on Nucleos(t)ide Therapy (clinicaltrials.gov) - P1 | N=56 | Recruiting | Sponsor: Virion Therapeutics | Phase classification: P1b ➔ P1 | Trial completion date: Jan 2025 ➔ Nov 2025 | Trial primary completion date: Jul 2024 ➔ Nov 2025

Phase classification • Trial completion date • Trial primary completion date • Viral vector • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Promising first-in-human, first-in-class, Phase 1B immunogenicity data of VRON-0200, a novel checkpoint modifier containing immunotherapy, for HBV functional cure (EASL-ILC 2024) - "As of March 15, 2024, a single, intramuscular low dose of VRON-0200 was safe, well tolerated, and, in 50% of pts, increased or induced T cell responses, to one or both peptides, even in pts without immune responses at baseline, prior to vaccination. These data support VRON-0200's continued evaluation as a potential simple, easy-to administer, interferon-sparing immunotherapy for HBV functional cure. Further immunologic and safety analyses are ongoing and will be presented."

Late-breaking abstract • P1 data • Hepatitis B • Hepatology • Herpes Simplex • Inflammation • CD8

First-in-Human, First-in-Class, Phase 1B Preliminary Safety Data of Vron-0200, A Novel Checkpoint Modifier Containing Immunotherapy, for HBV Functional Cure (APASL 2024) - "In this first report of safety data from VRON-0200, the prime dose has been well tolerated, with no significant safety concerns to date. The study is ongoing, and additional Cohort 1 clinical data will be presented."

Clinical • P1 data • Hepatitis B • Hepatology • Herpes Simplex • Inflammation • CD8

Ocean Biomedical (NASDAQ: OCEA) Announces Joint Venture Partner, Virion Therapeutics to Present Their First Clinical Study Data as an Accepted Late Breaker Presentation at 2024 APASL Global Liver Meeting (GlobeNewswire) - "Ocean Biomedical, Inc...today congratulates its joint venture partner, Virion Therapeutics, LLC, a clinical-stage biotechnology company developing T cell-based immunotherapies, for the acceptance of their abstract highlighting the first-ever human data from its novel checkpoint modifier immunotherapy for HBV functional cure, for late breaker oral presentation at the upcoming 33^rd Annual Meeting of APASL (The Asian Pacific Association for the Study of the Liver), taking place in Kyoto, Japan from March 27-31, 2024...The late breaker presentation will highlight the safety data observed, to date, in the ongoing Phase 1B clinical trial of VRON-0200."

Late-breaking abstract • P1 data • Hepatitis B • Infectious Disease

Virion Therapeutics and Joint Venture Partner, Ocean Biomedical (NASDAQ: OCEA), Announce First Patients Dosed with Novel Immunotherapy Evaluating a Functional Cure for Chronic Hepatitis B Virus Infection (PRNewswire) - "Virion Therapeutics...and its Joint Venture partner, Ocean Biomedical...announced that the first patients have been dosed in the Phase 1b clinical trial of its investigational VRON-0200 immunotherapy, which is being evaluated as a functional cure for patients with chronic Hepatitis B virus (HBV) infection....The international, first-in-human VRON-0200 Phase 1b study is currently enrolling patients in Hong Kong and New Zealand, with additional sites planned in the United States. Initial clinical data from this study are expected in early 2024."

P1 data • Trial status • Hepatitis B

Dose-Escalation Prime/Boost Therapeutic Vaccination Study Of 2 Chimp Adenoviral Vectors in Adults With Chronic HBV On Nucleos(t)Ide Therapy (clinicaltrials.gov) - P1b | N=48 | Recruiting | Sponsor: Virion Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Viral vector • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Dose-Escalation Prime/Boost Therapeutic Vaccination Study Of 2 Chimp Adenoviral Vectors in Adults With Chronic HBV On Nucleos(t)Ide Therapy (clinicaltrials.gov) - P1b | N=48 | Not yet recruiting | Sponsor: Virion Therapeutics

New P1 trial • Viral vector • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Intrahepatic CD8+ T cells correlate with significant declines in HBV viral load and S antigen following a single vaccination with VRON-0200 in an AAV mouse model (EASL-ILC 2023) - "VRON-0200 is the first therapeutic vaccine to show significant correlations between intrahepatic CD8+ T cells and HBV viral loads declines. S antigen declines were also observed and directly related to HBV clearance. These data further support the key role of HBV viral load and CD8+ T cells as endpoints for HBV functional cure and highlight VRON-0200’s clinical potential alone or in combination."

Preclinical • Hepatitis B • CD8 • IFNG

Preclinical immunogenicity and efficacy of VRON-0200: A novel therapeutic vaccine for potential Functional Cure therapies in patients with chronic HBV (APASL 2022) - No abstract available

Preclinical

[VIRTUAL] VRON-0200, A therapeutic HBV vaccine with an intrinsic checkpoint inhibitor elicits broad CD8+ T cell responses and sustained antiviral declines in preclinical studies (EASL-ILC 2021) - "The inclusion of gD into a therapeutic HBV vaccine enhances CD8+ T cell responses and is necessary for the observed sustained efficacy of the vaccine to reduce viral loads in the AAV8- 1.3HBV mouse model. Mice vaccinated with the gDHBV2 vector showed better viral control than those immunized with gDPolN stressing the importance of a broad-based immune response. A Phase 1b study of VRON-0200 is in planning."

Checkpoint inhibition • Preclinical • Oncology • CD8 • IFNG

Virion Therapeutics Presents Data Showing Enhanced and Sustained Virus Declines in Animals upon Immunization with VRON-0200, a Therapeutic Vaccine for Chronic Hepatitis B Virus (HBV) Infections at the International Liver Congress (ILC) (GlobeNewswire) - "Virion Therapeutics, LLC...presented an oral presentation...Top line results following vaccination include: Induction of potent, broad, and sustained CD8+ T cells to key HBV antigens detectable in blood, liver, and spleen...The addition of gD, Virion’s proprietary genetically encoded inhibitor of an early T cell checkpoint, was required for substantial antiviral activity...Virion is scheduled to begin patient enrollment in a First-In-Human Phase 1b clinical trial at the end of 2022."

New P1 trial • Preclinical • Hepatitis B • Infectious Disease

Virion Therapeutics Announces Presentation of Preclinical Data of VRON-0200, a Chronic Hepatitis B Virus (HBV) Therapeutic Vaccine, at the International Liver Congress (ILC) (GlobeNewswire) - "Virion Therapeutics, LLC...announced an upcoming presentation at ILC that will demonstrate that its VRON-0200 therapeutic HBV vaccine induces potent, broad, and sustained CD8+ T cell responses and lasting multi-log HBV DNA viral declines in a preclinical mouse model of chronic hepatitis B virus infection...VRON-0200 is a therapeutic vaccine that is rationally designed to help restore CD8+ T cell functions to control chronic HBV infection."

Preclinical • Hepatitis B • Infectious Disease