JNJ-64300535 / J&J - LARVOL DELTA

OSPREY: A Study of JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, Hepatitis B e Antigen (HBeAg)- Negative Participants With Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Janssen Research & Development, LLC | Active, not recruiting ➔ Completed

Trial completion • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Efficacy, safety, tolerability, and immunogenicity of JNJ-0535 following a reduction of viral antigen levels through administration of siRNA JNJ-3989 in patients with chronic HBeAg negative hepatitis B - interim data of the OSPREY study (EASL-ILC 2024) - P1 | "Treatment with JNJ-3989, JNJ-0535 and NA, continued or stopped was generally safe and well tolerated. HBsAg lowering, followed by vaccination in OSPREY, showed more favourable HBsAg kinetics during FU in patients that were able to stop NA treatment versus patients who continued NA treatment. A potential role of HBV specific polypositive CD4 T cells needs further elucidation."

Clinical • Late-breaking abstract • Hepatitis B • Hepatology • Infectious Disease • Inflammation • CD4

OSPREY: A Study of JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, Hepatitis B e Antigen (HBeAg)- Negative Participants With Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: Jun 2024 ➔ Jul 2023

Trial primary completion date • Hepatitis B • Hepatology • Infectious Disease • Inflammation

OSPREY: A Study of JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, Hepatitis B e Antigen (HBeAg)- Negative Participants With Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Phase classification: P1b ➔ P1

Phase classification • Hepatitis B • Hepatology • Infectious Disease • Inflammation

OSPREY: A Study of JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, Hepatitis B e Antigen (HBeAg)- Negative Participants With Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - P1b | N=24 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Hepatitis B • Hepatology • Infectious Disease • Inflammation

OSPREY: A Study of JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, Hepatitis B e Antigen (HBeAg)- Negative Participants With Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - P1b | N=23 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: May 2023 ➔ Aug 2024

Trial primary completion date • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Therapeutic vaccine JNJ-0535 induces a strong HBV-specific T-cell response in healthy adults and a modest response in chronic HBV-infected patients (EASL-ILC 2022) - "T cell responses induced in HV were superior to those in CHB patients at a JNJ-0535 dose of 6 mg in terms of the proportion of responders, the magnitude of fold-increase from baseline, the breadth (number of antigens) and CD4+ and CD8+ core-specific T cell polyfunctionality. This supports the hypothesis that CHB infection negatively impacts the ability of patients to induce T cells in response to therapeutic vaccination."

Clinical • Hepatitis B • Hepatology • Inflammation • CD4 • CD8 • IFNG

OSPREY: A Study of JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, Hepatitis B e Antigen (HBeAg)- Negative Participants With Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - P1b | N=23 | Recruiting | Sponsor: Janssen Research & Development, LLC | Not yet recruiting ➔ Recruiting

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

A Study of JNJ-64300535 in Healthy Participants (clinicaltrials.gov) - P1; N=14; Completed; Sponsor: Janssen Research & Development, LLC; Active, not recruiting ➔ Completed

Clinical • Trial completion • CD4 • CD8

OSPREY: A Study of JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, Hepatitis B e Antigen (HBeAg)- Negative Participants With Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - P1b; N=23; Not yet recruiting; Sponsor: Janssen Research & Development, LLC

Clinical • New P1 trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study of JNJ-64300535 in Healthy Participants (clinicaltrials.gov) - P1; N=14; Active, not recruiting; Sponsor: Janssen Research & Development, LLC; Recruiting ➔ Active, not recruiting

Enrollment closed • CD4 • CD8

A First-In-Human Study to Evaluate Safety, Tolerability, Reactogenicity, and Immunogenicity of JNJ-64300535, a DNA Vaccine, Administered by Electroporation-Mediated Intramuscular Injection, in Participants With Chronic Hepatitis B Who Are on Stable Nucleos(t)Ide Therapy and Virologically Suppressed (clinicaltrials.gov) - P1; N=30; Completed; Sponsor: Janssen Sciences Ireland UC; Active, not recruiting ➔ Completed

Trial completion • Hepatitis B • Hepatology • Infectious Disease • CD4 • CD8 • TNFA

A Study of JNJ-64300535 in Healthy Participants (clinicaltrials.gov) - P1; N=12; Recruiting; Sponsor: Janssen Research & Development, LLC; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • CD4 • CD8

A Study of JNJ-64300535 in Healthy Participants (clinicaltrials.gov) - P1; N=12; Not yet recruiting; Sponsor: Janssen Research & Development, LLC

Clinical • New P1 trial • CD4 • CD8