CLB-3000 / ClearB Therap - LARVOL DELTA

Study to Evaluate the Safety, Tolerability, Immunogenicity and Antiviral Activity of Multiple Doses of CLB-3000 in participants with Chronic Hepatitis B (ANZCTR) - P1 | N=12 | Completed | Sponsor: ClearB Therapeutics, Inc. | Active, not recruiting ➔ Completed

Trial completion • Hepatitis B • Infectious Disease • Inflammation

Study to Evaluate the Safety, Tolerability, Immunogenicity and Antiviral Activity of Multiple Doses of CLB-3000 in participants with Chronic Hepatitis B (ANZCTR) - P1 | N=12 | Active, not recruiting | Sponsor: ClearB Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

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

An mRNA vaccine exhibits anti-viral activity in mouse model of persistent hepatitis B infection (EASL-ILC 2024) - "Background and Aims: We previously reported declines in serum HBsAg levels and concomitant clearance of infected hepatocytes after administration of a therapeutic subunit adjuvanted vaccine, CLB-3000 which consists of two modified HBsAg variants displaying clearance profile (CP) associated loop 1 and 2 epitopes identified from patients who achieve functional cure (EASL 2021 poster 853, AASLD 2021 poster 829)... An mRNA therapeutic vaccine was highly efficacious in a murine model of persistent HBV infection with rapid plasma HBsAg decline and clearance, and clearance of infected hepatocytes. These findings further support the development of an mRNA based therapeutic vaccination approach in chronic hepatitis B patients."

Preclinical • Hepatitis B • Hepatology • Infectious Disease • Inflammation • MED23

Study to Evaluate the Safety, Tolerability, Immunogenicity and Antiviral Activity of Multiple Doses of CLB-3000 in participants with Chronic Hepatitis B (ANZCTR) - P1 | N=12 | Recruiting | Sponsor: ClearB Therapeutics, Inc.

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

Study to Evaluate the Safety, Tolerability, Immunogenicity and Antiviral Activity of Multiple Doses of CLB-3000 in participants with Chronic Hepatitis B (ANZCTR) - P1 | N=12 | Recruiting | Sponsor: ClearB Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Trial initiation date • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Study to Evaluate the Safety, Tolerability, Immunogenicity and Antiviral Activity of Multiple Doses of CLB-3000 in participants with Chronic Hepatitis B (ANZCTR) - P1 | N=12 | Not yet recruiting | Sponsor: ClearB Therapeutics, Inc.

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

Therapeutic vaccine candidate CLB-3000 (CLB-405 and CLB-505 adjuvanted with Alhydrogel): a Good Laboratory Practice (GLP)-compliant 15-week intramuscular toxicity study in rabbits with a 4-week recovery (EASL-ILC 2023) - "Repeated IM injection of CLB-3000 was well tolerated at doses up to 500 µg antigen (250 µg CLB-405 and 250 µg CLB-505) with 1000 µg Alhydrogel/animal, the highest dose tested. Findings in this study, which were limited to effects at the injection sites, were consistent with expected findings in a vaccine study formulated with adjuvant and were not considered adverse. The safety profile of CLB-3000 in NZW rabbits supports further investigation for the treatment of CHB patients."

Clinical • Preclinical • Hematological Disorders • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Ophthalmology

EVALUATION OF THE HEPATITIS B THERAPEUTIC VACCINE CANDIDATE CLB-3000 (CLB-405 + CLB-505 WITH ALHYDROGEL): A 9- OR 15-WEEK TOXICITY STUDY IN NEW ZEALAND WHITE (NZW) RABBITS WITH A 4-WEEK RECOVERY PERIOD (AASLD 2022) - "Repeated IM injection of CLB-3000 was well tolerated at doses up to 200 μg antigen (100 μg CLB-405 + 100 μg CLB-505) with 1000 μg Alhydrogel/animal, the highest dose tested. The safety and immunogenicity profile of CLB-3000 in NZW rabbits supports further investigation for the treatment of CHB patients."

Preclinical • Hematological Disorders • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Ophthalmology • CRP

IMMUNOGENICITY FOLLOWING INTRAMUSCULAR VACCINATION WITH INCREASING DOSE LEVELS OF RECOMBINANT HEPATITIS B SURFACE ANTIGEN (HBsAg) VARIANTS CLB-405 AND CLB-505 WITH OR WITHOUT ALHYDROGEL IN NEW ZEALAND WHITE (NZW) RABBITS (AASLD 2022) - "Recombinantly expressed and purified variants of HBsAg, CLB-405 and CLB-505, are immunogenic in female NZW rabbits. The addition of Alhydrogel increased the antibody response, justifying the inclusion of this adjuvant in the development of CLB-3000 for the treatment of CHB patients."

Preclinical • Gastrointestinal Cancer • Hepatitis B • Hepatocellular Cancer • Hepatology • Infectious Disease • Inflammation • Oncology • Solid Tumor

Therapeutic vaccination with CLB-3000 in a mouse model of chronic hepatitis B induces anti-HBs responses associated with functional cure (EASL-ILC 2022) - "CLB-3000 was highly efficacious in CHB mice as shown by rapid HBsAg decline, clearance from serum and liver, and seroconversion to CP-associated anti-HBs which mirrored clinical FC-associated anti-HBs responses. The data further support CLB-3000 development for the treatment of CHB."

Preclinical • Hepatitis B • Hepatology • Infectious Disease • Inflammation

ClearB Therapeutics Announces New Pre-clinical Hepatitis B Data in a Poster Presentation at AASLD 2021 (Businesswire) - "ClearB Therapeutics, Inc...announced today that its abstract titled 'Impact of various expression systems on efficacy of HBsAg therapeutic vaccines to achieve clearance in a mouse model of chronic hepatitis B' was accepted for poster presentation at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® 2021, taking place virtually November 12-15, 2021."

Preclinical • Hepatitis B • Infectious Disease