GSK Terminates Phase II Trial of Therapeutic HBV Vaccine GSK3528869 Due to Lack of Efficacy

On December 3, according to foreign media reports,GSKTerminate One ItemChronic Hepatitis B Therapeutic VaccineThe Phase II clinical trial of GSK3528869 was terminated. The reason is that the predetermined efficacy endpoint was not met after the last vaccine administration (at 24 weeks). To prioritize patient safety, GSK decided to terminate the study early.

GSK3528869 is a viral vector and adjuvant protein vaccine designed to achieve the goal of a functional cure for HBV by controlling and resolving clinical sequelae of infection, as well as reducing the need for further treatment.

This drug is one of GSK's faster-progressing hepatitis B drug pipelines. In addition, GSK has several other new mechanism hepatitis B innovative drugs targeting different mechanisms in Phase I-III clinical trials.

GSK3228836

Bepirovirsen (GSK836) is an antisense oligonucleotide (ASO) and a novel investigational hepatitis B drug co-developed by GSK and Ionis. It is currently undergoing Phase III trials as a monotherapy or in combination with other drugs featuring new mechanisms. Bepirovirsen has already received "Fast Track" designation in China, the United States, and Japan, and is expected to become the world’s first ASO to reach the market.

GSK4388067

GSK4388067 is a viral vector and adjuvant recombinant protein vaccine, a targeted immunotherapy for chronic hepatitis B virus infection patients aged 18 and above without decompensated cirrhosis. Direct-acting antiviral therapies target the hepatitis B virus itself, whereas immunotherapies do not directly target the hepatitis B virus but rather the body's immune system by mobilizing or activating immune cells. It is currently in Phase II clinical trials in combination with Bepirovirsen.

GSK5637608

GSK5637608 (JNJ-3989) is a small interfering RNA (siRNA therapy) co-developed by Arrowhead Bio and Johnson & Johnson. In October 2023, the two companies reached an agreement with GSK to transfer the development rights of JNJ-3989 to GSK. The drug is currently in Phase II clinical trials.

GSK3965193

GSK3965193 is a PAPD5/7 inhibitor currently in Phase I clinical trials. Preclinical animal studies have shown that this PAPD5/7 inhibitor can reduce hepatitis B surface antigen (HBsAg), and when used in combination with Bepirovirsen, it can further decrease HBsAg levels.

GSK5251738

GSK5251738 is a TLR8 agonist that does not directly target the hepatitis B virus but rather the body's immune system. It is currently in Phase I clinical trials.

Not only GSK, but in recent years, multiple pharmaceutical companies have encountered setbacks in hepatitis B. Last quarter, Roche terminated four hepatitis B projects; last year, Johnson & Johnson halted the development of all hepatitis drugs; other biotech companies, including Antios Therapeutics, Vir Biotechnology, Precision Biosciences, and Arbutus Biopharma, have also experienced closures or are in困境.