The treatment of hepatitis B has advanced remarkably over the past several decades. Even so, many patients still have to keep taking medication over the long term.

I have spent many years in pharmaceutical research and development. What I have come to feel through that experience is that even outstanding research results, on their own, do not reach the patients who need them.

HBNET was founded to carry the achievements created by many researchers — at Ehime University and beyond — through to real-world medical care.

This research is being conducted with the support of AMED, as part of the Ministry of Health, Labour and Welfare's program to overcome hepatitis B. What we are pursuing is the research and development of a new treatment for hepatitis B that draws on the body's own immune system. We are still only partway there, but with the cooperation of many researchers and medical professionals, we are advancing the development one step at a time.

Research cannot be done alone — and research results carry meaning only when they are put to use within society.

We will strive to make HBNET a bridge that connects university research with society. We sincerely ask for your continued understanding and support.

My name is Yoichi Hiasa, from the Department of Gastroenterology and Metabology at Ehime University Graduate School of Medicine.

Our department is currently proposing a therapeutic vaccine named HBNET-369 as an immunotherapy capable of achieving a functional cure for hepatitis B. Together with HBNET Co., Ltd., a venture company spun off from Ehime University, we are working toward the commercialization of this treatment.

The hepatitis B virus (HBV) escapes from the immune system and maintains a persistent infection, causing chronic hepatitis. Over a period of 20 to 30 years this leads to cirrhosis, and frequently to hepatocellular carcinoma. To prevent this unfortunate outcome, it is necessary to achieve a functional cure — a state of HBsAg negativity and undetectable HBV-DNA, the closest condition to having eradicated the persistent infection. However, achieving a functional cure is extremely difficult with the current standard treatments for HBV.

HBNET-369, which we are developing, serves as a therapeutic vaccine that can achieve functional cure, as well as a prophylactic vaccine that can induce HBs antibodies to prevent HBV infection. It uses the full-sequence HBs-L antigen combined with the HBc antigen. Unlike injectable formulations, it is administered as a nasal spray. Animal studies have already demonstrated that it effectively activates antigen-specific immunity, leading to the production of HBs antibodies and a reduction in HBs antigen levels. Although the amino acid sequences of HBs-L antigens differ by genotype, we have created the HBs-Lh antigen — a hybrid antigen that expresses two HBs-L antigens on the same lipid membrane particle — and have succeeded in achieving immunotherapeutic effects against all major HBV genotypes, from A to D.

We are currently developing this treatment with support from the Japan Agency for Medical Research and Development (AMED), aiming to conduct a Phase I clinical trial. We are seeking joint research partnerships with venture capital firms that can provide financial support and with pharmaceutical companies willing to collaborate on product development. We would be most grateful for your understanding and support.

Thank you very much for your consideration.