Shionogi and HanaVax Enter into a License Agreement for Streptcoccus Pneumoniae Vaccine Candidate

Osaka and Tokyo, Japan, September, 30, 2020 – Shionogi & Co., Ltd. (Head Office: Osaka, Japan; President & CEO: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) and HanaVax Inc. (Head Office: Tokyo, Japan; President & CEO: Pohsing Ng.; hereafter “HanaVax”), a drug-discovery venture company originating from the University of Tokyo, today announced they have entered into a license agreement for research, development, manufacturing, distribution, and commercialization of HanaVax’s Streptococcus pneumoniae (hereafter “S. pneumoniae”) nasal vaccine candidate. Shionogi will make an upfront payment to HanaVax in return for exclusive worldwide rights to this vaccine candidate. HanaVax will be eligible to receive additional development milestones and royalties based on sales of the vaccine.

The vaccine aims to prevent people from acquiring pneumococcal disease. Pneumonia is the fifth leading cause of death in Japan. S. pneumoniae is one of the most important pneumonia pathogens and the leading bacterial cause of pneumonia deaths worldwide. Infants and the elderly are especially vulnerable to S. pneumoniae, which can cause severe pneumonia, sepsis and meningitis, referred to collectively as “invasive pneumococcal diseases (IPD)”. Although S. pneumoniae is known to have more than 90 different serotypes, marketed vaccines are only able to cover a limited number of them. Therefore, unmet medical need remains for more comprehensive protection from IPD caused by serotypes not covered by the marketed vaccines.

The vaccine is comprised of PspA antigens, which are expected to provide broader protection than current vaccine antigens, carried in HanaVax’s proprietary cationic nanogel delivery system1. In the nonclinical studies, the vaccine effectively induced systemic and respiratory mucosal immunity2,3, and provided protection from S. pneumoniae infection3, when applied nasally. The vaccine will also avoid the pain associated with injections.

Shionogi and HanaVax will accelerate research and development of an innovative, next generation nasal vaccine to protect people from S. pneumoniae related diseases, by merging Shionogi’s expertise in infectious diseases with HanaVax’s pioneering research and technology related to mucosal immunity.







About PspA

Pneumococcal Surface Protein A (PspA) is known as a virulence factor found on the surface of all pathogenic S. pneumoniae bacteria. PspA is believed to help the bacteria avoid immune surveillance. It is expected to induce protection against a broader range of S. pneumoniae serotypes compared to current vaccines.

About HanaVax’s cationic nanogel delivery system

Mucosal immunity is of great importance for the prevention of respiratory system infections, because the respiratory mucosa is the first line of defense against pathogens. HanaVax’s proprietary cationic nanogel delivery formulation provides a protective carrier for antigens and consists of a polysaccharide pullulan molecule modified with cholesterol and cationic amines. The nanogel helps PspA antigens increase their retention on the mucosal surface and their gradual uptake by the immune cells. This effectively initiates the induction of both mucosal and systemic immunity.

About Shionogi

Shionogi is committed to “Protect people worldwide from the threat of infectious diseases” as our key focus. We are not limiting ourselves to the research and development of therapeutic medications, but are also focused on the total care of infectious disease, through awareness building, prevention, diagnosis, and treating exacerbations, as well as the infection itself. For more information, please visit https://www.shionogi.com/global/en/.

About HanaVax

HanaVax is a drug discovery biotechnology startup founded with the mission of “Developing nasal vaccines for a healthier society”. The proprietary nasal vaccine that is the subject of this license was developed on the basis of ten years of collaborative research between two pioneers of mucosal immunity and chemical engineering in the service of improved drug and vaccine delivery, Distinguished Prof. Dr. Hiroshi Kiyono (The University of Tokyo and Chiba University) and Prof. Dr. Kazunari Akiyoshi (Kyoto University). For more information, please visit https://www.hanavax.co.jp/en/.



1, Nochi T. et.al., “Nanogel antigenic protein delivery system for adjuvant-free intranasal vaccines” Nature Materials, 2010, 9, 572-578. https://www.nature.com/articles/nmat2784

2, Fukuyama Y. et al., “Nanogel-Based pneumococcal surface protein A nasal vaccine induces microRNA-associated Th17 cell responses with neutralizing antibodies against Streptococcus pneumoniae in macaques” Mucosal Immunology, 2015, 8, 1144-1153. https://www.nature.com/articles/mi20155

3, Kong H. Gyu et al., “Nanogel-Based PspA Intranasal Vaccine Prevents Invasive Disease and Nasal Colonization by Streptococcus pneumoniaeInfection and Immunity, 2013, 81, 1625-1634. https://iai.asm.org/content/81/5/1625.long