Background / Context / Abstract:

 The HBIG (Hepatitis B immune globulin or immunoglobulin) provides immediate, short-term protection against hepatitis B infection.  It is given as a shot when immediate protection against hepatitis B is needed, e.g., to prevent hepatitis B infection in people who have been exposed to the hepatitis B virus and have not received the hepatitis B vaccine.  Specific cases include needle stick accidents and mother-to-child transmission.  In the case of infants, HBIG administration and hepatitis B vaccination is given when the HBs (protein that forms the outer shell of HBV) antigen is negative after one month of age, and in the case of accidents, within 24 hours or 48 hours at the latest if both the HBs antigen and antibody of the injured person are negative.
 On the other hand, HBIG is mainly made by purifying HBV antibodies from donated blood, and therefore it is assumed that it may be difficult to secure the necessary and sufficient amount by that means alone.
 Under these circumstances, the inventors considered the preparation of recombinant HBIG monoclonal antibodies (mAbs).  After intensive investigation, they succeeded in producing several types of recombinant HBIG mAbs (humanized) and hybridomas that produce them.

Publication(s)

1. He Zhang, et al., and Toru Okamoto, Microbiol Immunol. (First published: 27 January 2022)
   “Establishment of monoclonal antibodies broadly neutralize infection of hepatitis B virus.”
   (DOI) https://doi.org/10.1111/1348-0421.12964
2. The 68th Annual Meeting of the Japanese Society for Virology.
   He Zhang, Yumi Itoh, Tatsuya Suzuki and Toru Okamoto, “Establishment of monoclonal antibodies broadly neutralize infection of hepatitis B virus.”

Development Stage

Several types of humanized mAbs (already cloned into plasmid vectors) have been obtained and their neutralizing activities have been confirmed.
(Samples for evaluation can be provided by MTA for a fee.)

Benefits:

Advantages

• Obtained a humanized mAb with high neutralizing activity.
• Can be recognized against several known escape mutant strains.
• Eliminates the need to rely on blood donations from HBV-infected patients and allows for a stable supply of the drug.

Potential Applications / Potential Markets:

Recombinant anti-HBs human immunoglobulin mAb drug.

State of Development / Opportunity / Seeking:

・Available for exclusive and non-exclusive licensing
・Exclusive/non-exclusive evaluation for defined period (set up for options)
・Collaborative/supportive research

※Seeking
1. Development partner
2. Licensing　

IP Status:

Applied in Japan, not yet published

Contact: