Unmet Need / Invention Novelty: Loss of hepatitis B surface antigen (HBsAg) is defined as a functional cure for chronic hepatitis B virus infection, but it is clinically challenged by the derivation of HBsAg from two sources that must be uniquely targeted: covalently closed circular DNA (cccDNA) and integrated HBV DNA (iDNA). Currently, no rapid method exists to distinguish the sources of HBsAg in patients with chronic hepatitis B (CHB). There is critical need for a method to rapidly and accurately identify the source of the HBsAg from liver tissue to help clinicians or clinical trial designers to subtype patients and choose appropriate therapeutics to maximize the likelihood of HBsAg loss.
Technical Details: Johns Hopkins researchers have developed a method to identify the source(s) of hepatitis B surface antigen (HBsAg) from liver tissue. The method consists of a sensitive and specific multiplex droplet digital PCR that characterizes the relative amounts of HBsAg that derive from cccDNA and/or iDNA, as indicators of responsiveness to treatments and patient outcome. Proof-of-concept studies using liver tissues from patients infected with hepatitis B, demonstrated a patient-specific enrichment of cccDNA or iDNA-derived transcripts . This evidence strongly supports that the technology can be used to stratify patients based on their predominant source of HBsAg.
Value Proposition:
· Simple and quantitative method to identify the source of HBsAg
· Requires small amounts of liver tissue from liver biopsy
· Specific and precise distinction between cccDNA and iDNA derived HBsAg
· Permits subtype specific and appropriate therapeutic selection from emerging therapeutics
Looking for Partners to: Develop & commercialize the technology as a prognostic tool for estimating treatment response, and a monitoring tool to improve patient outcomes based on the source of HBsAg in human clinical samples.
Stage of Development: Pre-clinical
Data Availability: Ex-vivo including proof-of-concept with clinical samples
