Maximal knowledge exploitation from our first-in human therapeutic vaccine trial (HEB-PEP) to treat chronic hepatitis B (MAX-HEB-PEP)
Optimal monitoring of the effect of ISA104, an experimental therapeutic vaccine for chronic hepatitis B virus infection.
We aim to expand our planned phase I clinical trial to test a novel therapeutic vaccine (ISA104) for chronic hepatitis B virus infection (cHBV) with additional patients and ancillary research to facilitate ISA104 clinical implementation.
Collaborating partner ISA Pharmaceuticals has previously demonstrated that a therapeutic vaccine based on antigenic synthetic long peptides (SLPs) derived from human papilloma virus (HPV - ISA101b) was able to cure chronic HPV infection and eradicate HPV-induced (pre-)malignant lesions, and to increase clinical response rates and survival in late stage cancer patients when combined with immune modulating therapy. Recently, in a prior PPP with ISA Pharmaceuticals (LSHM16056-HSGF-007), we developed SLPs to serve as active ingredients of ISA104, to treat cHBV. A second ongoing PPP (EMCLSH21007) allows us to test the safety and T cell stimulatory capacity of ISA104 in a phase I clinical trial. Now with this third PPP-allowance we act on recent insights that call for expansion of our research to maximize knowledge exploitation from the planned ISA104 clinical trial.
cHBV is a tremendous global health burden with 250 million patients worldwide, many of which will develop life-threatening liver disease. Currently, no effective curative treatment exists. Therapeutic vaccines harbor great potential to cure cHBV by training the immune system to clear virus infected cells.
The current PPP-allowance will allow us to: 1) include a group of 6 additional patients receiving placebo to learn how viral parameters and anti-viral immune responses naturally fluctuate 2) To test a new assay to monitor ISA104’s ability to trigger immune responses 3) To develop an assay to predict vaccine effect 4) To study virus-recognizing immune cells in greater detail.
Results from this project will substantially improve our understanding of anti-viral immune responses in cHBV patients and will help us to better design follow-up studies thereby aiding ISA104 clinical implementation.
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