HB-101 is based on Hookipa´s non-replicating Vaxwave technology and expresses two human CMV antigens, the tegument protein pp65, which induces CMV-specific T cells and a truncated isoform of the fusion protein gB, which elicits the production of CMV-neutralizing antibodies.
The clinical trial will be conducted at approximately 35 centers worldwide and will include a total of 150 male and female patients, aged 18 years or older. The patients will be randomised to receive either HB-101 or placebo at a ratio of 2: 1 prior to kidney transplantation.
Patients enrolled will be scheduled to have a living donor kidney transplantation after receiving two to three doses of HB-101.
In December 2016, Hookipa completed the active phase of a randomized, placebo controlled double blinded dose-escalating Phase 1 trial in healthy volunteers evaluating the safety and immunogenicity of HB-101.
In addition to demonstrating that HB-101 was well-tolerated, all three dose-groups receiving the candidate vaccine showed robust and statistically significant cellular and humoral immune responses when compared to placebo.
Hookipa Pharma Inc. is a clinical stage biopharmaceutical company developing a new class of immunotherapeutics targeting infectious diseases and cancers based on its proprietary arenavirus platform that is designed to reprogram the body's immune system.
Our proprietary arenavirus-based technologies, Vaxwave, a replication-deficient viral vector, and TheraT, a replication-attenuated viral vector, are designed to induce robust antigen specific CD8+ T cells and pathogen-neutralizing antibodies.
Both, Vaxwave and TheraT, are designed to allow for repeat administration while maintaining an immune response.
TheraT has the potential to induce CD8+ T cell response levels previously not achieved by other published immuno-therapy approaches. Our "off-the-shelf" viral vectors target dendritic cells in vivo to activate the immune system.
Cytomegalovirus is a common opportunistic pathogen in patients who have undergone solid organ transplantation.
The majority of recipients who are CMV-negative acquire a primary infection from a CMV-positive donor organ.
Viral replication in the recipient results in the virus entering the bloodstream, which can progress to end-organ disease.
Active CMV infection correlates with a higher risk of other infections, post-transplant lymphoma, organ rejection, and overall morbidity and mortality.
To prevent CMV infection and disease, transplant centers routinely employ either a prophylactic or preemptive strategy using ganciclovir or its oral prodrug valganciclovir.
The prophylactic approach is effective in preventing end-organ disease while on anti-viral prophylaxis, but patients remain at significant risk of developing viremia and late-onset disease once prophylaxis treatment ceases.
Late-onset disease can also be caused by strains of CMV that have developed resistance to ganciclovir, which then requires the use of more toxic second-line therapies. The preemptive approach requires close monitoring of CMV DNAemia via polymerase chain reaction (and, as a result, is often limited by practical considerations, given the need for frequent blood draws).
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