New York, US and Vienna, Austria, December 17, 2018 - HOOKIPA Pharma Inc. (“HOOKIPA”), a company developing a new class of immunotherapies targeting infectious diseases and cancers based on its proprietary arenavirus platform, today announced that it has dosed the first patient in its randomized, placebo-controlled, Phase 2 clinical trial to evaluate the safety and efficacy of HB-101, a bivalent prophylactic vaccine for cytomegalovirus (CMV), in CMV-negative patients awaiting kidney transplantation from living CMV-positive donors.
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 randomized 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.
Joern Aldag, HOOKIPA’s Chief Executive Officer said: “We are extremely pleased to dose our first patient in our global Phase 2, multicenter trial of our HB-101 candidate to develop a potentially life-saving therapy for patients undergoing solid organ transplantation. HB-101 is the first subunit vaccine designed to elicit robust CMV-specific CD8+ T cell responses and CMV-neutralizing antibodies to enter Phase 2 clinical trials. This trial, together with our planned proof-of-concept trial in cancer immunotherapy, is a big step towards validating our arenavirus technology platform.”
Dr. Igor Matushansky, HOOKIPA’s Global Head of Research and Development added: “This trial aims to assess the safety and immunogenicity of HB-101 and assess its efficacy compared to that of placebo in mitigating CMV viremia and in decreasing the use of anti-viral drugs to treat CMV viremia.”
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-1011. 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.
1. HOOKIPA Pharma Inc. (2017). Hookipa Biotech presents positive data from Phase 1 first-in-human trial of vaccine against cytomegalovirus [Press release]. Available at: https://www.hookipapharma.com/investors/press-releases/hookipa-biotech-presents-positive-data-from-phase-1-first-in-human-trial-of-vaccine-against-cytomega/ (Accessed: December 12, 2018).
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.
We have successfully completed a Phase 1 trial of a Vaxwave®-based prophylactic vaccine to protect against cytomegalovirus infection1. We have initiated enrollment for a Phase 2 trial in cytomegalovirus-negative patients awaiting kidney transplantation from cytomegalovirus-positive donors. To expand our infectious disease portfolio, we have entered into a collaboration and licensing agreement with Gilead Sciences, Inc. to jointly research and develop functional cures for HIV and Hepatitis B infections. We are building a proprietary immuno-oncology pipeline by targeting virally mediated cancer antigens, self-antigens and next-generation antigens.
Find out more about HOOKIPA online at www.hookipapharma.com.
*Registered in Europe; Pending in the US.
Cytomegalovirus (CMV) 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).
Issued for and on behalf of HOOKIPA by Instinctif Partners.
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