The paper concludes that HB-101 was well tolerated and induced CMV-specific poly-functional CD8 T cell and neutralizing antibody responses in nearly all subjects. The absence of vector-neutralizing antibody responses allowed all CMV antigen-specific immune responses to be increased in a statistically significant manner upon repeated vaccine re-administration, which should facilitate additional booster vaccinations. Hence, HOOKIPA's vaccine candidate holds promise for prevention of clinically significant CMV infection in transplant recipients and unborn children.
“The impact of CMV infections, especially in the field of immunosuppressed patients, like transplant recipients, is severe and a prophylactic CMV vaccine would be game-changing,” commented Paul Griffiths, MD DSc FRCPath, Professor of Virology, Institute of Immunity & Transplantation at University College London. “The field needs a vaccine that induces both cell-mediated and humoral immunity. These Phase 1 results from HOOKIPA are very encouraging, so I look forward to seeing the results from the Phase 2 trial that is underway in transplant patients.”
Cytomegalovirus, or CMV, is a virus that is commonly transmitted in childhood and early adulthood. Approximately 60% of the U.S. population has been exposed and is latently infected. Worldwide data indicate that half the people in industrialized countries and up to 99% of people in developing countries, including China and India, have been infected. Infections typically result in lifelong latent persistence of the virus with few symptoms, if any. However, in unborn children, when infected in utero, CMV infection can lead to significant morbidity and mortality. In addition, in immunosuppressed patients, such as transplant recipients, primary CMV infection or reactivation of CMV causes significant morbidity, mortality and graft rejection.
The publication, “A randomized dose-escalating Phase I trial of a replication-deficient lymphocytic choriomeningitis virus vector-based vaccine against human cytomegalovirus,” is available online in The Journal of Infectious Diseases.
HOOKIPA Pharma Inc. (NASDAQ: HOOK) 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.
HOOKIPA’s 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 technologies are designed to allow for repeat administration to augment and refresh immune responses. TheraT® has the potential to induce CD8+ T cell response levels previously not achieved by other immuno-therapy approaches. HOOKIPA’s “off-the-shelf” viral vectors target dendritic cells in vivo to activate the immune system.
HOOKIPA’s VaxWave®-based prophylactic Cytomegalovirus (CMV) vaccine candidate is currently in a Phase 2 clinical trial in CMV-negative patients awaiting kidney transplantation from living CMV-positive donors as well as CMV-positive patients awaiting kidney transplantation from CMV-positive or -negative donors. To expand its infectious disease portfolio, HOOKIPA has entered into a collaboration and licensing agreement with Gilead Sciences, Inc. to jointly research and develop functional cures for HIV and chronic Hepatitis B infections.
In addition, HOOKIPA is building a proprietary immuno-oncology pipeline by targeting virally mediated cancer antigens, self-antigens and next-generation antigens. The TheraT® based lead oncology product candidates, HB-201 and HB-202, are in development for the treatment of Human Papilloma Virus16-positive cancers. The Phase 1/2 clinical trial for HB-201 was initiated in December 2019. The HB-202 IND submission is intended for the first half of 2020.
Find out more about HOOKIPA online at www.hookipapharma.com.
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