Infectious Diseases

Hepatitis B Virus

An estimated 292 million people are living with HBV infection (defined as hepatitis B surface antigen positive). According to the WHO, HBV results in up to 1 million annual deaths globally, mostly from complications including liver cirrhosis and hepatocellular carcinoma. HBV virus is especially common in China and other Asian countries where mother-to-child transmission is an important source of transmission of the virus. HBV is second only to tobacco as a cancer-causing agent.

Our solution: HBV Therapy
The objective of the Hepatitis B virus (HBV) Program is to utilize the HOOKIPA Technologies to design arenavirus vectors (Lymphocytic Choriomeningitis Virus or Pichinde Virus based) suitable for treatment, cure or prevention of HBV. Together with our partner Gilead Sciences, we intend to develop functional therapies for patients already infected with HBV.

HOOKIPA has completed all of the required preclinical work on the HBV program. In August 2023, the Journal of Infectious Disease published peer-reviewed preclinical data on HB-400 showing that HB-400 induced robust, HBV-specific T cell and antibody responses in non-human primates and cleared detectable serum HBV antigens in a mouse model for chronic HBV infection. A Phase 1b clinical trial led by Gilead completed enrollment with 83 participants, and primary completion of the trial is expected in the first half of 2025.

Human Immunodeficiency Virus (HIV)

Today, HIV continues to be a major global public health issue, having claimed more than 35 million lives so far and affecting approximately 36.9 million people at the end of 2017. HIV research has come a long way since the discovery of the disease in the 1980’s but there is no cure for HIV infection. There are antiretroviral (ARV) drugs that control the virus and help prevent transmission. The goal now is to find a cure for HIV to change the lives of millions affected by the disease.

Our solution: HIV Therapy
The objective of the Human Immunodeficiency Virus (HIV) program is to use HOOKIPA’s technologies to design arenavirus vectors (Lymphocytic Choriomeningitis Virus or Pichinde Virus based) suitable for treatment, cure or prevention of HIV. Together with our partner Gilead Sciences, we intend to develop functional therapies for patients already infected with HIV.

In February 2022, HOOKIPA and Gilead agreed to advance its partnered HIV program. HOOKIPA assumed development responsibility for the HB-500 program through the completion of a Phase 1b clinical trial; Gilead has the exclusive right for further development thereafter. In November 2023, Hookipa received the FDA clearance of IND application for HB-500 and started the Phase 1b trial with the first person dosed in July 2024.

As of January 2025, the enrollment in the Phase 1b with 30 participants is finished with primary completion expected in the second half of 2025.