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, and Gilead intends to dose the first subject in a Phase 1 study in 2023.  HOOKIPA does not control the clinical timetable of the HBV therapy clinical program.

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, triggering a $54 million commitment from Gilead. 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. Financial terms included a $4 million preclinical milestone, a $15 million non-refundable initiation fee and $35 million equity commitment at a premium to market price.  If Gilead pursues further development, HOOKIPA is entitled to potential development and sales milestone payments exceeding $237 million, as well as royalties on net product sales.

The research phase of the HIV program has been completed, and the program is now in clinical development.  HOOKIPA aims to file the HIV program IND in 2023.