US-based biotechnology company HOOKIPA Pharma has dosed the first subject in a Phase Ib clinical trial of HB-500, a therapeutic vaccine candidate for human immunodeficiency virus (HIV).
The study is designed to assess the vaccine’s safety, tolerability and immune response in individuals with HIV who are on suppressive antiretroviral therapy.
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It will have two dose escalation cohorts, with participants being randomised to receive either HB-500 or a placebo.
The dosing of the first subject triggered a $5m milestone payment to HOOKIPA under its existing collaboration and license agreement with Gilead.
Under the agreed terms, HOOKIPA will progress the HIV programme through to completion of the Phase Ib trial.
Gilead holds exclusive rights to take over the programme’s development once the trial has ended.
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By GlobalDataHB-500 is one of two developmental programmes covered by the partnership between HOOKIPA and Gilead.
The investigational vaccine uses two replicating vectors derived from arenaviruses, specifically the Pichinde virus and lymphocytic choriomeningitis virus.
Its immunogens are designed to be distinct in their amino acid sequences, providing coverage for more than 80% of circulating HIV-1 viral variants.
HOOKIPA Pharma CEO Joern Aldag said: “HIV impacts the daily lives of millions globally, with no known curative treatment.
“While current treatments effectively block viral replication and can prevent progression to AIDS, they have not been shown to clear the virus from people living with HIV, requiring lifelong treatment.
“We have previously published impressive findings in our preclinical studies of HB-500, and we are happy to have begun the Phase Ib trial.
“Our team has worked tirelessly, alongside our great collaboration partners at Gilead, to reach this point, and we are excited to take an important step toward finding a curative treatment for HIV.”
Last year, HOOKIPA dosed the first patient in a Phase I trial of HB-400, a non-replicating arenaviral vaccine candidate for chronic hepatitis B.
