HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company focused on developing immunotherapeutics using its proprietary arenavirus platform, has received FDA clearance for its Investigational New Drug (IND) application for HB-500. This IND application pertains to a novel arenaviral therapeutic vaccine designed for the treatment of HIV. HOOKIPA will oversee the HIV program through the Phase 1b clinical trial, and subsequent development of the program is under the exclusive purview of Gilead.

HOOKIPA, emphasized the significance of this achievement, stating, “This marks our fourth active IND program at HOOKIPA—a testament to the broad potential of our arenavirus platform across multiple disease areas and indications. The ability to generate a potent and broad T cell response that can clear infected cells is critical for HIV control. Our novel arenaviral therapeutic vaccine offers promise in addressing the unmet need for a functional HIV cure.”

Recent research jointly conducted by HOOKIPA and Gilead, published in Nature Partner Journals (NPJ) Vaccines, served as the foundation for the IND submission. This research, using a simian immunodeficiency virus (SIV) model, demonstrated that the arenaviral therapeutic vaccination was well-tolerated and generated robust, high-quality, and durable immune responses in non-human primates. Furthermore, the vaccination significantly reduced SIV viral load and clinical illness compared to the placebo.

HB-500, the alternating, 2-vector arenaviral therapeutic vaccine for HIV treatment, utilizes lymphocytic choriomeningitis virus (LCMV) and Pichinde virus (PICV) as its arenaviral backbones. Both vectors encode the same HIV antigens. This 2-vector approach is designed to enhance the immune response against the target antigen.

HOOKIPA's collaboration and license agreement with Gilead encompass two separate development programs, with HB-500 being a significant component.

HIV remains a global public health challenge, affecting over 38 million people worldwide. While current treatments have extended the lives of individuals with HIV and reduced transmission, there is still no cure for HIV or AIDS.

 

Source: globenewswire.com

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