FDA accepts HOOKIPA’s IND application for HB-300 for the treatment of metastatic castration-resistant prostate cancer

25-Jul-2022

Novel arenaviral immunotherapy is directed against the prostate cancer targets PAP and PSA; Phase I/II trial to commence by early 2023

HOOKIPA Pharma, a company developing a new class of immunotherapies based on its proprietary arenavirus platform, has received US Food and Drug Administration (FDA) acceptance of its Investigational New Drug (IND) application for HB-300, a novel arenaviral immunotherapy for the treatment of metastatic castration-resistant prostate cancer.

“FDA acceptance of our IND application for HB-300 is a key milestone as we expand and diversify our oncology pipeline and arenavirus platform from viral antigens to self-antigens,” said Joern Aldag, Chief Executive Officer at HOOKIPA.

“With the concurrent acceptance of the Drug Master File, we have reduced cycle time between completion of preclinical studies and clinical entry of our pipeline projects.”

HB-300 is an alternating, 2-vector replicating arenaviral immunotherapy for metastatic castration-resistant prostate cancer. It uses the Lymphocytic Choriomeningitis Virus and Pichinde Virus as arenaviral backbones, with each expressing two well-defined antigens of prostate cancer, PAP and PSA.

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Subsequent clinical development may include addition of arenaviral therapeutics expressing a third antigen, PSMA. HOOKIPA’s approach is designed to focus the immune response against the target antigens. The technology has demonstrated the ability to induce potent antigen-specific T cell responses and anti-tumour activity in preclinical tumour models.

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