On July 25, 2022 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapies based on its proprietary arenavirus platform, reported that it has received U.S. 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 (Press release, Hookipa Pharma, JUL 25, 2022, View Source [SID1234616904]).
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"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."
About HB-300
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. 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-tumor activity in preclinical tumor models.
About the Drug Master File
A Drug Master File (DMF) is a voluntary submission to the FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. The information contained in the DMF may be used to support additional INDs and other submissions. The FDA accepted HOOKIPA’s submission of a Type II Master File to the FDA’s Center for Biologics Evaluation and Research to present data specific to HOOKIPA’s proprietary replicating arenavirus platform.
About prostate cancer
Prostate cancer is the most diagnosed cancer and fifth leading cause of death from cancer in men. There are several stages of prostate cancer, and prostate cancer cells usually need androgen hormones, such as testosterone, to grow. Treatment for early-stage prostate cancer often aims to lower testosterone levels to stop or slow growth. Metastatic castration-resistant prostate cancer is when the cancer has spread, or metastasized, to other parts of the body including the lymph nodes, bones, rectum, liver and lungs. Metastatic castration-resistant prostate cancer does not respond to hormone therapy. Currently, there are limited treatment options for people with metastatic castration-resistant prostate cancer and only 30 percent will survive beyond five years.