- Novel arenaviral immunotherapy is directed against the prostate cancer targets PAP and PSA; Phase 1/2 trial to commence by early 2023
- Drug
Master File (DMF) accepted to support future FDA submissions
“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
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
A Drug
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.
About HOOKIPA
Find out more about HOOKIPA online at www.hookipapharma.com.
For further information, please contact:
Media | Investors | |
Michael Szumera | ||
Executive Director - Communications | Executive Director - Investor Relations | |
michael.szumera@hookipapharma.com | matthew.beck@hookipapharma.com | |
+1 917 561 8905 | +1 917 209 6886 |
Forward Looking Statements
Certain statements set forth in this press release constitute “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by terms such as “believes,” “expects,” “plans,” “potential,” “would” or similar expressions and the negative of those terms. Such forward-looking statements involve substantial risks and uncertainties that could cause HOOKIPA’s research and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including HOOKIPA’s programs’ early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, HOOKIPA’s ability to successfully establish, protect and defend its intellectual property, risks relating to business interruptions resulting from the coronavirus (COVID-19) disease outbreak or similar public health crises, the impact of COVID-19 on the enrollment of patients and timing of clinical results, and other matters that could affect the sufficiency of existing cash to fund operations. HOOKIPA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see HOOKIPA’s quarterly report on Form 10-Q for the quarter ended
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