The patents (US Patent No. 10,722,564 and European Patent No. 3218504) are granted to the University of Geneva. HOOKIPA has exclusively licensed these patents from the University. The patent claims cover current product candidates based on HOOKIPA’s replicating arenavirus platform technology (TheraT®), including the Company’s lead oncology product candidates HB-201 and HB-202. These programs are currently in clinical development for the treatment of Human Papillomavirus 16-positive (HPV16+) cancers.
In addition to the replicating arenavirus platform patents, the USPTO recently granted a patent (US Patent No. 10,669,315) specifically related to HOOKIPA’s HB-201 and HB-202 product candidates, which are two different replicating arenavirus-based vectors encoding the same E7/E6 fusion protein. The patent protection for HB-201 and HB-202 conferred by these platform and product-specific patents extends to 2037 in the United States and 2035 in Europe (not taking into account potential Patent Term Extension or Supplementary Protection Certificates).
"The newly issued patents provide general, long-term patent protection for our arenavirus technology and related oncology programs. The combination of broad patents on our arenavirus platform and specific patents on product candidates underpin the commercial potential of the therapies we are developing,” said Joern Aldag, HOOKIPA’s Chief Executive Officer.
About Replicating Arenavirus Technology (TheraT®)
HOOKIPA’s proprietary and patented replicating arenavirus technology induces powerful immune responses. HOOKIPA’s replicating arenavirus constructs are engineered to be specific for antigens of choice. Arenaviruses have a natural ability to evade neutralization, enabling repeated intravenous delivery.
The replicating arenavirus platform is able to direct more than 50% of a mouse’s T cells to focus on a single target of choice. In various animal models, immunization with HOOKIPA’s replicating arenavirus resulted in elimination of a primary tumor and metastasis and provided long-term protection against a cancer re-challenge months after primary treatment. The Company believes that its arenavirus-based treatments are more potent immunotherapies than alternative therapeutic modalities.
HOOKIPA’s lead oncology programs, HB-201 and HB-202 for the treatment of Human Papillomavirus 16-positive cancers, are both based on its replicating arenavirus platform.
HOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical stage biopharmaceutical company developing a new class of immunotherapeutics targeting infectious diseases and cancers based on its proprietary arenavirus platform that reprograms the body’s immune system.
HOOKIPA’s proprietary arenavirus-based technologies, non-replicating (VaxWave®) and replicating (TheraT®), induce robust antigen-specific CD8+ T cells and pathogen-neutralizing antibodies. HOOKIPA’s “off-the-shelf” viral vectors target antigen presenting cells in vivo to activate the immune system. Both technologies enable repeat administration to augment and refresh immune responses. As a monotherapy, our replicating arenavirus technology has the potential to induce CD8+ T cell response levels previously not achieved by other immuno-therapy approaches.
HOOKIPA’s non-replicating prophylactic Cytomegalovirus (CMV) vaccine candidate is currently in a Phase 2 clinical trial for patients awaiting kidney transplantation. To expand its infectious disease portfolio, HOOKIPA entered into a collaboration and licensing agreement with Gilead Sciences, Inc. to research arenavirus-based functional cures for HIV and chronic Hepatitis B infections.
In addition, HOOKIPA is building a proprietary immuno-oncology pipeline by targeting virally mediated cancer antigens, self-antigens and next-generation antigens. The lead replicating arenavirus oncology product candidates, HB-201 and HB-202, are in development for the treatment of Human Papilloma Virus 16-positive cancers. The Phase 1/2 clinical trial for HB-201 was initiated in December 2019. The HB-202 IND application was cleared by the FDA in June 2020.
Find out more about HOOKIPA online at www.hookipapharma.com.
HOOKIPA 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 for HB-101 and other programs, and other matters that could affect the sufficiency of existing cash to fund operations and HOOKIPA’s ability to achieve the milestones under the agreement with Gilead. 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 March 31, 2020 which is available on the Security and Exchange Commission’s website at www.sec.gov and HOOKIPA’s website at www.hookipapharma.com.
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