HOOKIPA announces publication on the benefits of its novel arenaviral immunotherapeutics in cancer in Frontiers in Oncology

• Comprehensive review highlights potential of HOOKIPA’s versatile arenavirus platform as a new immunotherapy strategy to address critical unmet needs in cancer
• Pre-clinical and clinical data showcase potent, tumor-specific CD8+ T cell responses following intravenous administration of arenaviral immunotherapies

• Early clinical efficacy and safety observed with arenaviral immunotherapy, HB-200 offer promise for people with advanced Human Papillomavirus 16+ (HPV16+) cancer

NEW YORK and VIENNA, Austria., Oct. 14, 2021 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced the publication of a comprehensive review article on arenaviral immunotherapies in the peer-reviewed online journal, Frontiers in Oncology(Link). The article reinforces the potential of HOOKIPA’s versatile arenavirus platform as a promising strategy to elicit potent, tumor-specific T cell responses and help address critical unmet needs in the treatment of cancer.

“We believe there is broad potential for our foundational arenavirus platform to deliver novel immunotherapies for a range of cancers. The publication in Frontiers in Oncology validates the strength of our science as an emerging strategy in cancer treatment and offers hope to patients and clinicians who need more tools in their fight,” said Joern Aldag, Chief Executive Officer at HOOKIPA. “We remain focused on advancing our promising HB-200 program, including progressing to Phase 2 in the coming months, as well as exploring other cancer targets, like prostate cancer, based on our selection of tumor antigens.”

Taken together, the publication highlights several key advantages of HOOKIPA’s arenavirus platform, including the ability to:

• Directly target and activate antigen-presenting cells (APCs) to induce robust, polyfunctional CD8+ T cell responses;
• Target APCs without killing them (non-lytic), unlike other viral approaches which must infect tumor cells directly to be efficacious;
• Administer intravenously, which is accessible for all patients and less invasive than some intratumoral approaches required by other viral therapies;
• Further augment CD8+ T cell responses with administration of alternating vector therapy to levels previously not observed with other technologies;
• Induce sustained cytotoxic T lymphocyte (CTLs) responses and durable anti-tumor activity, indicating immunologic memory;
• Potentially work synergistically with PD-1 inhibitors, helping expand the number of people who may benefit from therapy and improve long-term outcomes.

The article also reviews clinical data from the ongoing HB-201/HB-202 trial in people with advanced HPV16+ cancers. The clinical data, as presented at the American Society of Clinical Oncology 2021 Annual Meeting, showed that HB-200 is highly immunogenic, inducing unprecedented levels of activated, tumor antigen-specific CD8+ T cells (up to 40 percent of the T cell pool). In addition, HB-201 monotherapy showed an 18 percent overall response rate and median progression-free survival of 3.45 months in heavily pre-treated head and neck cancer patients who progressed on standard of care, including checkpoint inhibitors. While the trial is ongoing, these initial data show results with monotherapy that are better than the current second-line standard of care in these advanced patients. The data offer clinical proof-of-concept for the arenavirus platform, which has the potential to target a range of cancers based on antigen selection.

About HB-201/HB-202
HB-201 and HB-202 are HOOKIPA’s lead oncology candidates engineered with the company’s proprietary replicating arenaviral vector platform. Each single-vector compound uses a different arenavirus backbone (Lymphocytic Choriomeningitis Virus for HB-201 and Pichinde Virus for HB-202), while expressing the same antigen, an E7E6 fusion protein derived from HPV16. In pre-clinical studies, alternating administration of HB-201 and HB-202 showed a ten-fold increase in immune response and better disease control than either compound alone. Both compounds are being evaluated in an ongoing Phase 1/2 study (NCT04180215) in individuals with treatment-refractory HPV16+ cancers who have progressed on standard of care, including checkpoint inhibitors.

About HOOKIPA
HOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies that mobilize and amplify targeted T cells and antibodies, the body’s natural infection killers, to fight or prevent serious disease.

HOOKIPA is developing a broad pipeline of potential first-in-class arenaviral immunotherapies in oncology and infectious disease. We are leveraging our proprietary, versatile platform to engineer arenaviral therapeutics that induce robust antigen-specific CD8+ T cells and pathogen-neutralizing antibodies to a broad range of self and non-self antigens, including viral antigens, tumor-associated antigens and neoantigens. Our immunotherapies are designed to use either non-replicating or replicating viral vectors based on the target disease, with the potential to induce CD8+ T cell response levels previously not achieved by other immunotherapy approaches.

HOOKIPA’s pipeline include three ongoing clinical trials in Human Papilloma Virus 16-positive cancers and Cytomegalovirus, as well as preclinical research in prostate cancer, HIV and Hepatitis B. The latter two are in collaboration with Gilead Sciences, Inc.

Find out more about HOOKIPA online at www.hookipapharma.com.

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 annual report on Form 10-Q for the financial year ended June 30, 2021 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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