Squamous Cell Carcinoma of the Oropharynx

Study done in collaboration with Memorial Sloan Kettering and led by Dr. Winston Wong, Head and Neck Oncologist and Dr. Alan Ho, Chief of the Head and Neck Oncology Service IIT will evaluate eseba-vec in patients who are HPV16+ after treatment for curative intent Potential to expand the eseba-vec HNSCC opportunity into adjuvant care Initial safety and efficacy data from IIT expected in 2026 NEW YORK and VIENNA, Oct. 30, 2024 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ: HOOK) (”HOOKIPA” or the “Company”), a clinical-stage biopharmaceutical company developing next generation immunotherapeutics for the treatment of cancer and serious infectious diseases, today announced that researchers at Memorial Sloan Kettering Cancer Center (MSKCC) have dosed the first patients in an investigator initiated trial (IIT) of eseba-vec, HOOKIPA’s human papillomavirus type 16 (HPV16+)-targeted investigational immunotherapeutic agent, in patients with minimal residual disease positive (MRD+) HPV-driven head and neck cancer. “Based on the positive Phase 2 data generated to date in recurrent/metastatic (R/M) HNSCC, we believe eseba-vec has broad potential across HPV16+ cancers. We are enthusiastic to explore the potential of eseba-vec as an adjuvant treatment for patients with locally advanced HNSCC and continue our collaboration with Drs. Wong and Ho and the team at MSKCC,” said Mark Winderlich, PhD, Chief Research and Development Officer at HOOKIPA. “We believe eseba-vec can help address unmet needs within the adjuvant setting and pave the way for us to help more patients with HNSCC.” Malte Peters, Chief Executive Officer of HOOKIPA added, “Eseba-vec was well tolerated and has demonstrated compelling efficacy in combination with pembrolizumab in HPV+ (R/M) HNSCC. We look forward to building on these promising findings with the expansion into adjuvant care. Our eseba-vec clinical development program in HNSCC continues to advance and we are on track to initiate our pivotal AVALON-1 Phase 2/3 study in the front-line setting for patients with HPV16+ oropharyngeal squamous cell carcinoma (OPSCC) in the fourth quarter of 2024. We expect initial safety and efficacy data from the IIT in 2026.” Winston Wong, MD, commented, “Targeted immunotherapeutic agents can play an important role in the care of patients with HPV16+ HSNCC. I am encouraged by the potential for eseba-vec in this setting based on promising Phase 2 combination data with pembrolizumab in the first line setting presented at this year’s American Society for Clinical Oncology annual meeting showing rapid and durable activation of antigen-specific CD8+ T cells and promising clinical response rates, especially in the CPS 20 or higher subgroup. Patients who are HPV16+ after receiving standard of care treatment for curative intent may also benefit from an immunotherapy treatment and we are currently testing whether eseba-vec may be a new, effective adjuvant treatment option.” The Phase 2, randomized, double-blind, placebo-controlled study (NCT06373380) will evaluate the use of eseba-vec in patients with minimal residual disease positive (MRD+) HPV-driven head and neck cancer. The primary endpoint of the study is disease-free survival. Secondary endpoints include an assessment of safety and tolerability. The study is expected to enroll approximately 50 patients. About eseba-vecEseba-vec (also known as HB-200) is an investigational immunotherapeutic agent being evaluated for HPV16 positive cancers. The first indication for eseba-vec is for the potential treatment of patients with HPV16+ recurrent/metastatic oropharyngeal squamous cell carcinoma (R/M OPSCC) with a PDL1 CPS of 20 or higher, in combination with pembrolizumab, in the first line (1L) setting. Eseba-vec has received Fast Track Designation from the U.S. Food and Drug Administration and PRIME designation from the European Medicines Agency for the treatment of 1L HPV16+ OPSCC. Eseba-vec was developed using HOOKIPA’s proprietary arenavirus platform. About HOOKIPAHOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company focused on developing next generation immunotherapeutics based on its proprietary arenavirus platform. The company’s product candidates are designed to induce specific, robust and durable CD8+ T cells and antibodies to eliminate cancers and serious infectious diseases. HOOKIPA’s pipeline includes biological therapies for oncology, targeting human papillomavirus type 16-positive (HPV16+) cancers, KRAS mutated cancers, and other targets. In addition, HOOKIPA has partnered with Gilead to develop therapies that are intended to provide functional cures for hepatitis B virus (HBV) and human immunodeficiency virus-1 (HIV-1). Find out more about HOOKIPA online at www.hookipapharma.com. Forward Looking StatementsCertain 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 “anticipates”, “believes”, “expects”, “plans”, “potential”, “will”, “would” or similar expressions and the negative of those terms. Forward-looking statements in this press release include HOOKIPA’s statements regarding the potential of its product candidates to improve the care of the patients it seeks to treat, HOOKIPA’s plans, strategies, expectations and anticipated milestones for its preclinical and clinical programs, including the timing of initiating clinical trials and patient enrollment, the availability and timing of results from preclinical studies and clinical trials and the expected safety profile of HOOKIPA’s product candidates. 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, plans and timelines for the preclinical and clinical development of its product candidates, including the therapeutic potential, clinical benefits and safety thereof, expectations regarding timing, success and data announcements of current ongoing preclinical and clinical trials, the ability to initiate new clinical programs, the risk that the results of current preclinical studies and clinical trials may not be predictive of future results in connection with current or future preclinical and clinical trials, including those for eseba-vec, HB-700, HB-400 and HB-500, 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, and HOOKIPA’s ability to continue as a going concern 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 Annual Report on Form 10-K for the year ended December 31, 2023, as well as discussions of potential risks, uncertainties, and other important factors in HOOKIPA’s subsequent filings with the Securities and Exchange Commission, which are available on the SEC’s website at https://sec.gov and HOOKIPA’s website at www.hookipapharma.com. All information in this press release is as of the date of the release, and HOOKIPA undertakes no duty to update this information unless required by law. Availability of Other Information About HOOKIPAInvestors and others should note that we announce material financial information to our investors using our investor relations website, www.ir.hookipapharma.com, SEC filings, press releases, public conference calls and webcasts. We use these channels, as well as social media, to communicate with our investors and the public about our company, and other issues. It is possible that the information we post on social media could be deemed to be material information. Therefore, we encourage investors, the media, and others interested in our company to review the information we post on the social media channels listed on our investor relations website. For further information, please contact: Investors Chuck PadalaChuck@LifeSciAdvisors.com

WALTHAM, Mass.--( BUSINESS WIRE )-- Naveris, Inc. , the leader in precision oncology diagnostics for viral-induced cancers, today announced the presentation of new data at the 66th Annual Meeting of the American Society for Radiation Oncology (ASTRO) , taking place September 29 – October 2, 2024, in Washington, D.C.. These presentations will showcase the role of the NavDx® test, the first and only clinically validated circulating Tumor Tissue Modified Viral (TTMV®)-HPV DNA blood test, in the management of HPV-driven oropharyngeal cancers, with a focus on integration into radiation oncology practices. “ASTRO is the premier gathering for radiation oncology professionals, providing the perfect platform to showcase how the NavDx test is transforming the care of patients with HPV-driven cancers,” said Barry M. Berger, M.D., Chief Medical Officer at Naveris. “These presentations will highlight the role of testing in personalizing treatment, enhancing real-time surveillance, and ultimately improving patient outcomes in the field of radiation oncology.” Oral Presentations: The following presentation will be part of SS 37 - H&N 1: Envisioning the Future: Leading Edge Research in HPV-Associated Oropharyngeal Cancer on Tuesday, October 1, 2024, from 3:00 PM – 4:00 PM EDT at the Walter E. Washington Convention Center (WWCC), Room 145: Tuesday, October 1, 2024 | 4:40 PM – 4:50 PM EDT The Preliminary Analysis of Circulating Human Papillomavirus DNA in a Phase III Trial of Concurrent Chemoradiation (CRT) with Intensity Modulated Proton Therapy (IMPT) vs. IMRT in Oropharyngeal Squamous Cell Carcinoma Presenting Author: Li Wang, M.D., Ph.D. | Senior Author: Steven Frank, M.D. MD Anderson Cancer Center, Houston, TX This large study analyzed over 1,000 blood samples and showed that the NavDx test can identify patients at risk for treatment failure earlier than imaging, demonstrating its potential as a robust biomarker to guide treatment intensity in HPV+ OPSCC. The following educational session presentation will also incorporate a discussion of the NavDx test: Monday, September 30, 2024 | 10:30 AM – 11:30 AM EDT | Room 151 EDU 24 - Integration of HPV ctDNA Testing into Clinical Practice for HPV+ OPSCC - Ready for Prime Time? Moderator: John Lukens, M.D. | Speakers: David Routman, M.D., Michelle Mierzwa, M.D., Dan Faden, M.D. University of Pennsylvania, Mayo Clinic, University of Michigan, Mass General Brigham This educational session will explore the use of HPV ctDNA testing in clinical practice for HPV+ OPSCC, incorporating the NavDx test as part of a broader discussion on using ctDNA for treatment guidance and monitoring. Poster Presentations: The following posters will be part of PQA 10 - Head & Neck Cancer and Health Services Research/Global Oncology on Wednesday, October 2, 2024, from 10:30 AM – 11:45 AM EDT at WWCC, Hall C: (3608) The Impact of Circulating Tumor Human Papillomavirus (HPV) DNA Clearance Kinetics on Disease Outcomes during Chemoradiation in Patients with HPV-Associated Oropharyngeal Cancer Presenter: Sujith Baliga, M.D. | Senior Author: David M. Blakaj, M.D., Ph.D. The Ohio State University, Columbus, OH This study shows that changes in NavDx test results during treatment can predict outcomes, with rapid clearance indicating better control and persistent positivity suggesting higher risk, highlighting NavDx as a tool for adjusting radiation therapy intensity based on patient risk. (3718) Tracking Circulating Tumor HPV DNA with Early Cessation of Radiotherapy in Oropharynx Cancer Presenter: Zubir Rentiya, M.D., MSc | Senior Author: Charles McLaughlin, M.D. University of Virginia, Charlottesville, VA This study shows that using mid-treatment NavDx test results to guide early cessation of radiotherapy led to excellent outcomes, with superior progression-free survival compared to patients completing the full course of treatment. (3639) Comparative Performance of ctHPVDNA and Imaging Surveillance for Oropharyngeal Cancer Following Radiotherapy Presenter: Yifu Ding, M.D., Ph.D. | Senior Author: Walter A. Stokes, M.D. Winship Cancer Institute of Emory University, Atlanta, GA This study found that NavDx outperforms imaging in post-radiotherapy surveillance, with fewer false positives and higher specificity. Naveris will be exhibiting at the conference at Booth #2037, where attendees can learn more about NavDx and its impact on improving care for patients with HPV-driven cancers in radiation oncology. For more information about Naveris and NavDx®, please visit www.naveris.com and www.NavDx.com . About Naveris Naveris is a privately held, commercial stage, precision oncology diagnostics company with facilities in Massachusetts and North Carolina. Since its founding in 2017, Naveris has been committed to improving outcomes for the millions of people at risk of developing viral-induced cancers with novel molecular diagnostics that enable earlier cancer detection. The company operates high-complexity testing clinical laboratories that are accredited by the College of American Pathologists and the New York State Department of Health Wadsworth Center, and are certified under CLIA. For more information on Naveris and the clinical impact of NavDx, please visit www.naveris.com and www.NavDx.com . NavDx has not been cleared or approved by the US Food and Drug Administration (FDA).

WALTHAM, Mass.--( BUSINESS WIRE )-- Naveris, Inc. , the leader in precision oncology diagnostics for viral-induced cancers, today announced the presentation of new data at the 2024 Annual Meeting of the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) , taking place September 28 – October 1, 2024 in Miami Beach, Florida. These presentations highlight the continued innovation of the NavDx ® test , the first and only clinically validated circulating Tumor Tissue Modified Viral (TTMV ® )-HPV DNA blood test, which aids in the detection and management of HPV-driven oropharyngeal cancers. “The AAO-HNS meeting provides a critical platform to share our latest advancements in the detection and management of HPV-associated oropharyngeal cancer,” said Barry M. Berger, M.D., Chief Medical Officer at Naveris. “The NavDx test continues to prove its value as a leading tool in detecting molecular residual disease, allowing clinicians to monitor patients post-treatment with precision and make informed decisions that can directly impact patient care.” Oral Presentations: The following three oral presentations will be part of the Scientific Oral Presentations 1 - Head and Neck Surgery session, which will be held on Saturday, September 28, 2024, from 9:30 AM – 10:30 AM EDT at the Miami Beach Convention Center (MBCC), Room 208. Saturday, September 28, 2024 | 9:42 AM – 9:48 AM EDT Circulating Tumor Tissue-Modified-Viral-HPV DNA and Correlation With Disease Burden in Oropharyngeal Cancer Presenting Author: Jaclyn Lee, M.D. | Senior Author: Michael C. Topf, M.D., MSCI Vanderbilt University Medical Center, Nashville, TN This study evaluates the association between pre-treatment TTMV-HPV DNA and clinical tumor staging, nodal staging, and imaging results in patients with HPV+ oropharyngeal squamous cell carcinoma (OPSCC), reporting an independent association between pretreatment TTMV-HPV DNA and clinical nodal staging. Saturday, September 28, 2024 | 9:54 AM – 10:00 AM EDT Association of Circulating Tumor HPV DNA Score and Clinicopathologic Characteristics in HPV-Associated Oropharyngeal Cancer Presenting Author: Shimrit Sharav, M.D. | Senior Author: Terry Day, M.D. Sarah Cannon Cancer Institute, Charleston, SC This study explores the relationship between TTMV-HPV DNA and clinicopathological factors, showing significant correlations between the TTMV-HPV DNA and nodal disease burden in HPV+ OPSCC patients. Saturday, September 28, 2024 | 10:12 AM – 10:18 AM EDT Liquid Biopsy in Diagnosis and Surveillance of HPV-Associated Oropharyngeal Cancer: A Systematic Review Presenting Author: Susmita Chennareddy, B.A. | Senior Author: Scott A. Roof, M.D. Icahn School of Medicine at Mount Sinai, New York, NY This systematic review assesses the diagnostic accuracy and clinical utility of circulating tumor DNA (ctDNA) technologies in HPV-associated OPSCC, including the NavDx assay, concluding that ctDNA demonstrates high sensitivity and specificity for disease detection, treatment monitoring, and recurrence surveillance. The following presentation will be part of Scientific Oral Presentations 3 - Head and Neck Surgery on Sunday, September 29, 2024, from 9:30 AM – 10:30 AM EDT at MBCC, Room 208. Sunday, September 29, 2024 | 9:54 AM – 10:00 AM EDT Examining Patients’ Opinions on NavDx During Head and Neck Cancer Surveillance: An Exploratory Study Presenting Author: Amanda Joy Bastien, M.D. | Senior Author: Allen S. Ho, M.D. Cedars Sinai, Los Angeles, CA This study evaluates patient opinions on NavDx as a molecular surveillance tool, highlighting themes such as convenience, cost, and perceived test validity. The following panel presentations will also incorporate a discussion of the NavDx test: Monday, September 30, 2024 | 8:00 AM – 9:00 AM EDT | MBCC, Room 207 HPV: Is It in Your DNA Moderator: Marianne Abouyared, M.D. | Panelists: Eleni Rettig, M.D., Rusha J. Patel, M.D., Antoine Eskander, M.D., Sc.M. University of California Davis Medical Center, Brigham and Women’s Hospital, The University of Oklahoma Health Sciences Center, Sunnybrook Health Sciences Centre This panel will discuss the role of HPV in oropharyngeal cancers, including the use of circulating HPV DNA (HPV ctDNA) as a surveillance tool, presenting evidence for its integration into clinical practice and how to navigate patient-provider conversations around HPV-related malignancies. Poster Presentations: Monday, September 30, 2024 | 12:00 PM – 1:00 PM EDT | Exhibit Hall A-D (0610) Association Between Routine Laboratory Inflammatory Indicators and Circulating Tumor DNA Levels in HPV-Positive Oropharyngeal Carcinoma Presenting Author: Ryan S. Ziltzer, M.D., MPH | Senior Author: Meghan T. Turner, M.D. West Virginia University, Morgantown, WV This pilot study suggests that certain inflammatory indices are significantly associated with higher TTMV-HPV DNA Scores in OPSCC, indicating their potential utility as surrogate markers for disease monitoring. Naveris will be exhibiting at the conference at Booth #718, where attendees can learn more about NavDx and its impact on optimizing surveillance of oropharyngeal cancer recurrence and informing the care of patients with HPV-driven cancers. For more information about Naveris and NavDx, please visit www.naveris.com and www.NavDx.com . About Naveris Naveris is a privately held, commercial stage, precision oncology diagnostics company with facilities in Massachusetts and North Carolina. Since its founding in 2017, Naveris has been committed to improving outcomes for the millions of people at risk of developing viral-induced cancers with novel molecular diagnostics that enable earlier cancer detection. The company operates high-complexity testing clinical laboratories that are accredited by the College of American Pathologists and the New York State Department of Health Wadsworth Center, and are certified under CLIA. For more information on Naveris and the clinical impact of NavDx, please visit www.naveris.com and www.NavDx.com . NavDx has not been cleared or approved by the US Food and Drug Administration (FDA).