Esepapogene Zalarnarepvec

Next-generation therapeutic cancer vaccines in development for various oncology indications sold to NeoTrail Therapeutics with an undisclosed purchase price NEW YORK and VIENNA, Austria, Feb. 03, 2026 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (OTCID: HOOK, “HOOKIPA”, the “Company”) today announced the sale of its immuno-oncology related assets, consisting primarily of the HB-200 (eseba-vec) and HB-700 development programs, to NeoTrail Therapeutics, Inc. (“NeoTrail”). The purchase price remains undisclosed. "We are delighted that the clinical development of these promising therapeutics will continue at NeoTrail with an opportunity to deliver patient benefit in multiple major market indications,” stated Mark Winderlich, Chief R&D Officer of HOOKIPA. The asset purchase agreement was signed on January 28, 2026, and the transaction is expected to close in the second quarter of 2026, subject to the satisfaction of customary closing conditions. About HB-200 Eseba-vec (also known as HB-200) is an investigational immunotherapeutic agent being evaluated for HPV16 positive cancers. HB-200 alternates the administration of both HB-201 (LCMV) and HB-202 (PICV), collectively referred to as “HB-200,” attenuated viral vectors, which on their own are replicating-based therapeutics expressing a non-oncogenic, but highly immunogenic, E7E6 fusion protein from HPV16. Positive preliminary data from a Phase 2 trial (NCT04180215) of HB-200 in combination with pembrolizumab in patients with recurrent/metastatic HPV16 positive head and neck cancers in the first line setting was presented in November 2024 at the Society for Immunotherapy of Cancer (SITC) Conference. Trial close out activities were completed before the end of 2025. HB-200 received Fast Track Designation from the U.S. Food and Drug Administration and PRIME designation from the European Medicines Agency. HB-200 was developed using HOOKIPA’s proprietary arenavirus platform. About HB-700 HB-700 is an investigational arenaviral immunotherapy designed to treat KRAS-mutated lung, colorectal, pancreatic and other cancers. HB-700 is a replicating 2-vector therapy that targets the most prevalent KRAS mutations (G12D, G12V, G12R, G12C and G13D) and has the potential to benefit more patients than single mutation inhibitors. HB-700 received Investigational New Drug application clearance from the Food and Drug Administration in April 2024 and is Phase 1 ready, with clinical trial material manufacturing completed. Forward Looking Statements Certain statements set forth in this press release constitute “forward-looking” statements. 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 expected closing of the asset purchase agreement and the therapeutic potential of HB-200 and HB-700. Such forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, market conditions, the failure of customary closing conditions to the asset purchase agreement, the uncertainties inherent in the drug development process, the risk that results of preclinical studies and clinical trials may not be predictive of future results in current or future preclinical and clinical trials, including those for HB-200 and HB-700, the regulatory approval process, the timing of regulatory filings and the challenges associated with manufacturing drug products. Any forward-looking statements and the information in this press release are as of the date of the release, and HOOKIPA undertakes no duty to update these forward-looking statements and information unless required by law. Availability of Other Information About HOOKIPA Investors and others should note that HOOKIPA announces material financial information to investors using the Company’s investor relations website, www.ir.hookipapharma.com, OTC Markets filings, press releases, public conference calls and webcasts. HOOKIPA uses these channels, as well as social media, to communicate with investors and the public about the company, and other issues. It is possible that the information HOOKIPA posts on social media could be deemed to be material information. Therefore, investors, the media, and others interested in HOOKIPA are encouraged to review the information on the social media channels listed on the Company’s investor relations website. For further information, please contact: IR@hookipapharma.com

HB-200 in combination with pembrolizumab doubled the objective response rate of 1st-line pembrolizumab for patients with recurrent/metastatic head and neck cancer HOOKIPA is preparing to start a pivotal trial of HB-200 in combination with pembrolizumab as 1st-line treatment of recurrent/metastatic HPV16+ head and neck cancer in 2024 Initial cohort of heavily pre-treated patients who received HB-200 monotherapy showed preliminary median overall survival of 14.2 months in the intent-to-treat population HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced positive preliminary data from its ongoing Phase 2 study of HB-200 in combination with pembrolizumab in patients with recurrent/metastatic Human Papillomavirus 16-positive (HPV16+) head and neck cancer. New data show a 43 percent objective response rate (ORR) with HB-200 in combination with pembrolizumab in checkpoint inhibitor (CPI)-naïve patients, doubling the 19 percent response rate for pembrolizumab alone. HOOKIPA plans to share the full data at a medical conference later this year and is preparing to start a pivotal trial of HB-200 in combination with pembrolizumab in the 1st-line setting in 2024. The company will host a webcast call June 1st at 8:00 a.m. EDT. “Given the unmet medical need for patients with recurrent/metastatic HPV16+ head and neck cancers, we are thrilled to share the preliminary data on HB-200 in combination with pembrolizumab as they show a robust improvement in objective response rate and prolonged tumor control compared to pembrolizumab alone,” said Joern Aldag, Chief Executive Officer at HOOKIPA. “Efficacy, immunogenicity and safety data observed in our HB-200 program to-date support our decision to progress to a pivotal trial of HB-200 in combination with pembrolizumab as 1st-line treatment for these patients. The data also underscore the scalability of our arenaviral platform across a range of cancers.” HB-200 results (NCT04180215) As of March 31, 2023, 35 patients with HPV16+ recurrent/metastatic head and neck cancers received HB-200 in combination with pembrolizumab as part of the Phase 2 study: 20 patients were treated with HB-200 and pembrolizumab in the 1st-line setting and 15 in the 2nd-line setting. All received HB-200 intravenously every three weeks for the first five doses and every six weeks thereafter. HB-200 means 2-vector therapy with alternating application of HB-201 (LCMV), HB-202 (PICV) vectors, encoding HPV16 E6/E7 antigens. 1st-line combination data HB-200 in combination with pembrolizumab demonstrated promising anti-tumor activity with a 43 percent objective response rate (6 of 14 patients with confirmed responses by investigator assessment under RECIST 1.1) among CPI-naïve patients with recurrent/metastatic HPV16+ PD-L1+ head and neck cancer. These data represent a doubling of the 19 percent objective response rate reported with pembrolizumab alone.1 As of March 31, 2023, 14 patients with at least two imaging assessments were included in the interim efficacy analysis. Six patients responded (one with confirmed complete response and five with confirmed partial responses), with a 71 percent disease control rate (10 of 14 patients), meaning stable disease or a complete or partial response. While recruitment is ongoing, based on these data, HOOKIPA is preparing to start a pivotal trial of HB-200 in combination with pembrolizumab as 1st-line treatment of recurrent/metastatic HPV16+ PD-L1+ head and neck cancers in 2024. 2nd-line plus combination data Data on HB-200 in combination with pembrolizumab in the 2nd-line plus setting are trending positively in this small initial cohort, but they are preliminary and need further maturation. As of March 31, 2023, five patients with at least two imaging assessments were included in the interim efficacy analysis based on RECIST 1.1. Preliminary results show one confirmed partial response and three patients with stable disease. Preliminary median progression-free survival in this small cohort was 5.3 months. Enrollment is ongoing, and a decision on a potential path forward in the 2nd-line plus setting will be made in 2024. Monotherapy data Given the limited options for heavily pre-treated patients with recurrent/metastatic HPV16+ head and neck cancers, HOOKIPA continues to evaluate HB-200 as monotherapy among these patients in the ongoing Phase 1/2 trial. Follow-up data show HB-200 monotherapy demonstrated a preliminary median overall survival of 14.2 months in the intent-to-treat population, indicating potential for prolonged clinical benefit in this heavily pre-treated population. These data are based on 11 patients who received HB-200 as monotherapy at the same dose being evaluated in combination with pembrolizumab, with a median follow-up period of 12.8 months. Additional patients are also being followed to continue to assess median overall survival in a larger cohort. Immunogenicity Importantly, new follow-up data from heavily pre-treated patients show an association between the induction of unprecedented levels of functional T cells after treatment with HB-200 monotherapy and clinical benefit. T cell increases were rapid and sustained for at least 8 months, as of data cut-off. Patients who achieved disease control after treatment with HB-200 monotherapy generally had greater CD8+ T cell infiltration in tumors compared to patients whose disease progressed, suggesting an association of HB-200-induced T cells and clinical benefit. The webcast and the presentation will be available within the Investors & Media section of HOOKIPA’s website at https://ir.hookipapharma.com/events. An archived replay will be accessible for 30 days following the event. About HB-200 HB-200 is HOOKIPA’s lead oncology candidate engineered with the company’s proprietary replicating arenaviral vector platform. It comprises two single-vector compounds with arenaviral backbones based on lymphocytic choriomeningitis virus and pichinde virus. Both express the same transgene encoding an E7E6 fusion protein derived from HPV16. HB-200 is an alternating 2-vector immunotherapy designed to further focus the immune response against the encoded antigen. HB-200 in combination with pembrolizumab received Fast Track Designation from the U.S. Food and Drug Administration for the treatment of 1st-line recurrent/metastatic HPV16+ head and neck cancers. About the HB-200 trial (NCT04180215) This Phase 1/2 clinical trial is an open-label trial evaluating HB-200 for the treatment of advanced HPV16+ cancers. Phase 1 assessed various dose levels, regimen, and modes of administration in a post-standard of care setting. Based on safety and tolerability, initial anti-tumor activity and T cell response data, HB-200 advanced for further development in Phase 2. The Phase 2 part of the trial is open-label with primary endpoints of efficacy based on objective response and disease control rate as defined by RECIST 1.1 and iRECIST. The trial is evaluating HB-200 in combination with pembrolizumab in the 1st-line and 2nd-line plus settings, as well as HB-200 alone in the post-standard of care setting. HOOKIPA anticipates sharing an additional data update at an upcoming medical conference. About Human Papillomavirus-driven Cancers Human Papillomavirus, or HPV, is a common viral infection estimated to cause about 5 percent of the worldwide cancer burden. This includes up to 60 percent of head and neck, 89 percent of cervical, 78 percent of vaginal, 88 percent of anal, 67 percent of vulvar and 50 percent of penile cancers. While there are numerous HPV types associated with cancer, HPV16 is the most common cause of cancer. Most HPV infections are cleared from the body with no lasting consequences. However, in some cases, HPV DNA becomes integrated into chromosomal DNA. When host cells take up this DNA, they express the HPV E6 and E7 proteins. This uptake can potentially lead to cancer since expression of these proteins leads to alterations in cell cycle control, which in turn predisposes these cells to become cancerous. About HOOKIPA HOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies, based on its proprietary arenavirus platform, which are designed to mobilize and amplify targeted T cells and thereby fight or prevent serious disease. HOOKIPA’s replicating and non-replicating technologies are engineered to induce robust and durable antigen-specific CD8+ T cell responses and pathogen-neutralizing antibodies. HOOKIPA’s pipeline includes its wholly owned investigational arenaviral immunotherapies targeting Human Papillomavirus 16-positive cancers, prostate cancers, and other undisclosed programs. HOOKIPA is collaborating with Roche on an arenaviral immunotherapeutic for KRAS-mutated cancers. In addition, HOOKIPA aims to develop functional cures of HBV and HIV in collaboration with Gilead. 1 Harrington et al. Pembrolizumab With or Without Chemotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Updated Results of the Phase III KEYNOTE-048 Study. Journal of Clinical Oncology. 2023;41(4);790-802. The content above comes from the network. if any infringement, please contact us to modify.