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HOOKIPA Pharma Announces Pivotal Phase 2/3 Trial Design for HB-200 in Combination with Pembrolizumab
NEW YORK and VIENNA, Austria, April 25, 2024 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ: HOOK, HOOKIPA or the Company), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced its final pivotal Phase 2/3 trial design for HB-200 in combination with pembrolizumab. The Phase 2/3 trial design and protocol are based on alignment with the U.S. Food and Drug Administration (FDA) following the Company’s Type C meeting with the FDA. The seamless Phase 2/3 trial is for the investigational product HB-200 in combination with pembrolizumab for the treatment of patients with Human Papillomavirus 16-positive (HPV16+) recurrent/metastatic PD-L1 CPS = 20 oropharyngeal squamous cell carcinoma (OPSCC) in the first line setting. The Company anticipates the first patient will be enrolled in the fourth quarter of 2024. The Company also announced acceptance of its HB-200 study abstract as an oral presentation at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting in the head and neck cancer session to be held on June 4, 2024. The presentation will include data for approximately 40 head and neck cancer patients treated with HB-200 in combination with pembrolizumab. “It has been a dream of mine—and my HOOKIPA colleagues—to translate our science into a product that will make an impact for patients and help them fight cancer and infectious diseases. I am happy to say that we are taking a very big step forward to making this dream a reality,” said Joern Aldag, Chief Executive Officer of HOOKIPA. “We believe our data is best-in-class and puts us in the lead position for OPSCC in the first line setting. We have alignment with the FDA on our pivotal trial design and protocol, as well as PRIME designation for HB-200 in combination with pembrolizumab for the treatment of patients with OPSCC in the first line setting from the European Medicines Agency. We believe our trial design and alignment with our primary regulators can help us reach a potential registration more quickly. Further, we have been accepted for an oral abstract presentation at ASCO in June 2024 where we will present an update from our Phase 1/2 trial with approximately 40 patients treated with the combination of HB-200 and pembrolizumab.” HB-200 in combination with pembrolizumab pivotal Phase 2/3 trial design summary
The Company will host a conference call today where HOOKIPA’s Executive Team will discuss the full details of the trial design, and the Company’s clinical development strategy for oncology. Call Details: Abstract details: ASCO 2024 Annual Meeting HB-200: Title: Neoadjuvant HPV16-specific arenavirus-based immunotherapy HB-200 plus chemotherapy followed by response-stratified de-intensification in HPV16+ oropharyngeal cancer: TARGET-HPV HB-700 About HB-200 HB-200 in combination with pembrolizumab received Fast Track Designation from the U.S. Food and Drug Administration and PRIME designation from the European Medicines Agency for the treatment of first-line HPV16+ recurrent/metastatic oropharyngeal squamous cell carcinoma. These designations are supported by preliminary clinical evidence from the Phase 1/2, open-label, clinical trial (NCT04180215) evaluating safety, T cell response, and efficacy based on objective response rate (ORR) and disease control rate (DCR) as defined by RECIST 1.1. and iRECIST. As presented at the European Society for Medical Oncology Annual Congress 2023, HB-200 in combination with pembrolizumab showed a 42 percent confirmed ORR and disease control rate DCR of 74 percent across 19 evaluable patients, doubling the 19 percent ORR for pembrolizumab alone.1 About HOOKIPA Find out more about HOOKIPA online at www.hookipapharma.com. 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. Forward Looking Statements This press release contains 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,” “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 positively impact quality of life and alter the course of disease in the patients it seeks to treat, HOOKIPA’s expectations regarding the design and protocol of the Company’s upcoming pivotal Phase 2/3 clinical trial of HB-200 in combination with pembrolizumab, the timing of patient enrollment in clinical trials and the availability of data therefrom, and the timing o submissions concerning regulatory approval, and other statements that are not historical fact. 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 risk that results of preclinical studies and clinical trials may not be predictive of future results in preclinical studies or 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 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 http://hookipapharma.com/. In addition, any forward-looking statements represent HOOKIPA’s views only as of today and should not be relied upon as representing its views as of any subsequent date. HOOKIPA explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Availability of Other Information About HOOKIPA For further information, please contact: Investors and Media |