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HOOKIPA Pharma Announces Pivotal Phase 2/3 Trial Design for HB-200 in Combination with Pembrolizumab

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HOOKIPA Pharma announced the final pivotal Phase 2/3 trial design for HB-200 in combination with pembrolizumab. The trial is for the first-line treatment of patients with HPV16+ recurrent or metastatic oropharyngeal squamous cell carcinoma. The Company has aligned with the FDA and anticipates enrolling the first patient in Q4 2024. The data will be presented at ASCO 2024 Annual Meeting, with two additional abstracts accepted. HOOKIPA's CEO expressed confidence in the trial design and potential for accelerated approval based on favorable results.
HOOKIPA Pharma ha annunciato il design definitivo della prova pivotale di fase 2/3 per HB-200 in combinazione con pembrolizumab. Questo studio è destinato al trattamento di prima linea dei pazienti affetti da carcinoma squamoso orofaringeo metastatico o ricorrente HPV16+. L'azienda si è coordinata con la FDA e prevede di arruolare il primo paziente nel quarto trimestre del 2024. I risultati saranno presentati all'Incontro Annuale dell'ASCO 2024, dove saranno accettati altri due abstract. Il CEO di HOOKIPA ha espresso fiducia nel design dello studio e nel potenziale di un'approvazione accelerata basata su risultati favorevoli.
HOOKIPA Pharma ha anunciado el diseño final del ensayo pivotal Fase 2/3 para HB-200 en combinación con pembrolizumab. El ensayo está dirigido al tratamiento de primera línea de pacientes con carcinoma escamoso orofaríngeo recurrente o metastásico HPV16+. La compañía ha alineado con la FDA y anticipa inscribir al primer paciente en el cuarto trimestre de 2024. Los datos serán presentados en la Reunión Anual de ASCO 2024, y se han aceptado dos resúmenes adicionales. El CEO de HOOKIPA expresó confianza en el diseño del ensayo y en el potencial para una aprobación acelerada basada en resultados favorables.
HOOKIPA Pharma는 HB-200을 pembrolizumab과 병용하여 실시하는 제2/3상 최종 핵심 임상시험 설계를 발표했습니다. 이 임상시험은 HPV16+ 재발성 또는 전이성 구강 편평세포암 환자의 1차 치료를 목적으로 합니다. 회사는 FDA와 조율을 마치고 2024년 4분기에 첫 환자 등록을 예상하고 있습니다. 데이터는 2024년 ASCO 연례 회의에서 발표될 예정이며, 추가로 두 개의 초록이 승인되었습니다. HOOKIPA의 CEO는 시험 설계와 유리한 결과에 기반한 가속 승인 가능성에 대해 자신감을 표했습니다.
HOOKIPA Pharma a annoncé la conception définitive de l'essai décisif de phase 2/3 pour HB-200 en combinaison avec le pembrolizumab. L'essai est destiné au traitement de première ligne des patients atteints de carcinome épidermoïde oropharyngé récurrent ou métastatique HPV16+. La société s'est alignée avec la FDA et prévoit d'enrôler le premier patient au quatrième trimestre de 2024. Les données seront présentées lors de la réunion annuelle de l'ASCO 2024, avec deux autres abstracts acceptés. Le PDG de HOOKIPA a exprimé sa confiance dans la conception de l'essai et le potentiel pour une approbation accélérée basée sur des résultats favorables.
HOOKIPA Pharma hat das endgültige Design der entscheidenden Phase-2/3-Studie für HB-200 in Kombination mit Pembrolizumab bekannt gegeben. Die Studie ist für die Erstlinienbehandlung von Patienten mit HPV16+ rezidivierendem oder metastasiertem oropharyngealem Plattenepithelkarzinom vorgesehen. Das Unternehmen hat sich mit der FDA abgestimmt und plant, den ersten Patienten im vierten Quartal 2024 zu rekrutieren. Die Daten werden auf der ASCO-Jahrestagung 2024 präsentiert, zusätzlich wurden zwei weitere Abstracts akzeptiert. Der CEO von HOOKIPA äußerte sich zuversichtlich über das Studiendesign und das Potenzial für eine beschleunigte Zulassung basierend auf positiven Ergebnissen.
Positive
  • Final pivotal Phase 2/3 trial design for HB-200 with pembrolizumab announced
  • Trial for first-line treatment of HPV16+ recurrent/metastatic oropharyngeal squamous cell carcinoma
  • Alignment with FDA, first patient enrollment expected in Q4 2024
  • Data to be presented at ASCO 2024 Annual Meeting with additional abstracts accepted
  • Potential for accelerated approval based on favorable results
Negative
  • None.

The announcement by HOOKIPA Pharma regarding the pivotal Phase 2/3 trial design of HB-200 in combination with pembrolizumab represents a critical step in addressing HPV16+ recurrent or metastatic oropharyngeal squamous cell carcinoma (OPSCC), a particularly aggressive cancer linked to the human papillomavirus (HPV). The seamless transition from Phase 2 to Phase 3 within the trial design suggests a more expedited approach to evaluating the drug's efficacy and safety, which could shorten development timelines. The potential for accelerated approval based on Phase 2 data indicates promising preliminary results.

From the perspective of the stakeholders, the alignment with FDA feedback and the PRIME designation by the European Medicines Agency suggest a regulatory confidence that could streamline the pathway to market approval. Pending the trial's outcomes, this could result in significant market penetration, especially considering the lack of current effective treatments for HPV16+ OPSCC in the first line setting. For investors, the anticipated primary analysis in 2026 offers a concrete timeline for when to expect pivotal data that may influence the company’s stock valuation.

The combination of HB-200, an arenavirus-based immunotherapy, with pembrolizumab, a PD-1 inhibitor, represents an innovative approach in treating OPSCC. HPV16+ cancers have been known to potentially respond better to immunotherapy, which could position HB-200 and pembrolizumab as a leading treatment, assuming clinical trial success. Moreover, the trial’s focus on patients with PD-L1 CPS ≥ 20 suggests an attempt to target individuals who are more likely to respond to immunotherapeutic strategies, thus potentially improving overall outcomes.

The expected data presentation at ASCO significantly contributes to the scientific community’s understanding of the treatment’s effects in a real-world setting. The stature of ASCO as a platform for disseminating oncology research further underscores the importance of the findings. For a clinician in the field, the trial design's complexity and the endpoints chosen—objective response rate and overall survival—are indicative of a thorough and patient-centric focus in the clinical development process.

For retail investors considering the implications of HOOKIPA Pharma's latest update, it is important to assess the company's clinical progress alongside their financial stability and market potential. The anticipation of an accelerated approval could result in an increased investor interest and potentially a surge in stock prices. However, investors should remain cautious, as clinical trials inherently carry a high level of risk. Delays, unexpected adverse effects, or failure to meet endpoints can significantly impact the company's financial outlook.

Moreover, the oncology market is highly competitive and the success of HB-200 and pembrolizumab in combination hinges not just on clinical efficacy but also on health economics and reimbursement scenarios. Keeping an eye on competitors and parallel developments within the field will be essential for understanding HOOKIPA’s long-term financial viability and the potential return on investment for those holding or considering the acquisition of HOOK stock.

  • Phase 2/3 pivotal trial design and protocol for HB-200 in combination with pembrolizumab for the first-line treatment of patients with HPV16+ recurrent or metastatic OPSCC aligned with FDA feedback
  • HB-200 accepted for oral abstract presentation at ASCO 2024 Annual Meeting with data from approximately 40 patients treated with HB-200 in combination with pembrolizumab
  • Two additional abstracts for HB-200 and HB-700 accepted for the ASCO 2024 Annual Meeting
  • Company to host investor call at 8:00 a.m. ET on Thursday, April 25, 2024, to highlight path to potential registration; participant details below

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 trial will treat patients with HPV16+ recurrent/metastatic PD-L1 CPS ≥ 20 oropharyngeal squamous cell carcinoma in the first line setting.
  • The trial is expected to enroll approximately 250 patients across the seamless Phase 2/3 design. 
  • Patients will be randomized one-to-one for HB-200 plus pembrolizumab or placebo plus pembrolizumab.
  • The primary endpoints are objective response rate for the Phase 2 portion and overall survival for the Phase 3 portion.
  • The Company may seek accelerated approval based on data from the Phase 2 portion of the trial, from approximately half of the Phase 2/3 study patients, if favorable.
  • Phase 2 primary analysis expected in 2026 with potential subsequent filing for accelerated approval.

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:
HOOKIPA HB-200 Phase 2/3 Clinical Trial Update
Thursday, April 25, 2024, 8:00 a.m. ET
Webcast Registration
Dial-in Registration

Abstract details: ASCO 2024 Annual Meeting

HB-200:
Title: HB-200 arenavirus-based immunotherapy plus pembrolizumab as first-line treatment of patients with recurrent/metastatic HPV16-positive head and neck cancer: Updated results
Presenter: Dr. Alan L. Ho, Head and Neck Oncologist at Memorial Sloan Kettering Cancer Center and a trial investigator
Abstract Type: Oral abstract
Session Name: Head and Neck Cancer
Session Date and Time: June 4, 2024; 9:45 AM-12:45 PM CDT
Abstract Number: 6005

Title: Neoadjuvant HPV16-specific arenavirus-based immunotherapy HB-200 plus chemotherapy followed by response-stratified de-intensification in HPV16+ oropharyngeal cancer: TARGET-HPV
Presenter: Dr. Ari Rosenberg, Principal Investigator, TARGET-HPV Trial, University of Chicago Medicine
Abstract Type: Rapid oral abstract
Session Name: Head and Neck Cancer
Session Date and Time: June 3, 2024; 8:00 AM-9:30 AM CDT
Abstract Number: 6017
Trial Sponsor: UChicago Medicine

HB-700
Title: Development of an arenavirus-based immunotherapy for treatment of KRAS mutant cancer
Abstract Type: Abstract only
Session Date: May 23, 2024
Abstract Number: e14672

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 (LCMV) and pichinde virus (PICV). 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 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
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, KRAS-mutated cancers, and other unnamed indications. In addition, HOOKIPA aims to develop functional cures of HBV and HIV in collaboration with Gilead.

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
Investors and others should note that we announce material financial information to our investors using our investor relations website (https://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 members and the public about our company, our services 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 U.S. social media channels listed on our investor relations website.

For further information, please contact:

Investors and Media
Michael Kaiser
michael.kaiser@hookipapharma.com
+ 1 (917) 984 7537


FAQ

What is the trial design announced by HOOKIPA Pharma for HB-200 in combination with pembrolizumab?

HOOKIPA announced the final pivotal Phase 2/3 trial design for HB-200 in combination with pembrolizumab for the first-line treatment of patients with HPV16+ recurrent or metastatic oropharyngeal squamous cell carcinoma.

When is the first patient expected to be enrolled in the trial?

The first patient is anticipated to be enrolled in the fourth quarter of 2024.

Where will the data from the trial be presented?

The data will be presented at the ASCO 2024 Annual Meeting.

What did HOOKIPA's CEO express confidence in regarding the trial design?

HOOKIPA's CEO expressed confidence in the trial design and potential for accelerated approval based on favorable results.

What is the primary focus of the trial in terms of patient population?

The trial focuses on patients with HPV16+ recurrent/metastatic oropharyngeal squamous cell carcinoma.

HOOKIPA Pharma Inc.

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About HOOK

hookipa pharma inc. is a clinical stage company developing products to prevent and cure infectious diseases and cancer. with this goal in mind we created unique and cutting-edge technologies which reprogram and stimulate the immune system. our arenavirus technologies, vaxwave®, a replication-deficient viral vector, and therat®, an attenuated replicating vector, induce potent pathogen-neutralizing antibodies and cd8+ t cells. both, vaxwave® and therat®, can be administered repeatedly while maintaining their efficacy. therat® induced cd8+ t cell responses to tumor antigens reach frequencies and potencies matching or exceeding those observed after adoptive t cell therapy. hookipa’s “off-the shelf” viral vectors are administered systemically. they target dendritic cells in vivo and activate the immune system. in immune-oncology, this mechanism enables to fight solid tumors systemically, both primary and secondary (metastatic). at hookipa we have successfully completed a phase 1 trial of a