HOOKIPA Pharma Doses First Patients with Eseba-vec as Adjuvant Therapy in Phase 2 Investigator Lead Trial for Head & Neck Cancer
HOOKIPA Pharma (NASDAQ: HOOK) has initiated dosing in a Phase 2 investigator-led trial evaluating eseba-vec as adjuvant therapy for HPV16+ head and neck cancer patients. The study, conducted in collaboration with Memorial Sloan Kettering Cancer Center, will assess the treatment in patients with minimal residual disease positive (MRD+) HPV-driven head and neck cancer. The randomized, double-blind, placebo-controlled study aims to enroll approximately 50 patients, with initial safety and efficacy data expected in 2026. The primary endpoint is disease-free survival. This trial expands on positive Phase 2 data in recurrent/metastatic HNSCC, with the company also planning to initiate the pivotal AVALON-1 Phase 2/3 study in Q4 2024.
HOOKIPA Pharma (NASDAQ: HOOK) ha avviato la somministrazione in una sperimentazione clinica di Fase 2 guidata da ricercatori, valutando eseba-vec come terapia adiuvante per pazienti con cancro alla testa e al collo HPV16+. Lo studio, condotto in collaborazione con il Memorial Sloan Kettering Cancer Center, valuterà il trattamento in pazienti con malattia residua minima positiva (MRD+) da HPV. Lo studio randomizzato, in doppio cieco e controllato con placebo mira a reclutare circa 50 pazienti, con i primi dati di sicurezza ed efficacia attesi nel 2026. L'obiettivo primario è la sopravvivenza senza malattia. Questa sperimentazione amplia i dati positivi della Fase 2 in caso di HNSCC ricorrente/metastatico, con l'azienda che prevede anche di avviare lo studio pivotale AVALON-1 di Fase 2/3 nel quarto trimestre del 2024.
HOOKIPA Pharma (NASDAQ: HOOK) ha iniciado la dosificación en un ensayo de fase 2 dirigido por investigadores que evalúa eseba-vec como terapia adyuvante para pacientes con cáncer de cabeza y cuello positivo para HPV16+. El estudio, realizado en colaboración con el Memorial Sloan Kettering Cancer Center, evaluará el tratamiento en pacientes con enfermedad residual mínima positiva (MRD+) impulsada por HPV. El estudio aleatorizado, doble ciego y controlado con placebo tiene como objetivo inscribir aproximadamente a 50 pacientes, con datos preliminares de seguridad y eficacia esperados para 2026. El objetivo principal es la supervivencia libre de enfermedad. Este ensayo amplía los datos positivos de la fase 2 en HNSCC recurrente/metastásico, y la compañía también planea iniciar el estudio pivotal AVALON-1 de fase 2/3 en el cuarto trimestre de 2024.
HOOKIPA Pharma (NASDAQ: HOOK)는 eseba-vec을 HPV16+ 두경부암 환자의 보조 요법으로 평가하는 2상 연구에서 투약을 시작했습니다. Memorial Sloan Kettering Cancer Center와 협력하여 진행되는 이 연구는 최소 잔여 질환 양성(MRD+) HPV에 의한 두경부암 환자를 대상으로 치료를 평가합니다. 이 무작위 이중 맹검 위약 대조 연구는 약 50명의 환자를 등록할 계획이며, 초기 안전성 및 효능 데이터는 2026년에 예상됩니다. 주요 목표는 무병 생존입니다. 이번 연구는 재발성/전이성 HNSCC의 긍정적인 2상 데이터를 확대하며, 회사는 2024년 4분기에 AVALON-1 2/3상 주요 연구를 시작할 계획입니다.
HOOKIPA Pharma (NASDAQ: HOOK) a initié l'administration dans un essai de phase 2 dirigé par des enquêteurs, évaluant eseba-vec en tant que thérapie adjuvante pour les patients atteints de cancer de la tête et du cou HPV16+. L'étude, menée en collaboration avec le Memorial Sloan Kettering Cancer Center, évaluera le traitement chez les patients ayant une maladie résiduelle minimale positive (MRD+) induite par le HPV. L'étude randomisée, en double aveugle et contrôlée par placebo, vise à recruter environ 50 patients, avec les premières données de sécurité et d'efficacité attendues en 2026. Le principal objectif est la survie sans maladie. Cet essai s'appuie sur des données positives de phase 2 dans les HNSCC récurrents/métastatiques, l'entreprise prévoyant également de lancer l'étude pivot AVALON-1 de phase 2/3 au quatrième trimestre de 2024.
HOOKIPA Pharma (NASDAQ: HOOK) hat mit der Dosierung in einer von Forschern geleiteten Phase-2-Studie begonnen, in der eseba-vec als adjuvante Therapie für HPV16+ Kopf- und Halskrebspatienten bewertet wird. Die Studie, die in Zusammenarbeit mit dem Memorial Sloan Kettering Cancer Center durchgeführt wird, wird die Behandlung bei Patienten mit minimaler residueller Krankheitslast (MRD+) bei HPV-positivem Kopf- und Halskrebs bewerten. Die randomisierte, doppelblinde, placebo-kontrollierte Studie zielt darauf ab, etwa 50 Patienten zu rekrutieren, wobei die ersten Sicherheits- und Wirksamkeitsdaten für 2026 erwartet werden. Der primäre Endpunkt ist das krankheitsfreie Überleben. Diese Studie baut auf positive Phase-2-Daten zu rezidivierenden/metastatischen HNSCC auf, und das Unternehmen plant auch, die entscheidende AVALON-1 Phase 2/3-Studie im vierten Quartal 2024 zu starten.
- Expansion of eseba-vec clinical program into adjuvant therapy setting
- Previous Phase 2 data showed promising clinical response rates in combination with pembrolizumab
- On track to initiate pivotal AVALON-1 Phase 2/3 study in Q4 2024
- Initial safety and efficacy data not expected until 2026
- Small trial size of approximately 50 patients
Insights
The initiation of a new Phase 2 trial for eseba-vec in the adjuvant setting represents a significant expansion of HOOKIPA's clinical program. The study's focus on MRD+ HPV-driven head and neck cancer patients addresses an important unmet medical need. Previous Phase 2 data showed promising results in combination with pembrolizumab, particularly in CPS 20 or higher subgroup.
The collaboration with Memorial Sloan Kettering adds credibility to the research. The 50-patient randomized, double-blind, placebo-controlled study design is robust, though investors should note that initial data won't be available until 2026. This timeline, combined with the planned AVALON-1 Phase 2/3 study, suggests a comprehensive but lengthy development pathway.
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-vec
Eseba-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 HOOKIPA
HOOKIPA 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 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 “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.
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FAQ
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