HOOKIPA Pharma’s Eseba-vec Highlighted in SITC Late-Breaker
HOOKIPA Pharma presented updated Phase 2 data for eseba-vec combined with pembrolizumab as front-line therapy for HPV16+ relapsed/metastatic head and neck cancer. The study showed a 52% overall response rate and 80% disease control rate in PD-L1 CPS>20 patients (n=27). Preliminary data indicated median progression-free survival exceeding 16 months and a 12-month overall survival rate of 83%. At the selected Phase 3 dose level, the 55% response rate represents approximately double the historical pembrolizumab monotherapy results. The treatment demonstrated manageable toxicity with only 7.6% serious treatment-related adverse events.
HOOKIPA Pharma ha presentato dati aggiornati della Fase 2 per eseba-vec combinato con pembrolizumab come terapia di prima linea per il cancro della testa e del collo recidivante/metastatico HPV16+. Lo studio ha mostrato un 52% tasso di risposta generale e un 80% tasso di controllo della malattia nei pazienti con PD-L1 CPS>20 (n=27). I dati preliminari hanno indicato una sopravvivenza libera da progressione mediana superiore ai 16 mesi e un tasso di sopravvivenza generale a 12 mesi dell'83%. Alla dose selezionata per la Fase 3, il tasso di risposta del 55% rappresenta circa il doppio dei risultati storici della monoterapia con pembrolizumab. Il trattamento ha dimostrato una tossicità gestibile con solo il 7,6% di eventi avversi seri correlati al trattamento.
HOOKIPA Pharma presentó datos actualizados de la Fase 2 para eseba-vec combinado con pembrolizumab como terapia de primera línea para el cáncer de cabeza y cuello metastatico/recidivante HPV16+. El estudio mostró un 52% de tasa de respuesta global y un 80% de tasa de control de la enfermedad en pacientes con PD-L1 CPS>20 (n=27). Los datos preliminares indicaron una supervivencia libre de progresión mediana de más de 16 meses y una tasa de supervivencia general a 12 meses del 83%. En el nivel de dosis seleccionado para la Fase 3, la tasa de respuesta del 55% representa aproximadamente el doble de los resultados históricos de la monoterapia con pembrolizumab. El tratamiento mostró una toxicidad manejable, con solo un 7,6% de eventos adversos graves relacionados con el tratamiento.
HOOKIPA Pharma는 HPV16+ 재발/전이성 두경부암에 대한 1차 치료제로서 pembrolizumab과 함께 사용된 eseba-vec의 업데이트된 2상 데이터를 발표했습니다. 연구 결과는 PD-L1 CPS>20 환자(n=27)에서 52% 전체 반응률과 80% 질병 조절률을 보였습니다. 초기 데이터는 중앙 무진행 생존 기간이 16개월을 초과하고 12개월 전반적인 생존률이 83%임을 나타냈습니다. 선택된 3상 용량 수준에서 55%의 반응률은 기존의 pembrolizumab 단독 요법 결과의 약 두 배에 해당합니다. 치료는 관리 가능한 독성을 나타내며 치료 관련 심각한 부작용은 단 7.6%에 불과합니다.
HOOKIPA Pharma a présenté des données mises à jour de la Phase 2 pour eseba-vec combiné avec pembrolizumab comme thérapie de première ligne pour le cancer de la tête et du cou à HPV16+ en rechute/métastatique. L'étude a montré un taux de réponse global de 52% et un taux de contrôle de la maladie de 80% chez les patients avec PD-L1 CPS>20 (n=27). Les données préliminaires ont indiqué une survie sans progression médiane dépassant 16 mois et un taux de survie globale à 12 mois de 83%. Au niveau de dose sélectionné pour la Phase 3, le taux de réponse de 55% représente environ le double des résultats historiques de la monothérapie par pembrolizumab. Le traitement a montré une toxicité gérable avec seulement 7,6% d'événements indésirables graves liés au traitement.
HOOKIPA Pharma hat aktualisierte Phase-2-Daten zu eseba-vec in Kombination mit Pembrolizumab als Erstlinientherapie bei HPV16+-rezidivierten/metastasierten Kopf-Hals-Krebs präsentiert. Die Studie zeigte eine 52% Gesamtansprechrate und eine 80% Krankheitskontrollrate bei Patienten mit PD-L1 CPS>20 (n=27). Vorläufige Daten wiesen auf eine mediane progressionsfreie Überlebenszeit von über 16 Monaten und eine 12-Monats-Gesamtüberlebensrate von 83% hin. Auf der ausgewählten Phase-3-Dosierungsstufe entspricht die Ansprechrate von 55% ungefähr dem Doppelten der historical Pembrolizumab Monotherapie-Ergebnisse. Die Behandlung zeigte eine handhabbare Toxizität mit nur 7,6% schwerwiegenden behandlungsbezogenen Nebenwirkungen.
- 52% overall response rate in PD-L1 CPS>20 patients
- 80% disease control rate in the study population
- Preliminary median PFS >16 months
- 12-month overall survival rate of 83%
- 66.7% of confirmed responders ongoing
- 55% ORR at Phase 3 dose level, double the historical pembrolizumab monotherapy results
- Low serious adverse event rate of 7.6%
- None.
Insights
The Phase 2 trial results for eseba-vec in combination with pembrolizumab show significant promise in treating HPV16+ head and neck cancer. The
Key highlights include a high disease control rate of
For the selected Phase 3 dose level, the
Phase 2 trial evaluating eseba-vec/pembrolizumab combination resulted in a
NEW YORK and VIENNA, Nov. 11, 2024 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ: HOOK, “HOOKIPA”, the “Company”), a clinical-stage biopharmaceutical company developing next generation immunotherapeutics for the treatment of cancer and serious infectious disease, today announced that clinical collaborator Alan Ho, MD, PhD, Chief of the Head and Neck Oncology Service at Memorial Sloan Kettering Cancer Center, presented updated Phase 2 data from a study evaluating eseba-vec in combination with pembrolizumab as front line (1L) therapy in the setting of human papillomavirus type 16 positive (HPV16+) relapsed or metastatic head and neck squamous cell carcinoma (R/M HNSCC) at the 39th Annual Meeting for the Society for Immunotherapy in Cancer (SITC2024), being held in Houston Texas from November 8 – 10, 2024.
The late-breaking poster presentation focused on results from a subset of patients (PD-L1 CPS >20, n=27, with 25 response evaluable patients). The data showed an overall response rate (ORR) of
“The expanded data presented at SITC 2024 are encouraging to HOOKIPA. They provide highly consistent proof-of-concept results which suggest that the combination treatment could lead to improved clinical outcomes and survival in patients with HPV16+ R/M HNSCC CPS>20 in the first line setting,” said Mark Winderlich, PhD, Chief Research and Development Officer.
Dr. Ho commented, “As a medical oncologist who specializes in head and neck cancers, I am inspired by the results of the expanded eseba-vec/pembrolizumab Phase 2 study because of the potentially clinically meaningful response rate and encouraging PFS and OS data. In addition, the regimen has a manageable safety profile that ensures most patients can maintain treatment.”
The late-breaking poster: Eseba-vec (HB-200) plus pembrolizumab as first-line treatment of recurrent/metastatic HPV16-positive head and neck cancer: updated results in PD-L1 CPS ≥20 patients will be available on November 11, 2024 on the HOOKIPA website on the “Scientific Publications” tab of the “Our Science” page.
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 Sciences, Inc. 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”, “could”, “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 and the potential of eseba-vec in combination with pembrolizumab to improve clinical outcomes and survival in patients. 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 (also known as HB200), 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 U.S. Securities and Exchange Commission (SEC), 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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