IO Biotech Completes Enrollment in Phase 2 Trial of its Investigational, Off-the-shelf Therapeutic Cancer Vaccine, IO102-IO103, as Neoadjuvant/Adjuvant Treatment for Patients with Resectable Melanoma or Head and Neck Cancer
IO Biotech (IOBT) has completed enrollment ahead of schedule for its Phase 2 basket trial studying IO102-IO103, its lead therapeutic cancer vaccine candidate, in combination with Merck's KEYTRUDA®. The trial focuses on treating resectable melanoma or squamous cell carcinoma of the head and neck (SCCHN) before and after surgery.
The multicenter trial has enrolled 93 patients across sites in the United States, Europe, and Australia. The study's primary endpoint is major pathologic response (MPR), measuring the reduction in viable tumor cells after treatment. Secondary endpoints include pathological complete response, ORR, disease-free survival, event-free survival, and safety.
Initial data from this Phase 2 trial is expected in 2025, coinciding with anticipated results from the company's Phase 3 trial in advanced melanoma patients in the first half of 2025. The vaccine is designed as an off-the-shelf option and has shown encouraging clinical activity without significant systemic toxicity across three first-line advanced cancer indications.
IO Biotech (IOBT) ha completato l'arruolamento anticipato per il suo trial multicentrico di Fase 2 che studia IO102-IO103, il suo principale candidato vaccinale terapeutico contro il cancro, in combinazione con KEYTRUDA® di Merck. Il trial si concentra sul trattamento del melanoma resecabile o del carcinoma squamoso della testa e del collo (SCCHN) prima e dopo l'intervento chirurgico.
Lo studio ha arruolato 93 pazienti in vari centri degli Stati Uniti, Europa e Australia. L'obiettivo primario dello studio è la risposta patologica maggiore (MPR), che misura la riduzione delle cellule tumorali vitali dopo il trattamento. Gli obiettivi secondari includono la risposta patologica completa, ORR, sopravvivenza libera da malattia, sopravvivenza libera da eventi e sicurezza.
I dati iniziali di questo trial di Fase 2 sono attesi nel 2025, in coincidenza con i risultati previsti dal trial di Fase 3 dell'azienda sui pazienti con melanoma avanzato nella prima metà del 2025. Il vaccino è progettato come un'opzione pronta all'uso e ha dimostrato un'attività clinica incoraggiante senza tossicità sistemica significativa in tre indicazioni di cancro avanzato in prima linea.
IO Biotech (IOBT) ha completado la inscripción anticipadamente para su ensayo clínico de Fase 2 que estudia IO102-IO103, su principal candidato a vacuna terapéutica contra el cáncer, en combinación con KEYTRUDA® de Merck. El ensayo se centra en el tratamiento del melanoma resecable o carcinoma de células escamosas de cabeza y cuello (SCCHN) antes y después de la cirugía.
El ensayo multicéntrico ha inscrito a 93 pacientes en sitios de Estados Unidos, Europa y Australia. El objetivo primario del estudio es la respuesta patológica mayor (MPR), que mide la reducción de células tumorales viables después del tratamiento. Los objetivos secundarios incluyen la respuesta patológica completa, ORR, supervivencia libre de enfermedad, supervivencia sin eventos y seguridad.
Se esperan datos iniciales de este ensayo de Fase 2 en 2025, coincidiendo con los resultados anticipados del ensayo de Fase 3 de la compañía en pacientes con melanoma avanzado en la primera mitad de 2025. La vacuna está diseñada como una opción lista para usar y ha mostrado actividad clínica alentadora sin toxicidad sistémica significativa en tres indicaciones de cáncer avanzado de primera línea.
IO Biotech (IOBT)는 IO102-IO103에 대한 2상 배스켓 시험 enrolling을 계획보다 빨리 완료했습니다. 이 후보는 Merck의 KEYTRUDA®와의 병용 요법으로 치료되는 주된 항암 백신 후보입니다. 시험은 수술 전후에 재절제 가능 멜라노마 또는 두경부(SCCHN)의 편평세포암 치료에 중점을 두고 있습니다.
다기관 시험은 미국, 유럽 및 호주 전역의 사이트에서 93명의 환자를 등록했습니다. 연구의 주요 목표는 치료 후 생존하는 종양 세포 감소를 측정하는 주요 병리학적 반응(MPR)입니다. 보조 목표에는 병리학적 완전 반응, ORR, 질병 없는 생존, 사건 없는 생존 및 안전성이 포함됩니다.
이 2상 시험의 초기 데이터는 2025년에 예상되며, 2025년 상반기에는 진행성 멜라노마 환자에 대한 회사의 3상 시험 결과와 coinciding 될 것입니다. 이 백신은 즉시 사용할 수 있는 옵션으로 설계되었으며, 세 가지 일차 치료 진행성 암 적응증에 대한 중요한 전신 독성 없이 고무적인 임상 활동을 나타냈습니다.
IO Biotech (IOBT) a terminé l'inscription en avance pour son essai clinique de Phase 2 étudiant IO102-IO103, son principal candidat-vaccin thérapeutique contre le cancer, en combinaison avec KEYTRUDA® de Merck. L'essai se concentre sur le traitement du mélanome résécable ou du carcinome à cellules squameuses de la tête et du cou (SCCHN) avant et après la chirurgie.
L'essai multicentrique a inscrit 93 patients sur des sites aux États-Unis, en Europe et en Australie. L'objectif principal de l'étude est la réponse pathologique majeure (MPR), qui mesure la réduction des cellules tumorales viables après le traitement. Les objectifs secondaires comprennent la réponse pathologique complète, ORR, la survie sans maladie, la survie sans événements et la sécurité.
Les données initiales de cet essai de Phase 2 sont attendues en 2025, coïncidant avec les résultats prévus de l'essai de Phase 3 de l'entreprise chez des patients atteints de mélanome avancé au premier semestre 2025. Le vaccin est conçu comme une option prête à l'emploi et a montré une activité clinique encourageante sans toxicité systémique significative dans trois indications de cancer avancé en première ligne.
IO Biotech (IOBT) hat die Rekrutierung vor dem Zeitplan für seine Phase-2-Basket-Studie abgeschlossen, die IO102-IO103, seinen führenden therapeutischen Impfstoffkandidaten gegen Krebs, in Kombination mit Mercks KEYTRUDA® untersucht. Die Studie konzentriert sich auf die Behandlung von resektablem Melanom oder Plattenepithelkarzinom im Kopf- und Halsbereich (SCCHN) vor und nach einer Operation.
Die multizentrische Studie hat 93 Patienten in Zentren in den Vereinigten Staaten, Europa und Australien rekrutiert. Das primäre Studienziel ist die bedeutende pathologische Antwort (MPR), die den Rückgang der lebenden Tumorzellen nach der Behandlung misst. Sekundäre Endpunkte umfassen die pathologische vollständige Remission, ORR, krankheitsfreie Überlebensrate, ereignisfreies Überleben und Sicherheit.
Die ersten Daten aus dieser Phase-2-Studie werden 2025 erwartet, zeitgleich mit den voraussichtlichen Ergebnissen der Phase-3-Studie des Unternehmens bei Patienten mit fortgeschrittenem Melanom in der ersten Hälfte von 2025. Der Impfstoff ist als sofort einsetzbare Option konzipiert und hat eine vielversprechende klinische Aktivität ohne wesentliche systemische Toxizität in drei ersten Behandlungsansätzen gegen fortgeschrittenen Krebs gezeigt.
- Early completion of Phase 2 trial enrollment with 93 patients
- Concurrent Phase 3 trial in advanced melanoma with results expected H1 2025
- Demonstrated clinical activity without significant systemic toxicity in three first-line cancer indications
- None.
Insights
The early completion of enrollment in this Phase 2 basket trial represents a significant clinical development milestone for IO Biotech's therapeutic cancer vaccine program. The trial's design, combining IO102-IO103 with KEYTRUDA® in both neoadjuvant and adjuvant settings, is strategically positioned to target a important treatment gap in resectable melanoma and head & neck cancer.
The enrollment of 93 patients across multiple continents strengthens the trial's statistical power and geographic diversity. The primary endpoint of major pathologic response (MPR) is a well-validated surrogate marker that could provide early signals of efficacy. The expected data readout timeline aligning with their Phase 3 melanoma trial in 2025 could create a robust data package for potential regulatory submissions.
From a market perspective, targeting early-stage resectable cancers significantly expands the potential patient population beyond the current late-stage focus. The collaboration with Merck and KEYTRUDA®, the leading PD-1 inhibitor with
The perioperative immunotherapy approach being tested here is particularly compelling. Early intervention with IO102-IO103's T-cell activating mechanism, combined with PD-1 blockade, could potentially create a more favorable immune environment before surgery when tumor burden is lower. This could translate to better long-term outcomes.
The inclusion of both melanoma and SCCHN cohorts is strategically sound, as both cancer types are known to be immunologically 'hot' tumors. The multi-modal approach of surgery plus dual immunotherapy could potentially reduce recurrence rates, which remain a significant challenge in these cancers. The absence of significant systemic toxicity in previous trials is particularly noteworthy for a perioperative setting where safety is paramount.
-- Enrollment Completed Ahead of Schedule --
-- Initial Data Expected in 2025 --
NEW YORK, Jan. 09, 2025 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines, completed enrollment in its neoadjuvant/adjuvant Phase 2 basket trial (IOB-032/PN-E40). The trial is studying IO102-IO103, the company’s lead investigational therapeutic cancer vaccine candidate, in combination with Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), given before (neoadjuvant) and after (adjuvant) surgery with curative intent in patients with resectable melanoma or squamous cell carcinoma of the head and neck (SCCHN).
“We are pleased to have completed enrollment early in this study, as it signifies an important step in exploring the potential of our investigational therapeutic cancer vaccine, IO102-IO103, across a range of solid tumors at an earlier stage of disease progression,” said Mai-Britt Zocca, PhD, President and CEO of IO Biotech. “Our off-the-shelf cancer vaccine is designed to be a readily available option for patients and has demonstrated encouraging clinical activity without significant systemic toxicity across three first line advanced cancer indications – melanoma, lung cancer and head and neck cancer. With data from our Phase 3 trial in patients with advanced melanoma expected in the first half of 2025 and initial data from this Phase 2 basket trial also expected in 2025, we hope to add to the accumulating evidence of potential benefit of this combination therapy across a range of difficult-to-treat cancers.”
IOB-032/PN-E40, a multicenter, multi-cohort clinical trial, has enrolled 93 patients at sites in the United States, Europe, and Australia to evaluate anti-tumor activity, safety, and biomarker data of IO102-IO103 in combination with pembrolizumab as neoadjuvant and adjuvant treatment in patients with resectable tumors. The primary endpoint is major pathologic response (MPR), which refers to reduction in viable tumor cells after treatment, defined as pCR (
Qasim Ahmad, MD, Chief Medical Officer of IO Biotech, added, “The importance of systemic immunotherapy in the perioperative setting and its potential to change early treatment paradigms for a variety of cancers cannot be understated. This approach is being recognized as a critical opportunity to improve outcomes for patients by reducing the risk of recurrence and improving long-term survival. The interest we received from physicians and the rapid enrollment rate for this trial signifies the need for effective treatment options for patients with resectable melanoma and SCCHN. We are grateful to patients, families and investigators for their participation in this trial and for advancing the body of research for the oncology community.”
About IOB-032/PN-E40 Phase 2 Solid Tumor Basket Trial
IOB-032/PN-E40 (NCT05280314) is a multicenter Phase 2 basket trial investigating the IO102-IO103 immuno-modulatory therapeutic cancer vaccine in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) as neo-adjuvant/adjuvant treatment of patients with solid tumors at sites in Australia, the United States, France, Germany, Spain, and Denmark. The study completed enrollment in all cohorts: 18 patients with melanoma in cohort A and 16 patients with SCCHN in cohort B, both as single arm cohorts receiving combination of IO102-IO103 with pembrolizumab. In cohort C, 59 melanoma patients were randomized 1:1 to either the combination of IO102-IO103 with pembrolizumab or pembrolizumab alone, with some patients still in screening, who, if they pass the entry criteria, will be allowed to join the study. In the neo-adjuvant period, for all cohorts, treatment is every 3 weeks (Q3W) for 3 cycles (melanoma) or 2-3 cycles (SCCHN). Patients entering the study will be scheduled for surgery and begin neoadjuvant treatment 4-9 weeks prior. Surgery will be followed by adjuvant treatment with the same regimen for 15 cycles. Cohort C patients with poor pathological response to pembrolizumab alone in the neo-adjuvant phase (>
About IO102-IO103
IO102-IO103 is an investigational, immune-modulatory, off-the-shelf therapeutic cancer vaccine designed to kill both tumor cells and immune-suppressive cells in the tumor microenvironment (TME) by stimulating activation and expansion of T cells against indoleamine 2,3-dioxygenase (IDO1) positive and/or programmed death-ligand 1 (PD-L1) positive cells. The company is currently conducting a pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254) investigating IO102-IO103 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) versus pembrolizumab alone in patients with advanced melanoma, a Phase 2 basket trial (IOB-022/KN-D38; NCT05077709) investigating IO102-IO103 in combination with pembrolizumab as first line treatment in patients with advanced solid tumors, and a Phase 2 basket trial (IOB-032/PN-E40; NCT05280314) investigating IO102-IO103 in combination with pembrolizumab as neo-adjuvant/adjuvant treatment of patients with solid tumors. Enrollment in the three ongoing company-sponsored clinical trials is now complete.
The clinical trials are sponsored by IO Biotech and conducted in collaboration with Merck, which is supplying pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
About IO Biotech
IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulatory therapeutic cancer vaccines based on its T-win® platform. The T-win platform is based on a novel approach to cancer vaccines designed to activate and expand T cells to target both tumor cells and the immune-suppressive cells in the tumor microenvironment. IO Biotech is advancing its lead cancer vaccine candidate, IO102-IO103, in clinical trials, and additional pipeline candidates through preclinical development. Based on positive Phase 1/2 first line metastatic melanoma data, IO102-IO103, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), has been granted a Breakthrough Therapy Designation for the treatment of advanced melanoma by the US Food and Drug Administration. IO Biotech is headquartered in Copenhagen, Denmark and has US headquarters in New York, New York.
For further information, please visit www.iobiotech.com. Follow us on our social media channels on LinkedIn and X (@IOBiotech).
Forward-Looking Statement
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including regarding the timing or outcome of initial data from the IOB-032/PN-E40 study, the primary analysis of the company’s Phase 3 trial, other current or future clinical trials, their progress, enrollment or results, or the company’s financial position or cash runway, are based on IO Biotech’s current assumptions and expectations of future events and trends, which affect or may affect its business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Except to the extent required by law, IO Biotech undertakes no obligation to update these statements, whether as a result of any new information, future developments or otherwise.
Contact:
Investors
Maryann Cimino, Director of Investor Relations
IO Biotech, Inc.
617-710-7305
mci@iobiotech.com
Media
Julie Funesti
Salutem
917-498-1967
Julie.Funesti@salutemcomms.com
FAQ
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