IO Biotech Announces Late-Breaking Abstract in Advanced Melanoma Selected for Oral Presentation at ESMO Congress 2025
IO Biotech (Nasdaq: IOBT) announced that its late-breaking abstract has been selected for oral presentation at the 2025 ESMO Congress in Berlin. The presentation will showcase results from their Phase 3 trial evaluating IO102-IO103 cancer vaccine plus pembrolizumab versus pembrolizumab monotherapy in first-line advanced melanoma.
Additionally, the company will present a poster featuring final data from their Phase 2 basket trial, including efficacy, safety, and survival data for first-line treatment in non-small cell lung cancer (NSCLC) and squamous cell carcinoma of head and neck (SCCHN). The presentations are scheduled for October 19-20, 2025, with Prof. Jessica Hassel delivering the oral presentation and Dr. Jonathan W. Riess presenting the poster.
IO Biotech (Nasdaq: IOBT) ha annunciato che il suo abstract di ultima ora è stato selezionato per una presentazione orale al Congresso ESMO 2025 a Berlino. La presentazione esporrà i risultati del loro trial di fase 3 che valuta il vaccino IO102-IO103 per il cancro insieme a pembrolizumab rispetto a pembrolizumab in monoterapia nel melanoma avanzato in prima linea. Inoltre, l'azienda presenterà un poster con dati finali dal loro trial a basket di fase 2, includendo dati di efficacia, sicurezza e sopravvivenza per il trattamento di prima linea in NSCLC e SCCHN. Le presentazioni sono previste per il 19-20 ottobre 2025, con la Prof.ssa Jessica Hassel a tenere la presentazione orale e il Dr. Jonathan W. Riess a presentare il poster.
IO Biotech (Nasdaq: IOBT) anunció que su abstract de última hora ha sido seleccionado para una presentación oral en el Congreso ESMO 2025 en Berlín. La presentación mostrará resultados de su ensayo de fase 3 que evalúa la vacuna oncológica IO102-IO103 más pembrolizumab frente a pembrolizumab en monoterapia en melanoma avanzado en primera línea. Además, la empresa presentará un póster con datos finales de su ensayo basket de fase 2, que incluyen datos de eficacia, seguridad y supervivencia para el tratamiento de primera línea en NSCLC y SCCHN. Las presentaciones están programadas para los días 19-20 de octubre de 2025, con la Prof. Jessica Hassel realizando la presentación oral y el Dr. Jonathan W. Riess presentando el póster.
IO Biotech (나스닥: IOBT)이 늦은 발표 초록이 2025 ESMO 학회에서 베를린 개최 구두 발표로 선정되었다고 발표했습니다. 발표는 1차 전이성 흑색종에서 IO102-IO103 암백신 + pembrolizumab 대 pembrolizumab 단독 요법을 평가하는 3상 시험의 결과를 선보일 예정입니다. 또한 이 회사는 Phase 2 바스켓 트라이얼의 최종 데이터를 포함한 포스터를 발표할 예정이며, 1차 치료 NSCLC 및 SCCHN에서의 효능, 안전성, 생존 데이터를 다룹니다. 발표는 2025년 10월 19-20일로 예정되어 있으며, 구두 발표는 Jessica Hassel 교수, 포스터 발표는 Jonathan W. Riess 박사가 진행합니다.
IO Biotech (Nasdaq: IOBT) a annoncé que son abstract de dernière minute a été sélectionné pour une présentation orale au Congrès ESMO 2025 à Berlin. La présentation mettra en avant les résultats de leur essai de phase 3 évaluant le vaccin anticancéreux IO102-IO103 en association avec le pembrolizumab par rapport au pembrolizumab en monothérapie chez le mélanome avancé en première ligne. De plus, l'entreprise présentera un poster avec des données finales de leur trial basket de phase 2, incluant l'efficacité, la sécurité et les données de survie pour le traitement de première ligne dans le NSCLC et le SCCHN. Les présentations sont prévues les 19 et 20 octobre 2025, avec la Prof. Jessica Hassel assurant la présentation orale et le Dr Jonathan W. Riess présentant le poster.
IO Biotech (Nasdaq: IOBT) gab bekannt, dass sein late-breaking Abstract für eine mündliche Präsentation auf dem ESMO-Kongress 2025 in Berlin ausgewählt wurde. Die Präsentation wird Ergebnisse aus ihrem Phase-3‑Trial zeigen, das den Krebsimpfstoff IO102-IO103 plus Pembrolizumab gegenüber Pembrolizumab‑Monotherapie bei Erstlinien-Therapie des fortgeschrittenen Melanoms bewertet. Zusätzlich wird das Unternehmen ein Poster mit Enddaten aus ihrem Phase-2-Basket-Trial vorstellen, einschließlich Wirksamkeit, Sicherheit und Überleben bei der Erstlinienbehandlung von NSCLC und SCCHN. Die Präsentationen finden am 19. bis 20. Oktober 2025 statt, wobei Prof. Jessica Hassel die mündliche Präsentation durchführt und Dr. Jonathan W. Riess das Poster präsentiert.
أعلنت IO Biotech (المدرجة في Nasdaq: IOBT) أن الملخص المتطور أُختير لعرض شفهي في مؤتمر ESMO 2025 الذي سيعقد في برلين. ستعرض الجلسة نتائج من تجربتها من المرحلة الثالثة التي تقيم لقاح IO102-IO103 ضد السرطان مع pembrolizumab مقارنةً بـ pembrolizumab كعلاج أحادي في الورم الميلانيني المتقدم في خط العلاج الأول. بالإضافة إلى ذلك، ستقدم الشركة ملصقاً يتضمن البيانات النهائية من تجربة سلة من المرحلة 2، بما في ذلك بيانات الفعالية والسلامة والبقاء على قيد الحياة في العلاج من الخط الأول لـ NSCLC وSCCHN. من المقرر أن تقام الفعالية في 19-20 أكتوبر 2025، وستقدم الأستاذة د. جيسيكا هسل العرض الشفهي والدكتور جوناثان و. رييس عرض الملصق.
IO Biotech（纳斯达克：IOBT）宣布，其晚间突破摘要已被选中在 2025 年 ESMO 大会 于柏林进行口头报告。该报告将展示其 三期试验 的结果，该试验评估 IO102-IO103 癌症疫苗联合 pembrolizumab 相较于 pembrolizumab 单药在前线晚期黑色素瘤中的治疗效果。此外，公司还将展示一个 来自其 Phase 2 basket 试验的最终数据的海报，包括前线治疗在 NSCLC 与头颈鳞状细胞癌（SCCHN）中的有效性、安全性及生存数据。相关报告定于 2025 年 10 月 19-20 日进行，口头报告由 Jessica Hassel 教授进行，海报由 Jonathan W. Riess 博士展示。
- Selection as a late-breaking abstract at ESMO, typically reserved for high-quality research with clinical practice implications
- Secured prominent oral presentation slot for Phase 3 melanoma trial results
- Multiple cancer indications being studied (melanoma, NSCLC, SCCHN) showing pipeline expansion
- None.
Insights
IO Biotech's Phase 3 melanoma cancer vaccine data secured prestigious late-breaking oral presentation at ESMO 2025, signaling potentially significant results.
This announcement represents a significant milestone for IO Biotech's cancer vaccine program. The selection of their Phase 3 trial results (IOB-013/KN-D18) as a late-breaking abstract and Proffered Paper at ESMO 2025 is particularly notable, as these slots are typically reserved for high-impact clinical data with practice-changing potential. The trial evaluates IO102-IO103, an IDO/PD-L1 vaccine, in combination with pembrolizumab versus pembrolizumab alone in first-line advanced melanoma patients.
The designation as a late-breaking abstract suggests the data likely contains meaningful efficacy or safety findings. In the competitive immuno-oncology landscape, this combination approach targeting both IDO and PD-L1 pathways represents an innovative strategy that could potentially enhance response rates beyond what's currently achievable with pembrolizumab monotherapy, which has response rates of approximately 30-40% in advanced melanoma.
Additionally, the company will present final Phase 2 basket trial data (IOB-022/KN-D38) with updated progression-free survival, overall survival, and biomarker data across multiple tumor types including NSCLC and SCCHN. This multi-tumor approach could significantly expand the potential market opportunity beyond melanoma if positive signals are observed.
The timing of these presentations in October 2025 will be critical for IO Biotech, as positive Phase 3 data would likely accelerate their regulatory timeline, while compelling Phase 2 data could support expansion into additional indications.
- Oral presentation will highlight the results from the randomized Phase 3 trial (IOB-013/KN-D18) of IO102-IO103 cancer vaccine plus pembrolizumab for first-line (1L) advanced melanoma
- Poster presentation will share final data from Phase 2 basket trial (IOB-022/KN-D38) of IO102-IO103 cancer vaccine plus pembrolizumab for 1L treatment of solid tumors
NEW YORK, Sept. 23, 2025 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines, today announces a late-breaking abstract has been accepted and selected as a Proffered Paper oral presentation at the 2025 European Society for Medical Oncology (ESMO) Congress taking place in Berlin, Germany from October 17-21, 2025.
The oral presentation will highlight the results from the randomized Phase 3 trial assessing the efficacy and safety of IO102-IO103 (IDO/PD-L1 vaccine) in combination with pembrolizumab vs pembrolizumab monotherapy in 1L advanced melanoma. In addition, final data from the Phase 2 basket trial with updated efficacy and safety data, median progression-free survival (PFS), landmark PFS and overall survival data, as well as biomarker and translational data for 1L treatment in non-small cell lung cancer (NSCLC) and squamous cell carcinoma of head and neck (SCCHN), will be presented in a poster session. Details of the presentations are as follows:
| Title: | IO102-IO103 cancer vaccine plus pembrolizumab for first-line (1L) advanced melanoma: Primary Phase 3 results (IOB-013/KN-D18) | ||
| Speaker: | Jessica Hassel, MD, Professor at the Department of Dermatology and National Center for Tumor Diseases at the University Hospital Heidelberg Germany | ||
| Category: | Proffered Paper Session: Melanoma and other skin tumours | ||
| Date & Time: | Monday, October 20, 2025; 8:30 – 10:00 CEST | ||
| Lecture time: | 9:50 – 10:00 CEST |
Late-breaking abstracts at ESMO are generally reserved for high-quality, new research findings from randomized Phase 2 or Phase 3 trials with implications for clinical practice or understanding of disease processes. Proffered papers are oral presentations of original data of superior quality, followed by expert discussion and perspectives.
| Title: | IO102-IO103 cancer vaccine plus pembrolizumab for first line (1L) treatment of advanced solid tumors: Final results of a Phase 2 basket trial | ||
| Presenter: | Jonathan W. Riess, MD, MS, UC Davis Comprehensive Cancer Center | ||
| Category: | Investigational immunotherapy | ||
| Presentation #: | 1557P | ||
| Date & Time: | Sunday, October 19, 2025; 12:00 – 12:45 CEST |
The poster may be found on the “Posters & Publications” page of the IO Biotech website at the start of the meeting.
About Cylembio®
Cylembio® (imsapepimut and etimupepimut, adjuvanted) is an investigational, immune-modulatory, off-the-shelf therapeutic cancer vaccine candidate 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 1 (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 Cylembio 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 Cylembio 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 Cylembio in combination with pembrolizumab as neo-adjuvant/adjuvant treatment of patients with solid tumors. Enrollment in the Phase 3 trial was completed rapidly by December 2023 with topline results from this trial reported in the third quarter of 2025. Enrollment in the two ongoing company-sponsored Phase 2 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 Cylembio.
Cylembio® is a registered trademark of IO Biotech ApS, a subsidiary of IO Biotech.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the US and Canada).
About the IOB-013/KN-D18 Pivotal Phase 3 Clinical Trial
IOB-013/KN-D18 (ClinicalTrials.gov: NCT05155254) is an open label, randomized Phase 3 pivotal clinical trial evaluating Cylembio® in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma. Enrollment in the trial was completed by December 2023 with a total of 407 patients enrolled from more than 100 centers across the United States, Europe, Australia, Turkey, Israel and South Africa. The primary endpoint of the study was progression free survival. Secondary endpoints include overall response rate, overall survival, durable objective response rate, complete response rate, duration of response, time to complete response, disease control rate, and incidence of adverse events and serious adverse events (safety and tolerability). Biomarkers in the blood and tumor tissue will also be assessed as exploratory endpoints. The company reported topline results from this trial in the third quarter of 2025. IO Biotech is sponsoring the Phase 3 trial and Merck is supplying pembrolizumab.
About the IOB-022/KN-D38 Phase 2 Solid Tumor Basket Trial
IOB-022/KN-D38 (NCT05077709) is a non-comparative, open label trial to investigate the safety and efficacy of Cylembio® in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in the first-line treatment of metastatic non-small cell lung cancer (NSCLC) or metastatic squamous cell carcinoma of the head and neck (SCCHN) at sites in the United States, Spain, and the United Kingdom. IO Biotech is sponsoring the Phase 2 trial and Merck is supplying pembrolizumab.
About IO Biotech
IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf 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 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, Cylembio®, in clinical trials, and additional pipeline candidates through preclinical development. 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 statements regarding the timing or outcome of communications with regulatory authorities including the FDA, the timing or outcome of the submission of marketing applications, including a BLA, for Cylembio, the timing or outcome of the launch of Cylembio, and statements regarding other current or future clinical trials, their timing, 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
Edelman
917-498-1967
julie.funesti@edelman.com
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