Drugs / IO102-IO103
last change Dec 2025 re-read 3 minutes ago

IO102-IO103

Peptide

Developed for
metastatic melanoma
Investigated by
IO Biotech · Merck Sharp & Dohme LLC · Syneos Health

Trials 1

2023202420252026
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 3 NCT05155254 May 2022 → May 2025 overdue metastatic melanoma IO Biotech Active not recruiting Missed primary

News releases announcing trial results or a regulatory action · 17

DateIssuerRelease
2025-12-15 IO Biotech Results IO Biotech Announces Publication of Five-year Clinical Outcomes of Phase 1/2 Trial in Nature Communications iobiotech.com ↗
The MM1636 results published today showed the five-year follow-up analysis of IO102-IO103 in combination with nivolumab in patients with metastatic melanoma, demonstrating durable clinical activity with a 25.5-month median progression-free survival (PFS).
2025-10-20 IO Biotech Results IO Biotech Presents Phase 3 Results for Cylembio® plus KEYTRUDA® (pembrolizumab) in First-line Advanced Melanoma at ESMO 2025 iobiotech.com ↗
Despite the narrow miss on statistical significance, I am encouraged by the clinically meaningful improvement in progression-free survival observed with IO102-IO103 plus pembrolizumab.
2025-09-29 IO Biotech Regulatory IO Biotech Provides Update Following Pre-BLA Meeting with FDA iobiotech.com ↗
The FDA has recommended that IO Biotech not submit a BLA based on the data from the IOB-013 clinical trial.
2025-04-25 IO Biotech Results IO Biotech Presents New Data at AACR 2025 Supporting Dual Mechanism and Immune Activation of Cancer Vaccines IO102-IO103 and IO170 iobiotech.com ↗
IO102-IO103, a dual-antigen vaccine targeting IDO1+ and PD-L1+ cells, generated strong T-cell responses and modulated the tumor microenvironment in two mouse models, where IDO1 and PD-L1 vaccine each contributed differently to control tumor growth.
2024-11-07 IO Biotech Results IO Biotech Reports its Off-the-Shelf Therapeutic Cancer Vaccine, IO102-IO103, in Combination with KEYTRUDA® Demonstrates Promising Activity and Durability in First-line Treatment of Patients with Metastatic Lung Cancer in Phase 2 IOB-022 Study iobiotech.com ↗
Metastatic non-small cell lung cancer (NSCLC) patients treated in the first line setting with IO102-IO103 in combination with Keytruda® demonstrated promising activity with an overall response rate of 55% unconfirmed/48% confirmed, disease control rate of 81%, and approximately 50% of patients without disease progression at 12 months; median duration of response not reached
2024-09-14 IO Biotech Results IO Biotech Announces Positive Results from Phase 2 Trial of IO102-IO103 in the First-line Treatment of Advanced Head and Neck Cancer iobiotech.com ↗
The data from 18 efficacy evaluable patients demonstrated: Achievement of the primary endpoint – confirmed 44.4% overall response rate (ORR) in a PD-L1 high population of patients with SCCHN irrespective of HPV status.
2024-08-30 IO Biotech Results IO Biotech Updates on Pivotal Phase 3 Trial of IO102-IO103 in Combination with KEYTRUDA® (pembrolizumab) as a First-Line Treatment for Patients with Advanced Melanoma iobiotech.com ↗
Based on their review of the safety and efficacy data, the IDMC recommended that the trial continue without modifications and noted that no new safety signals were observed.
2024-04-09 IO Biotech Results IO Biotech Presents New Data at AACR 2024 Further Supporting Dual Mechanism of Action of Lead Cancer Vaccine, IO102-IO103 iobiotech.com ↗
2024-03-06 IO Biotech Results IO Biotech Announces Acceptance of Abstract to be Presented at the 2024 American Association for Cancer Research (AACR) Annual Meeting iobiotech.com ↗
These findings further support the potential that co-administration of the dual antigen vaccine IO102-IO103 can benefit patients due to its impact on two separate immune resistance pathways, IDO1 and PD-L1, respectively.
2023-11-01 IO Biotech Results IO Biotech Presents Three Posters at the Society for Immunotherapy of Cancer’s (SITC) 38th Annual Meeting iobiotech.com ↗
The data in this poster demonstrate enhanced in vivo anti-tumor effect when IDO and PD-L1 vaccines are co-administered in these models, further supporting the clinical observations regarding our lead investigational therapeutic vaccine candidate, IO102-IO103, which targets IDO and PD-L1.
2023-10-23 IO Biotech Results Encouraging Preliminary Data from a Phase 2 Trial Evaluating IO102-IO103 in Combination with Pembrolizumab for First-line Treatment of Patients with Non-small Cell Lung Cancer and Squamous Cell Carcinoma of the Head and Neck Presented at the European Society for Medical Oncology (ESMO) Congress iobiotech.com ↗
2023-09-12 IO Biotech Results IO Biotech Announces New Data Related to its IO102-IO103 Therapeutic Cancer Vaccine Presented Today at the IASLC 2023 World Conference on Lung Cancer iobiotech.com ↗
Encouraging interim data support the potential of IO102-IO103 in combination with pembrolizumab as first-line treatment in non-small cell lung cancer

All press releases naming this drug 23 releases

DateIssuerRelease

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as IO102-IO103 ClinicalTrials.gov intervention name — accepted as the source's own label NCT05155254 ↗
Modality Peptide “IDO peptide antigen (IO102) and PD-L1 peptide antigen (IO103)” NCT05155254 ↗
Route Subcutaneous “administered subcutaneously” NCT05155254 ↗