IO Biotech, Inc. · OTC:IOBTQ
IO Biotech — ESMO Congress 2025
21 slides from IO Biotech's conference presentation, Oct 20, 2025
Slide 1: IO102-IO103 plus pembrolizumab for first line advanced melanoma: phase 3 primary results
IO102-IO103 cancer vaccine plus pembrolizumab for first line advanced melanoma: primary results from a randomized phase 3 trial (IOB-013/KN-D18) JC Hassel1, A Arance2, MS Carlino3, P Ascierto4, S Sandhu5, I Puzanov6, A Eggermont7, O Hamid8, L Mortier9, P Rutkowski10, C Coetzee11, SB Karaca12, S Grab
Slide 2: Declaration of interests
Declaration of interests J.C. Hassel reports speaker honoraria from BMS, Delcath, Immunocore, MSD, Novartis, Pierre Fabre, Sanofi and Sun Pharma, and honoraria for advisory board participation from Onkowissen and Sun Pharma Jessica C. Hassel Content of this presentation is copyright and responsibili
Slide 3: IO102-IO103 immune-modulatory, off-the-shelf cancer vaccine
IO102-IO103 immune-modulatory, off-the-shelf cancer vaccine • A unique investigational immune-modulatory cancer vaccine targeting IDO1 and PD-L1 positive tumor cells and immuno-suppressive cells within the tumor microenvironment IO102-IO103 Subcutaneous Activation and T cells attack both IDO1 and PD
Slide 4: Effects of IO102-IO103 in the TME
Effects of IO102-IO103 in the TME Translational data from phase 1/2 study1 1. Evidence of T cells infiltration at tumor sites 2. Increase of PD-L1 and IDO expressing cells on both immune and tumor cells 3. Evidence of T cell clonal expansion in the tumor Number CD3+ and CD8+ T cells at Treatment ind
Slide 5: IOB-013/KN-D18: Trial design
IOB-013/KN-D18: Trial design Global, randomized, phase 3 trial Eligibility criteria Stratification for randomization Randomization Endpoints Primary endpoint • Untreated advanced melanoma Disease Stage IO102-IO103 plus Pembrolizumab 200 mg q3w • PFS by blinded independent central review o Unresectab
Slide 6: Baseline characteristics
Baseline characteristics IO102-IO103 plus pembrolizumab Pembrolizumab IO102-IO103 plus pembrolizumab Pembrolizumab (n=203) (n=204) (n=203) (n=204) Median age (range), years 71.0 (59.0–78.0) 69.0 (60.0–78.0) Baseline metastatic stage, n (%) Age groups, n (%) M0 26 (12.8) 22 (10.8) <65 years 78 (38.4)
Slide 7: Primary endpoint: PFS
Primary endpoint: PFS Blinded independent central review Kaplan–Meier estimate of PFS in ITT determined by BICR per RECISTv1.1 and stratified by PD-L1 status and disease stage 100 80 Median follow-up of 23 months IO102-IO103 plus 60 55.3% 51.2% pembrolizumab Pembrolizumab PFS (%) N=203 N=204 40 47.2
Slide 8: Subgroups: PFS per blinded independent central review
Subgroups: PFS per blinded independent central review IO102-IO103 plus Pembrolizumab Unstratified hazard ratio pembrolizumab for progression-free survival Subgroup no. of events (no. of patients) (95% CI) Overall 99 (203) 119 (204) 0.77 (0.59 to 1.01) Randomization stratification (IXRS) baseline dis
Slide 9: Pre-specified analysis: PFS per PD-L1 status
Pre-specified analysis: PFS per PD-L1 status* PD-L1 positive tumors PD-L1 negative tumors 100 100 Median PFS, 22.1 versus 16.6 months Median PFS, 16.6 versus 3.0 months 80 HR, 0.93; 95% CI, 0.65 to 1.32 80 HR, 0.54; 95% CI, 0.35 to 0.85 Survival probability (%) Survival probability (%) 60 60 40 40 2
Slide 10: Secondary endpoints: ORR and duration of response
Secondary endpoints: ORR and duration of response Blinded independent central review Kaplan–Meier estimate of duration of confirmed objective response IO102-IO103 plus Pembrolizumab pembrolizumab N=204 100 N=203 80 Duration of objective response ORR, n (%) 91 (44.8%) 84 (41.2%) (confirmed) (%) 60 CR
Slide 11: Summary of adverse events
Summary of adverse events IO102-IO103 plus pembrolizumab, Pembrolizumab, N=200 N=198 Any grade, n (%) Grade 3–4, n (%) Any grade, n (%) Grade 3–4, n (%) Any AEs* 194 (97.0) 75 (37.5) 187 (94.4) 69 (34.8) AE leading to discontinuation of study treatment 31 (15.5) 15 (7.5) 31 (15.7) 13 (6.6) Serious A
Slide 12: Treatment-related AEs occurring in at least 10% of patients
Treatment-related AEs occurring in at least 10% of the patients in any treatment group IO102-IO103 plus pembrolizumab, N=200 Pembrolizumab, N=198 Any grade, n (%) Grade 3–4, n (%) Any grade, n (%) Grade 3–4, n (%) Pruritus 42 (21.0) 0 40 (20.2) 1 (0.5) Fatigue 40 (20.0) 1 (0.5) 37 (18.7) 0 Injection
Slide 13: IO102-IO103 vaccine-specific immune responses
IO102-IO103 vaccine-specific immune responses Vaccine-specific immune responses assessed by IFN-ƴ ELISpot assay Preliminary correlation between vaccine-specific PBMCs were isolated from patients at baseline, week 10, and end of treatment immune response and clinical response IO102-IO103 plus pembrol
Slide 14: Key findings and conclusions
Key findings and conclusions • IO102-IO103 plus pembrolizumab showed a median PFS of 19.4 months versus 11.0 months with pembrolizumab alone (HR, 0.77; 95% CI, 0.58 to 1.00; P=0.0558) • The primary endpoint of PFS narrowly missed statistical significance threshold of P≤0.045 • Improvement in PFS fav
Slide 15: Thank you!
Thank you! Thank you to those who have made this trial possible: • The patients and their families • The investigators and all the site staff • IO Biotech team European Society for Medical Oncology (ESMO) This trial (ClinicalTrials.gov NCT05155254) was sponsored Via Ginevra 4, CH-6900 Lugano by IO B
Slide 16: Immune-modulatory cancer vaccines are distinct from traditional cancer vaccines
Immune-modulatory cancer vaccines are a distinct from traditional cancer vaccines IO102-IO103 is an investigational, immune modulatory, off-the-shelf, therapeutic cancer vaccine1,2 Immune-modulatory vaccine3 Neoantigen vaccine4 Cancer vaccine5,6 Antigen • Immune regulatory target • Neoantigen • Tumo
Slide 17: IO102-IO103 is an investigational, immune-modulatory, off-the-shelf cancer vaccine
IO102-IO103 is an investigational, immune-modulatory, off-the-shelf cancer vaccine1,2 PREPARATION3,4 SUBCUTANEOUS ADMINISTRATION5 IO102 and IO103 are administered as 85 µg IO102 85 µg IO103 separate subcutaneous injections 21-amino-acid peptide 19-amino-acid peptide Injections should be around 5 cm
Slide 18: IOB-013/KN-D18: Statistical plan
IOB-013/KN-D18: Statistical plan • Sample size calculation • PD-L1 assessment • A minimum of 380 patients were required to observe 226 events for 89% • PD-L1 expression in tumor tissue (archival or acquired at screening) was power based on assumed hazard ration of 0.65, with type I error controlled
Slide 19: Forest plot for PFS determined by blinded independent central review
Forest plot for PFS determined Randomization stratification (IXRS) baseline metastasis stage by blinded independent central review *PD-L1 expression in tumor tissue was assessed at a central laboratory by IHC with clone 22C3; based on the MEL Score approach as per Duad et al. J Clin Oncol 2016 using
Slide 20: Post-hoc analysis: PFS for patients with no prior (neo-)adjuvant anti-PD-1 therapy
Post-hoc analysis: PFS for patients with no prior (neo-)adjuvant anti-PD-1 therapy Kaplan–Meier estimate of PFS for patients with no prior (neo-)adjuvant anti-PD-1 therapy Excluding patients with prior anti-PD-1 therapy as neoadjuvant/adjuvant therapy, median PFS was 24.8 months with IO102-IO103 plu
Slide 21: Secondary endpoint: Overall survival
Secondary endpoint: Overall survival Kaplan–Meier estimate of OS in ITT and stratified by PD-L1 status and disease stage Median follow-up of 23 months HR, 0.79; 95% CI, 0.57 to 1.10 Endpoint not mature IO102-IO103 plus pembrolizumab Pembrolizumab Jessica C. Hassel CI, confidence interval; HR, hazard