IO102-IO103

P2, N=60, Recruiting, IO Biotech | N=30 --> 60

Lastly, IDO1 and PDL1-specific CD4+ T cell clones from melanoma patients treated with IO102-IO103 vaccine could selectively target cells differentially expressing IDO1 or PDL1.Our data collectively show that cells expressing IDO1 and PD-L1 represent distinct populations in the TME thus targetable by the IDO1-PD-L1 vaccination approach...These data are supported by ex vivo functional assays using target specific T cells from vaccinated patients. Altogether, our data support the use of a dual antigen approach to reduce the immunosuppression and enhance anti-tumor effect.

P2, N=30, Recruiting, IO Biotech | Trial completion date: Aug 2028 --> Jan 2027 | Trial primary completion date: Sep 2025 --> Apr 2025

P3, N=407, Active, not recruiting, IO Biotech | Recruiting --> Active, not recruiting

P2, N=30, Recruiting, IO Biotech | Not yet recruiting --> Recruiting

P2, N=30, Not yet recruiting, IO Biotech | N=60 --> 30 | Trial completion date: Mar 2029 --> Aug 2028 | Trial primary completion date: Feb 2025 --> Sep 2025

Treatment with IO102-IO103 plus nivolumab in anti-PD-1 naïve metastatic melanoma shows high clinical activity and is well tolerated ( Kjeldsen, Nat Med 2021). Enrollment is ongoing. Additional clinical and biomarker data from trial patients are planned to be presented at the meeting.

P3, N=380, Recruiting, IO Biotech | Trial completion date: May 2027 --> Sep 2027 | Trial primary completion date: Apr 2025 --> Jul 2025

P1, N=30, Recruiting, Mamta Parikh | Not yet recruiting --> Recruiting

P2, N=43, Recruiting, Memorial Sloan Kettering Cancer Center

P2; Trial primary completion date: Apr 2023 --> Apr 2024

P1, N=30, Not yet recruiting, Mamta Parikh

These follow-up data confirmed long-lasting activity for anti-PD-1 therapy naïve patients with metastatic melanoma treated with the IDO/PD-L1 vaccine and nivolumab with unprecedented CRR and ORR rates of 50% and 80% respectively. Importantly, patient subgroups with unfavorable prognostic baseline characteristics obtained remarkable response rates as well. 1 2 Initial results are reported in Nature Medicine, December 2021 IO Biotech (www.iobiotech.com) has licensed the patent of the vaccine IO102/IO103 T-win®

P2, N=60, Not yet recruiting, IO Biotech | Trial completion date: Sep 2028 --> Mar 2029 | Initiation date: Apr 2023 --> Sep 2023 | Trial primary completion date: Jul 2024 --> Feb 2025

P2, N=60, Not yet recruiting, IO Biotech | Trial completion date: Mar 2028 --> Sep 2028 | Initiation date: Oct 2022 --> Apr 2023 | Trial primary completion date: Jan 2024 --> Jul 2024

P2, N=60, Not yet recruiting, IO Biotech | Initiation date: May 2022 --> Oct 2022

P2, N=17, Recruiting, Cliniques universitaires Saint-Luc- Université Catholique de Louvain | N=11 --> 17

Combined IO102-IO103 and anti-PD-1 therapy (nivolumab) has already shown a robust signal of clinical activity (overall response rate [ORR], 80%; complete response rate [CRR], 43%; median progression-free survival [PFS], 26 months) and was well tolerated with minimal added toxicity to nivolumab in a Phase 1/2 study of anti-PD1-naïve patients with metastatic melanoma (Kjeldsen, et al. Exploratory endpoints include biomarker and immune marker correlative studies, and PFS by iRECIST. The trial will assess the opportunity for a positive risk–benefit based on 2 efficacy boundaries for the ORR and 6-month PFS rate in each arm, with cohort expansion permitted if a clinically relevant efficacy signal is observed.

P2; Not yet recruiting --> Recruiting | Initiation date: Oct 2021 --> Feb 2022 | Trial primary completion date: Dec 2022 --> Apr 2023

P2, N=60, Not yet recruiting, IO Biotech

Background: Immunotherapy is an effective treatment for patients with metastatic melanoma. The combination of an PD-L1/IDO peptide vaccine and nivolumab is an effective treatment for patients with metastatic melanoma. The clinical efficacy- and survival data are very encouraging with ORR of 80% of which 46.7% were CR. After a median follow-up of 32 months, the mPFS was 25.3 months which is twice the expected for patients receiving standard treatment of care.

We tested a first-in-class immune-modulatory vaccine (IO102/IO103) against indoleamine 2,3-dioxygenase (IDO) and PD ligand 1 (PD-L1), targeting immunosuppressive cells and tumor cells expressing IDO and/or PD-L1 (IDO/PD-L1), combined with nivolumab. T cell influx of peripherally expanded T cells into tumor sites was observed in responding patients, and general enrichment of IDO- and PD-L1-specific clones after treatment was documented. These clinical efficacy and favorable safety data support further validation in a larger randomized trial to confirm the clinical potential of this immunomodulating approach.

P3, N=300, Recruiting, IO Biotech | Not yet recruiting --> Recruiting

P3, N=300, Not yet recruiting, IO Biotech

P2; N=90; Not yet recruiting; Sponsor:IO Biotech