Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IO102-IO103 · 5 trials · 12 indications
PFS defined as the time from randomization to the first documented disease progression ((based on Independent Review Committee in accordance with RECIST v1.1) or death from any cause.
Progressive disease (PD), stable disease (SD), partial response (PR), complete response (CR) calculated on basis of changes in circulating lymphocytes and lymphnode/spleen/liver size according to criteria from the international working group on CLL (IW-CLL).
Major pathologic response, defined as pathologic complete response (pCR) (0% residual viable tumor) or near pCR (≤10% residual viable tumor)
Confirmed Objective Response Rate according to RECIST v1.1
Safety and toxicity will be evaluated according to Common Terminology Criteria for Adverse Events version 5.0 and pre-defined treatment-limiting toxicities.
| Arm | Type | Description |
|---|---|---|
| IO102-IO103 + pembrolizumab | EXPERIMENTAL | IO102-IO103 subcutaneous injections (85µg) every 3 weeks for a maximum 35 cycles (up to 2 years treatment). Additional dose given during the induction period on Day 8 of cycles 1 and 2. Each patient can be treated for a maximum of 37 administrations in total (up to 2 years treatment). Pembrolizumab 200 mg intravenously every 3 weeks for a maximum of 35 cycles. |
| pembrolizumab | ACTIVE_COMPARATOR | Pembrolizumab 200 mg intravenously every 3 weeks for a maximum of 35 cycles (up to 2 years treatment). |
| Vaccination | EXPERIMENTAL | Untreated CLL patients with unmutated IgHV gene with a cut of at maximum of 2 % mutations. According to guidelines from the European Research Initiative on CLL (ERIC). |
| Cohort A - Melanoma | EXPERIMENTAL | Cutaneous resectable Stage III melanoma. Neoadjuvant Treatment (3 cycles): Subcutaneous IO102-IO103 (IO102 85 μg and IO103 85 μg) and intravenous Pembrolizumab KEYTRUDA® 200mg Q3W. Post-surgery Treatment (15 cycles): Subcutaneous IO102-IO103 (IO102 85 μg and IO103 85 μg) and intravenous Pembrolizumab KEYTRUDA® 200mg Q3W. |
| Cohort B - SCCHN | EXPERIMENTAL | Stage III or IVA resectable locoregionally advanced Squamous cell carcinoma of the head and neck (SCCHN) of the oral cavity, oropharynx (HPV-negative), hypopharynx, or larynx Neoadjuvant Treatment (2-3 cycles): Subcutaneous IO102-IO103 (IO102 85 μg and IO103 85 μg) and intravenous Pembrolizumab KEYTRUDA® 200mg Q3W Post-surgery Treatment (15 cycles): Subcutaneous IO102-IO103 (IO102 85 μg and IO103 85 μg) and intravenous Pembrolizumab KEYTRUDA® 200mg Q3W. |
| Cohort C | EXPERIMENTAL | Cutaneous resectable Stage III melanoma. Neoadjuvant Treatment (3 cycles): Subcutaneous IO102-IO103 (IO102 85 μg and IO103 85 μg) and intravenous Pembrolizumab KEYTRUDA® 200mg Q3W (Arm A) versus intravenous Pembrolizumab KEYTRUDA® 200mg Q3W alone (Arm B) Post-surgery Treatment (15 cycles): Subcutaneous IO102-IO103 (IO102 85 μg and IO103 85 μg) and intravenous Pembrolizumab KEYTRUDA® 200mg Q3W (Arm A) versus Pembrolizumab KEYTRUDA® 200mg Q3W alone (Arm B) |
| Arm A (NSCLC) | EXPERIMENTAL | NSCLC patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W |
| Arm B (SCCHN) | EXPERIMENTAL | SCCHN patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W |
| Arm C (mUBC) | EXPERIMENTAL | mUBC patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W |
| Treatment (IO102-IO103, pembrolizumab) | EXPERIMENTAL | Patients receive PD-L1/IDO peptide vaccine SC and pembrolizumab IV on study. Patients also undergo CT and/or CT/PET and collection of blood samples throughout the trial. |
| Name | Type | Description |
|---|---|---|
| IO102-IO103 | DRUG | IO102-IO103 comprises IDO peptide antigen (IO102) and PD-L1 peptide antigen (IO103) emulsified with adjuvant (Montanide ISA 51 VG) administered subcutaneously |
| Pembrolizumab | DRUG | Pembrolizumab administered intravenously |
| PD-L1, PD-L2 peptides with Montanide ISA51 | COMBINATION_PRODUCT | PD-L1: 19 amino acid sequence from the PD-L1 protein; PD-L2: 21 amino acid sequence from the PD-L2 protein; The peptides are dissolved in dimethyl sulphoxide (DMSO) and mixed with Montanide. |
| Pembrolizumab KEYTRUDA® | DRUG | Pembrolizumab KEYTRUDA® administered intravenously |
| IO102-IO103 in combination with pembrolizumab | DRUG | The experimental drug IO102-IO103 is for SC injection and consist of IDO and PD-L1 peptides |
| PD-L1/IDO Peptide Vaccine | BIOLOGICAL | Given SC |
Inclusion Criteria: 1. Histologically or cytologically confirmed stage III (unresectable) or stage IV melanoma, as per American Joint Committee on Cancer 8th edition guidelines not amenable to local therapy 2. Patients are treatment naive, that is, no previous systemic anticancer therapy for unrese...
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IO102-IO103 is an investigational therapeutic cancer vaccine developed by IO Biotech, Inc. It is designed to target PD-L1 and is being studied in oncology across several tumor types, including melanoma, non-small cell lung cancer, and bladder cancer. It is given in combination with pembrolizumab in its clinical trials.
IO102-IO103 targets PD-L1. It is a peptide-based immune-modulatory vaccine that combines IDO and PD-L1 peptides with Montanide ISA51, formulated to direct an immune response against cells expressing PD-L1. It is studied in combination with pembrolizumab, a checkpoint inhibitor.
IO102-IO103 is developed by IO Biotech, Inc., which trades under the ticker IOBTQ. The company is running the clinical program for the vaccine across multiple cancer indications, including a Phase 3 study in advanced melanoma and Phase 2 studies in other solid tumors.
IO102-IO103 is in Phase 2 development overall, with a Phase 3 trial also conducted in advanced melanoma. It is investigational and is being evaluated in combination with pembrolizumab. Studies span melanoma, non-small cell lung cancer, head and neck cancer, and non-muscle invasive bladder cancer.
IO102-IO103 has been studied in NCT05155254, a Phase 3 trial in advanced melanoma with 407 patients, NCT05280314, a Phase 2 neoadjuvant and adjuvant trial in resectable tumors, NCT05077709, a completed Phase 2 trial in metastatic NSCLC, SCCHN, or mUBC, and NCT05843448, a Phase 1 trial in BCG-unresponsive non-muscle invasive bladder cancer.