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 immune-modulatory therapeutic being developed by IO Biotech, Inc. for several cancer types. It is studied in combination with pembrolizumab (KEYTRUDA) and targets PD-L1. It is not yet approved and remains in clinical development across melanoma, non-small cell lung cancer, bladder cancer, and head and neck cancer studies.
IO102-IO103 is being studied for metastatic and unresectable melanoma, high risk non-muscle invasive bladder urothelial carcinoma, non-small cell lung cancer, head and neck squamous cell carcinoma, and chronic lymphocytic leukemia. It is an investigational agent and is not approved for any indication.
IO102-IO103 targets PD-L1. It is described as a PD-L1 and IDO peptide based immune-modulatory therapeutic, and it is administered with pembrolizumab, a PD-1 checkpoint inhibitor, in the clinical programs. The combination approach is designed to stimulate immune responses against tumor cells expressing these targets.
IO102-IO103 is developed by IO Biotech, Inc., which trades under the ticker IOBT. The company is running the clinical program, including studies combining IO102-IO103 with pembrolizumab (KEYTRUDA) in multiple tumor types.
IO102-IO103 is in Phase 2 development overall, with individual studies spanning Phase 1 through Phase 3. It is investigational and has not been approved by the FDA. The Phase 3 study in advanced melanoma is active but not recruiting, while Phase 1 and Phase 2 studies are recruiting or completed.
IO102-IO103 has been studied in NCT05843448, a Phase 1 trial in BCG-unresponsive or intolerant non-muscle invasive bladder cancer; NCT05280314, a Phase 2 neoadjuvant and adjuvant trial in resectable melanoma and head and neck cancer; NCT05155254, a Phase 3 trial in advanced melanoma; and NCT05077709, a completed Phase 2 trial in metastatic NSCLC, SCCHN, or mUBC.