Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IO102-IO103 · 2 trials · 4 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.
Major pathologic response, defined as pathologic complete response (pCR) (0% residual viable tumor) or near pCR (≤10% residual viable tumor)
| 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). |
| 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) |
| 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 |
| Pembrolizumab KEYTRUDA® | DRUG | Pembrolizumab KEYTRUDA® administered intravenously |
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 cancer therapy being studied for the treatment of melanoma, including metastatic melanoma. It is also being evaluated in patients with resectable tumors and squamous cell carcinoma of the head and neck. The drug is currently in Phase 2 clinical development.
IO102-IO103 targets PD-L1, a protein involved in immune checkpoint regulation. By targeting PD-L1, the therapy aims to modulate the immune system's response to cancer cells. This mechanism is being studied in combination with other treatments for advanced melanoma and other tumor types.
IO102-IO103 is being developed by IO Biotech, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol IOBT. IO Biotech is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy.
IO102-IO103 is currently in Phase 2 clinical development. It has received Breakthrough Therapy designation from the FDA, which is granted to expedite the development and review of drugs for serious conditions. The drug is investigational and has not yet been approved by regulatory authorities.
IO102-IO103 is being studied in two clinical trials. NCT05155254 is a Phase 3 trial combining IO102-IO103 with pembrolizumab versus pembrolizumab alone in advanced melanoma, with 407 participants. NCT05280314 is a Phase 2 trial of neoadjuvant and adjuvant IO102-IO103 with pembrolizumab in resectable tumors, enrolling 60 patients.
No, IO102-IO103 is not the same as pembrolizumab. Pembrolizumab is an anti-PD-1 antibody marketed as KEYTRUDA. IO102-IO103 is a separate investigational therapy that targets PD-L1. The two drugs are being studied in combination in clinical trials for melanoma and other cancers.