Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INKmune · 1 trial · 3 indications
Measurement of peripheral blood activated NK cell (memory like NK cell phenotype) percentage by flow cytometry to \>2 times pre-treatment percentage.
Measurement of frequency and severity of Dose-Limiting Toxicities (DLT).
| Arm | Type | Description |
|---|---|---|
| Cohort 1: 1 x 10^8 INKmune | EXPERIMENTAL | In Dose Escalation: INKmune therapy will be administered by a slow intravenous injection via conventional blood giving set. Approximately 18 patients will receive 3 weekly IV doses of INKmune on Day 1, 8, and 15 as per the below: * In Cohort 1, the initial planned dose is 1 x 10\^8 INKmune; * In Cohort 2, the weekly dose will increase to 3 x 10\^8 INKmune; * In Cohort 3, the weekly dose will increase to 5 x 10\^8 INKmune. In Dose Expansion: INKmune therapy will be administered by a slow intravenous injection via conventional blood giving set. Approximately 12 patients will receive 3 weekly IV doses of INKmune on Day 1, 8, and 15 as per the below: Following mBOIN termination and MTD identification, patients will be enrolled in up to two candidate optimal dose levels (no higher than the MTD) for final optimal dose determination. |
| Cohort 2: 3 x 10^8 INKmune | EXPERIMENTAL | In Dose Escalation: INKmune therapy will be administered by a slow intravenous injection via conventional blood giving set. Approximately 18 patients will receive 3 weekly IV doses of INKmune on Day 1, 8, and 15 as per the below: * In Cohort 1, the initial planned dose is 1 x 10\^8 INKmune; * In Cohort 2, the weekly dose will increase to 3 x 10\^8 INKmune; * In Cohort 3, the weekly dose will increase to 5 x 10\^8 INKmune. In Dose Expansion: INKmune therapy will be administered by a slow intravenous injection via conventional blood giving set. Approximately 12 patients will receive 3 weekly IV doses of INKmune on Day 1, 8, and 15 as per the below: Following mBOIN termination and MTD identification, patients will be enrolled in up to two candidate optimal dose levels (no higher than the MTD) for final optimal dose determination. |
| Cohort 3: 5 x 10^8 INKmune | EXPERIMENTAL | In Dose Escalation: INKmune therapy will be administered by a slow intravenous injection via conventional blood giving set. Approximately 18 patients will receive 3 weekly IV doses of INKmune on Day 1, 8, and 15 as per the below: * In Cohort 1, the initial planned dose is 1 x 10\^8 INKmune; * In Cohort 2, the weekly dose will increase to 3 x 10\^8 INKmune; * In Cohort 3, the weekly dose will increase to 5 x 10\^8 INKmune. In Dose Expansion: INKmune therapy will be administered by a slow intravenous injection via conventional blood giving set. Approximately 12 patients will receive 3 weekly IV doses of INKmune on Day 1, 8, and 15 as per the below: Following mBOIN termination and MTD identification, patients will be enrolled in up to two candidate optimal dose levels (no higher than the MTD) for final optimal dose determination. |
| Name | Type | Description |
|---|---|---|
| INKmune | BIOLOGICAL | INKmune is a patented biologic delivery system and method for cancer treatment using in vivo priming and activation of natural killer (NK) cells in order to achieve tumor cell lysis. INKmune is a suspension of INB16 cells which have been rendered replication incompetent that does not require donor matching. |
Inclusion Criteria: 1. Male subjects over 18 years of age at time of screening. 2. Blood Prostate Specific Antigen (PSA) of \>1.0 ng/ml at time of screening. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 at time of screening. 4. Histologic confirmation of adenocarcinoma prosta...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/ GEH200521- Part A |
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | - | Undisclosed |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
INKmune is an investigational monoclonal antibody being studied for the treatment of cancer, specifically metastatic castration-resistant prostate cancer (mCRPC). It is currently in Phase 1 clinical development and is not yet approved by the FDA.
INKmune is a monoclonal antibody, but its specific molecular target has not been disclosed. The drug is being investigated for its potential role in treating metastatic castration-resistant prostate cancer, though the exact mechanism of action is not publicly detailed.
INKmune is being developed by INmune Bio Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol INMB. The company is conducting clinical research to evaluate the drug's safety and efficacy in cancer patients.
INKmune is in Phase 1 clinical development. It has completed one Phase 1 trial, and it remains an investigational drug that has not received FDA approval. Further clinical studies would be needed to advance its development.
INKmune has been studied in one completed Phase 1 clinical trial, identified as NCT06056791, titled 'Study of INKmune in Patients With mCRPC (CaRe Prostate)'. This trial enrolled 12 male patients aged 18 years and older with metastatic castration-resistant prostate cancer in the United States.
No, INKmune is the drug being studied, while CaRe Prostate is the name of the clinical trial. The trial, identified as NCT06056791, evaluated INKmune in patients with metastatic castration-resistant prostate cancer and has been completed.