Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IMM-101 · 1 trial · 2 indications
* WHO definition of "influenza-like illness" (ILI) \[Fitzner 2018\] or confirmed viral/bacterial respiratory infection AND * Results in a change or delay in cancer treatment or requirement for and unscheduled medical assesment, hospitalization or death.
| Arm | Type | Description |
|---|---|---|
| IMM-101 | EXPERIMENTAL | The treatment regimen with IMM-101 will be one 1.0 mg (= 0.1 mL) dose given on Day 0, followed by a second dose of 0.5 mg (= 0.05 mL) on Day 14 (-2/+5 days), and a third Dose of 0.5 mg (= 0.05 mL) on Day 45 (+/-14 days) |
| Observation | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| IMM-101 | BIOLOGICAL | Three doses of IMM-101 on days 0, 14, and 45. |
| Observation | OTHER | No active treatment. Observation only |
Inclusion Criteria: * Patient must be undergoing (or be planned to undergo) active treatment for one or more solid malignancy, lymphoma or myeloma. active treatment includes adjuvant, neoadjuvant and palliative intent treatment with surgery, radiation, chemotherapy, targeted therapy or immunotherap...
| 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 |
IMM-101 is an investigational monoclonal antibody being studied for use in cancer patients at increased risk of exposure to respiratory infections and severe COVID-19 related infections. It is currently in Phase 3 clinical development and has not been approved by the FDA.
IMM-101 is being developed by Applied Therapeutics, Inc. (NASDAQ: APLT). The company is conducting clinical trials to evaluate the drug's potential in oncology patients.
IMM-101 is in Phase 3 clinical development. It is an investigational drug and has not yet received regulatory approval. The Phase 3 trial has been completed.
IMM-101 was evaluated in a completed Phase 3 trial (NCT04442048) that enrolled 195 participants. The trial compared immunization with IMM-101 versus observation for prevention of respiratory and severe COVID-19 related infections in cancer patients at increased risk of exposure.
Yes, IMM-101 is a monoclonal antibody. It is being studied as an immunization approach in cancer patients to help prevent respiratory infections and severe COVID-19 related infections.