Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RP3 · 1 trial · 1 indication
Percentage of participants with DLTs
Percentage of participants with TEAEs
Percentage of participants with SAEs
Percentage of participants with TEAEs ≥ Grade 3
Percentage of participants experiencing events requiring withdrawal from treatment.
RP2D of RP3 based on the safety and response data collected during the dose escalation phase (Part 1)
| Arm | Type | Description |
|---|---|---|
| Dose escalation of RP3 - superficial and/or deep/visceral tumors | EXPERIMENTAL | Dose escalation of RP3 alone in 2 cohorts with intratumoral (IT) injections including use of imaging guided injection for deep tumors. |
| Dose combination of RP3 and anti-PD1 therapy - superficial and/or deep/visceral tumors | EXPERIMENTAL | Dose combination of RP3 and anti-PD1 therapy. IT injections of RP3 including use of imaging guided injection for deep tumors. |
| Seronegative cohort | EXPERIMENTAL | Doses of RP3 (IT) in HSV seronegative participants. |
| Name | Type | Description |
|---|---|---|
| RP3 | BIOLOGICAL | Genetically modified HSV-1 |
| Nivolumab | BIOLOGICAL | anti-PD1 monoclonal antibody |
Inclusion Criteria: * Patients with advanced or metastatic non-neurological solid tumors, who have progressed on standard therapy or cannot tolerate standard therapy, or for whom there is no standard therapy preferred to enrollment in a clinical study * All patients must consent to provide archival...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
RP3 is an investigational monoclonal antibody being developed by Replimune Group, Inc. for the treatment of advanced solid tumors. It is designed to engage three immune targets at once and is currently in Phase 1 clinical development. RP3 has not been approved by the FDA and remains an experimental therapy.
RP3 targets CD40L, 4-1BBL, and CTLA-4. By binding these three targets, the antibody is designed to stimulate immune activation through CD40 and 4-1BB costimulatory pathways while blocking the CTLA-4 inhibitory checkpoint. This multi-target approach aims to enhance antitumor immune responses in patients with advanced solid tumors.
RP3 is being developed by Replimune Group, Inc., which trades on the Nasdaq under the ticker REPL. The company is the sponsor of the clinical program evaluating RP3 in advanced solid tumors.
RP3 is in Phase 1 clinical development. It is an investigational agent and has not received FDA approval. The Phase 1 program is evaluating RP3 as a monotherapy and in combination with nivolumab in patients with advanced solid tumors.
RP3 is being studied in the Phase 1 trial NCT04735978, titled Study of RP3 Monotherapy and RP3 in Combination With Nivolumab in Patients With Solid Tumours. The trial has enrolled 123 patients, is active but not recruiting, and is running in the United States, France, Greece, Spain, and the United Kingdom.
RP3 is being evaluated for the treatment of advanced solid tumors. The Phase 1 trial NCT04735978 studies RP3 both as a monotherapy and in combination with nivolumab in adults aged 18 years and older. RP3 is investigational and has not been approved for any indication.