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DRUG:

RP3

i
Other names: RP3, genetically modified HSV-1, genetically modified herpes simplex type 1 virus
Associations
Company:
Replimune
Drug class:
CTLA4 inhibitor, CD137 modulator, CD40 stimulant
Associations
3ms
Study of RP3 Monotherapy and RP3 in Combination With Nivolumab in Patients With Solid Tumours (clinicaltrials.gov)
P1, N=123, Active, not recruiting, Replimune Inc. | Trial completion date: Apr 2024 --> Nov 2026 | Trial primary completion date: Apr 2024 --> Nov 2026
Trial completion date • Trial primary completion date • Combination therapy
|
Opdivo (nivolumab) • RP3
7ms
Enrollment change • Combination therapy • Oncolytic virus • Mismatch repair • Metastases
|
EGFR (Epidermal growth factor receptor)
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • RP2 • RP3
11ms
Enrollment change • Trial withdrawal • Combination therapy • Oncolytic virus • Metastases
|
PD-L1 (Programmed death ligand 1)
|
CDKN2A negative
|
Opdivo (nivolumab) • carboplatin • paclitaxel • RP3
11ms
RP2/RP3 in Combination With Atezolizumab and Bevacizumab for the Treatment of Patients With CRC (clinicaltrials.gov)
P2, N=60, Active, not recruiting, Replimune Inc. | Recruiting --> Active, not recruiting
Enrollment closed • Combination therapy • Oncolytic virus • Mismatch repair • Metastases
|
EGFR (Epidermal growth factor receptor)
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • RP2 • RP3
11ms
RP3 in Combination With 1L or 2L Therapy in Patients With Locally Advanced Unresectable or Metastatic HCC (clinicaltrials.gov)
P2 | N=60 | Not yet recruiting | Sponsor: Replimune Inc. | Trial primary completion date: Jan 2027 ➔ Apr 2027
Oncolytic virus • Combination therapy • Trial primary completion date
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • RP3
11ms
Study of RP3 Monotherapy and RP3 in Combination With Nivolumab in Patients With Solid Tumours (clinicaltrials.gov)
P1, N=123, Active, not recruiting, Replimune Inc. | Recruiting --> Active, not recruiting
Enrollment closed • Combination therapy
|
Opdivo (nivolumab) • RP3
11ms
An open-label clinical trial of RP2 and RP3 oncolytic immunotherapy in combination with atezolizumab plus bevacizumab for the treatment of patients with advanced colorectal carcinoma. (ASCO-GI 2024)
Safety will be assessed by physical examination, clinical laboratory evaluations, vital signs, and monitoring for adverse events (AEs; including serious AEs). Clinical trial information: NCT05733611.
Clinical • Combination therapy • Oncolytic virus • Metastases
|
MSI (Microsatellite instability) • CD40 (CD40 Molecule)
|
MSI-H/dMMR • CSF2 expression
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • RP2 • RP3
12ms
RP3 in Combination With 1L or 2L Therapy in Patients With Locally Advanced Unresectable or Metastatic HCC (clinicaltrials.gov)
P2, N=60, Not yet recruiting, Replimune Inc. | Initiation date: Oct 2023 --> Feb 2024
Trial initiation date • Combination therapy • Oncolytic virus • Metastases
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • RP3
1year
Trial initiation date • Combination therapy • Oncolytic virus • Metastases
|
PD-L1 (Programmed death ligand 1)
|
CDKN2A negative
|
Opdivo (nivolumab) • carboplatin • paclitaxel • RP3
over1year
Trial initiation date • Combination therapy • Oncolytic virus • Metastases
|
PD-L1 (Programmed death ligand 1)
|
CDKN2A negative
|
Opdivo (nivolumab) • carboplatin • paclitaxel • RP3
over1year
Enrollment open • Combination therapy • Oncolytic virus • Mismatch repair • Metastases
|
EGFR (Epidermal growth factor receptor)
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • RP2 • RP3
over1year
RP3 in Combination With 1L or 2L Therapy in Patients With Locally Advanced Unresectable or Metastatic HCC (clinicaltrials.gov)
P2 | N=60 | Not yet recruiting | Sponsor: Replimune Inc. | Initiation date: Jun 2023 ➔ Sep 2023
Oncolytic virus • Combination therapy • Trial initiation date
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • RP3
over1year
An ongoing open-label, phase 2 trial of RP2 Or RP3 oncolytic immunotherapy in combination with atezolizumab and bevacizumab for the treatment of patients with advanced colorectal carcinoma (ESMO-GI 2023)
AE severity will be evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0.Clinical trial identification: NCT05733611.Editorial acknowledgement: Medical writing and editorial support were provided by Marita Chakhtoura, PhD, of AlphaBioCom, LLC, a Red Nucleus Company (King of Prussia, PA, USA) and were funded by Replimune Inc. (Woburn, MA, USA).Legal entity responsible for the study: Replimune Inc.
Clinical • P2 data • Combination therapy • Oncolytic virus • MSi-H Biomarker • PD(L)-1 Biomarker • IO biomarker • Metastases
|
MSI (Microsatellite instability) • CD40 (CD40 Molecule)
|
MSI-H/dMMR • CSF2 expression
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • RP2 • RP3
over1year
Trial in progress: An open-label, multicenter study investigating RP3 oncolytic immunotherapy in combination with first- or second-line systemic atezolizumab and bevacizumab in locally advanced unresectable or metastatic hepatocellular carcinoma (LCS 2023)
The primary endpoint is overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Secondary endpoints are safety, ORR using HCC modified RECIST, duration of response, complete response rate, and progression-free survival.
Clinical • Combination therapy • Oncolytic virus • Metastases
|
CD40LG (CD40 ligand)
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • RP3
over1year
Preclinical characterization and clinical biomarker studies with RP3, a novel oncolytic immunotherapy expressing a fusogenic protein, a human anti-CTLA-4 antibody, hCD40L and h4-1BBL (AACR 2023)
Preclinical experiments from mice models confirmed the robust expression of CD40-L, 4-1BBL and anti-CTLA-4 in RP3-injected tumors. Biomarker studies from patients demonstrate increases in CD8-T cell infiltration and PD-L1 expression post RP3 +/- nivolumab treatment, including increases in the expression of genes associated with response to anti-PD-1 therapy. These data indicate the potential for broad utility of RP3 in a range of tumor types, including in tumors that are not sensitive to PD-1 blockade.
Preclinical • Oncolytic virus • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • CD40LG (CD40 ligand) • CD86 (CD86 Molecule)
|
PD-L1 expression • BRAF V600E • BRAF V600
|
Opdivo (nivolumab) • RP3
over1year
New P2 trial • Combination therapy • Oncolytic virus • Metastases
|
PD-L1 (Programmed death ligand 1)
|
CDKN2A negative
|
Opdivo (nivolumab) • carboplatin • paclitaxel • RP3
over1year
Oncolytic virus • Combination therapy • New P2 trial
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • RP3
over1year
Oncolytic virus • Combination therapy • New P2 trial
|
EGFR (Epidermal growth factor receptor)
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • RP2 • RP3