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DRUG:

RP2

i
Other names: RP2
Associations
Company:
Replimune
Drug class:
CTLA4 inhibitor, G-CSF stimulant
Related drugs:
Associations
6d
Enrollment open • Combination therapy • Checkpoint inhibition • Metastases
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Opdivo (nivolumab) • Yervoy (ipilimumab) • RP2
2ms
Study of RP2 in Combination With Second-line Therapy in Patients With Locally Advanced Unresectable or Metastatic HCC (clinicaltrials.gov)
P2, N=30, Recruiting, Replimune Inc. | Not yet recruiting --> Recruiting | N=60 --> 30 | Trial completion date: Jul 2027 --> Jul 2028 | Trial primary completion date: Apr 2027 --> Dec 2027
Enrollment open • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Oncolytic virus • Metastases
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Avastin (bevacizumab) • Tecentriq (atezolizumab) • RP2
2ms
New P2/3 trial • Combination therapy • Checkpoint inhibition • Metastases
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Opdivo (nivolumab) • Yervoy (ipilimumab) • RP2
7ms
Enrollment change • Combination therapy • Oncolytic virus • Mismatch repair • Metastases
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EGFR (Epidermal growth factor receptor)
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Avastin (bevacizumab) • Tecentriq (atezolizumab) • RP2 • 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
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EGFR (Epidermal growth factor receptor)
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Avastin (bevacizumab) • Tecentriq (atezolizumab) • RP2 • 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
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MSI (Microsatellite instability) • CD40 (CD40 Molecule)
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MSI-H/dMMR • CSF2 expression
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Avastin (bevacizumab) • Tecentriq (atezolizumab) • RP2 • RP3
over1year
Enrollment open • Combination therapy • Oncolytic virus • Mismatch repair • Metastases
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EGFR (Epidermal growth factor receptor)
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Avastin (bevacizumab) • Tecentriq (atezolizumab) • RP2 • 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
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MSI (Microsatellite instability) • CD40 (CD40 Molecule)
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MSI-H/dMMR • CSF2 expression
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Avastin (bevacizumab) • Tecentriq (atezolizumab) • RP2 • RP3
over1year
Oncolytic virus • Combination therapy • New P2 trial
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EGFR (Epidermal growth factor receptor)
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Avastin (bevacizumab) • Tecentriq (atezolizumab) • RP2 • RP3
over2years
Clinical biomarker studies with an enhanced potency oncolytic HSV expressing an anti-CTLA-4 antibody, as a single agent and combined with nivolumab in patients with advanced solid tumors indicates potent immune activation. (AACR 2022)
A particularly striking change was observed in a biopsy obtained from a liver lesion from a tebantafusp and ipi/pembro-failed uveal melanoma patient. The biomarker data presented indicates broad immune activation by RP2 and demonstrates that clinical response does not correlate with baseline PD-L1 and CD8 expression status. Clinical responses were often associated with increases in gene signatures associated with cytotoxic T, NK and Th1 cells. These data indicate the potential for broad utility of RP2 in a range of tumor types, including in patients with primary or acquired resistance to immune checkpoint blockade.
Clinical • PD(L)-1 Biomarker • IO biomarker
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PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • IDO1 (Indoleamine 2,3-dioxygenase 1) • CD68 (CD68 Molecule) • CSF2 (Colony stimulating factor 2) • FOXP3 (Forkhead Box P3) • TRB (T Cell Receptor Beta Locus)
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PD-L1 expression • CSF2 expression • CTLA4 expression • PD-L1 expression + CD8 positive • FOXP3 expression
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nCounter® PanCancer IO 360™ Panel
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Keytruda (pembrolizumab) • Opdivo (nivolumab) • RP2
over3years
[VIRTUAL] Clinical biomarker studies with two fusion-enhanced versions of oncolytic HSV (RP1 and RP2) alone and in combination with nivolumab in cancer patients indicate potent immune activation (AACR 2021)
The tumor inflammation signature score (TIS) was also calculated.Preliminary Phase 1/2 biomarker data from paired tumor biopsies include the following: Immunohistochemistry for CD8 and PD-L1 (n=30) indicated robust and increased infiltration of CD8+ T cells and PD-L1 expression, both after combined treatment with RP1 and nivolumab and after single agent RP2 across different tumor types, and including reversal of T cell exclusion following prior combined treatment with ipilimumab and nivolumab in melanoma. Consistent with the pre-clinical data, preliminary clinical biomarker data indicate substantial increase in CD8 T cell infiltration and PD-L1 expression, as well as increased TIS score in the majority of patients treated with RP2 alone or RP1 and nivolumab combination. Particularly marked effects were seen in some patients with clinical responses which occurred independent of both baseline PD-L1 and prior anti-PD1 therapy status, which suggests potential broad utility of the RP1/2 treatment approach in igniting an anti-tumor immune response. Tumor mutation burden analysis and T cell receptor sequencing are currently underway and further updates of the dataset will be presented.
Combination therapy • Late-breaking abstract • Clinical • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
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TMB (Tumor Mutational Burden) • CD8 (cluster of differentiation 8) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • CXCL9 (Chemokine (C-X-C motif) ligand 9) • CD27 (CD27 Molecule) • CSF2 (Colony stimulating factor 2)
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PD-L1 expression • CSF2 expression • CTLA4 expression • High inflammation signature scores
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PD-L1 IHC 28-8 pharmDx
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Opdivo (nivolumab) • Yervoy (ipilimumab) • RP2 • vusolimogene oderparepvec (RP1)