RP3 / Replimune - LARVOL DELTA

RPx: A Study to Assess the Long-term Safety Outcomes in Patients Previously Treated With RP1, RP2, or RP3 (clinicaltrials.gov) - P=N/A | N=50 | Not yet recruiting | Sponsor: Replimune Inc. | Initiation date: Jun 2025 ➔ Nov 2025

Trial initiation date • Hepatocellular Cancer • Melanoma • Oncology • Solid Tumor

RPx: A Study to Assess the Long-term Safety Outcomes in Patients Previously Treated With RP1, RP2, or RP3 (clinicaltrials.gov) - P=N/A | N=50 | Not yet recruiting | Sponsor: Replimune Inc.

New trial • Hepatocellular Cancer • Hepatology • Melanoma • Oncology • Solid Tumor

Study of RP3 Monotherapy and RP3 in Combination With Nivolumab in Patients With Solid Tumours (clinicaltrials.gov) - P1 | N=123 | Active, not recruiting | Sponsor: Replimune Inc. | Trial completion date: Apr 2024 ➔ Nov 2026 | Trial primary completion date: Apr 2024 ➔ Nov 2026

Combination therapy • Monotherapy • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

RP2/RP3 in Combination With Atezolizumab and Bevacizumab for the Treatment of Patients With CRC (clinicaltrials.gov) - P2 | N=4 | Active, not recruiting | Sponsor: Replimune Inc. | N=60 ➔ 4

Combination therapy • Enrollment change • Metastases • Mismatch repair • Oncolytic virus • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • EGFR

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

Combination therapy • Metastases • Oncolytic virus • Trial primary completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

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) - P2 | "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 • Metastases • Oncolytic virus • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CD40 • MSI

An open-label, multicenter study investigating RP3 oncolytic immunotherapy in combination with first- or second-line systemic atezolizumab plus bevacizumab in patients with locally advanced unresectable or metastatic hepatocellular carcinoma. (ASCO-GI 2024) - P2 | "Secondary endpoints are safety, ORR using HCC modified RECIST, duration of response, complete response rate, and progression-free survival. Clinical trial information: NCT05733598."

Clinical • Combination therapy • Metastases • Oncolytic virus • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • CD40LG

Study of RP3 in Combination With Nivolumab and Other Therapy in Patients With Locoregionally Advanced or Recurrent SCCHN (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Replimune Inc. | N=130 ➔ 0 | Not yet recruiting ➔ Withdrawn

Combination therapy • Enrollment change • Metastases • Oncolytic virus • Trial withdrawal • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

RP2/RP3 in Combination With Atezolizumab and Bevacizumab for the Treatment of Patients With CRC (clinicaltrials.gov) - P2 | N=60 | Active, not recruiting | Sponsor: Replimune Inc. | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Metastases • Mismatch repair • Oncolytic virus • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • EGFR

Study of RP3 Monotherapy and RP3 in Combination With Nivolumab in Patients With Solid Tumours (clinicaltrials.gov) - P1 | N=123 | Active, not recruiting | Sponsor: Replimune Inc. | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Monotherapy • Oncology • Solid Tumor

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: Oct 2023 ➔ Feb 2024

Combination therapy • Metastases • Oncolytic virus • Trial initiation date • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Study of RP3 in Combination With Nivolumab and Other Therapy in Patients With Locoregionally Advanced or Recurrent SCCHN (clinicaltrials.gov) - P2 | N=130 | Not yet recruiting | Sponsor: Replimune Inc. | Initiation date: Sep 2023 ➔ Jan 2024

Combination therapy • Metastases • Oncolytic virus • Trial initiation date • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Replimune Reports Fiscal First Quarter 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "RP3 in combination with atezolizumab and bevacizumab in first (1L) and second-line (2L) hepatocellular carcinoma (HCC): Two signal finding cohorts of 30 patients each will be enrolled in collaboration with Roche. The first cohort will enroll 1L patients treated with SOC atezolizumab combined with bevacizumab and RP3, and the second cohort will enroll patients who have progressed on 1L immunotherapy (including atezolizumab/bevacizumab), and will be treated with atezolizumab combined with bevacizumab and RP3. This clinical trial is expected to initiate this quarter."

Trial status • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Study of RP3 in Combination With Nivolumab and Other Therapy in Patients With Locoregionally Advanced or Recurrent SCCHN (clinicaltrials.gov) - P2 | N=130 | Not yet recruiting | Sponsor: Replimune Inc. | Initiation date: Jun 2023 ➔ Sep 2023

Combination therapy • Metastases • Oncolytic virus • Trial initiation date • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

RP2/RP3 in Combination With Atezolizumab and Bevacizumab for the Treatment of Patients With CRC (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Replimune Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • EGFR

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) - P2 | "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 • Combination therapy • IO biomarker • Metastases • Oncolytic virus • P2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CD40 • MSI

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

Combination therapy • Metastases • Oncolytic virus • Trial initiation date • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

A phase 2, open-label, multicenter study investigating efficacy and safety of RP3 oncolytic immunotherapy combined with other therapies in patients with locoregionally advanced or recurrent squamous cell carcinoma of the head and neck. (ASCO 2023) - P2 | "For recurrent/metastatic (R/M) SCCHN, standard first-line therapy includes immune checkpoint inhibitors (anti–PD-1) ± chemotherapy or cetuximab, chemotherapy ± cetuximab, or salvage surgery; prognoses are poor, and benefit of anti–PD-1 therapy is generally limited to pts with positive PD-L1 combined positive score (CPS)... Pts in the LA cohort (up to ~100 pts) must have inoperable, previously untreated, high-risk SCCHN eligible for curative intent CCRT and will be randomized 1:1 to receive RP3 + standard of care cisplatin-based CCRT, followed by nivolumab (nivo), vs CCRT alone...Pts in the R/M cohort (up to ~30 pts) must have R/M SCCHN eligible for first-line systemic therapy for locoregional recurrence and/or distant metastases and PD-L1 CPS < 20, and will receive RP3 + nivo + carboplatin/paclitaxel...The primary endpoint for the R/M cohort is overall response rate. Clinical trial information: NCT05743270."

Clinical • Metastases • Oncolytic virus • P2 data • Head and Neck Cancer • Hematological Malignancies • Herpes Simplex • Immune Modulation • Leukemia • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD40 • PD-L1

An open-label clinical trial of RP2 and RP3 oncolytic immunotherapy in combination with atezolizumab and bevacizumab for the treatment of patients with advanced colorectal carcinoma. (ASCO 2023) - P2 | "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 • Metastases • Oncolytic virus • Colorectal Cancer • Gastrointestinal Cancer • Hematological Disorders • Hematological Malignancies • Herpes Simplex • Leukemia • Microsatellite Instability • Oncology • Solid Tumor • CD40 • MSI

An open-label, multicenter study investigating RP3 oncolytic immunotherapy in combination with first- or second-line systemic atezolizumab and bevacizumab therapy in patients with locally advanced unresectable or metastatic hepatocellular carcinoma. (ASCO 2023) - P2 | "Secondary endpoints are safety, ORR using HCC modified RECIST, duration of response, complete response rate, and progression-free survival. Clinical trial information: NCT05733598."

Clinical • Combination therapy • Metastases • Oncolytic virus • CNS Disorders • Gastrointestinal Cancer • Gastrointestinal Disorder • Hematological Malignancies • Hepatic Encephalopathy • Hepatocellular Cancer • Hepatology • Herpes Simplex • Immune Modulation • Leukemia • Nephrology • Oncology • Renal Disease • Solid Tumor • CD40LG

Study of RP3 in Combination With Nivolumab and Other Therapy in Patients With Locoregionally Advanced or Recurrent SCCHN (clinicaltrials.gov) - P2 | N=130 | Not yet recruiting | Sponsor: Replimune Inc.

Combination therapy • Metastases • New P2 trial • Oncolytic virus • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Replimune Presents RP1 Data from the IGNYTE anti-PD1 Failed Melanoma Cohort and RP2 Data in Uveal Melanoma at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (GlobeNewswire) - "Three additional trial-in-progress abstracts were presented at ASCO outlining Phase 2 development plans for RP2 and RP3. A Phase 2, open-label, multicenter study investigating efficacy and safety of RP3 oncolytic immunotherapy combined with other therapies in patients with locoregionally advanced or recurrent squamous cell carcinoma of the head and neck (SCCHN)....An open-label clinical trial of RP2 and RP3 oncolytic immunotherapy in combination with atezolizumab and bevacizumab for the treatment of patients with advanced colorectal carcinoma (CRC)....An open-label, multicenter study investigating RP3 oncolytic immunotherapy in combination with first- or second-line systemic atezolizumab and bevacizumab therapy in patients with locally advanced unresectable or metastatic hepatocellular carcinoma (HCC)....These clinical trials are currently in the trial set up phase and are expected to initiate around mid-year."

Trial status • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

An open-label, multicenter study investigating RP3 oncolytic immunotherapy in combination with first- or second-line systemic atezolizumab and bevacizumab therapy in patients with locally advanced unresectable or metastatic hepatocellular carcinoma. (ASCO-GI 2023) - "The primary endpoint includes overall response rate (ORR) by RECIST v1.1. Secondary endpoints are safety, ORR using HCC mRECIST, duration of response, complete response rate, and progression-free survival."

Clinical • Combination therapy • Metastases • Oncolytic virus • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • CD40LG

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 • Metastases • Oncolytic virus • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • CD40LG

Replimune to Present at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (GlobeNewswire) - "Replimune Group, Inc...announced multiple presentations at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago, IL from June 2-6, 2023. Replimune has one abstract selected for a poster discussion session that will include updated results from the first 75 patients treated with RP1 combined with nivolumab from the anti-PD1 failed melanoma cohort of the IGNYTE clinical trial. In addition, the Company will also present data from the Phase 1 trial of RP2 combined with nivolumab in uveal melanoma, and trial-in-progress posters from the RP2/3 programs."

P1 data • P1/2 data • Trial status • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Melanoma • Oncology • Solid Tumor • Uveal Melanoma