On January 8, 2025 Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported that the first patients have been enrolled in studies evaluating RP2 in two different settings: checkpoint naïve metastatic uveal melanoma; and second-line recurrent or metastatic hepatocellular carcinoma (HCC) (Press release, Replimune, JAN 8, 2025, View Source [SID1234649509]).
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"On the heels of our BLA submission for RP1 and designation as breakthrough therapy, we are pleased that the first patients have been enrolled in both the RP2 HCC clinical trial and the registration intended study of RP2 in metastatic uveal melanoma," said Sushil Patel, Ph.D., CEO of Replimune. "We are excited to explore the broader potential of the RPx platform and these RP2 clinical trials will play an important part of our future development plans."
RP2-202 Clinical Trial in Metastatic Uveal Melanoma
Uveal melanoma is a type of cancer that occurs in the tissues of the eye. Up to 50 percent of patients with uveal melanoma may develop metastatic disease. The most common site of metastasis for uveal melanoma is the liver and is estimated to occur in 90-95% of cases.1
"We are honored and excited to be able to offer this clinical trial to our patients with uveal melanoma, a group of patients for whom treatment options are very limited," said Dr. Justin Moser, an associate clinical investigator in the Cancer Research Division of HonorHealth Research Institute, where he specializes in uveal melanoma. "We hope that, by providing our patients with early access to treatments through clinical trials, that we will be able to help give them longer, higher-quality lives."
During ASCO (Free ASCO Whitepaper) 2024, results from an open-label, multicenter, Phase 2 study of RP2 alone or combined with nivolumab in a cohort of patients with uveal melanoma (n=17) were presented. RP2 administered as monotherapy or in combination with nivolumab demonstrated an overall response rate of 29.4%, with a disease control rate of 58.8%.
The RP2-202 trial (NCT06581406) is a randomized, phase 2/3 study that will enroll approximately 280 patients and evaluate RP2 in combination with nivolumab versus ipilimumab in combination with nivolumab in immune checkpoint inhibitor-naïve adult patients with metastatic uveal melanoma. The primary endpoints of the study are overall survival and progression free survival. Key secondary endpoints are overall response rate and disease control rate. For additional information about the RP2-202 clinical trial and to learn more about eligibility, please visit our clinical trials page here.
RP2-003 Clinical Trial in Hepatocellular Carcinoma
HCC is the third leading cause of cancer-related deaths in the world. Prognosis is generally poor with the majority of HCC cases diagnosed in the advanced stage. HCC comprises approximately 75 to 85 percent of primary liver cancer cases.
The RP2-003 trial (NCT05733598) is an open label trial that will enroll 30 patients and evaluate RP2 combined with the second-line therapy of atezolizumab and bevacizumab in patients with locally advanced unresectable, recurrent and/or metastatic HCC. The primary endpoint of the study is overall response rate (ORR) per modified RECIST 1.1 criteria. Key secondary endpoints are ORR per RECIST modified for HCC and duration of response. The study is being conducted under a collaboration and supply agreement with Roche. For additional information about the RP2-003 trial and to learn more about eligibility, please visit our clinical trials page here.
About RP2
RP2 is a derivative of RP1, Replimune’s lead product candidate that is based on a proprietary new strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response. RP2 additionally expresses an anti-CTLA-4 antibody-like molecule, as well as GALV-GP-R- and GM-CSF. RP2 is intended to provide targeted and potent delivery of these proteins to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic-immune-based efficacy on tumors and limiting off-target toxicity.