On November 3, 2023 Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel portfolio of oncolytic immunotherapies, reported updated interim results from ARTACUS, a Phase 1/2 clinical trial evaluating RP1 monotherapy for the treatment of skin cancers in patients who have had solid organ or hematopoietic cell transplants (Press release, Replimune, NOV 3, 2023, View Source [SID1234636972]). The data were presented today by Dr. Michael R. Midgen of the University of Texas MD Anderson Cancer Center during an oral session (Abstract #777) at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in San Diego.

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Treatment with RP1 monotherapy led to an overall response rate (ORR) of 34.8 percent (8 of 23 evaluable patients, including 5 complete responses and 3 partial responses). Of the 23 evaluable patients, 20 had cutaneous squamous cell carcinoma (CSCC) and 3 had merkel cell carcinoma (MCC) with responses observed in 6 CSCC patients and 2 patients with MCC. One patient treated for CSCC also had a complete response of a new primary basal cell carcinoma which appeared post baseline that was treated with RP1. Most responses were ongoing as of the data cutoff date of September 18, 2023. There was no evidence of allograft rejection including of hepatic and lung allografts. RP1 monotherapy was well tolerated, and the safety profile was similar to the profile in non-immunocompromised patients with advanced skin cancers. The slides are available on the Replimune website under presentations.

"These data demonstrating an overall response rate of nearly 35 percent with good durability of benefit to date show that RP1 monotherapy has clinically meaningful anti-tumor activity in a difficult to treat patient population receiving chronic immunosuppressive treatment and where systemic immunotherapy may not be a viable option," said Robert Coffin, President and Chief Research and Development Officer of Replimune. "Patients receiving organ transplants are highly susceptible to skin cancer at a rate which is far higher than in the general population. Based on the data to date, we believe that RP1 monotherapy may potentially provide a safe and effective option for patients that currently have a limited number of treatments available."

About ARTACUS
ARTACUS is a multicenter, open-label, two-part Phase 1b/2 study evaluating RP1 as monotherapy for the treatment of locally advanced or metastatic cutaneous malignancies in patients who underwent a kidney, liver, heart, lung, or other solid organ transplant, or hematopoietic cell transplantation, who are on chronic immunosuppressive treatment, in whom systemic immunotherapy is typically contra-indicated. Researchers will assess the safety of RP1 and also evaluate its ability to shrink tumors.

About RP1
RP1 is Replimune’s lead product candidate and 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.