On December 7, 2022 Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel class of tumor-directed oncolytic immunotherapies, reported that the Company has entered into a Master Clinical Trial Collaboration and Supply Agreement in relation to Replimune’s RP2/3 program in colorectal cancer (CRC) and hepatocellular carcinoma (HCC) (Press release, Replimune, DEC 7, 2022, View Source [SID1234624902]). Specifically, the companies will collaborate in third-line (3L) CRC and in first- and second-line (1L & 2L) HCC. Under the terms of the agreement, the companies will share costs and Roche will supply its currently approved drugs, atezolizumab and bevacizumab for 2L HCC and 3L CRC combined with RP3. Roche will also supply atezolizumab and bevacizumab for 1L HCC combined with RP3, and for 3L CRC combined with RP2. Approximately 30 patients will be enrolled within each cohort. Replimune will have responsibility for operationalizing the clinical trial.
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Atezolizumab in combination with bevacizumab is FDA approved and the current standard of care for the 1L treatment of unresectable HCC, with current treatment options for the treatment of 2L HCC being very limited. Combining RP3 with atezolizumab and bevacizumab has the potential to increase response rates and clinical benefit for patients with 1L disease, and to provide a much needed option for patients with 2L disease. While, bevacizumab is FDA approved to treat metastatic colorectal cancer, or mCRC, for first- or second-line treatment in combination with chemotherapy, late line CRC is a significant unmet need.
"This collaboration announcement is in keeping with our philosophy of partnering with industry leaders in oncology and in indications where our immunotherapies have the potential to become a key cornerstone of treatment," said Pamela Esposito, Ph.D., Chief Business Officer of Replimune. "With similar collaborations already in place for our lead candidate RP1 with Regeneron and Bristol-Myers Squibb, we believe this latest cost and supply sharing collaboration with Roche, a leader in GI cancers, will help us efficiently advance RP2/3 for the development of CRC and HCC."
Replimune remains on track to initiate its Phase 2 development program with RP2/3 in the first half of 2023. As previously announced, this program is intended to include Phase 2 clinical trials in squamous cell carcinoma of the head and neck (SCCHN; locally advanced and recurrent/metastatic), hepatocellular carcinoma (HCC; first line and second line) and colorectal cancer (CRC; third line), combined with current standard of care where appropriate.
About RP2 & RP3
RP2 and RP3 are enhanced potency oncolytic versions of HSV that express a fusogenic glycoprotein which provides robust immunogenic cell death together with additional immune-activating proteins. RP2 additionally expresses an anti-CTLA-4 antibody-like molecule and GM-CSF and RP3 additionally expresses the anti-CTLA-4 antibody-like molecule and the immune co-stimulatory pathway activating proteins CD40L and 4-1BBL. RP2 and RP3 are 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.