- Replimune Group Inc REPL announced initial data from the first 75 patients from the anti-PD1 failed cutaneous melanoma cohort of the IGNYTE clinical evaluating RP1 (vusolimogene oderparepvec) combined with Bristol-Myers Squibb Co's BMY Opdivo (nivolumab).
- The overall response rate (ORR) was 36%, and the complete response (CR) rate was 20% compared to the 12.5% shown in the prior 16 patients presented in June 2022.
- Safety data with RP1 + nivolumab continues to demonstrate an attractive safety profile, with predominantly ‘on target' Grade 1-2 side effects indicative of systemic immune activation.
- The Company also provided new data from the ongoing Phase 1 clinical trial evaluating RP2 and RP3, demonstrating promising early signals in metastatic tumors and multiple soft tissue sarcomas.
- Concurrently, Replimune announced a clinical trial and supply agreement for its RP2/3 program in colorectal cancer (CRC) and hepatocellular carcinoma (HCC) with Roche Holdings AG RHHBY.
- Specifically, the companies will collaborate in third-line (3L) CRC and 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.
- Replimune remains on track to initiate its Phase 2 development program with RP2/3 in the first half of 2023.
- Price Action: REPL shares are up 16.10% at $21.94 on the last check Wednesday.
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