RP1 Clinical Trial Results & Opportunities - In anti-PD1 failed melanoma patients, RP1 plus Nivolumab achieved an Objective Response Rate (ORR) of 32.9% and a median Duration of Response (mDoR) of 33.7 months[78] - In responders, responses in non-injected lesions occurred with similar frequency and depth as injected lesions, indicating systemic benefit[78] - Patients with deep/visceral (+/- superficial) injections had numerically higher response rates vs those who received superficial injections only[78] - In solid organ transplant patients with locally advanced CSCC, RP1 monotherapy achieved an ORR of 34.6% and a Disease Control Rate (DCR) of 65.4%[220] - In a study of resectable cutaneous Squamous Cell Carcinoma (cSCC), RP1 monotherapy resulted in a 100% overall response rate, with 83% achieving pathological complete response[214] RPx Platform Expansion & Pipeline - The company is planning RPx expansion into additional skin cancers, liver and thoracic primary/metastatic cancers[174] - A confirmatory Phase 3 trial (IGNYTE-3) is underway in melanoma, randomizing patients to RP1 + Nivolumab vs Treatment of Physician's Choice[179] - A registrational REVEAL study is ongoing for RP2 in metastatic Uveal Melanoma, comparing RP2 + Nivolumab to Ipilimumab + Nivolumab[243] - RP2 is being evaluated in liver primary/metastases, including a cohort with RP2 + Bevacizumab + Atezolizumab in 2L PD-(L)1 failed Hepatocellular Carcinoma (HCC)[246] Commercialization & Market Opportunity - The company estimates ~10,000 addressable patients across lines of therapy for RP1 in the US melanoma market[111] - The company estimates RPx has the potential to reach up to ~125,000 patients in the US across various cancer types[251] - The company has hired and trained a commercial organization of ~60 customer-facing team members[108]