Medical need

Colorectal cancer (CRC) is the 3rd most common cancer diagnosed worldwide accounting for 10% of all tumors, the 2nd in Europe and the 4th in the US. CRC is the 2nd cause of mortality due to cancer in Europe, in the US, and worldwide. In Europe and US, there were 0.7 million newly diagnosed colorectal cancer patients in 2022. Approximately 25% of patients will present with stage IV at diagnosis and an additional 25–50% of patients with early-stage disease progress to metastatic disease. At least 25 to 50% of patients with CRC will develop colorectal liver metastases (CRLM) during the course of their disease (NCCN Version 3.2024) in a synchronous or metachronous manner within 5 years of the initial diagnosis (Wang et al., 2023).

In patients with CRLM, the 5-year survival reaches roughly 50% after resection of liver metastasis but most recurrences occur within the first two years after resection and the patients continue to be at risk for recurrence in subsequent years. Approximately 15% of patients have CRLM that are amenable to upfront surgery. While, liver surgical resection is a curative-intent treatment, 60 to 70% of these will experience recurrence (Kotani et al., 2022). Based on available studies, it is recommended by international guidelines and common practice to propose peri-operative FOLFOX chemotherapy to subjects with upfront resectable CRLM. Nevertheless, it is clear that improving the overall survival of these subjects remains an unmet need, as more than half of them generally suffer from tumor recurrence despite optimal multidisciplinary treatment (Yokoi et al. 2023, Abdalla et al. 2004). 

Combining novel therapeutics such as PDC*Neo vaccine with standard therapy (including surgery and peri-operative FOLFOX chemotherapy) is expected to boost the host immune system against tumor specific antigens and has the potential to improve PFS and OS.