Replimune Group and Incyte have entered a clinical trial collaboration and supply agreement to study RP1 together with INCB99280 in patients with high-risk, resectable cutaneous squamous cell carcinoma (CSCC).

As part of the deal, Replimune will supply its lead oncolytic immunotherapy product candidate RP1 while Incyte will sponsor and initiate the trial.

Replimune will also share equally in the costs of the study, which is anticipated to commence early next year.

Replimune chief research and development officer Robert Coffin said: “We are excited to enter into this collaboration with Incyte to explore the use of RP1 prior to surgery as we believe that our tumour-directed oncolytic immunotherapies could have a great impact in the neoadjuvant setting both in CSCC and in other cancer types, given the high rates of complete responses we’ve seen to date, and data indicating RP1 is generally very well tolerated.

“The unique potential of the RPx platform to induce a patient-specific anti-tumour immune response with an off-the-shelf treatment speaks to the practicality and broad potential utility of the approach, and exploring its use with Incyte’s oral PD-L1 inhibitor has the potential to improve the patient experience further.”

Based on a new strain of herpes simplex virus, RP1 is built for robust tumour-selective replication.

It is genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF to maximise potency in killing tumours, immunogenicity to cause the death of tumour cells and activate a systemic anti-tumour immune response.

Incyte clinical development haematology and oncology group vice-president Lance Leopold said: “Our oral PD-L1 programme has shown promising safety and efficacy in early studies thus far, and we look forward to adding to the growing body of evidence for INCB99280 and learning more about its potential to improve clinical outcomes.”