Pharma Focus Europe

Replimune and Incyte Announce Clinical Trial Collaboration and Supply Agreement to Evaluate RP1 and INCB99280 in Cutaneous Squamous Cell Carcinoma Patients

Tuesday, August 01, 2023

Replimune Group, Inc. (NASDAQ: REPL) and Incyte (NASDAQ: INCY) have jointly announced a clinical trial collaboration and supply agreement. The collaboration aims to investigate the combination of Replimune's lead product candidate, RP1, with Incyte's small molecule oral PD-L1 inhibitor, INCB99280. Replimune is a clinical stage biotechnology company specializing in tumor-directed oncolytic immunotherapies, while Incyte is a global biopharmaceutical company.

The clinical trial will focus on studying RP1 prior to surgery in the neoadjuvant setting for cutaneous squamous cell carcinoma (CSCC) and other cancer types. RP1 has demonstrated promising results with high rates of complete responses and good tolerability in previous data. It is known for its ability to induce a patient-specific anti-tumor immune response.

Incyte's oral PD-L1 inhibitor, INCB99280, has also shown promising safety and efficacy in early studies. The combination of RP1 and INCB99280 will be evaluated in patients with high-risk, resectable CSCC. The clinical trial is expected to begin in early 2024, with Incyte taking the lead in initiating and sponsoring the study. Both companies will share the costs of the trial equally, and Replimune will provide Incyte with the necessary supply of RP1 for the study.

RP1, Replimune's lead oncolytic immunotherapy product candidate, is based on a genetically engineered herpes simplex virus. It selectively replicates within tumors and is armed with a fusogenic protein (GALV-GP R-) and GM-CSF to enhance tumor killing potency, promote immunogenic tumor cell death, and activate a systemic anti-tumor immune response.

INCB99280, on the other hand, is a potent and selective small molecule oral PD-L1 inhibitor with promising clinical activity and safety in patients with solid tumors. It is currently being evaluated in multiple Phase 2 studies both as monotherapy and in combination with other antitumor agents.

Both companies express excitement about the collaboration and the potential to improve clinical outcomes for patients with CSCC and other cancer types by combining these innovative therapies.

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