The company will collaborate with Merck and Pfizer to evaluate ilixadencel, an off-the-shelf cell-based cancer immune primer, in combination with avelumab, a human anti-PD-L1 monoclonal antibody, in a planned multi-indication Phase Ib/II clinical trial.
Immunicum will initiate a study of ilixadencel in the fourth quarter of 2018. Following completion of the Ib portion of the study, a Phase II study will be conducted using the checkpoint inhibitor avelumab in combination with ilixadencel to evaluate the safety and efficacy of the combination in patients with advanced head and neck cancer and gastric adenocarcinoma. Immunicum will be responsible for conducting the study and continues to retain all commercial rights to ilixadencel.
“We are delighted to work with Merck KGaA and Pfizer to further establish ilixadencel’s potential as a backbone component of combination cancer therapies in different forms of solid tumors where there is a high unmet medical need,” said Carlos de Sousa, CEO of Immunicum. “This collaboration will greatly benefit the study by providing access to avelumab and represents our first corporate agreement that supports the development of ilixadencel.”
Avelumab has received accelerated approval by the US Food and Drug Administration (FDA) for the treatment of patients with metastatic Merkel cell carcinoma (MCC) and previously treated patients with locally advanced or metastatic urothelial carcinoma (mUC), and is under further clinical evaluation across a range of tumor types under a global strategic alliance between Merck KGaA and Pfizer.
