Genome & Company has entered into a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany and Pfizer to evaluate the safety, tolerability, biological and clinical activities of GEN-001 therapy in combination with avelumab, a human anti-PD-L1 therapy, in multiple cancer indications.
Under the terms of this agreement, Genome & Company will be the sponsor of the study, and Merck KGaA, Darmstadt, Germany and Pfizer will supply avelumab for the phase 1/1b clinical trial that is expected to be commenced in 2020 in the U.S. Both parties will have access to the clinical data.
The combination trial is designed to be a first-in-human (FIH) study including dose escalation and expansion cohorts to evaluate the safety and preliminary efficacy.
"GEN-001 has been developed as the backbone of Genome & Company's immuno-oncology pipeline, and we are delighted to collaborate with the global leaders in oncology such as Merck KGaA, Darmstadt, Germany and Pfizer on this phase 1/1b clinical trial for this combination of GEN-001 and avelumab. We are excited to investigate how the preclinical data of this combination will be translated to humans. We look forward to initiating this clinical trial in the coming months," said Dr. Jisoo Pae, CEO of Genome & Company.
Avelumab (BAVENCIO®) in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).