Genome & Company, Merck and Pfizer have signed a clinical trial collaboration and supply agreement to evaluate GEN-001 therapy in oncology indications as part of Phase I/Ib clinical trial.
Under the agreement, the companies will evaluate the safety, tolerability, biological and clinical activities of GEN-001 therapy in combination with human anti-PD-L1 therapy, avelumab.
The study will be sponsored by Genome & Company, while Merck and Pfizer will supply avelumab for the combination trial that is expected to start this year in the US.
Both Merck and Pfizer can access the data from the clinical trial, which has been designed to be a first-in-human (FIH) study, including dose-escalation and expansion cohorts to evaluate the safety and preliminary efficacy.
Genome & Company CEO Dr Jisoo Pae said: “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 and Pfizer on this Phase I/Ib 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.”
Avelumab in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
The US Food and Drug Administration (FDA) also granted accelerated approval for avelumab to treat metastatic Merkel cell carcinoma (mMCC) and locally advanced or metastatic urothelial carcinoma (mUC).
GEN-001 has immune-modulating activities and comprises a single strain bacteria isolated from the gut of healthy human volunteers.
Last October, Pfizer reported positive results from the Phase III JADE MONO-1 clinical trial of its investigational Janus kinase 1 (JAK1) inhibitor, abrocitinib, in patients with moderate to severe atopic dermatitis.