4D pharma has announced a clinical trial collaboration and supply agreement with Merck KGaA and Pfizer for Bavencio (avelumab), an immunotherapy approved as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma. The treatment is co-developed and co-commercialised by Merck KGaA and Pfizer.
4D pharma intends to commence a clinical trial in 2021 to evaluate Bavencio in combination with MRx0518 as a first-line maintenance therapy for patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy.
“With this second clinical trial collaboration for MRx0518 with a leading immune checkpoint inhibitor, 4D is able to evaluate MRx0518 in a new combination and earlier treatment setting. Following the promising data already generated in combination with checkpoint inhibitor pembrolizumab in refractory patients, and MRx0518 monotherapy data demonstrating single agent immuno-modulation presented last year at SITC, this collaboration allows us to continue to build a broad understanding of the safety and efficacy of MRx0518 across a range of solid tumors and stages of disease,” said Duncan Peyton, CEO, 4D pharma. “The combination of MRx0518 with Bavencio has the potential to further enhance the positive clinical outcomes achieved by Bavencio for the significant number of patients in this treatment setting.”
MRx0518 is single strain live biotherapeutic product in development for the treatment of cancer. It’s delivered as an oral capsule and stimulates the body’s immune system, directing it to produce cytokines and immune cells that are known to attack tumours. It is currently being evaluated in three clinical trials in patients with cancer. MRx0518-I-001 is a neoadjuvant monotherapy study in a variety of solid tumours and is being conducted at Imperial College London. MRx0518-I-002 is in combination with Keytruda in patients whose disease has previously progressed on anti-PD-1 therapies.
The Coordinating Investigator of the study is at The University of Texas MD Anderson Cancer Center, Houston, USA, with multiple additional sites in the US. The study is being done in collaboration with MSD. MRx0518-I-003 is in combination with preoperative radiotherapy in resectable pancreatic cancer. A fourth clinical trial of MRx0518 in combination with Bavencio in the first-line maintenance setting for urothelial carcinoma, done in collaboration with Merck and Pfizer, is expected to initiate in 2021.
