Register Now: From Clinical to Commercial: Accelerating ADC Late-Stage Development with Technology Innovation and Integrated Platform
|Articles|February 14, 2021

4D pharma Signs Clinical Trial Collaboration and Supply Agreement with Merck and Pfizer

4D pharma has signed a clinical trial collaboration and supply agreement with Merck and Pfizer for Bavencio (avelumab).

According to a Feb. 8, 2021 press release, 4D pharma has signed a clinical trial collaboration and supply agreement with Merck and Pfizer for Bavencio (avelumab)—an immunotherapy approved as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma.

4D pharma expects to commence clinical trials evaluating the combination of Bavencio—which is co-developed and co-commercialized by Merck and Pfizer—with its single strain live biotherapeutic product, MRx0518 in 2021. The aim of the clinical trial will be to evaluate the combination therapy as a first-line maintenance therapy for patients with local 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, in the press release. “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.”

Source: 4D pharma


Related to this article

The BioPharm Brief: An AI-Designed Multibody ADC Enters the Clinic, Blackstone Backs Pfizer’s Monthly GLP-1, and enGene Readies a Bladder Cancer BLA
FDA clears the IND for Biolojic Design’s BD200, an AI-designed Trop2/Nectin-4 multibody ADC; Blackstone Life Sciences agrees to provide Pfizer up to $1.5 billion to develop its monthly GLP-1 receptor agonist berobenatide; and enGene Therapeutics plans a year-end BLA for detalimogene voraplasmid in BCG-unresponsive non-muscle invasive bladder cancer.
The BioPharm Brief: FDA Designations for a Bispecific CAR-T, a BLA for Friedreich’s Ataxia, and Phase 2b MASH Data for Efinopegdutide
FDA grants RMAT and Fast Track designations to AbelZeta’s CD20/CD19 bispecific CAR-T prizlon-cel in relapsed or refractory large B-cell lymphoma, Larimar Therapeutics completes a BLA seeking accelerated approval of nomlabofusp for Friedreich’s ataxia, and Merck’s GLP-1/glucagon receptor agonist efinopegdutide meets its primary endpoint in a phase 2b MASH trial.