The University of Texas MD Anderson Cancer Center and 4D pharma today announced a strategic collaboration to evaluate 4D's live biotherapeutic oncology pipeline across a range of cancer settings. The alliance brings together MD Anderson's translational medicine and clinical research capabilities with 4D's expertise in the discovery and development of live biotherapeutics. The collaboration will initially assess the 4D's lead oncology candidate, MRx0518, as a potential treatment for solid tumors.
The first clinical trial, an open label Phase I study of MRx0518 in combination with Keytruda® and conducted in collaboration with Merck & Co., Inc., Kenilworth, N.J., has been initiated and is due to open shortly. The study will enroll up to 132 patients with metastatic cancer across multiple histologies including non-small cell lung cancer, renal cell carcinoma, bladder cancer and melanoma, who have not responded to prior anti-PD-1 therapy.
Subsequent studies are also being planned under the collaboration, including using MRx0518 in combination with stereotactic body radiotherapy (SBRT) for the treatment of pancreatic cancer.
"This alliance, with one of the leading oncology research centers in the world, will provide a strong and long-term foundation for the development of 4D's live biotherapeutics in cancer," said Duncan Peyton, 4D's chief executive officer. "The current study, which is one of the first live biotherapeutic programs to reach the clinic in the immuno-oncology space, represents an important step forward in the development of MRx0518 and 4D's broader oncology franchise. We look forward to continuing to work with our partners at MD Anderson to progress this study and help bring this therapy to patients."
Live biotherapeutics employ strains of gut bacteria that have been isolated from healthy human donors, and which are encapsulated, administered orally, and delivered to the gut as a therapeutic. Each strain is selected for its functionality to perform a specific role in combatting a disease.
"MD Anderson is focused on providing the best possible care for cancer patients, including implementing the latest new treatment modalities," said Shubham Pant, M.B.B.S., associate professor of Investigational Cancer Therapeutics at MD Anderson. "The gut microbiome has emerged as an important next-generation target in cancer therapy and we hope that live biotherapeutics will have the potential to make a significant difference for patients across a range of cancers.