![]() The first clinical study, an open label Phase I study of MRx0518 in combination with Keytruda® and conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ., USA, has been initiated and is due to open shortly. The collaboration will initially assess 4D’s lead oncology candidate, MRx0518, as a potential treatment for solid tumours. 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. Hansen created a joint venture contract development and manufacturing organization that would specialize in LBPs, as the companies anticipates greater development in this therapeutic modality.4D pharma plc (AIM: DDDD) and The University of Texas MD Anderson Cancer Center today announced a strategic collaboration to evaluate 4D’s Live Biotherapeutic oncology pipeline across a range of cancer settings. The company holds 4,900-square-feet of manufacturing space, with the capacity to scale up to 3,000L fermentation. In addition, the company outlines that it holds the manufacturing capacity to produce its LBPs in-house, from preclinical to commercial scale. Wider than its partnership with Merck, 4D’s Blautix, a candidate for IBS, is at the Phase II clinical trial stage and in a Phase I trial, the company noted, was able to demonstrate that patients showed improvements in symptoms and an increase in microbiome diversity. MRx0518 is an LBPs product consisting of a lyophilized formulation of a proprietary strain of bacterium. ![]() The ongoing Phase I/II will determine whether the addition of one capsule, twice daily, of MRx0518, alongside doses of Keytruda, is of benefit in patients who have progressed on PD-1 inhibitors. Merck has already tapped into 4D’s technology through a clinical trial looking into the potential for the former’s commercial product, Keytruda (pembrolizumab), to be paired with the latter’s MRx0518 as combination treatment for solid tumors. MicroRx is 4D’s proprietary platform that is able to select bacteria that have a potential therapeutic effect in specific diseases. UK-headquartered, 4D Pharma specializes in LBPs and has three candidates in clinical trials, including a potential treatment for irritable bowel syndrome (IBS), oncology, and asthma. Should Merck choose to exercise its option on any program, it will be responsible for development, manufacturing and commercialization.ĭaria Hazuda, CSO of Merck’s VP of infectious disease and vaccines discovery research, explained why 4D’s technology is of interest: “By applying 4D's MicroRx technology we hope to gain meaningful insights into the role of the host microbiome in modulating the immune response and ultimately protection conferred by vaccines.” ![]() ![]() The partnership will specifically look to develop live biotherapeutics (LBPs) for vaccines. ![]() Merck, known as MSD outside of North America and Mexico, provided an undisclosed upfront payment for each potential indication, and offered $347.5m (€316m) in potential milestone payments. ![]()
0 Comments
Leave a Reply. |