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. 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. Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: MRx-4DP0004. 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. MRx-4DP0004 is an oral, immunomodulatory, single strain live biotherapeutic product, that has been demonstrated to reduce airway inflammation in the treatment of patients with asthma. 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. |
Details
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |