BiomX Ltd., a microbiome company developing both natural and engineered phage therapies, announced completion of construction of a new state-of-the-art manufacturing facility. The new facility is located at the company’s headquarters in Ness Ziona and will support clinical manufacturing of BiomX’s candidate phage products and in the future could be expanded to support commercial manufacturing needs.
“In this new age of live biotherapeutics, which include phage as well as human-derived cells and bacteria, manufacturing has become a major step on the path to clinical development,” said Jonathan Solomon, BiomX’s CEO. “Owning and operating our own manufacturing facility provides us with a competitive advantage by allowing close oversight and control, thus enhancing our ability to meet our manufacturing needs in a timely manner. Moreover, the ability to quickly and flexibly respond to new pre-clinical and clinical data allows us to modify our phage cocktails accordingly.”
Phage are viruses that specifically infect bacteria. BiomX develops a specific composition (or cocktail) of phage as product candidates targeting each of its bacterial targets. Phage manufacturing requires first the manufacturing of a specific bacterial strain that, in a second stage, is used to host the growth of the phage.
The new facility has been designed to support the necessary manufacturing requirements for BiomX’s future clinical development, including the manufacturing of BX002. BX002 is a drug candidate phage cocktail designed to target bacterial strains that potentially have a role in the onset and aggravation of inflammatory bowel disease (IBD), for which clinical trials are expected to start in 2020. In its current configuration, the site can support clinical manufacturing for BiomX’s future Phase 1 and 2 trials in both IBD and primary sclerosing cholangitis (PSC), and can be expanded for Phase 3 and commercial stages.