Vaxcyte, Inc., a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, and Lonza, a global manufacturing partner to the pharmaceutical, biotech and nutraceutical markets, announced the companies have entered into a new commercial manufacturing agreement. Expanding on their existing collaboration, this agreement supports the potential global commercialization of Vaxcyte’s PCV candidates, VAX-24 and VAX-31, in both the adult and pediatric populations. This agreement complements Vaxcyte’s plans to utilize existing Lonza infrastructure to advance clinical development and the anticipated initial U.S. launch of VAX-24 for the adult population.
Under the terms of the agreement, Lonza will provide Vaxcyte with a custom-built manufacturing suite as part of Lonza’s Ibex Dedicate Biopark at its Visp (CH) site to manufacture key components, including drug substances, for Vaxcyte’s PCV franchise. Beginning with VAX-24, which is moving into late-stage clinical development, Vaxcyte’s dedicated manufacturing suite is expected to meet the potential long-term market demand for both the adult and pediatric populations globally. The design of the dedicated manufacturing suite is nearly complete, with equipment installation expected to begin in 2024. Lonza is anticipated to create up to 300 new jobs upon reaching peak capacity.
Grant Pickering, Chief Executive Officer and Co-founder, Vaxcyte, commented: “Following the successful completion of our VAX-24 Phase 2 adult studies, and as we prepare for Phase 3 clinical studies, we are excited to expand our relationship with Lonza, a preeminent contract development and manufacturing organization, and put into motion the key steps required to establish large-scale and long-term commercial manufacturing capacity for our PCV candidates. This outcome is consistent with our strategic objectives and financial plan. We expect this dedicated manufacturing suite within Lonza’s Ibex facility will enable us to scale up effectively to meet the potential supply demands for VAX-24, followed by VAX-31, our 31-valent PCV, across all populations and on a global scale.”
Over the past year, Vaxcyte has made significant progress with its VAX-24 clinical program, reporting positive results for two Phase 2 studies in adults and initiating a Phase 2 study in infants. The positive data from the VAX-24 adult Phase 2 clinical program support a potential best-in-class profile for Vaxcyte’s 24-valent PCV candidate by virtue of its broader coverage and improved immune responses compared to the standard-of-care. VAX-24 was designed to address an important public health need by expanding coverage beyond the standard-of-care and including the serotypes that are responsible for a significant portion of invasive pneumococcal disease (IPD) currently in circulation in both infants and adults.
Jean-Christophe Hyvert, President, Biologics, Lonza, added: “Our expanded relationship with Vaxcyte highlights the value of our services on the path towards commercialization. Having supported the early-stage clinical development of Vaxcyte’s PCV programs, we are pleased to continue our long-standing collaboration by supporting the late-stage clinical manufacturing utilizing our unique Ibex Dedicate offering, with the capability to provide commercial supply of their products.”