Vaxcyte, Lonza on track to build manufacturing capacity for pneumococcal conjugate vaccines
Vaxcyte and contract manufacturer Lonza are on track to building a manufacturing suite at Lonza’s Ibex Dedicate Biopark in Visp, Switzerland to support Vaxcyte’s pneumococcal conjugate vaccines, according to the clinical-stage vaccine company’s fourth quarter and full-year 2024 financial results.
In 2024, Vaxcyte incurred an additional $127.8 million in capital and facility expenditures related to the ongoing construction of a dedicated manufacturing suite at Lonza to support the potential global launch of its pneumococcal conjugate vaccine (PCV) programs.
Vaxcyte’s total investment to date in the Lonza project is $214.3 million, which is about 60% to 70% of the company’s original $300 million to $350 million estimate that remains on track, president and CFO Andrew Guggenhime told analysts in a conference call on Tuesday.
“Our clinical progress continues to be driven by strong operational execution including manufacturing scale-up,” CEO Grant Pickering told analysts on the call. “As part of our long-standing partnership with Lonza, we are executing on our plan to establish a purpose-built, large-scale manufacturing suite within Lonza’s Ibex dedicated biopark.”
Pickering noted that the build-out of the dedicated facility began in late 2023 and remains on track to be completed by early 2026. He said the manufacturing suite at Lonza “will play a critical role in supporting the future global commercial supply for both the adult and pediatric indications, ensuring we have the capacity to meet anticipated demand.”
Under the collaboration announced in October 2023, Lonza is providing Vaxcyte with a custom-built manufacturing suite as part of the contract manufacturer’s Ibex Dedicate Biopark in Visp, Switzerland to manufacture key components — including drug substances — for Vaxcyte’s PCV franchise. At the time, Lonza said it anticipated creating up to 300 new jobs once the suite reached its peak capacity.
Vaxcyte will leverage its existing manufacturing infrastructure with Lonza to support the expected U.S. launch of the VAX-31 vaccine candidate for adults, including to build inventory, according to Pickering.
The VAX-31 adult Phase 3 pivotal, non-inferiority study will be initiated by mid-2025, with topline data expected in 2026. For the pediatric indication, Vaxcyte expects to announce topline safety, tolerability and immunogenicity data from the VAX-24 infant Phase 2 study primary immunization series by the end of the first quarter of 2025, with topline data from the booster dose anticipated by the end of this year.
The company recently advanced the VAX-31 infant Phase 2 study to the second and final stage, with topline data for the primary immunization series expected in mid-2026.