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In its Q4 earnings call to investors on February 25, vaccine developer Vaxcyte expressed optimism about its VAX-31 invasive pneumococcal disease (IPD) vaccine program and discussed the company’s efforts to scale manufacturing through its partnership with Lonza.
“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,” said Grant Pickering, CEO of Vaxcyte.
Lonza’s Ibex Biomanufacturing Complex in Visp, Switzerland is home to a custom-built manufacturing platform for Vaxcyte. The companies signed an agreement to collaborate on global manufacturing for Vaxcyte’s VAX-24 and VAX-31 vaccine candidates for broad-spectrum pneumococcal conjugate vaccines (PCVs) in October 2023.
Vaxcyte committed $127.8 million in 2024 to its dedicated manufacturing suite, bringing its total investment in the project to $214.3 million. Vaxcyte expects increased spending in 2025 related to research and development. Said Pickering, “This expected increase is primarily the result of manufacturing-related investments to prepare for our initial launch in the adult market, including to build inventory, the initiation of the VAX-31 adult Phase 3 clinical program, and the growth in the number of our employees to support these and other initiatives.”
The company is making steady progress with its VAX-24 as well, though it is still in an earlier stage of development. That vaccine hit a snag in 2021 due to setbacks during the COVID-19 pandemic, but Phase II trials are now well-funded and underway.
But given vaccine-skeptic Robert F. Kennedy’s recent confirmation to lead the Department of Health and Human Services (HHS) in the US, companies such as Vaxcyte must consider possible changes in government oversight as they work toward commercialization. The firm announced the establishment of a dedicated public affairs function to enhance engagement with US policy makers.
“We have been working constructively with the new administration to ensure that science-driven evidence-based policies continue to guide vaccine development and public health decision-making,” said Andrew Guggenhime, president and CFO of Vaxcyte. “In parallel, we will continue to engage with the FDA [US Food and Drug Administration], CDC [Centers for Disease Control and Prevention], and ACIP [Advisory Committee on Immunization Practices] to foster a regulatory framework that continues to encourage investment in vaccine, innovation, and manufacturing.”
“We are leveraging our existing manufacturing infrastructure with Lonza to support the anticipated US launch of VAX-31 for the adult population,” Pickering said. “With this foundation in place, we are well-prepared to execute on our plans and bring broad-spectrum vaccines to market. Our ability to advance these programs is underpinned by a strong financial position, ensuring we have the resources to advance clinical development, scale manufacturing, and drive commercialization.”
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