Vaxcyte and Lonza Expand Collaboration for Global Commercial Manufacturing of Broad-Spectrum Pneumococcal Conjugate Vaccines (PCVs)

• New agreement to establish global commercial manufacturing capacity for Vaxcyte’s PCV candidates, VAX-24 and VAX-31, in adult and pediatric populations
• Expanded collaboration builds on Vaxcyte’s current strategy to conduct initial commercial launch of VAX-24 in adults from existing Lonza facilities in Visp (CH)
• Long-standing relationship between the companies further enhanced as Vaxcyte progresses lead vaccine candidate into late-stage clinica development
• New purpose-built large-scale manufacturing suite in Lonza’s Ibex^® Dedicate Biopark

Vaxcyte, Inc. (Nasdaq: PCVX), 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, today 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.”

About Vaxcyte

Vaxcyte is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. The Company is developing broad-spectrum conjugate and novel protein vaccines to prevent or treat bacterial infectious diseases. Vaxcyte’s lead candidate, VAX-24, is a 24-valent, broad-spectrum, carrier-sparing PCV being developed for the prevention of IPD and is poised to move into late-stage development. VAX-31, the only 31-valent PCV in development, is a follow-on candidate to VAX-24 and part of the Company’s PCV franchise.

Vaxcyte is re-engineering the way highly complex vaccines are made through modern synthetic techniques, including advanced chemistry and the XpressCF™ cell-free protein synthesis platform, exclusively licensed from Sutro Biopharma, Inc. Unlike conventional cell-based approaches, the Company’s system for producing difficult-to-make proteins and antigens is intended to accelerate its ability to efficiently create and deliver high-fidelity vaccines with enhanced immunological benefits. Vaxcyte’s pipeline also includes VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease; and VAX-GI, a vaccine program designed to prevent Shigella. Vaxcyte is driven to eradicate or treat invasive bacterial infections, which have serious and costly health consequences when left unchecked.

For more information, visit www.vaxcyte.com.

About Pneumococcal Disease

Pneumococcal disease (PD) is an infection caused by Streptococcus pneumoniae (pneumococcus) bacteria. It can result in IPD, including meningitis and bacteremia, and non-invasive PD, including pneumonia, otitis media and sinusitis. In the United States, approximately 320,000 people get pneumococcal pneumonia each year, which is estimated to result in approximately 150,000 hospitalizations and 5,000 deaths. Pneumococci also cause over 50% of all cases of bacterial meningitis in the United States. Antibiotics are used to treat PD, but some strains of the bacteria have developed resistance to treatments. The morbidity and mortality due to PD are significant, particularly for young children and older adults, underscoring the need for a more broad-spectrum vaccine.