The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for VAX-24, Vaxcyte’s 24-valent pneumococcal conjugate vaccine for the prevention of invasive pneumococcal disease.
The decision was based on positive topline results from a Phase I/II proof-of-concept study, which evaluated the safety, tolerability and immunogenicity of VAX-24 in adults 18-64 years of age.
VAX-24 met the primary safety and tolerability objectives, demonstrating a safety profile similar to Prevnar 20 (PCV20) for all doses studied. The study also demonstrated that VAX-24 met or exceeded the established regulatory immunogenicity standards for all 24 serotypes at the conventional 2.2mcg dose.
“The FDA’s Breakthrough Therapy designation supports further acceleration of the VAX-24 development program in adults, while also providing validation of the potential of VAX-24 to deliver broader coverage and better immune responses relative to the standard of care,” said Grant Pickering, Chief Executive Officer and Co-Founder of Vaxcyte.
“Our focus remains on advancing our VAX-24 clinical programs in both adults and infants and we anticipate announcing the topline data from the Phase II study in adults 65 and older in the second quarter of 2023.”
The FDA’s Breakthrough Therapy process is designed to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition.