USA – Curevo Biopharma is preparing to challenge GlaxoSmithKline’s (GSK) dominance in the shingles vaccine market after securing US $110 million in funding and bringing on a former GSK executive to aid in the development of its vaccine candidate, amezosvatein.
The Series B funding round was led by European investment firm Medicxi, with participation from new investors OrbiMed, Sanofi Ventures, and HBM Healthcare Investments.
The funds will be used to expand Curevo’s ongoing Phase II clinical trial (NCT05304351) for amezosvatein, a non-mRNA adjuvanted subunit vaccine.
An additional 640 healthy volunteers will be enrolled to determine the optimal dose ahead of Phase III trials, which are expected to begin in mid-2025.
A new competitor in the shingles vaccine market
Shingles is a painful rash caused by the reactivation of the varicella-zoster virus, the same virus responsible for chickenpox.
The only U.S. Food and Drug Administration (FDA)-approved shingles vaccine currently available is GSK’s Shingrix (zoster vaccine recombinant), which has dominated the market since its approval in 2017.
Shingrix has been a major revenue driver for GSK, generating nearly £848 million ($1.06 billion) in 2024.
Market analysis by GlobalData’s Pharma Intelligence Center projects that Shingrix sales could surpass US $5 billion by 2028.
The previous shingles vaccine, Zostavax, developed by Merck, was discontinued in the U.S. in 2020 due to Shingrix’s superior effectiveness and safety profile.
Curevo’s vaccine candidate has already demonstrated promising results in Phase II trials, showing a 100% vaccine response compared to Shingrix’s 97.9%.
Additionally, the trial found that amezosvatein had lower rates of local and systemic adverse effects, which could position it as a more tolerable alternative to Shingrix.
Strategic leadership additions
To bolster its development efforts, Curevo has recruited former GSK vaccine lead Moncef Slaoui to its board of directors.
Slaoui played a key role in the development of multiple vaccines at GSK, including Shingrix, Cervarix (HPV vaccine), and Mosquirix (malaria vaccine).
He also served as chief scientific adviser to Operation Warp Speed, the U.S. government’s COVID-19 vaccine initiative.
“I have been collaborating with the Curevo team for several weeks now,” said Slaoui. “I’m very excited to work with them to help perfect shingles vaccination, adding good tolerability to the exceptional efficacy achieved by the current vaccine. The data so far show Curevo’s adjuvant technology has the attributes to succeed in this endeavor.”
Another major addition to Curevo’s board is Tal Zaks, former chief medical officer at Moderna.
Zaks oversaw the development of Moderna’s COVID-19 mRNA vaccine and previously held positions at GSK and Sanofi.
Market uncertainty amid policy changes
As Curevo pushes forward, the shingles vaccine market faces potential disruption due to policy scrutiny from the new U.S. government.
Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. has raised concerns about the safety and effectiveness of vaccines, including those on the national immunization schedule, such as Shingrix.
GSK’s Chief Commercial Officer Luke Miels has acknowledged these challenges, stating that the company anticipates a decline in vaccine sales this year due in part to potential changes in U.S. vaccination policies.