Seattle-based Curevo Vaccine has raised $110 million in Series B funding to advance development of amezosvatein, its next-generation vaccine candidate for shingles prevention. The financing will support expanded clinical trials as the company aims to deliver a vaccine with efficacy comparable to current options but with an improved tolerability profile.
The funding round was led by European biotech investor Medicxi, with participation from new investors OrbiMed, HBM Healthcare Investments, and Sanofi Ventures. Existing investors RA Capital Management, Janus Henderson Investors, Adjuvant Capital, and founding investor GC Biopharma also contributed to the round.
Concurrent with the financing, Moncef Slaoui, PhD, former Chief Scientific Advisor to Operation Warp Speed and previous Chair of GSK's vaccine business, has been appointed as Curevo's Board Chair, bringing decades of vaccine development expertise to the company.
Expanding Clinical Development
The Series B proceeds will fund an extension of Curevo's successful Phase 2 program to include an additional 640 participants, with special focus on adults over age 70 – a key demographic for shingles vaccination. This expanded trial, designed with regulatory feedback, is scheduled to begin in mid-2025 and aims to finalize dose selection ahead of pivotal Phase 3 studies.
"This Series B round will fund the extension of our successful Phase 2 program into an additional 640 participants, including the key population of adults over age 70, to finalize dose selection ahead of the Phase 3 program," said George Simeon, MBA/MPH, Curevo's CEO. "Designed based upon feedback from regulators and other stakeholders, this short extension trial will begin mid-2025 and serve to set the company for clinical, strategic, and regulatory success."
Addressing an Unmet Need in Shingles Prevention
Shingles, caused by reactivation of the varicella zoster virus (VZV), affects millions globally each year. The condition manifests as a painful, blistering skin rash, with 10-18% of patients developing postherpetic neuralgia, a serious long-lasting nerve pain condition.
While GSK's Shingrix currently dominates the $4+ billion global shingles vaccine market with strong efficacy data, its adoption has been hampered by tolerability concerns and accessibility issues. Curevo aims to address these limitations with amezosvatein, which has shown promising immunogenicity and improved tolerability in early clinical studies.
Dr. Slaoui, who helped develop numerous successful vaccines at GSK including Shingrix, expressed enthusiasm about Curevo's approach: "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."
The Science Behind Amezosvatein
Amezosvatein (CRV-101) is a non-mRNA adjuvanted subunit vaccine that, like Shingrix, uses glycoprotein E (gE) as its antigen. This protein has been proven to elicit long-term protective immune responses against shingles.
What differentiates amezosvatein is its adjuvant formulation, which contains an optimized version of the TLR4 agonist used in Shingrix. The SLA-SE adjuvant was developed at Seattle's Access to Advanced Health Institute (AAHI), while the vaccine was licensed from South Korea's Mogam Institute for Biomedical Research.
Giovanni Mariggi, PhD, co-founder and Partner at Medicxi, who will join Curevo's Board of Directors, highlighted the market opportunity: "Patients, doctors, and payors are very clear a new shingles vaccine like amezosvatein would be welcome in the global marketplace. Amezosvatein's activity and improved tolerability profile could allow it to be a significant product in the shingles vaccines market."
Strategic Leadership Additions
In addition to Dr. Slaoui, Curevo is strengthening its leadership with the appointment of Tal Zaks, MD/PhD, to its Board of Directors representing OrbiMed. Dr. Zaks previously served as Chief Medical Officer at Moderna, where he led development of their COVID-19 mRNA vaccine.
"The fact amezosvatein contains an optimized version of the TLR4 agonist with a known mechanism of action reduces biological risk while providing the competitive advantage of potentially improved tolerability, which should position it as the first choice for people who want to be protected from shingles," said Dr. Zaks.
Market Potential and Competitive Landscape
The global shingles vaccine market, currently dominated by GSK's Shingrix with $4.3 billion in 2024 sales, represents a substantial opportunity for Curevo. Industry analysts note that despite Shingrix's strong efficacy profile, its adoption has been limited by tolerability concerns, with many patients experiencing significant injection site reactions and systemic side effects.
If amezosvatein can maintain comparable efficacy while delivering on its promise of improved tolerability, it could potentially capture significant market share and expand the overall market by reaching patients who have avoided vaccination due to concerns about side effects.
Path Forward
With the new funding secured and expanded clinical trials planned, Curevo is positioning itself for potential regulatory submissions in the coming years. The company's streamlined development approach, guided by experienced vaccine industry veterans, aims to bring amezosvatein to market efficiently while generating the robust data needed to compete in this valuable therapeutic area.
The expanded Phase 2 trial beginning mid-2025 will provide critical data on dose selection and tolerability in older adults, setting the stage for the pivotal Phase 3 program that will ultimately determine whether amezosvatein can deliver on its promise of combining strong efficacy with improved patient experience.
