Positive Phase 2 Results for Curevo's Shingles Vaccine Amezosvatein Versus Shingrix

Curevo Vaccine, a clinical-stage biotechnology firm, has reported promising results from a Phase 2 trial of their non-mRNA adjuvanted subunit vaccine, amezosvatein, also known as CRV-101. The trial, which involved 876 participants aged 50 and above, compared amezosvatein directly with Shingrix, a leading shingles vaccine.

The trial demonstrated that amezosvatein was non-inferior to Shingrix in terms of humoral immune response, with all primary endpoints met. Notably, amezosvatein showed a 100% vaccine response rate, slightly surpassing Shingrix's 97.9%. Furthermore, amezosvatein exhibited a lower incidence of local and systemic adverse events, which is a significant advantage, especially for a vaccine targeting an older demographic.

Dr. Guy De La Rosa, Curevo’s Chief Medical Officer, highlighted the importance of a tolerability-focused vaccine, given the low vaccine coverage rates for shingles. Amezosvatein was specifically designed to offer high effectiveness alongside superior tolerability. The Phase 2 data has excited the Curevo team, who are now preparing to move the vaccine into global Phase 3 trials in 2024.

In the Phase 2 trial, participants receiving amezosvatein reported no Grade 3 solicited local or systemic adverse events, and the rates of Grade 2 solicited systemic side effects were significantly lower compared to those receiving Shingrix. Dr. William Smith, the primary investigator of the trial and a board-certified physician with extensive clinical trial experience, emphasized the global need for a shingles vaccine with better tolerability and accessibility.

George Simeon, Curevo’s CEO, noted the significant market opportunity for amezosvatein, given the low immunization rates against shingles in various countries. The company is committed to making the vaccine available globally to address this unmet need.

Amezosvatein targets the glycoprotein 'E' (gE) antigen, which is known to elicit a protective immune response against shingles. The vaccine uses an adjuvant that boosts the immune response to the gE antigen, similar to Shingrix, but with an engineered safety profile aimed at minimizing adverse effects.

Shingles, or herpes zoster, is a reactivation of the chickenpox virus and can lead to severe pain and complications such as post-herpetic neuralgia, which can last for months or even years. The condition can also affect vision and has been linked to an increased risk of heart attack, stroke, and dementia.

Curevo Vaccine is a Seattle-based company focused on developing vaccines that are both accessible and well-tolerated, aiming to reduce the burden of infectious diseases. Their lead product, amezosvatein, is poised to enter the next phase of trials, with the potential to improve vaccination rates and protect against the debilitating effects of shingles.