Next-Generation Shingles Vaccine Candidate Compares Well

Curevo Vaccine today announced positive data from a Phase 2 trial of amezosvatein (a non-mRNA, adjuvanted subunit vaccine also known as CRV-101) head-to-head versus the U.S. FDA-approved Shingrix® vaccine.

According to the Company's press release on January 7, 2024, Amezosvatein met all primary endpoints in the randomized, controlled, observer-blind Phase 2 trial, including demonstrating non-inferiority to Shingrix as measured by humoral immune response.

Amezosvatein also exhibited lower rates of solicited local and systemic adverse events. Amezosvatein was engineered to have a best-in-class safety profile.

Like Shingrix, amezosvatein uses a subunit protein antigen called glycoprotein 'E' (gE).

Targeting the gE antigen is proven to elicit a long-term, protective immune response to prevent shingles.

Also, like Shingrix, amezosvatein uses an adjuvant targeting the TLR4 pathway to boost the immune response to the gE antigen.

"Fewer than 5% of eligible adults in most European countries and China have received both doses of Shingrix," noted George Simeon, Curevo's Chief Executive Officer, "and two-thirds of adults in the USA still need to be immunized against shingles.

As of January 8, 2024, various shingles vaccines are available in over 30 countries.

Based upon these clinical study results, Curevo will advance amezosvatein into global Phase 3 trials in 2024 to address a market for shingles vaccination currently exceeding $4 billion. 

Virtually all adults have been exposed to the varicella-zoster virus, and around 30% will develop shingles at least once in their lifetime. 

Also called 'herpes zoster,' shingles occur when the varicella-zoster virus causing childhood chickenpox re-emerges from sensory ganglion nervous system cells where the virus lies dormant after initial exposure.