GC’s US affiliate Curevo extends shingles vaccine trial

GG Biopharma’s US affiliate Cuervo registers first patient in the Phase II extension trial

640 participants aged 50 and older… aims to determine the optimal dosage based on existing Phase II trial results

The company promptly initiated clinical trials following its Series B funding and began accelerating its Phase 3 and commercialization strategies."

GC Biopharma (CEO Eun-Chul Huh) announced on the 4th that its U.S.

 

affiliate Curevo Vaccine has completed the enrollment of its first patient in the Phase 2 extension study of its shingles vaccine amezosvatein.

 

This clinical trial was designed based on the results of the previously conducted Phase II trial.

 

The extension trial will serve as a step toward determining the optimal dose prior to entering Phase III clinical trials, and the company explained that the study incorporates feedback from regulatory authorities and key stakeholders.

 

The Phase 2 extension includes the key population of adults over age 50, targeting randomization of 640 participants to receive amezosvatein or Shingrix, the currently approved shingles vaccine.

 

The company stated, “The inclusion of the key population of adults aged 70 and older holds significance in securing efficacy and safety data for the vaccine in the elderly population.” “I’m so proud of the Curevo team’s drive to get amezosvatein to people looking for a shingles vaccine alternative,” stated Dr.

 

Guy De La Rosa, Chief Medical Officer for Curevo.

 

“We are also proud to be working with a great collection of clinical trial sites, whose excitement for this trial and the overall potential of amezosvatein is gratifying.” “To enroll our first patients just over two months after announcing our $110 million Series B round demonstrates the Curevo team’s ability to execute quickly,” added George Simeon, Curevo’s CEO.

 

Curevo plans to accelerate the entry of amezosvatein into Phase III clinical trials, as well as its commercialization and global approval strategies.

 

Curevo is a vaccine-specialized subsidiary established in 2018 by GC Biopharma in Seattle, Washington, USA.

 

As of the end of last year, GC Biopharma held a 78% stake in the company.

 

Curevo secured a total investment of USD 60 million in its Series A funding round in 2022 and completed its Series B round in March this year with an investment of USD 110 million.