GC said Monday that its U.S. subsidiary Cuervo has received U.S. Food and Drug Administration approval to go ahead with phase 1 clinical trial for CRV-101, a shingles vaccine.
The company plans to conduct the trial on 90 healthy adults.
'CRV-101' is a new shingles vaccine through the first premium vaccine development project of GC that focuses on basic vaccines.
The company set up Cuervo in the United States to focus on local clinical development and grow its vaccines into a global product as many countries recognize drug safety and efficacy certified in the U.S., which in turn, leads to the expansion of overseas markets.
“GC’s establishing a separate subsidiary locally means that it plans not only to receive cooperation and attract investment from global companies,” the company said.
Cuervo has successfully entered clinical trials through collaboration with the Infectious Disease Research Institute (IRDI), a non-profit American research organization with a wealth of experience in the clinical development of vaccines. The company noted that the clinical trial is an important turning point in evaluating whether CRV-101 can become a next-generation vaccine.
Professor Corey Casper, CRV-101 Project Leader at Curevo and IDRI's Chief Scientific Officer, also said, "While there have been significant recent advances in the development of new shingles vaccines, there remains a need to continue innovating novel strategies for this important health priority. This large Phase 1 study will allow us to study whether CRV-101 is safe and well-tolerated in healthy adults, and to characterize the immune response to vaccination."
This vaccine has been engineered with the latest advancements in protein science and immune stimulating molecules that the company thinks should make it highly effective while minimizing the side effects that often accompany shingles vaccination, Casper added.
Premium vaccines are growing at double-digit rates every year, and the market is snowballing. In particular, the pharmaceutical industry is anticipating that the global shingles vaccine market of $800 million will double in the next decade.