Immuno-oncology firm Agenus (Nasdaq:AGEN) and its partner GSK (NYSE:GSK) have announced positive headline results from a pre-specified efficacy interim analysis of the AReSVi 006 Phase 3 trial of an experimental respiratory syncytial virus (RSV) vaccine.
RSV infects most children before the age of 2. Some 75,000 to 125,000 children are hospitalized as a result of the virus annually, according to data from the National Institute of Allergy and Infectious Diseases.
But RSV can also pose a risk to older adults, especially those with chronic conditions, as the CDC noted.
The Agenus and GSK study focused on adults at least 60 years of age.
The analysis of the Phase 3 trial was the first to show a statistically significant and clinically meaningful efficacy in older adults.
Agenus and GSK note that the AReSVi 006 study exceeded its primary endpoint without observing any unexpected safety concerns.
The companies hope to file regulatory submissions in the second half of 2022.
“The need for vaccines offering long-lasting efficacy and scalable production processes has been amplified by the current pandemic,” said Dr. Garo H. Armen, Agenus CEO, in a news release.
The AReSVi 006 vaccine candidate makes use of the QS-21 STIMULON saponin-based adjuvant, which is derived from the soapbark tree Quillaja saponaria Molina.
The popular Shingrix vaccine Shingrix uses the same adjuvant.
Agenus operates a subsidiary known as SaponiQx focused on the sustainable manufacturing of QS-21 STIMULON.
AGEN shares dipped 10.98% to $1.46 while GSK shares were up 1.77% to $43.80.
A number of other companies, including Moderna, are also developing RSV vaccines.