Antibodies from Vaccine Remain Two Years Out
Source: Edward White
December 7, 2023 (Investorideas.com Newswire) This was shown in recent clinical trial results of a biotech's single-dose vaccine against chikungunya evaluated in adults, noted an H.C. Wainwright & Co. report.
Valneva SE's (VALN:NASDAQ; VLA:FRA) vaccine against chikungunya, called Ixchiq (VLA1553), showed the presence of antibodies in adults 24 months after injection, according to recent data from the VLA1553-303 study, H.C. Wainwright & Co. analyst Edward White reported in a December 4 research note.
"These positive 24-month antibody persistence data, which are in line with positive 12-month data previously reported last December, are expected to supplement the existing U.S. Food and Drug Administration (FDA) approval and ongoing regulatory approval processes," White wrote. He explained that the FDA, on Nov. 9, granted Ixchiq accelerated approval for individuals 18 years of age and older at increased risk of exposure to chikungunya.
Also, the agency awarded Valneva a tropical disease priority review voucher (PRV), which, White purported, could be worth around US$100 million (US$100M) based on the most recent PRV sale of US$103M."
136% Possible Gain
The France-based specialty vaccine firm currently has a stock price of about US$11.01 per share, which compares to H.C. Wainwright's target price of US$26 per share, noted White.
Inherent in these figures is the potential for a 136% return on investment.
Valneva is a Buy.
High Seroresponse Rate
White reported that study VLA1553-303, which included a follow-up at 24 months, met the primary endpoint, with Ixchiq demonstrating a 97% seroresponse rate two years post-vaccination.
"Antibody levels remained high and well above the seroresponse threshold," the analyst wrote.
Further, antibody levels were as robust in adults age 65 and older as they were among their younger counterparts.
During the 24-month follow-up period, no safety concerns were reported.
Going to Market
Valneva plans to commercialize Ixchiq in the U.S. and, according to White, believes it has enough product and a team ready to proceed.
H.C. Wainwright estimates Ixchiq sales will hit €40M in 2024 and increase thereafter, reaching €350M in 2028.
Looking to the future of the annual global market for chikungunya vaccines, Valneva predicts it will surpass US$500M by 2032, White reported.
Along with potentially launching Ixchiq in the U.S. in early 2024, Valneva anticipates receiving a recommendation for this vaccine from the Advisory Committee on Immunization Practices within the U.S. Centers for Disease Control and Prevention sometime in Q1/24.
Valneva is seeking a green light for Ixchiq elsewhere in the world, too. Currently, the European Medicines Agency and Health Canada are reviewing marketing applications for it. Approvals could happen around mid-2024.
Also on the horizon are results from the ongoing Phase 3 study of Ixchiq in adolescents in Brazil. Valneva will use the positive pivotal immunogenicity data reported from this trial last month in support of its request for label expansion in the States and for licensure in Brazil.
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