Curevo’s shingles vaccine equals GSK’s Shingrix in phase 2 head-to-head

2024-01-08

疫苗临床2期临床结果

Curevo’s shingles vaccine equals GSK’s Shingrix in phase 2 head-to-head

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来源: FierceBiotech

The company honed in on the safety profile as a potential market differentiator from Shingrix.

When Curevo Vaccine decided to go head-to-head with GSK in the Shingles space it seemed like a bold move for the small, privately held biotech—but so far it's paying off.

The Seattle-based company’s non-mRNA, adjuvanted subunit vaccine has held its own against the Big Pharma’s blockbuster Shingles vaccine in a phase 2 trial. The study of 876 patients aged 50 and over demonstrated that amezosvatein, also known as CRV-101, produced a robust humoral immune response at day 84 that was non-inferior to GSK’s market leader.

Specifically, CRV-101 elicited a 100% vaccine response rate compared to Shingrix’s 97.9%, according to Curevo. CRV-101 was also linked to lower rates of solicited local and systemic adverse events, the Seattle-based biotech noted in a Jan. 7 release.

The company honed in on the safety profile as a potential market differentiator for its vaccine contender, pointing out that the drop-off in adverse events was “especially apparent when comparing higher grades of solicited local and systemic adverse events occurring within seven days of each dose.”

If confirmed in a phase 3 trial, this would “represent a significant advantage for amezosvatein since higher-grade adverse events interfering with daily activities are of particular concern to those considering being vaccinated for shingles,” Curevo explained.

The biotech aims to kick off that late-stage trial this year, with an eye fixed firmly on “a market for shingles vaccination currently exceeding $4 billion,” it said.

“Despite Shingrix being available for several years, vaccine coverage rates remain disappointingly low,” Curevo’s Chief Medical Officer Guy De La Rosa said in the release. “A growing body of evidence suggests tolerability issues contribute to both vaccine hesitancy and avoidance of the required second dose. Amezosvatein was developed specifically to provide high vaccine effectiveness and best-in-class tolerability. We are very excited by these phase 2 data.”

However that phase 3 trial pans out, it's going to be an uphill climb for the Seattle biotech, which joins a number of companies—including powerhouse duo Pfizer and BioNTech—in trying to steal a bit of the market share from GSK. Shingrix secured a record year for the U.K. pharma in 2022, bringing in 2.9 billion pounds ($3.6 billion) in sales.

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