Curevo Vaccine is hoping $60 million in financing will help the small biotech literally go head-to-head against GlaxoSmithKline's market-dominating shingles vaccine Shingrix.
The new series A financing will fund a phase 2b head-to-head trial of Curevo's shingles vaccine CRV-101 against Shingrix. The biotech said the study will enroll 678 people with the cash supporting initiation through topline data.
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 is the U.K. pharma giant's second-best-selling individual drug, totaling more than $2.3 billion in sales last year. The shot further cemented itself in the market last year after the number of countries it's available in more than doubled to 17. The FDA also expanded approval to all adults and the CDC’s Advisory Committee on Immunization Practices followed up with a formal recommendation of the vaccine for adults 19 or older.
Curevo is moving CRV-101 on to the mid-stage study after phase 1 results showed that all participants—regardless of dosing levels—reported at least a four-fold increase in antibody response against the most abundant protein found in the shingles virus.
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Where the company hopes to separate itself from Shingrix is in tolerability. The vaccine was found to be well tolerated with a low rate of moderate side effects reported by participants during a phase 1 study. The phase 2b is designed to compare the safety and immunogenicity of CRV‑101 vs. Shingrix.
Shingrix was recently hit with a new safety label from the FDA warning of the increased risk of a rare neuro autoimmune disorder called Guillain-Barré Syndrome. Even so, the agency still stressed that the benefits of vaccination outweighed the risks. In 2018, a CDC official said that one in six recipients of Shingrix experienced side effects severe enough to keep them from doing their normal activities.
Pfizer and BioNTech, which announced a new partnership to develop a shingles vaccine in January, are also targeting safety as a way to improve on the standard of care.
RA Capital Management and Adjuvant Capital led the fundraising round for Curevo, with founding investor and South Korean biopharma GC Pharma also contributing.