In phase 2 head-to-head comparison, Curevo’s shingles vaccine is equivalent to GSK’s Shingrix

Curevo Vaccine’s bold strategic move to enter the competitive Shingles vaccine market against industry giant GSK has proven to be a success for the company. Despite being privately held, Curevo has emerged triumphant in a phase 2 trial, showcasing the effectiveness of its non-mRNA, adjuvanted subunit vaccine, CRV-101 (also known as amezosvatein), when compared to GSK’s renowned Shingles vaccine.

In the extensive phase 2 trial involving 876 participants aged 50 and above, CRV-101 demonstrated its capability to elicit a strong humoral immune response by day 84. Curevo reported a 100% vaccine response rate for CRV-101, surpassing GSK’s Shingrix, which achieved a response rate of 97.9%. Furthermore, CRV-101 exhibited lower rates of solicited local and systemic adverse events, a significant aspect highlighted in Curevo’s January 7 release.

Amezosvatein is the designated non-proprietary name for CRV-101, an investigational non-mRNA adjuvanted subunit vaccine developed by Curevo. Similar to Shingrix, amezosvatein incorporates a subunit protein antigen known as glycoprotein ‘E’ (gE).  Also known as herpes zoster, shingles occur when the varicella-zoster virus, responsible for childhood chickenpox, reactivates from sensory ganglion nervous system cells where it remains dormant following the initial exposure. Almost all adults have encountered the varicella-zoster virus, and approximately 30% will experience shingles at least once.

The engineering of amezosvatein aimed to establish an outstanding safety profile, surpassing existing standards, and streamlining the manufacturing process to enhance the accessibility of the vaccine.

Curevo strategically positions the safety profile of its vaccine as a potential distinguishing factor in the market. The company emphasizes the noteworthy reduction in adverse events, especially higher-grade ones occurring within seven days of each dose. Curevo foresees that if this advantage is confirmed in a phase 3 trial, it could effectively address concerns regarding adverse events that might impede daily activities, thereby fostering greater acceptance of shingles vaccination.

Looking forward, Curevo is set to commence a phase 3 trial this year to tap into the lucrative shingles vaccination market, estimated to be valued at over $4 billion. Curevo’s Chief Medical Officer, Guy De La Rosa, underscores the persistently low vaccine coverage rates, attributing them to tolerability issues related to the required second dose requirement. Amezosvatein, developed for optimal vaccine effectiveness and superior tolerability, presents an enticing prospect based on the promising phase 2 data.

While Curevo maintains optimism about its vaccine’s potential, it acknowledges the challenges ahead. Competing with established players such as Pfizer and BioNTech, Curevo faces the formidable task of securing market share from GSK, whose Shingrix achieved record-breaking sales of £2.9 billion ($3.6 billion) in 2022. The shingles vaccine landscape is highly competitive, and the outcome of the phase 3 trial will play a pivotal role in determining Curevo’s success in this challenging market.

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