Big pharma group GSK has been ruling the market for shingles vaccines for many years, but little Dynavax Technologies has aspirations to knock off its crown.
The Emeryville, California-based biotech has just released topline results from a phase 1/2 head-to-head study comparing its Z-1018 vaccine to GSK’s $4.5 billion blockbuster Shingrix, showing comparable efficacy but an edge for its shot on tolerability.
At all the doses tested, Z-1018 was associated with fewer local and systemic post-injection reactions in the first stage of the study, which enrolled nearly 120 healthy participants aged 50 to 69 years.
The best performing dose achieved a 100% antibody response, versus 96.9% with Shingrix, with cell-based responses (CD4+ cells) of 89.7% and 93.5%, respectively.
Now, Dynavax will move ahead with a second stage of the study, testing a 100 mcg dose with its proprietary adjuvant CpG 1018 and alum given in two doses eight weeks apart, before the end of the year. That will involve an older age group of 70-plus, who are most at risk of developing shingles and – if the results are positive – will open the door to registration trials.
Shingles is caused by the herpes zoster virus (HZV), which also causes chickenpox. While the immune system can generally shake off the symptoms of chickenpox, HZV lies dormant and – if a person’s immune system starts to diminish – can reawaken, resulting in painful skin lesions.
“Shingles is a painful disease driven by cellular immune decline with age,” commented Dynavax’s chief medical officer Robert Janssen.
“A vaccine that provides a strong immune response alongside favourable tolerability, compared to the current standard of care, could provide an important new option for protection against this debilitating disease.”
There are around 1 million cases of shingles annually in the US, according to the Centres for Disease Control and Prevention (CDC) data.
“These positive data mark an important inflexion point for our novel shingles vaccine programme as we strive to develop a product with a potential best-in-class profile [and] disrupt the multi-billion-dollar shingles vaccine market,” said Dynavax’s chief executive, Ryan Spencer.
“We met our goal for this study, as the results show immune responses comparable to Shingrix, along with a favourable tolerability profile, and provide the basis for selecting the dose and regimen to advance into further development.”
Other companies working on vaccines that could challenge Shingrix include Pfizer and BioNTech, which have been partnering on an mRNA-based vaccine since 2022 and have a candidate in early-stage clinical testing, and Curevo, which has a non-mRNA subunit vaccine called amezosvatein (CRV-101) in phase 2.
