The ability of adjuvants to boost the immune response to antigens has particular benefits during a pandemic. Firstly, adjuvants can reduce the effective dose and, in doing so, increase manufacturing output. Secondly, adjuvants can enable vaccines to confer immunity to seniors and other people with weakened immune systems.
In the context of COVID-19, those benefits could result in vaccines that protect the older people who are most at risk from the virus and increase the number of doses available, thereby cutting the time it takes to immunize enough of the population to bring the pathogen under control.
That thinking has led the Gates Foundation to award Dynavax a $3.4 million grant to pay for the scale up of production batch size of the CpG 1018 adjuvant.
Dynavax uses the adjuvant in its approved hepatitis B vaccine Heplisav-B. However, the hepatitis B vaccine serves a far smaller market than COVID-19 prophylactics — the shot generated net sales of $34.6 million last year — and as such Dynavax lacks the capacity to support the production of the hundreds of millions of adjuvanted-coronavirus doses that may be required.
With the support of the Gates Foundation, Dynavax plans to establish the capacity to make up to 750 million adjuvanted doses a year. The target is in the middle of the 600 million to 1 billion range that Dynavax said its contract manufacturer could theoretically support using existing installed capacity.
How much capacity Dynavax ultimately needs will depend on the success of the vaccines in which its adjuvant is being used. In recent months, Dynavax has agreed to provide its CpG 1018 adjuvant for use in COVID-19 vaccines in development at Clover Biopharmaceuticals, Medicago, Medigen, Sinovac and Valneva.
Clover and Medicago have already begun clinical testing, while Medigen and Valneva are set to move their prospects into humans later this year. Dynavax expects to strike additional agreements.
GlaxoSmithKline is also providing an adjuvant to Clover and Medicago, as well as to Sanofi. None of the companies have generated data so far to show whether the choice of adjuvant affects outcomes.
In the event CpG 1018 is the preferred adjuvant for multiple approved COVID-19 vaccines, even Dynavax’s ramped-up production capacity could prove insufficient. Dynavax CEO Ryan Spencer told investors earlier this month that the company could ship upward of 1 billion adjuvants a year if it was “a little bit more creative.”
The size of the business opportunity awaiting Dynavax remains unclear. Spencer said it will depend on where the products are sold, given the differences in vaccine prices between high and low-income countries, but the volumes involved mean it could be significant whatever the geographic mix.
“We have a number of programs which give us many shots on goal for success. And like I said before when we had this conversation, success looks like hundreds and millions of doses. So, we do believe that Dynavax will be able to generate significant value to the extent we can supply large coronavirus programs,” said Spencer.