First, lackluster data forced GlaxoSmithKline and partner Sanofi back to the drawing board with their COVID-19 shot. Now, another would-be vaccine partner has decided to ditch GSK's vaccine booster and use another company's instead.
China's Clover Biopharmaceuticals had been testing its vaccine candidate with two adjuvants, one from GSK and the other from Dynavax. Adjuvants are designed to increase the effectiveness of a vaccine.
With phase 1 numbers in, Clover reviewed preclinical data and results from that trial—and took into account “manufacturing considerations”—in deciding to reject GSK's version and use Dynavax's in late-stage testing.
In the phase 1 study, the vaccine—combined with either the GSK or Dynavax adjuvant—"performed well," Clover said, and "induced high levels of neutralizing antibodies while demonstrating favorable safety and tolerability profiles."
Now, Clover and Dynavax expect their study to start in the first half of the year. A potential interim efficacy result could come midyear.
For GSK, it's the second R&D setback in the span of a few months. The vaccine giant and Big Pharma partner Sanofi late last year posted data showing their candidate failed to trigger the desired immune response in people 50 years and older. The companies now plan to start a phase 2b trial this month with a new antigen formulation, aiming for potential authorizations in the fourth quarter.
The Big Pharma partners aren't alone in having trouble in coronavirus vaccine research, though: Fellow vaccine expert Merck & Co. bowed out of the field last week after getting a late start.
Clover, for its part, kicked off its coronavirus vaccine work last January and partnered with GSK last February. In April, the company scored backing from the Coalition for Epidemic Preparedness Innovations. Then, in July and November, CEPI and Clover expanded their collaboration as the program proceeded through various stages of testing. All told, CEPI has pledged up to $328 million to support the vaccine’s development.
CEPI is also supporting Dynavax now: On Monday, the group unveiled up to $99 million in funding as Dynavax works to manufacture its CpG 1018 adjuvant. The $99 million will come in the form of a forgivable loan and aims to support hundreds of millions of vaccine doses this year.
The adjuvant stockpile will be available first for CEPI partners to purchase to support licensed vaccines, and remaining adjuvants can be sold to other CEPI partners to support their research. After Dynavax sells the adjuvant stockpile, it’ll reimburse CEPI for the manufacturing costs. If all the potential vaccines that could use the adjuvant fail in testing, CEPI will forgive the loan.