GSK dumps universal flu vaccine after interim data readout

GlaxoSmithKline has dumped a universal flu vaccine after getting a look at interim phase 1 data. The clinical data and other results persuaded GSK to stop development of the candidate once it finishes the ongoing study. 

The influenza vaccine, GSK3816302A, combines the Icahn School of Medicine Mount Sinai’s (ISMMS) chimeric hemagglutinin (cHA) technology and GSK’s AS03 adjuvant in a bid to develop a shot that protects against all current and future circulating influenza strains, thereby eliminating the need to develop new jabs and administer them each year. 

GSK continues to apply its adjuvants and other technologies to the development of universal flu vaccines. But early data on GSK3816302A suggests it is unlikely to be the breakthrough program. 

"The candidate vaccine induced a cross-reactive immune response and demonstrated the beneficial role of the adjuvant included. However, the boosting effect of the second dose was not as strong as was expected for the cHA technology. In addition, the immunological persistence data available are insufficient to conclude that an influenza vaccine made with this technology will likely be supra-seasonal," a spokesperson for GSK said. 

GSK moved the vaccine into a phase 1 trial in 470 healthy volunteers in 2017. The clinical trial was designed to compare the safety and tolerability of nine unadjuvanted and adjuvanted supra-seasonal universal flu vaccine formulations to placebo and GSK’s quadrivalent seasonal influenza vaccine.

The study is assessing the effects of delivering one or two primary doses, plus a booster shot one year after the initial vaccination, and will continue to do so through its previously targeted 2020 completion date. But beyond that, GSK will stop development and feed the lessons it learned from the trial back into its discovery programs. 

ISMMS will continue to develop cHA “in a variety of research platforms,” a spokesperson for GSK said. 

GSK revealed the termination in a first-quarter pipeline update (PDF) that also featured news of its decision to stop development of a next-generation strep pneumonia vaccine. The candidate advanced as far as phase 2 before GSK decided to call time on the project.

The pipeline changes leave GSK with 13 clinical-phase vaccine candidates. That figure has held steady over the past year, with some quarter-to-quarter variation, while the size of the oncology pipeline has mushroomed. GSK now lists 17 cancer drugs in its clinical pipeline, up from eight this time last year. 

Under the scientific leadership of Hal Barron, GSK is betting that leveraging its immunology expertise will enable it to come from behind in immuno-oncology and claim a slice of the growing market.