GlobeImmune's ($GBIM) in-development vaccine for hepatitis B missed the mark in a Phase II trial, marring the value of a program licensed to Gilead Sciences ($GILD).
The vaccine, GS-4774, is designed to galvanize the body's T cells to rear up and fight hep B infection. Recruiting 178 patients with chronic hep B, GlobeImmune tested GS-4774 in combination with standard oral antivirals, finding that the vaccine charted no improvement in hep B surface antigen levels, a key measure of viral activity, compared to the older drugs alone. At 24 weeks, even the highest doses of GS-4774 failed to meet the study's primary endpoint, GlobeImmune said, though the vaccine did chart a positive--but not statistically significant--effect after 48 weeks.
Pointing to three patients who got the highest dose and posted notable surface antigen reductions, GlobeImmune believes the trial "suggests initial biologic activity" for GS-4774, CEO Timothy Rodell said in a statement. The vaccine was also safe and well tolerated in the study, the company said.
Investors were less optimistic about the results, however, sending the biotech's shares down roughly 50% on Wednesday.
Now the vaccine's future will largely be up to Gilead, which bought into the program back in 2011. The partners are working through a second Phase II study in treatment-naive hep B patients and may wait to make a final decision on GS-4774 until data from that trial are available.
Beyond its top vaccine, GlobeImmune's pipeline includes preclinical treatments for tuberculosis, HIV and delta virus, plus a handful of mid-stage oncology treatments partnered with Celgene ($CELG).
- read the statement