GlobeImmune Announces First Quarter 2015 Results and Corporate Highlights

LOUISVILLE, CO--(Marketwired - May 14, 2015) - GlobeImmune, Inc. (NASDAQ: GBIM) today announced its first quarter 2015 financial results and corporate highlights.

"We are pleased with the progress made across all of our programs," said Timothy C. Rodell, M.D., FCCP, President and CEO of GlobeImmune, Inc. "Particularly, we are excited about the recent initiation of the Phase 2 trial of GI-6301 at the NCI for patients with chordoma. To our knowledge, this will be the first randomized placebo-controlled trial of a therapeutic agent performed to date in this patient population."

Corporate Highlights

GS-4774
GS-4774, exclusively licensed to Gilead Sciences, Inc., is a therapeutic vaccine engineered to activate an HBV-specific T cell immune response to eliminate, or clear virus from, cells containing HBV. GS-4774 is being developed to increase the hepatitis B surface antigen (HBsAg) seroconversion rate, which is generally considered a cure, when used in combination with oral antiviral therapy. Gilead has initiated two Phase 2 trials of GS-4774:

• The 0101 trial, initiated in 2013, is designed to investigate GS-4774 in combination with ongoing oral antiviral treatment in patients with chronic HBV infection. The 0101 trial is a multicenter, multinational trial that enrolled 175 patients in a randomized, open-label design comparing three different doses of GS-4774 (2YU, 10YU or 40YU, with one YU equal to 10 million yeast cells), administered in combination with oral antiviral therapy versus antiviral treatment alone. The primary endpoint for this trial is decline in serum HBsAg. This trial is fully-enrolled, and 48-week results are expected to be available in the first half of 2015. These results may be submitted to an upcoming scientific conference. [www.clinicaltrials.gov; NCT01943799]
• The 1401 trial, initiated in 2014, is designed to investigate GS-4774 in patients with chronic HBV infection who are currently not receiving treatment. The 1401 trial is a multicenter, multinational trial designed to enroll 175 patients in a randomized, open-label design comparing three different doses of GS-4774 (2YU, 10YU, or 40YU), administered in combination with tenofovir disoproxil fumarate, or TDF, versus TDF alone. The primary endpoint for this trial is decline in serum HBsAg. The 1401 trial is enrolling patients, and the 48-week results are projected to be available in the middle of 2016. [www.clinicaltrials.gov; NCT02174276]

GI-6301