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July 21, 2014
08:09 EDTGNCAGenocea announces Phase 2 GEN-003 optimization trial
Genocea Biosciences announced the start of a Phase 2 dose optimization trial for GEN-003. The Phase 2 dose optimization study will enroll approximately 300 subjects from 17 institutions in the U.S. and will study six combinations of two antigen doses with each of three adjuvant doses alongside a placebo. All subjects will receive three doses of GEN-003 or placebo at 21-day intervals. The primary end point for the study is the change from baseline in viral shedding rate. The study is also designed to evaluate the impact on percentage of days with genital herpes lesions as reported by patients. Subjects receiving GEN-003 will be followed for 12 months after the last dose. Previously the company announced results from its Phase 1/2a clinical trial of GEN-003, which demonstrated, in the 30 microgram dose group, statistically significant reductions from baseline in viral shedding and genital lesion rates of up to 52% and 65% respectively, with a durability of effect to six months after dosing. The company said, "We look forward to announcing interim results from this trial in the middle of 2015.”
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November 21, 2014
08:33 EDTGNCAGenocea enters into loan and security agreement with Hercules Technology
Genocea Biosciences (GNCA) announced that it has entered into a loan and security agreement with Hercules Technology Growth Capital (HTGC) for a term loan of up to $27M. The proceeds of the initial draw of $12M will be used to repay Genocea’s existing term loan facility and to provide additional working capital for general corporate purposes. Genocea can draw up to an additional $5M at its option through June 30, 2015. Two further tranches of $5M each can be drawn down at Genocea’s option on or prior to December 15, 2015 subject to the achievement of certain clinical and corporate milestones. Additionally, Genocea entered into an equity rights letter agreement with Hercules pursuant to which Hercules purchased 223,463 shares of Genocea’s common stock at $8.95 per share, the closing price of Genocea’s common stock as reported on The NASDAQ Global Market on November 19, 2014.
November 17, 2014
08:58 EDTGNCAGenocea management to meet with Needham
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