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Genocea Reports First Quarter 2016 Financial Results

- Positive 12-month efficacy data for GEN-003 for genital herpes strengthens value proposition -

- Multiple 2016 clinical milestones for GEN-003 anticipated -

CAMBRIDGE, Mass., May 05, 2016 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. GNCA, +3.58% a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, today reported corporate highlights and financial results for the first quarter ended March 31, 2016.

"Our positive GEN-003 Phase 2 12-month efficacy data suggests that annual treatment with GEN-003 may offer genital herpes patients similar benefits to a full year of daily administration of oral antivirals. These data give us confidence in the potential of GEN-003 to become the cornerstone therapy for patients suffering from genital herpes," said Chip Clark, president and chief executive officer of Genocea. "For our recently initiated Phase 2b efficacy trial, we anticipate reporting virologic efficacy data in the third quarter of 2016, which we anticipate will confirm the efficacy of GEN-003 manufactured using improved processes at an increased scale. We expect clinical efficacy data versus placebo against potential Phase 3 endpoints at six months post dosing around the end of 2016 and we expect to conduct our end-of-Phase 2 meeting with the FDA in the first quarter of 2017. We also continue to advance our academic collaborations in the immuno-oncology field and expect to provide further updates in the coming months on our potential path to the clinic in 2017 for a neoantigen-based cancer vaccine."

Recent Business Highlights and Anticipated Milestones

GEN-003 - Immunotherapy for treatment of genital herpes in Phase 2 development. Greater than $1 billion potential revenue opportunity in U.S. alone

- Reported positive 12-month efficacy data from Phase 2 dose optimization trial
- Full data to be presented at an upcoming scientific meeting

In March 2016, Genocea announced positive 12-month efficacy data from its Phase 2 dose optimization trial evaluating GEN-003 for the treatment of genital herpes. GEN-003 demonstrated statistically significant reductions compared to baseline in the rate of viral shedding 12 months after dosing as well as sustained efficacy across secondary clinical endpoints, in each case across multiple dose groups. GEN-003 was safe and well tolerated by patients, with no serious adverse events reported related to the vaccine in the trial.

Multiple anticipated 2016 clinical milestones for GEN-003

- Phase 2b virologic efficacy data expected in third quarter of 2016
- Phase 2b 6-month clinical efficacy data expected in late 2016
- End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) expected in Q1 2017

In the third quarter of 2016, Genocea expects to report virologic efficacy data from a Phase 2b trial to confirm the efficacy of GEN-003 manufactured with Phase 3 processes at increased scale. Around the end of 2016, Genocea expects to report 6-month clinical efficacy versus placebo against the potential Phase 3 endpoint of the percentage of patients that are lesion free at 6-months after dosing. Positive data would provide an important step toward the end-of-Phase 2 meeting with the FDA, which is expected to occur in the first quarter of 2017.

This ongoing trial has enrolled approximately 135 subjects across the U.S. who have a history of recurrent genital herpes. Subjects will be randomized to one of three dose groups - placebo, 60ug per protein / 50ug of adjuvant, and 60ug per protein / 75ug of adjuvant - and will be monitored...