Genocea Biosciences, Inc., a biopharmaceutical company, discovers and develops novel vaccines and immunotherapies to treat infectious diseases. The company uses its proprietary discovery platform AnTigen Lead Acquisition System to design vaccines and immunotherapies that act through T cell immune responses. Its lead product candidate is GEN-003, a therapeutic vaccine or immunotherapy that is in Phase 2 trial for the treatment of genital herpes infections. It is also developing GEN-001, a product candidate that is in pre-clinical stage for treating chlamydia prophylaxis; GEN-002, which is in pre-clinical stage for the treatment of genital herpes prophylaxis; and GEN-005 that is in research st...
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Genocea Biosciences, Inc. - Special Call
Sep 29 16
To discuss positive results from its ongoing Phase 2b trial evaluating a new Phase 3-ready formulation of GEN-003 for the treatment of genital herpes
Genocea Biosciences, Inc. Announces Positive Results from its Ongoing Phase 2b Trial Evaluating a New Phase 3-Ready Formulation of GEN-003
Sep 29 16
Genocea Biosciences, Inc. announced positive results from its ongoing Phase 2b trial evaluating a new Phase 3-ready formulation of GEN-003 for the treatment of genital herpes. The study achieved its primary endpoint, with GEN-003 demonstrating a statistically significant reduction of 40% in the rate of viral shedding in the 60 µg per protein /50 µg of Matrix-M2 dose group compared to both baseline and placebo. The viral shedding rate reduction for this dose was consistent with its performance at the same time point in a prior Phase 2 trial. During the 28-day observation period immediately after completion of dosing, the 60 µg per protein /50 µg of Matrix-M2 dose of GEN-003 demonstrated a statistically significant 40% reduction from baseline in the viral shedding rate versus a marginal increase of 6% for placebo. The 60 µg per protein /75 µg of Matrix-M2 dose demonstrated a 27% reduction in the viral shedding rate. This Phase 2b trial is the first study testing potential Phase 3 endpoints with an improved formulation of GEN-003 - manufactured with commercially-scalable processes - which will be used in future Phase 3 trials. The trial enrolled 131 subjects from 9 institutions in the United States. Subjects have been randomized to one of three dose groups - placebo, 60 µg per protein /50 µg of Matrix-M2 and 60 µg per protein /75 µg of Matrix M2 - and have received three injections at 21-day intervals. Viral shedding rate reductions were measured to demonstrate the efficacy of the new formulation. The study will also compare GEN-003 efficacy to placebo for the clinical endpoints of: the proportion of patients who are lesion free at six and 12 months after dosing; the time to first lesion recurrence after dosing; and, the impact on percentage of days with genital herpes lesions at six and 12 months after dosing. All subjects will be followed for 12 months after the last dose.
Genocea Biosciences, Inc. Announces Unaudited Consolidated Earnings Results for the Second Quarter and Six Months June 30, 2016; to Provide Report on Viral Shedding Data from an Ongoing Phase 2B Trial
Aug 4 16
Genocea Biosciences, Inc. announced unaudited consolidated earnings results for the second quarter and six months June 30, 2016. For the quarter, the company reported loss from operations of $10,704,000 compared to $10,026,000 a year ago. Net loss was $11,023,000 or $0.39 per basic and diluted share compared to $10,314,000 or $0.43 per basic and diluted share a year ago. R&D expenses decreased $0.3 million, to $6.7 million, from the same period in 2015. The decrease was driven by the conduct of a smaller Phase 2 trial for GEN-003 in comparative quarterly periods and lower GEN-003 manufacturing costs due to the timing of activities in support of clinical trial supply. GEN-004 costs were also lower due to the Phase 2a trial which was ongoing in the second quarter of 2015 and has since been completed. These lower costs were partially offset by higher personnel and lab-related costs to advance company’s preclinical product candidates and develop the ATLAS platform for immuno-oncology.
For the six months, the company reported grant revenue of $235,000 compared to $236,000 a year ago. Loss from operations was $20,133,000 compared to $21,803,000 a year ago. Net loss was $20,774,000 or $0.74 per basic and diluted share compared to $22,398,000 or $1.04 per basic and diluted share a year ago.
In September, the company expects to report viral shedding data from an ongoing phase 2b trial. Approximately 135 subjects have been randomized to one of three dose groups - placebo, 60 µg per protein /50 µg of adjuvant and 60 µg per protein /75 µg of adjuvant - and are being monitored for 12 months. Around the end of 2016, the company expects to report 6-month clinical efficacy data from this phase 2b trial. The placebo-controlled data will represent the first opportunity to measure GEN-003 against potential phase 3 clinical endpoints at 6-months after dosing. Following these two data readouts, The company expects to conduct an end-of-phase 2 meeting with the FDA in the first quarter of 2017. During this meeting, the company will confirm the phase 3 program for GEN-003, which it expects to initiate in the second half of 2017. The company also expects to commence a phase 2b antiviral combination study in the fourth quarter of 2016. Six-month clinical efficacy data from this trial is expected in the second half of 2017. If GEN-003 is additive to the effect of chronic suppressive oral anti-viral therapy, the company believes this would further strengthen GEN-003’s value proposition to patients and physicians.