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February 07, 2016 1:10 AM ET

Biotechnology

Company Overview of Genocea Biosciences, Inc.

Company Overview

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 II trials to treat genital herpes infections. It is also developing GEN-004, a Phase II vaccine for the prevention of pneumococcal infections; GEN-001 that is in pre-clinical product candidate for treating chlamydia prophylaxis; GEN-002, which is in pre-clinical stage for the treatment of HSV-...

100 Acorn Park Drive

5th Floor

Cambridge, MA 02140

United States

Founded in 2006

57 Employees

Phone:

617-876-8191

Key Executives for Genocea Biosciences, Inc.

Chief Executive Officer, President and Director
Age: 46
Total Annual Compensation: $393.6K
Chief Financial Officer and Secretary
Age: 40
Total Annual Compensation: $285.2K
Chief Medical Officer
Age: 63
Total Annual Compensation: $366.1K
Compensation as of Fiscal Year 2014.

Genocea Biosciences, Inc. Key Developments

Genocea Biosciences, Inc. Commences Dosing in Phase 2b Study for Genital Herpes Treatment, GEN-003

Genocea Biosciences, Inc. announced the commencement of the dosing phase in a Phase 2b clinical trial for GEN-003 for the treatment of genital herpes. Patient screening for the trial, which was initiated in December 2015, is complete. The Company expects to report top-line viral shedding data from the immediate post-dosing observation period in mid-2016 and clinical efficacy data against potential Phase 3 study endpoints at six months after dosing in the second half of 2016. The Phase 2b study will enroll approximately 135 subjects from nine institutions in the United States. Subjects will be randomized to one of two dose levels of GEN-003 or placebo, and receive three injections at 21-day intervals. Viral shedding rate reductions will be measured to demonstrate the activity 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 is currently conducting a Phase 2 dose optimization study with an anticipated 12-month data read out later in the first quarter of 2016. In October, the Company announced positive results from a planned interim analysis of data collected six months after dosing. At its best performing dose of 60 µg per protein /75 µg of Matrix-M2TM adjuvant, GEN-003 demonstrated a statistically significant 58% reduction from baseline in the viral shedding rate (p<0.0001), the primary endpoint of the study. In a planned secondary analysis, the proportion of patients receiving GEN-003 who were lesion-free at six months after dosing ranged from approximately 30% to 50%, similar to results reported in clinical trials with oral antiviral therapies. In addition, the time to first recurrence after completion of dosing showed a range of 152 days to greater than 180 days among dose groups. In a further secondary analysis measuring the impact on genital lesion rates, GEN-003 demonstrated sustained and statistically significant reductions from baseline in five of six dose groups ranging from 43% to 69%. The Phase 2 study continued to show that GEN-003 is safe and well tolerated by patients, with no serious adverse events related to the vaccine.

Genocea Biosciences, Inc. Presents at Boston Biotech East West CEO Conference, Jan-10-2016 11:00 AM

Genocea Biosciences, Inc. Presents at Boston Biotech East West CEO Conference, Jan-10-2016 11:00 AM. Venue: Four Seasons Hotel, 757 Market St., San Francisco, CA 94103, United States. Speakers: Chip Clark.

Genocea Biosciences, Inc. Enters into the First Amendment to the Loan and Security Agreement

On December 17, 2015, Genocea Biosciences, Inc. entered into the first amendment to the Loan and Security Agreement by and between Hercules Technology Growth Capital, Inc. and the Company, dated as of November 20, 2014. Pursuant to the Loan Agreement, the Company may borrow term loan facilities of up to $27.0 million comprised of a term loan in an aggregate principal amount of up to Twelve Million Dollars and term loans (each a Term B Loan Advance) in an aggregate principal amount of up to Fifteen Million Dollars. Each Term B Loan Advance will be available in increments of $5.0 million dollars upon the achievement of certain milestones for certain limited periods of time. Prior to entering into the First Amendment, the Company had $12.0 million outstanding under the Term Loans with no further borrowing eligibility. The First Amendment requires the Company to drawn additional $5.0 million Term B Loan Advance upon the effectiveness of the First Amendment, permits the Company to draw a Term Loan B Advance in the amount of $5.0 million available through December 15, 2016 and permits the Company to draw an additional Term Loan B Advance in the amount of $5.0 million available through December 15, 2016 subject to the company demonstrating sufficient evidence of continued clinical progression of its GEN-003 product and making favorable progress in applying its proprietary technology platform toward the development of novel immunotherapies with application in oncology. The First Amendment also extends the interest only period through June 30, 2017.

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