Genocea Biosciences, Inc. Announces Positive Clinical Results from Planned Interim Analysis of Ongoing Placebo-Controlled Phase 2b Trial Evaluating Gen-003 for the Treatment of Genital Herpes Infections
January 05, 2017 at 06:36 am
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Genocea Biosciences, Inc. announced positive clinical results from a planned interim analysis of its ongoing placebo-controlled Phase 2b trial evaluating GEN-003 for the treatment of genital herpes infections. Even in a trial this small, at six months after dosing, GEN-003 demonstrated statistically significant improvements versus placebo across multiple clinical endpoints. The 60 µg per antigen /50 µg of adjuvant dose of GEN-003 significantly reduced the rate of genital lesions during the six months following dosing compared to placebo (4.5% of days vs. 7.9%, respectively; 41% reduction vs. placebo, p<0.05). The genital lesion rate is an important overall measure of disease that captures both the frequency and duration of recurrences, both of which are important to both patients and their caregivers. In the trial, GEN-003 also consistently demonstrated significant benefits versus placebo across several other clinical endpoints across the dose groups. In aggregate, the data from the GEN-003 Phase 2 clinical trials continue to support the selection of the 60 µg per antigen /50 µg of adjuvant dose for the planned Phase 3 program. GEN-003 also continues to demonstrate a safety profile appropriate for its therapeutic setting in the judgment of the trial’s independent Drug Monitoring Committee.
Genocea Biosciences, Inc. is a biopharmaceutical company. The Company is engaged in discovering and developing cancer immunotherapies using its proprietary ATLAS platform. The ATLAS platform can profile each patient's CD4+ and CD8+ T cell immune responses to every potential target or antigen identified by next-generation sequencing of that patient's tumor. ATLAS zeroes in on both antigens that activate anti-tumor T cell responses and inhibitory antigens, or Inhibigens, that drive pro-tumor immune responses. Its GEN-009 is an investigational neoantigen vaccine delivering adjuvanted synthetic long peptides from ATLAS-identified neoantigens. The Company has a license agreement with Harvard College (Harvard), granting the Company a sublicensable license to one patent family, to develop, make, use, market licensed products, and perform licensed services related to the ATLAS discovery platform.
Genocea Biosciences, Inc. Announces Positive Clinical Results from Planned Interim Analysis of Ongoing Placebo-Controlled Phase 2b Trial Evaluating Gen-003 for the Treatment of Genital Herpes Infections