Genocea Biosciences (GNCA) Presents New 12 Month Data on GEN-003

October 28, 2016 7:37 AM EDT

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Genocea Biosciences, Inc. (NASDAQ: GNCA), a company developing T cell-directed vaccines and immunotherapies, today presented new 12 month immunogenicity data from the Phase 2a trial of its genital herpes immunotherapy GEN-003. This analysis shows that GEN-003 immunization results in the development of CD4+ polyfunctional T cells, which indicates that GEN-003 is stimulating a multi-faceted T cell immune response to genital herpes. The presentation also details the strong, antigen-specific antibody responses elicited by GEN-003 for up to 12 months post-dosing, consistent with its sustained effect on viral shedding and clinical disease at the same time point. Data were presented at the Infectious Disease Society of America (IDSA) annual meeting in New Orleans, Louisiana.

“These data provide strong evidence of clear and robust T and B cell immune responses that support the positive 12 month clinical results from the Phase 2a trial, which show that GEN-003 has a significant and durable effect on genital herpes viral shedding and clinical disease for at least 12 months after dosing,” said Jessica Baker Flechtner, Ph.D., chief scientific officer at Genocea. “We are particularly excited about the data showing the development of polyfunctional T cells, which are considered to deliver a more effective immune response than those T cells which secrete only one mediator. This immunological data once again demonstrates that GEN-003 can have a true biological effect against genital herpes and supports our confidence in its potential to become a cornerstone treatment for this serious disease.”

Twelve-month clinical data previously reported from this Phase 2a trial found that, for the 60 μg per protein / 50 μg of adjuvant dose, which has been selected as the best dose for Phase 3 trials, viral shedding was reduced by 66 percent vs. baseline (p<0.0001). Significant clinical efficacy was also demonstrated at this dose with a 65 percent reduction in the genital lesion rate vs. baseline (p=0.003) and 30 percent of patients remaining lesion free for 12 months post dosing. These data show that a single course of injections with GEN-003 can result in similar outcomes to taking a year of daily oral antiviral therapy.

This new analysis found that GEN-003 induced polyfunctional T cells post-immunization that peaked at day 8 and persisted through at least day 50. This data could have important implications for the understanding of how the immune system controls genital herpes infections given that polyfunctional T cells have been linked to the control of HIV and other persistent viral infections. Furthermore, mean IgG titers increased up to 21-fold to ICP4.2 and 8-fold to gD2DTMR and persisted 7- and 3-fold above baseline, respectively, at one year. Mean neutralizing antibody titers increased more than 5-fold and remained more than 2-fold over baseline at one year. These increases in antigen-specific immune response was accompanied by reductions in both viral shedding and genital lesion rates. (Poster #1343, Functional Antibody Responses to GEN-003, a Herpes Simplex Virus Immunotherapy that Durably Reduces Viral Shedding up to 12 Months Post Dosing, Friday, October 28, 2016 between 12:30pm and 2:00pm ET).

About the GEN-003 Phase 2a Clinical Trial This Phase 2a study enrolled 310 subjects from 17 institutions in the United States. Subjects were randomized to one of six dosing groups of either 30 µg or 60 µg per protein paired with one of three adjuvant doses (25 µg, 50 µg, or 75 µg). A seventh group received placebo. Subjects received three doses of GEN-003 or placebo at 21-day intervals. Baseline viral shedding and genital lesion rates were established for each subject in a 28-day observation period prior to the commencement of dosing by collecting 56 genital swab samples (two per day), which were analyzed for the presence of HSV-2 DNA, and by recording the days on which genital lesions were present. This 28-day observation period was repeated immediately after the completion of dosing and at six and, twelve months following dosing. No booster doses were given. After the 28-day observation period immediately after dosing, patients in the placebo arm were rolled over across the 6 active combinations of GEN-003 and Matrix-M2 under a separate protocol.

For more information about this clinical study of GEN-003 please visit www.clinicaltrials.gov.



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