Hope For Fighting Herpes

Gen-003 genital herpes vaccine candidate successfully completes phase 2b clinical trial

After waiting 20 years, there may be a new treatment for people infected with genital herpes.

A biopharmaceutical company developing vaccines and immunotherapies for patients with genital herpes announced positive results from a Phase 2b clinical trial for GEN-003.

In this clinical trial, GEN-003 reduced the median genital lesion rate versus placebo by 49 percent over 12 months.

Importantly, these results were achieved at the expected Phase 3 primary endpoint. No changes were observed to the previously established safety profile of GEN-003.

GEN-003 is a first-in-class investigational T cell-directed immunotherapy designed to elicit both a T cell and B cell immune response.

There is no cure for herpes.

Genital Herpes affects more than 400 million people worldwide and causes recurrent, painful genital lesions. Herpes can be transmitted to sexual partners, even when the disease is asymptomatic.

Antiviral medications can, however, prevent or shorten outbreaks during the period of time the person takes the medication. In addition, daily suppressive therapy for herpes can reduce the likelihood of transmission to partners, according to the Centers for Disease Control and Prevention. (CDC). 

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“These data and the continued progress of GEN-003 show the potential of this immunotherapy to change the treatment paradigm for patients with genital herpes infections,” said Jonathan Temte, M.D., Ph.D., M.S., former chair of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP).

“The benefits of using a periodic immunization to achieve fewer and shorter genital herpes outbreaks without the compliance challenges of a daily pill burden would represent an extremely important alternative for patients with genital herpes.”

In January 2017, Genocea Biosciences, Inc. reported that the 60 µg per antigen / 50 µg of adjuvant dose of GEN-003 significantly reduced the median genital lesion rate during the six months following dosing compared to placebo.

Throughout the Phase 2b trial, Genocea Biosciences, Inc. did not report drug-related serious adverse events or grade 4 reactogenicity, and discontinuations due to adverse events have been low and similarly distributed across active dose groups and placebo.

A 12-month extension of this study (GEN-003-005) is currently underway to examine the safety, efficacy and durability of a single maintenance dose administered at 12 months after initial dosing.

Genocea Biosciences, Inc., the manufacturer of GEN-003, reports inducing a T cell response against genital herpes is critical to treating the clinical symptoms of disease and controlling transmission of the infection.

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