GEN-003 is an experimental immunotherapy vaccine comprised of 2 HSV-2 proteins, glycoprotein D2 and ICP4.2, and Matrix-M2 adjuvant (M2).
Gen-003 is indicated to reduce lesions as well as decrease the viral shedding of Genital herpes.
In the phase 2 clinical trial, the GEN-003 was given as 1 intramuscular injection of the assigned dose every 21 days up to 3 doses.
Genital Herpes is a sexually transmitted disease (STD) caused by HSV-1 or HSV-2.
This common STD is mostly associated with HSV-2 infection, which affects more than 400 million people aged 15 to 49 years worldwide, including many Americans; however, HSV-1 is also an important cause of genital herpes, which is estimated to affect about 140 million people in the same age group.
There are nine human herpesviruses. Three of these herpesviruses are known as alpha-herpes viruses due to their ability to establish latent infections in neurons. Both HSV1 and HSV2 can cause oral and genital lesions. HSV3 is also known as chickenpox upon initial infection and shingles later in life when the virus is reactivated.
February 19, 2019, The phase 2 clinical trial NCT02515175 was updated to reflect the termination of this study due to the 2017 business decision to cease GEN-003 spending.
Clinical Trial NCT02515175: Evaluating New Formulation of Therapeutic HSV-2 Vaccine
- This Phase 2 study is a randomized, double-blind, placebo-controlled clinical trial of a new formulation of GEN-003 for treatment of HSV-2 genital infection.
- Eligible subjects will enter a baseline period to collect anogenital swabs for 28 consecutive days prior to randomization.
- Each subject will receive up to 3 doses at 21-day intervals then complete a second set of anogenital swabs for 28 consecutive days after the third dose.
- Each subject will be followed for one year after the third dose
Despite positive phase 2 trial results, Genocea Biosciences, Inc, has decided to stop work on this candidate.
GEN-003 now appears under the “Partnering” section of Genocea’s website and is listed as “a Phase 3-ready investigational immunotherapy for the treatment of genital herpes infections.”
Clinical Trial NCT03146403: Maintenance Dose Study of GEN-003 in Subjects With Genital Herpes Infection
- The main purpose of this phase 2 study is to see if a maintenance dose of GEN-003 reduces the number of days that subjects have a genital herpes recurrence.
- The second purpose of the study is to evaluate the safety and tolerability of a maintenance dose of GEN-003.