GEN-003 sustains reduced genital lesion, viral shedding rate 2 years later

Genocea Biosciences, Inc. announced that their immunotherapy for the treatment of genital herpes, GEN-003, demonstrated sustained reductions 24 months after dosing in the genital lesion rate and the viral shedding rate in patients, according to phase 2 study results.

“These long-term durability data reinforce our conviction that GEN-003 could become the cornerstone treatment for patients with genital herpes,” Chip Clark, president and CEO of Genocea, said in the press release. “We believe the data suggest a single course of treatment of GEN-003 could offer significant clinical, virologic and convenience benefits to patients generally, and especially those dissatisfied with current treatments, for at least 2 years with no maintenance dosing.”

Photo of Chip Clark
Chip Clark

GEN-003 is a T-cell–directed immunotherapy that is designed to produce T-cell and B-cell immune responses against genital herpes, according to the release. The vaccine contains antigens ICP4 and gD2 and is combined with the novel adjuvant Matrix-M (Novavax).

Throughout the trial, GEN-003 continuously demonstrated safety appropriate for its therapeutic setting. The 24-month clinical results came from an extension of a phase 2 dose-optimization study that began in 2014, in which 310 patients were randomly assigned to one of six dosing groups – either 30 g or 60 g of each of two protein antigens – paired with three Matrix-M adjuvant doses (25 g, 50 g or 75 g). Another group received placebo to compare the results.

Participants received three doses of GEN-003 or placebo at 21-day intervals, with 28-day observation before the start of dosing and again immediately after the completion of dosing at 6, 12 and 24 months following. Patients in the placebo arm were rolled over across the six active dose groups under a separate protocol after the 28-day observational period immediately after dosing. The two most promising doses from this phase 2 trial (60 g per protein combined with either 50 g or 75 g of adjuvant) have been advanced into an ongoing phase 2b trial, which showed positive 6-month clinical efficacy data reported earlier this year.

Genocea has completed its End of Phase 2 meeting with the FDA, and expects GEN-003 will be ready for phase 3 development by the end of 2017.

“Given our successful End of Phase 2 meeting with the FDA, we continue to plan a phase 3 program design consistent with previous guidance,” Clark said. “We believe that these new data, together with the body of positive clinical results to date and these FDA discussions, give us momentum to advance our pioneering product candidate to phase 3 readiness this year."

Disclosures: Clark is an employee of Genocea.

Genocea Biosciences, Inc. announced that their immunotherapy for the treatment of genital herpes, GEN-003, demonstrated sustained reductions 24 months after dosing in the genital lesion rate and the viral shedding rate in patients, according to phase 2 study results.

“These long-term durability data reinforce our conviction that GEN-003 could become the cornerstone treatment for patients with genital herpes,” Chip Clark, president and CEO of Genocea, said in the press release. “We believe the data suggest a single course of treatment of GEN-003 could offer significant clinical, virologic and convenience benefits to patients generally, and especially those dissatisfied with current treatments, for at least 2 years with no maintenance dosing.”

Photo of Chip Clark
Chip Clark

GEN-003 is a T-cell–directed immunotherapy that is designed to produce T-cell and B-cell immune responses against genital herpes, according to the release. The vaccine contains antigens ICP4 and gD2 and is combined with the novel adjuvant Matrix-M (Novavax).

Throughout the trial, GEN-003 continuously demonstrated safety appropriate for its therapeutic setting. The 24-month clinical results came from an extension of a phase 2 dose-optimization study that began in 2014, in which 310 patients were randomly assigned to one of six dosing groups – either 30 g or 60 g of each of two protein antigens – paired with three Matrix-M adjuvant doses (25 g, 50 g or 75 g). Another group received placebo to compare the results.

Participants received three doses of GEN-003 or placebo at 21-day intervals, with 28-day observation before the start of dosing and again immediately after the completion of dosing at 6, 12 and 24 months following. Patients in the placebo arm were rolled over across the six active dose groups under a separate protocol after the 28-day observational period immediately after dosing. The two most promising doses from this phase 2 trial (60 g per protein combined with either 50 g or 75 g of adjuvant) have been advanced into an ongoing phase 2b trial, which showed positive 6-month clinical efficacy data reported earlier this year.

Genocea has completed its End of Phase 2 meeting with the FDA, and expects GEN-003 will be ready for phase 3 development by the end of 2017.

“Given our successful End of Phase 2 meeting with the FDA, we continue to plan a phase 3 program design consistent with previous guidance,” Clark said. “We believe that these new data, together with the body of positive clinical results to date and these FDA discussions, give us momentum to advance our pioneering product candidate to phase 3 readiness this year."

Disclosures: Clark is an employee of Genocea.