Good news for GEN-003

“We are very pleased to have demonstrated such a powerful impact on genital herpes clinical disease in this trial, supporting the groundbreaking potential of GEN-003 to be the first-ever therapeutic vaccine for a chronic infection and the first advance in the treatment of genital herpes in more than 20 years,” said Chip Clark, president and CEO of Genocea. “We look forward to meeting with the FDA in the first quarter of 2017 and to commencing our GEN-003 Phase 3 program in the fourth quarter of 2017. It’s an exciting time for Genocea as we also continue to extend the potential of our ATLAS platform to harness the power of T cells in immuno-oncology.”

GEN-003 is a first-in-class T cell-directed immunotherapy designed with Genocea’ ATLAS platform and is meant to trigger a T cell and B cell immune response. ATLAS profiles the spectrum of T cell responses mounted by human immune systems in response to disease and identifies antigen targets that drive effective T cell responses.

The Phase 2b trial was the first one to test possible Phase 3 endpoints with the new formulation of GEN-003 that will be used in upcoming Phase 3 trials. A total of 131 patients were enrolled and divided into three treatment arms to receive three injections at 21-day intervals: placebo, 60 µg per antigen/50 µg of adjuvant and 60 µg per antigen/75 µg of adjuvant.

The treatment arm in which patients received 60 µg per antigen/50 µg of adjuvant dose of GEN-003 led to a significant reduction in the rate of genital lesions during the six months after dosing vs. placebo (4.5 percent of days vs. 7.9 percent, respectively; 41 percent reduction vs. placebo). Genital lesion rate is considered to be an important overall disease metric that captures frequency and duration of recurrences.

“In my experience, genital herpes is unique among sexually transmitted diseases, in terms of its physical and emotional impact on patients, who experience significant fear upon receiving the diagnosis, as well as isolation during their lifelong struggle with the disease,” said Dr. Nicholas Van Wagoner, assistant professor of medicine in the Division of Infectious Diseases at the University of Alabama at Birmingham. “Today’s results, showing that GEN-003 significantly reduces the number of days with genital lesions, indicates that GEN-003 has the potential to be a much-needed additional treatment option that could address compliance challenges and help me take better care of my patients.”

Genocea touched on those compliance challenges in a presentation and conference call regarding these new data. More than 400 million people worldwide live with genital herpes, and existing therapeutic options only partially control clinical symptoms and viral shedding, a process which drives disease transmission, and often require daily dosing. Genocea reported that based on market research, current estimates are that some 2.6 million patients in the United States require daily antiviral use to manage their disease, which leads to a significant pill burden. Yearly maintenance dosing could greatly improve compliance and quality of life, and Genocea noted in its presentation that it is also looking at a Phase 2 extension to investigate whether GEN-003 could be dosed as infrequently as every two years.

This past September, Genocea reported that the trial had achieved its primary endpoint, as GEN-003 showed a statistically significant reduction of 40 percent in the rate of viral shedding in the 60 µg per antigen/50 µg of adjuvant dose group compared to baseline and placebo. GEN-003 has also continued to demonstrate a safety profile appropriate for its therapeutic setting, per the judgment of the independent drug monitoring committee for this trial.

“We believe we have in GEN-003 a Phase 3-ready program with blockbuster potential,” Clark stated in the conference call. “There is a large, unmet need in patients with genital herpes, a disease with epidemic proportions which is continuing to grow. We believe that these dynamics drive a $2-billion global revenue opportunity for GEN-003. We have successfully conducted three clinical trials which have demonstrated meaningful clinical efficacy against endpoints that matter to patients, with a product that could be dosed at most every year.”

“We have a rich year of milestones ahead of us, and continue to explore global development and commercialization partnership opportunities for GEN-003 to help us maximize the potential of the product,” he concluded.