CAMBRIDGE, MA, USA I October 19, 2015 I Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, today announced that top-line results from a Phase 2a clinical trial for GEN-004, its universal vaccine candidate against pneumococcus, showed consistent reductions versus placebo in the pre-specified endpoints of the rate and density of colonization, but that neither of the endpoints achieved statistical significance. GEN-004 was safe and well tolerated by subjects.
“We are currently working with our advisors to better understand these results and to determine a next step for this program. While we did not hit statistical significance in this study, the consistent apparent effect gives us confidence in the vaccine concept and in the potential for GEN-004. At this time, we believe it is possible that future trials would require a change in some combination of dose, adjuvant or trial population to confirm any effect,” said Chip Clark, president and chief executive officer of Genocea. “For the time being, we are removing the development of GEN-004 from our near-term plans to focus our resources on the ongoing Phase 2 program for GEN-003, our immunotherapy for genital herpes, for which we recently announced positive six-month efficacy results, and on maximizing the potential of our preclinical pipeline and our ATLAS technology for T cell target discovery.”
The Phase 2a human challenge study was a randomized, double-blind, placebo-controlled study of 98 healthy adults. Subjects were randomized in a 1:1 ratio to receive GEN-004 or placebo. Subjects received three doses at four-week intervals. Following the third dose, participants were inoculated intra-nasally with pneumococcus serotype 6B. Nasal washes were performed at two, seven and 14 days post inoculation.
GEN-004 reduced the colonization rate, measured by microbiological culture, by between 22 and 25 percent versus placebo across those measurement time points. When measured by the presence of pneumococcal DNA, the reductions ranged between 18 and 36 percent. Additionally the median density of colonization measured by microbiological culture for GEN-004 treated subjects ranged from zero to 2 colony forming units (“CFUs”) per mL of nasal wash compared to one to 11 CFUs per mL for the placebo group. When measured by the presence of pneumococcal DNA, the median densities ranged from zero to 10 copies per mL in treated subjects and 19 to 52 copies per mL in placebo subjects. None of the differences were statistically significant. There was no difference in the duration of colonization between GEN-004 and placebo.
“A reduction in pneumococcal colonization in the nasopharynx would have important implications for prevention of pneumococcal disease,” said Steven Pelton, MD, Professor of Pediatrics and Epidemiology, Boston University Schools of Medicine and Public Health. “These results show that GEN-004, with its protein subunit approach, may have potential to reduce a broad spectrum of pneumococcal disease syndromes, but further work is needed to improve the vaccine.”
The Company will discuss these results further during its third quarter 2015 earnings conference call in November.
About GEN-004
GEN-004 is a potential universal pneumococcal vaccine, which contains three unique conserved pneumococcal protein antigens, SP0148, SP1912, and SP2108, shown by ATLAS™ to be associated with protective TH17 T cell responses against pneumococcus in humans. For more information about GEN-004, please visit http://www.genocea.com/platform-pipeline/pipeline/gen004-for-pneumococcus/.
About Streptococcus pneumoniae
Streptococcus pneumoniae (also known as pneumococcus) is a major cause of infectious disease-related death worldwide. The World Health Organization (WHO) estimates that up to 1.6 million people, including 800,000 children, die annually worldwide from pneumococcal infection.
Pneumococcus naturally colonizes the nasopharynx, or nose and throat, as a precursor to infection. Pneumococcus causes non-invasive pneumococcal disease (NIPD) when it spreads from the nasopharynx into the upper and lower respiratory system to cause diseases such as otitis media (ear infection) and non-bacteremic pneumonia. When it enters the bloodstream, pneumococcus can cause invasive pneumococcal disease (IPD), including life-threatening illnesses such as sepsis, meningitis and bacteremic pneumonia.
In childhood, immunity to pneumococcus is developed prior to the establishment of protective antibody responses. Scientists believe that this immunity is driven by a rare type of T cells called TH17 CD4+ T cells, which prevent establishment of disease by clearing pneumococcus from the nasopharynx.
About Genocea
Genocea is harnessing the power of T cell immunity to develop life-changing vaccines and immunotherapies. T cells are increasingly recognized as a critical element of protective immune responses to a wide range of diseases, but traditional discovery methods have proven unable to identify the targets of such protective immune response. Using ATLAS™, its proprietary technology platform, Genocea identifies these targets to potentially enable the rapid development of medicines to address critical patient needs. Genocea’s pipeline of novel clinical stage T cell-enabled product candidates includes GEN-003 for genital herpes, GEN-004 for the prevention of infection by all serotypes of pneumococcus, and earlier-stage programs in chlamydia, genital herpes prophylaxis, malaria and cancer immunotherapy. For more information, please visit the company’s website at www.genocea.com.
SOURCE: Genocea
