- Consistent Reductions vs. Placebo in Rate and Density of Colonization; Not Statistically Significant -
- Development Suspended Pending Further Review of Data and Potential Paths Forward -
"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
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
The Company will discuss these results further during its third quarter 2015 earnings conference call in November.
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.
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.
Forward Looking Statements
Statements herein relating to future business performance, conditions
or strategies and other financial and business matters, including
expectations regarding clinical developments, are forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act. Genocea cautions that these forward-looking statements are
subject to numerous assumptions, risks and uncertainties, which change
over time. Factors that may cause actual results to differ materially
from the results discussed in the forward-looking statements or
historical experience include risks and uncertainties, including
Genocea's ability to progress any product candidates in preclinical or
clinical trials; the scope, rate and progress of its preclinical studies
and clinical trials and other research and development activities;
anticipated clinical trial results; current results may not be
predictive of future results; even if the data from preclinical studies
or clinical trials is positive, regulatory authorities may require
additional studies for approval and the product may not prove to be safe
and efficacious; Genocea's ability to enter into future collaborations
with industry partners and the government and the terms, timing and
success of any such collaboration; risks associated with the manufacture
and supply of clinical and commercial product; the cost of filing,
prosecuting, defending and enforcing any patent claims and other
intellectual property rights; Genocea's ability to obtain rights to
technology; competition for clinical resources and patient enrollment
from drug candidates in development by other companies with greater
resources and visibility; the rate of cash utilized by Genocea in its
business and the period for which existing cash will be able to fund
such operation; Genocea's ability to obtain adequate financing in the
future through product licensing, co-promotional arrangements, public or
private equity or debt financing or otherwise; general business
conditions; competition; business abilities and judgment of personnel;
the availability of qualified personnel and other factors set forth
under "Risk Factors" in Genocea's Annual Report on Form 10-K for the
fiscal year ended
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