Genocea Announces Positive Durability Data from 6-Month Analysis of Phase 2 Clinical Trial of Genital Herpes Immunotherapy GEN-003
- Sustained viral shedding rate reduction of 58 percent from baseline at best dose improves upon established attractive product profile -
- Efficacy seen consistently across several potential Phase 3 clinical endpoints -
- End of Phase 2 meeting with
- Company to host conference call at 9 a.m. ET today; data to be presented at IDWeek 2015 -
In a planned secondary analysis to assess the impact on genital lesion rates, a patient-reported measurement of clinical disease, GEN-003 demonstrated sustained and statistically significant reductions from baseline in five of six dose groups ranging from 43 to 69 percent. In addition, the proportion of patients receiving GEN-003 who were lesion-free at six months after dosing ranged from approximately 30 to 50 percent, similar to results reported in clinical trials with oral antiviral therapies. A further secondary analysis measuring the time to first recurrence after completion of dosing showed a range of 152 days to greater than 180 days among dose groups. The Phase 2 trial continues to show that GEN-003 is safe and well tolerated by patients, with no serious adverse events related to the vaccine.
"These data confirm the durable virological and clinical effect of
GEN-003 to at least six months post dosing and further improve upon the
results in our prior Phase 1/2a trial," said
"The majority of people with genital herpes treat their disease
episodically, but episodic treatment is not effective at either reducing
the frequency of painful lesion outbreaks or periods of asymptomatic
shedding, when the majority of disease transmission occurs,"
said Nicholas Van Wagoner, M.D. Ph.D., Assistant Professor of Medicine,
Data will be presented in poster number 898 at IDWeek 2015TM
on
About the GEN-003 Phase 2 Clinical Trial
In
This Phase 2 study enrolled 310 subjects from 17 institutions in the
For more information about this clinical study of GEN-003 please visit www.clinicaltrials.gov.
Conference Call
Genocea management will host a conference
call and webcast today at
About GEN-003
Inducing a T cell response against HSV-2 is
critical to treating the clinical symptoms of disease and controlling
transmission of the infection. GEN-003 is a first-in-class T-cell
directed immunotherapy designed to elicit both a T cell and B cell
(antibody) immune response. The immunotherapy was designed using
Genocea's ATLAS™ platform, which profiles the comprehensive spectrum of
actual T cell responses mounted by humans in response to disease, to
identify antigen targets that drive T cell response. GEN-003 includes
the antigens ICP4 and gD2 along with Matrix-M2TM adjuvant,
which Genocea licensed from Novavax, Inc. For more information about
GEN-003, please visit http://www.genocea.com/platform-pipeline/pipeline/gen003-for-genital-herpes/.
About Genital Herpes
Genital Herpes affects more than 400
million people worldwide and causes recurrent, painful genital lesions.
It can be transmitted to sexual partners, even when the disease is
asymptomatic. Current genital herpes therapies only partially control
clinical symptoms and viral shedding, a process which drives disease
transmission. Incomplete control of genital lesions and transmission
risk, expense and the perceived inconvenience of taking a daily
medication are hurdles for long-term disease management. Immunity
through T cells is believed to be particularly critical to the control
and possible prevention of genital herpes infections.
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.
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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