CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, today announced positive results from a planned interim analysis of data collected six months after dosing from its ongoing Phase 2 dose optimization trial evaluating GEN-003 for the treatment of genital herpes. At its best performing dose of 60 µg per protein / 75 µg of Matrix-M2TM adjuvant, GEN-003 demonstrated a statistically significant 58 percent reduction from baseline in the viral shedding rate (p<0.0001), the primary endpoint of the study.
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 Chip Clark, president and chief executive officer of Genocea. “These data support the potential of GEN-003 to serve as a cornerstone therapy for genital herpes infections with convenient, long term viral shedding and symptom control. Given the excellent results at six months, which reinforce GEN-003’s existing strong profile, upside exists from potential efficacy at twelve months. We look forward to this data in the first quarter of 2016 and to advancing GEN-003 towards an end-of-Phase 2 meeting with the FDA in late 2016.”
"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, Division of Infectious Diseases, at the University of Alabama at Birmingham. “These six month data demonstrate the potential for a therapeutic vaccine to advance the treatment of this serious disease, providing durable efficacy, similar to chronic suppressive treatment with oral antivirals, with increased convenience and the potential for better compliance by patients."
Data will be presented in poster number 898 at IDWeek 2015TM on Friday, October 9, 2015 between 12:30 p.m. and 2:00 p.m. PST in the San Diego Convention Center Poster Hall. Nicholas Van Wagoner, M.D. Ph.D., will present the findings.
About the GEN-003 Phase 2 Clinical Trial
In May 2015,
Genocea reported initial positive top-line data from this Phase 2 dose
optimization trial, which showed that during the 28-day observation
period immediately after completion of dosing, the best dose of 60 µg
per protein / 75 µg of Matrix-M2TM adjuvant demonstrated a
highly statistically significant (p < 0.0001) 55 percent reduction from
baseline in the viral shedding rate. All dose combinations tested
demonstrated a statistically significant viral shedding rate reduction
versus baseline and only the lowest dose combination did not demonstrate
a statistically significant reduction versus placebo. A planned
secondary analysis to assess impact on patient-reported genital lesion
rates demonstrated a statistically significant reduction from baseline
in all groups, including the placebo group.
This Phase 2 study enrolled 310 subjects from 17 institutions in the United States. Subjects were randomized to one of six dosing groups of either 30 µg or 60 µg per protein paired with one of three adjuvant doses (25 µg, 50 µg, or 75 µg). A seventh group received placebo. Subjects received three doses of GEN-003 or placebo at 21-day intervals. Baseline viral shedding and genital lesion rates were established for each subject in a 28-day observation period prior to the commencement of dosing by collecting 56 genital swab samples (two per day), which were analyzed for the presence of HSV-2 DNA, and by recording the days on which genital lesions were present. This 28-day observation period was repeated immediately after the completion of dosing and at six and, in time, twelve months following dosing. No booster doses will be given. After the 28-day observation period immediately after dosing, patients in the placebo arm were rolled over to 1 of the 6 active combinations of GEN-003 and Matrix-M2TM.
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 9 a.m. ET. The conference call may be accessed
by dialing (844) 826-0619 for domestic participants and (315) 625-6883
for international callers (reference conference ID 55798395). A live
webcast of the conference call will be available online from the
investor relations section of the Company's website at http://ir.genocea.com.
A webcast replay of the conference call will be available on the Genocea
website beginning approximately two hours after the event, and will be
archived for 30 days.
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 December 31, 2014
and other filings with the Securities and Exchange Commission (the
“SEC”). Further information on the factors and risks that could affect
Genocea’s business, financial conditions and results of operations is
contained in Genocea’s filings with the SEC, which are available at www.sec.gov.
These forward-looking statements speak only as of the date of this press
release and Genocea assumes no duty to update forward-looking statements.