- Trial meets statistical significance vs.
placebo for multiple clinical endpoints through six months -
Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical
company developing T cell-directed vaccines and immunotherapies,
today announced positive clinical results from a planned interim
analysis of its ongoing placebo-controlled Phase 2b trial
evaluating GEN-003 for the treatment of genital herpes infections.
Even in a trial this small, at six months after dosing, GEN-003
demonstrated statistically significant improvements versus placebo
across multiple clinical endpoints.
The 60 µg per antigen / 50 µg of adjuvant dose of GEN-003
significantly reduced the rate of genital lesions during the six
months following dosing compared to placebo (4.5 percent of days
vs. 7.9 percent, respectively; 41% reduction vs. placebo,
p<0.05). The genital lesion rate is an important overall measure
of disease that captures both the frequency and duration of
recurrences, both of which are important to both patients and their
caregivers. In the trial, GEN-003 also consistently demonstrated
significant benefits versus placebo across several other clinical
endpoints across the dose groups (see data summary below).
In aggregate, the data from the GEN-003 Phase 2 clinical trials
continue to support the selection of the 60 µg per antigen / 50 µg
of adjuvant dose for the planned Phase 3 program. GEN-003 also
continues to demonstrate a safety profile appropriate for its
therapeutic setting in the judgment of the trial’s independent Drug
Monitoring Committee.
“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 chief executive officer 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.”
“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 Nicholas Van Wagoner, M.D., Ph.D., Assistant
Professor of Medicine, 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.”
Summary of Reported Clinical Endpoint Data
Secondary clinical endpoint |
Placebo(n=44) |
60/50(n=43) |
60/75(n=44) |
Mean genital lesion rate (percent of days with lesions over
6 months) |
7.9 |
% |
4.5 |
% |
4.6 |
% |
p-value versus placebo(1) |
NA |
0.03 |
|
0.03 |
|
Mean duration of recurrences (days) |
4.8 |
|
3.3 |
|
4.3 |
|
p-value versus placebo(1) |
NA |
0.01 |
|
0.64 |
|
Mean number of recurrences over 6 months |
2.7 |
|
2.1 |
|
1.9 |
|
p-value versus placebo(1) |
NA |
0.08 |
|
0.02 |
|
Kaplan-Meier estimate of percent recurrence free after
first dose |
10 |
% |
29 |
% |
31 |
% |
p-value versus placebo(2) |
NA |
0.03 |
|
0.03 |
|
Kaplan-Meier estimate of percent recurrence free after last
dose |
13 |
% |
22 |
% |
36 |
% |
p-value versus placebo(2) |
NA |
0.17 |
|
0.02 |
|
Statistical tests pre-specified in Phase 2b trial protocol as
follows:(1) Wilcoxon Rank Sum test(2) Log rank test
About the GEN-003 Phase 2b Clinical Trial This
Phase 2b trial is the first study testing potential Phase 3
endpoints with the improved formulation of GEN-003 – manufactured
with commercially-scalable processes – that will be used in future
Phase 3 trials. The trial enrolled 131 subjects from 9 institutions
in the United States. Subjects have been randomized to
one of three dose groups - placebo, 60 µg per antigen / 50 µg of
adjuvant and 60 µg per antigen / 75 µg of adjuvant - and have
received three injections at 21-day intervals. All subjects will be
followed for 12 months after the last dose.
In September 2016, Genocea reported that the trial achieved its
primary endpoint, with GEN-003 demonstrating 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
both baseline and placebo. Safety in the trial is continuously
reviewed by an independent Drug Monitoring Committee. There has
been no grade 4 reactogenicity or related serious adverse events in
this trial and discontinuations due to adverse events have been low
and similarly distributed across active dose groups and placebo.
12-month clinical data from the trial is expected in the middle of
2017.
For more information about this GEN-003 clinical study, visit
www.clinicaltrials.gov.
Conference Call Genocea management will host a
conference call and webcast today at 9 a.m. ET to review these
data. The conference call may be accessed by dialing (844) 826-0619
for domestic participants and (315) 625-6883 for international
callers (reference conference ID 44780200). 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 genital herpes 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 and identifies antigen
targets that drive effective T cell responses. GEN-003 includes the
antigens ICP4 and gD2 along with Matrix-M™ adjuvant (licensed
from Novavax, Inc. (NASDAQ:NVAX)). For more information about
GEN-003, please visit the GEN-003 section of our website.
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 immunity. 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 includes GEN-003, a
novel T cell-enabled immunotherapy for genital herpes currently in
Phase 2 clinical development, and earlier-stage investments in
immuno-oncology. For more information, please visit the company's
website at www.genocea.com.
About Matrix-MMatrix-M™ is a next-generation,
patented saponin-based adjuvant comprised of purified saponin
fractions mixed with synthetic cholesterol and a phospholipid to
form stable particles than can be readily formulated with a variety
of vaccine antigens. Saponin-based adjuvants act in part by
stimulating the entry of antigen-presenting cells into the
injection site and enhancing antigen presentation in the local
lymph nodes. Thus, Matrix-M™ induces both a cell-mediated and
antibody mediated immune response. Matrix-M is manufactured
by Novavax, Inc (NASDAQ:NVAX), in Uppsala Sweden.
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 ability of ATLAS to identify promising
oncology vaccine and immunotherapy product candidates; 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, 2015 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.
For media:
Liz Bryan
Spectrum Science Communications
O: 202-587-2526
lbryan@spectrumscience.com
For investors:
Jonathan Poole
Genocea Biosciences
O: 617-876-8191
jonathan.poole@genocea.com
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