Genocea’s Genital Herpes Immunotherapy GEN-003 Demonstrates Significant Reduction of Viral Shedding in Phase 2b Clinical Tr...
September 29 2016 - 7:30AM
- Trial achieves primary endpoint -
Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical
company developing T cell-directed vaccines and immunotherapies,
today announced positive results from its ongoing Phase 2b trial
evaluating a new Phase 3-ready formulation of GEN-003 for the
treatment of genital herpes. The study 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 protein / 50 µg of Matrix-M2 dose group compared to both
baseline and placebo. The viral shedding rate reduction for this
dose was consistent with its performance at the same time point in
a prior Phase 2 trial.
“We are very encouraged by this positive data and have now
selected a dose of 60 µg per protein / 50 µg of Matrix-M2 of
GEN-003 for our planned Phase 3 trials. This is the third
consecutive trial in which GEN-003 has demonstrated a statistically
significant reduction in viral activity immediately post-dosing. In
the previous Phase 2 trial, success in this measure translated into
a significant impact on genital herpes clinical disease, durable to
at least 12 months,” said Chip Clark, president and chief
executive officer of Genocea. “This body of data supports our
strong belief that GEN-003 could be a cornerstone treatment for
genital herpes. We look forward to reporting six-month
placebo-controlled clinical data from this trial in January 2017
and expect to commence our Phase 3 program in the second half of
2017.”
During the 28-day observation period immediately after
completion of dosing, the 60 µg per protein / 50 µg of Matrix-M2
dose of GEN-003 demonstrated a statistically significant 40 percent
reduction from baseline in the viral shedding rate versus a
marginal increase of 6 percent for placebo. The 60 µg per protein /
75 µg of Matrix-M2 dose demonstrated a 27 percent reduction in the
viral shedding rate. The top-line viral shedding rate reductions
for all of the dose groups in the trial are summarized in the
following table:
|
60 µg per protein /50 µg of
Matrix-M2 |
60 µg per protein /75 µg of
Matrix-M2 |
Placebo |
Viral shedding rate reduction |
|
-40 |
% |
|
-27 |
% |
|
+6 |
% |
p-value vs. baseline* |
|
0.03 |
|
|
0.16 |
|
|
0.76 |
|
p-value vs. placebo* |
|
0.05 |
|
|
0.20 |
|
NA |
|
|
|
|
|
|
|
|
* Statistical analysis performed using a modified Poisson model
(refined since Phase 2a trial with reference to advances in the
field: Magaret, Amalia, "Models for HSV shedding must account for
two levels of overdispersion" (January 2016). UW Biostatistics
Working Paper Series. Working Paper 410.
http://biostats.bepress.com/uwbiostat/paper410)
Safety in the trial was continuously reviewed by an independent
Data Safety Monitoring Board. There was no grade 4 reactogenicity
or related serious adverse events in this trial and
discontinuations due to adverse events were low and similarly
distributed across active dose groups and placebo.
“The established clinical profile of GEN-003 is one that could
be highly beneficial to patients looking for an effective treatment
which potentially offers greatly improved convenience over daily
oral antivirals, the only current treatment option for the millions
of people suffering from genital herpes,” said Lori A. Panther,
M.D., MPH, Infectious Diseases specialist at Beth Israel Deaconess
Medical Center and Assistant Professor of Medicine at Harvard
Medical School. “I’m extremely encouraged by these results,
once again demonstrating that GEN-003 reduces viral shedding.
Control of viral shedding is fundamental to the control of genital
herpes outbreaks and the epidemic spread of the disease.”
About the GEN-003 Phase 2b Clinical Trial This
Phase 2b trial is the first study testing potential Phase 3
endpoints with an improved formulation of GEN-003 - manufactured
with commercially-scalable processes - which 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 protein / 50 µg of
Matrix-M2 and 60 µg per protein / 75 µg of Matrix M2 - and have
received three injections at 21-day intervals. Viral shedding rate
reductions were measured to demonstrate the efficacy of the new
formulation. The study will also compare GEN-003 efficacy to
placebo for the clinical endpoints of: the proportion of patients
who are lesion free at six and 12 months after dosing; the time to
first lesion recurrence after dosing; and, the impact on percentage
of days with genital herpes lesions at six and 12 months after
dosing. All subjects will be followed for 12 months after the last
dose.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 to review this 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 87103963). 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, to identify antigen
targets that drive T cell response. GEN-003 includes the antigens
ICP4 and gD2 along with Matrix-M2TM adjuvant, which Genocea
licenses 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 (development suspended pending further data analysis
and consultation with our advisers), and earlier-stage programs in
cancer immunotherapy, chlamydia, genital herpes prophylaxis and
malaria . 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 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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