- Statistically significant result on expected
Phase 3 primary endpoint with Phase 3 dose -- Positive results on
multiple secondary clinical endpoints -- Potentially the first new
treatment in more than 20 years for the millions infected with
genital herpes -- Conference call today at 8 a.m. ET -
Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical
company developing novel vaccines and immunotherapies targeting T
cell antigens, announced today positive 12-month top-line data from
the Phase 2b clinical trial for GEN-003, its immunotherapy
candidate for patients with genital herpes.
In this 131-subject Phase 2b clinical trial, GEN-003 reduced the
median genital lesion rate (or percent days with genital lesions)
versus placebo by 49 percent (p=0.01) over the 12 months’ post
dosing at the 60 µg per antigen / 50 µg of adjuvant dose.
Importantly, these results were achieved at the Phase 3 dose and
expected Phase 3 primary endpoint. Other clinical endpoints for
this dose improved or were consistent with previously reported
positive data. No changes were observed to the previously
established safety profile of GEN-003.
Chip Clark, President and CEO of Genocea, commented: “We believe
these data further solidify the strong clinical profile for
GEN-003, which could provide durable, convenient efficacy to a
large and, we believe, highly dissatisfied patient population and
serve as a cornerstone treatment of this burdensome disease.”
“These data and the continued progress of GEN-003 show the
potential of this immunotherapy to change the treatment paradigm
for patients with genital herpes infections,” said Jonathan Temte,
M.D., Ph.D., M.S., former chair of the Centers for Disease Control
and Prevention’s Advisory Committee on Immunization Practices
(ACIP). “The benefits of using a periodic immunization to achieve
fewer and shorter genital herpes outbreaks without the compliance
challenges of a daily pill burden would represent an extremely
important alternative for patients with genital herpes. I believe
the potential individual and societal benefits of a treatment such
as GEN-003 to address the uncontrolled growth in genital herpes
infections resonates with the goals of bodies such as the
ACIP.”
Conference CallGenocea management will host a
conference call and webcast today at 8 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 60267894). 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 the GEN-003 Phase 2b Clinical TrialThe
Phase 2b trial (GEN-003-003) was a randomized, double-blind,
placebo-controlled study evaluating potential Phase 3 endpoints
with a formulation of GEN-003 manufactured with
commercially-scalable processes and expected to be used in future
Phase 3 trials. The trial enrolled 131 subjects from 9 institutions
in the United States. Subjects were 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 received three injections at
21-day intervals. Subjects were followed for 12 months after the
last dose was administered.
In September 2016, Genocea reported that the trial achieved its
primary endpoint, with GEN-003 demonstrating a statistically
significant reduction in the rate of viral shedding in the 60 µg
per antigen / 50 µg of adjuvant dose group compared to both
baseline and placebo. In January 2017, the company reported that
the 60 µg per antigen / 50 µg of adjuvant dose of GEN-003
significantly reduced the median genital lesion rate during the six
months following dosing compared to placebo. Safety in the trial is
continuously reviewed by an independent Drug Monitoring Committee.
Throughout the trial, there have been no drug-related serious
adverse events or grade 4 reactogenicity and discontinuations due
to adverse events have been low and similarly distributed across
active dose groups and placebo. A 12-month extension of this study
(GEN-003-005) is currently underway to examine the safety, efficacy
and durability of a single maintenance dose administered at 12
months after initial dosing.
Summary of Reported 12 Month Data
Endpoint |
60/50(n=43) |
60/75(n=44) |
Placebo(n=44) |
Number of subjects contributing clinical data |
43 |
|
44 |
|
44 |
|
Median genital lesion rate (percent of days with lesions
over 12 months) |
2.3 |
% |
2.8 |
% |
4.5 |
% |
Percent reduction versus placebo |
-49 |
% |
-37 |
% |
NA |
p-value versus placebo(1) |
0.01 |
|
NS |
NA |
Median number of recurrences over 12 months |
1.5 |
|
2.0 |
|
4.0 |
|
Percent reduction versus placebo |
-63 |
% |
-50 |
% |
NA |
p-value versus placebo(1) |
0.01 |
|
NS |
NA |
Median duration of recurrences (days) |
2.7 |
|
4.0 |
|
3.6 |
|
Percent reduction versus placebo |
-25 |
% |
11 |
% |
NA |
p-value versus placebo(1) |
0.02 |
|
NS |
NA |
Kaplan-Meier estimate of percent recurrence free after
first dose |
20 |
% |
16 |
% |
7 |
% |
p-value versus placebo(2) |
0.04 |
|
NS |
NA |
Kaplan-Meier estimate of percent recurrence free after last
dose |
20 |
% |
17 |
% |
8 |
% |
p-value versus placebo(2) |
NS |
0.05 |
|
NA |
Number of subjects contributing shedding data |
30 |
|
32 |
|
31 |
|
Viral shedding rate reduction from baseline |
-42 |
% |
-39 |
% |
-52 |
% |
p-value versus baseline(3) |
0.02 |
|
NS |
0.03 |
|
p-value versus placebo(3) |
NS |
NS |
NA |
Statistical tests pre-specified in Phase 2b trial protocol as
follows:(1) Wilcoxon Rank Sum test(2) Log rank test(3) Poisson
mixed effect model with empirical varianceNS = p>0.05
About GEN-003Inducing 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 investigational 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 the
Genocea website.
About Genital HerpesGenital 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 Biosciences, Inc.Genocea is
harnessing the power of T cell immunity to develop life-changing
vaccines and immunotherapies. While traditional immunotherapy
discovery methods have largely used predictive methods to propose T
cell targets, or antigens, Genocea has successfully developed
ATLAS™, its proprietary technology platform, to identify clinically
relevant antigens of T cells based on actual human immune
responses. Genocea used ATLAS to identify the antigens in its lead
clinical candidate, GEN-003, an investigational immunotherapy to
treat genital herpes, and is currently using ATLAS in
immuno-oncology applications to develop neoantigen cancer vaccines
(with an IND filing expected by the end of 2017), general cancer
vaccines and a vaccine targeting cancers caused by Epstein-Barr
Virus. For more information, please visit 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 StatementsStatements 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 that 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; anticipated timing for initiation of new clinical
trials; 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 to continue its clinical programs
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, 2016 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:
Jennifer LaVin
207-360-0473
jennifer.lavin@genocea.com
For investors:
Jonathan Poole
617-876-8191
jonathan.poole@genocea.com
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