Genocea Announces Strategic Shift to Immuno-oncology and the Development of Neoantigen Cancer Vaccines
September 25 2017 - 4:30PM
- Superior ATLASTM platform for neoantigen
selection (1) - - Exploring strategic alternatives for GEN-003
-- Announces corporate restructuring -
Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical
company discovering and developing novel vaccines and
immunotherapies targeting T cell antigens, today announced a
strategic shift to immuno-oncology and a focus on the development
of neoantigen cancer vaccines, including GEN-009, its lead
candidate for which it expects to file an Investigational New Drug
(IND) application by early 2018. Genocea also announced it is
exploring strategic alternatives for GEN-003, its Phase 3-ready
investigational immunotherapy for the treatment of genital herpes.
Consequently, Genocea is ceasing GEN-003 spending and activities
and is reducing its workforce by approximately 40 percent.
Genocea has confidence that it is positioned for leadership in
the development of neoantigen cancer vaccines through its unique
antigen identification capabilities and vaccinology expertise. More
specifically, the company believes that antigen selection is a
crucial determinant of neoantigen vaccine efficacy and that
previously presented head-to-head data show that ATLAS, the only
platform to comprehensively identify the actual neoantigens to
which a patient’s CD4+ and CD8+ T cells respond, is a superior
approach for identifying neoantigens for personalized vaccines
compared to methods used by others developing similar products.
The company plans to initiate a Phase 1 clinical trial for
GEN-009 in a range of tumor types in the first half of 2018 and
expects to report initial immunogenicity data in the first half of
2019. GEN-009 is an adjuvanted peptide vaccine designed to direct a
patient’s T cells to attack their tumor. Antigens in a patient’s
vaccine are selected by Genocea’s proprietary ATLAS platform.
Chip Clark, president and chief executive officer of Genocea,
commented: “With our research and development efforts now focused
entirely on neoantigen cancer vaccines, we believe the power of
ATLAS to identify the right vaccine antigens, combined with our
vaccinology expertise, gives us the opportunity to create value for
our shareholders by developing best-in-class vaccines for cancer
patients and achieving leadership in this exciting field.
“To our teammates who’ve given so much to advance GEN-003, we
offer our profound thanks for their dedication. Due to their
efforts, GEN-003 has the potential to serve as a cornerstone
treatment for genital herpes infections. We see this strategic
process, which is already underway, as the best way to drive to
commercial launch of and maximize shareholder value from
GEN-003.”
Financial GuidanceAs a result of the workforce
restructuring, which is anticipated to be completed by the end of
the third quarter, Genocea estimates annualized savings of
approximately $6.5 million in personnel-related costs, with
estimated one-time severance and related costs of approximately
$1.1 million in the third quarter of 2017. Genocea now expects that
its existing cash and cash equivalents are sufficient to support
its operating expenses and capital expenditure requirements into
the middle of 2018.
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 is currently using ATLAS in immuno-oncology
applications to develop neoantigen cancer vaccines and exploring
partnership opportunities for general cancer vaccines and a vaccine
targeting cancers caused by Epstein-Barr Virus. Genocea is
exploring strategic alternatives for GEN-003, its Phase 3-ready
immunotherapy candidate for the treatment of genital herpes. For
more information, please visit www.genocea.com.
About Neoantigen Cancer Vaccines and
GEN-009Neoantigens are personalized tumor mutations that
are seen as ‘foreign’ by an individual’s immune system(2). Data
published in recent years have indicated that an individual’s
response to neoantigens drives checkpoint inhibitor efficacy(3) and
that it is possible to vaccinate an individual against their own
neoantigens(4), GEN-009 is an adjuvanted neoantigen peptide vaccine
that is designed to direct a patient’s immune system to attack
their tumor. GEN-009’s neoantigen peptides are identified by
Genocea’s proprietary ATLAS platform, which recalls a patient’s
pre-existing CD4+ and CD8+ T cell immune responses to their tumor.
Following ATLAS neoantigen identification, Genocea will manufacture
a personal vaccine for each patient.
References (1)
https://www.genocea.com/assets/Kaufmann_AACR2017.pdf; (2) Yadav,
Gubin, 2015; (3) Schumacher, Schreiber, 2015; (4) Ott, Sahin,
2017
Forward-Looking StatementsStatements herein
relating to future business performance, conditions or strategies
and other financial and business matters, including statements
regarding Genocea’s product candidates, and its ability to finance
contemplated development activities and fund operations for a
specified period, the cause, size, timing and impact of Genocea’s
workforce reduction and related activities, including costs and
annual savings anticipated in connection with the reduction, 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; 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
Poole617-876-8191jonathan.poole@genocea.com
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