- GEN-003 Phase 2b placebo-controlled clinical efficacy data six months after dosing
- Announced new research collaborations with
- Neoantigen cancer vaccine IND expected in 2017 -
"Genocea is a leader in the development of innovative therapies at the forefront of the T cell revolution with GEN-003 for genital herpes and our emerging work in immuno-oncology," said
GEN-003 Program Highlights
Today, Genocea highlighted the significant body of clinical data it has generated over the course of three clinical trials for what may be the first new therapy for genital herpes in more than 20 years. GEN-003 is a first-in-class T cell-directed immunotherapy designed to elicit both a T cell and B cell immune response to antigens prioritized using the ATLAS platform. Genocea's ATLAS platform profiled the comprehensive spectrum of actual T cell responses mounted by humans in response to their genital herpes disease to identify the antigen targets that drove protective T cell responses.
Based on clinical data to date, as well as market research showing the significant dissatisfaction among patients with current treatment options for genital herpes, GEN-003 may offer patients an important new treatment option with the promise of improved ‘real-world' clinical outcomes and sustained reductions in viral shedding with the convenience of annual maintenance dosing. The Company expects to report six-month clinical efficacy data from its ongoing Phase 2b placebo-controlled trial in
Genocea also today for the first time presented the results of extensive new market research based on GEN-003's demonstrated clinical profile, suggesting that patients, physicians and payers all view GEN-003 favorably.
Immuno-Oncology Program Highlights
A Genocea presentation followed, introducing its immuno-oncology strategy and highlighting the unique ability of its ATLAS platform to comprehensively elucidate the T cell responses that patients make to cancers.
This capability is currently being applied to profiling T cell responses of patients who are treated with checkpoint inhibitors and other immune modulators, with the goal of finding signatures of T cell response that associate with positive and negative outcomes. Genocea plans to use these insights to help prospectively define, in a commercial or clinical setting, patients who could benefit from these therapies.
Genocea is also advancing a personalized neoantigen cancer vaccine program toward the filing of an Investigational New Drug (IND) application in 2017. This program leverages Genocea's deep vaccinology experience along with ATLAS's differentiated ability to select vaccine antigens based on an individual's comprehensive T cell responses to the mutations in their own cancer. The company believes that ATLAS overcomes the weaknesses of conventional algorithm approaches to cancer antigen selection, which have significant false positive prediction rates.
The company also updated progress on the development of a vaccine for cancers associated with Epstein Barr Virus (EBV). ATLAS screening has already identified novel T cell antigens, including those which appear to be associated with natural immunity against EBV infection and antigen selection and prioritization is ongoing.
This morning, the Company announced a research collaboration with Checkmate to characterize patterns of T cell responses to tumor-associated antigens in advanced melanoma. The goal of the collaboration is to identify the specificity and characteristics of T cells associated with protective T cell responses to potentially optimize clinical development and ultimately, clinical practice with CMP-001. ATLAS will be used to profile the T cell responses of approximately 20 patients enrolled in Checkmate's ongoing Phase 1b clinical trial of CMP-001 in combination with the checkpoint inhibitor pembrolizumab to a library of tumor-associated antigens common to patients with advanced melanoma. The T cell response signatures of those patients who respond to CMP-001 / pembrolizumab combination therapy will be compared to the signatures of those who do not respond, thereby potentially identifying antigens associated with positive or negative patient outcomes.
Genocea also announced this morning a new collaboration with
R&D Day Replay
A replay of the R&D day can be accessed at: http://ir.genocea.com/events.cfm.
ATLAS is a first of its kind proprietary rapid antigen identification screening system designed to find targets of protective T cell responses. The technology solves challenges to date associated with finding targets of T cell responses. ATLAS can examine T cell responses from large, diverse human populations, and comprehensively screen every potential antigen from a pathogen or cancer in a rapid, high-throughput manner, taking weeks versus years to find relevant antigens. Because targets identified by ATLAS are based on actual human immune responses to all potential antigens, with no guesswork or predictions, by the time these candidates reach clinical trials there may be a greater likelihood of success in clinical development. This approach provides the ability to identify smarter targets for use in developing vaccines and immunotherapies to treat infectious disease, cancer and autoimmunity.
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 ATLASTM, 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 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.
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 product candidates in oncology; 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
Liz Bryan Spectrum Science CommunicationsO: 202-955-6222 email@example.com For investors: Jonathan Poole Genocea BiosciencesO: 617-876-8191 firstname.lastname@example.org
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