Genocea Presents Positive Findings from ATLASTM Immuno-Oncology Research Collaboration at 2015 SITC Annual Meeting

- ATLAS Identifies Targets of T cell Responses Associated with Checkpoint Inhibitor Therapy -

- Findings Suggest Different T cell Responses to Checkpoint Inhibitor Therapy Between Responders and Non-responders -

CAMBRIDGE, Mass.--()--Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, today announced findings that support the potential of ATLAS, the Company’s proprietary rapid antigen identification screening system, to profile responses to immunotherapies for cancer. This analysis, in which ATLAS identified the specificity and characteristics of T cell responses in cancer patients, will be presented as a late-breaker at the Society for Immunotherapy of Cancer’s (SITC) 30th Anniversary Annual Meeting & Associated Programs in National Harbor, Maryland. The poster, #342, entitled Immunoprofiling of T cell responses in melanoma patients undergoing CPI therapy, will be presented on Saturday, November 7, 2015 between 12:00 - 2:00 p.m. ET.

In this pilot study, funded by the Ludwig Trust, Genocea partnered with Darren Higgins, Ph.D., professor of microbiology and immunobiology at Harvard Medical School and F. Stephen Hodi, Jr., M.D., director of the Melanoma Center at Dana-Farber Cancer Institute, to conduct a retrospective analysis of 10 checkpoint inhibitor (CPI) treated patients’ T cell responses to 23 known tumor-associated antigens. By analyzing the immune responses of both responders and non-responders to CPI therapy, ATLAS successfully identified the cancer antigens to which either (or both) CD4+ or CD8+ T cells became activated. Although this research was not powered to draw firm conclusions, the analysis of T cell responses in patients receiving CPI therapy revealed a pattern indicating a greater breadth of T cell activation for responders than non-responders. The study also revealed preliminary evidence that different characteristics of T cell responses emerge when comparing patients who respond and those who do not. Some T cell responses did not correspond with improved patient outcomes, and may be classified as “decoys,” further validating the ability of ATLAS to distinguish clinically relevant targets of T cell responses.

“The breakthroughs we’ve seen in the immuno-oncology field to date have been profound, yet emerging treatment approaches do not yet include an understanding of who may respond to therapy and why,” said Jessica Baker Flechtner, Ph.D., senior vice president of research at Genocea. “These findings provide strong proof of concept that ATLAS can take a panoramic view of a large, diverse population of cancer patients and reveal clinically relevant signatures of protective responses. We believe we are uniquely positioned to utilize our technology to enable smarter profiling – indicating what must be present to see a benefit from therapy – as well as smarter identification of T cell antigens to drive cancer vaccine development.”

The collaboration with Dana-Farber is ongoing as Genocea continues to analyze more blood samples to characterize T cell response profiles that may be prognostic of CPI efficacy, and to identify T cell antigens that may be included in novel immunotherapies.

About ATLAS

ATLAS is a first of its kind proprietary rapid antigen identification screening system that finds 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 target indication 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.

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 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, and earlier-stage programs in chlamydia, genital herpes prophylaxis, malaria and cancer immunotherapy. 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 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 December 31, 2014 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.

Contacts

For media:
Spectrum Science Communications
Megan Lustig, 202-955-6222
mlustig@spectrumscience.com
or
For investors:
Genocea Biosciences
Jonathan Poole, 617-876-8191
jonathan.poole@genocea.com

Contacts

For media:
Spectrum Science Communications
Megan Lustig, 202-955-6222
mlustig@spectrumscience.com
or
For investors:
Genocea Biosciences
Jonathan Poole, 617-876-8191
jonathan.poole@genocea.com