Company to present late-breaking clinical trial update for TiTAN trial of GEN-011, Genocea’s neoantigen-targeted peripheral T cell therapy for solid tumors

The PLANET manufacturing process reliably generates abundant, high-quality neoantigen-specific T cells

Preclinical data indicate that Inhibigens™ accelerate tumor growth in animal models of pancreatic cancer and melanoma

CAMBRIDGE, Mass., March 08, 2022 (GLOBE NEWSWIRE) —

Genocea Biosciences, Inc.

(NASDAQ: GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, will present clinical, preclinical, and manufacturing data at next month’s American Association for Cancer Research (AACR) Annual Meeting 2022 to be held from April 8-13 in New Orleans. The findings include late-breaking clinical data from the TiTAN™ clinical trial for the neoantigen-targeted peripheral T cell therapy product candidate GEN-011, results demonstrating successful production of GEN-011 using Genocea’s PLANET™ manufacturing process, and new preclinical data on Inhibigens™, antigens of suppressive immune responses uniquely identifiable by Genocea’s ATLAS™ platform.

The TiTAN trial is an open-label, multi-center Phase 1/2a study of GEN-011, which is comprised of neoantigen-targeted peripherally-derived T cells (NPTs) that are screened for patient-specific neoantigens by Genocea’s ATLAS platform. The platform identifies, through a bioassay, each patient’s anti-tumor neoantigens and pro-tumor Inhibigens. The PLANET manufacturing process selectively expands T cells specific to the ATLAS-identified neoantigens. Of the patient samples entering PLANET, 100% have either successfully yielded a released drug product or are in process.

“The preclinical data strengthen our conviction that using ATLAS to identify and selectively include T cells that drive anti-tumor responses and exclude Inhibigens whose T cells promote tumor growth enhances the potential of GEN-011 to treat of solid tumor cancers,” said Thomas Davis, MD, Chief Medical Officer of Genocea. “By taking a comprehensive approach to neoantigen identification, we are creating new and potentially more effective cell therapies for patients.”

Details on poster presentations for the TiTAN clinical trial patient data, the PLANET manufacturing process and Inhibigens are shared below.

AACR POSTER SESSION CATEGORY: Phase 1 Adult Clinical Trials



Poster #CT153



Title:



TiTAN: a phase 1 study of GEN-011, a neoantigen-targeted peripheral blood-derived T cell therapy with broad neoantigen targeting



Presenter: Maura Gillison, MD, PhD, MD Anderson Cancer Center

Date: Monday, April 11, 2022

Time: 1:30 p.m. – 5:00 p.m. CT

AACR POSTER SESSION CATEGORY: Inflammation, Immunity, and Cancer



Poster #2088



Title:



The PLANET manufacturing process reproducibly generates high-quality neoantigen-targeted peripheral T cells (NPTs) for adoptive T cell therapy in the TiTAN clinical trial



Presenter: Harshal Zope, PhD, Genocea Biosciences

Date: Monday, April 11, 2022

Time: 1:30 p.m. – 5:00 p.m. CT

AACR POSTER SESSION CATEGORY: Clinical Research Excluding Trials



Poster #2745



Title:



ATLAS-identified Inhibigen-specific responses accelerate tumor growth in mouse melanoma and pancreatic cancer



Presenter: Jessica Flechtner, PhD, Genocea Biosciences

Date: Tuesday, April 12, 2022

Time: 9:00 a.m. – 12:30 p.m. CT

Posters will be available on-demand on the AACR website at

www.aacr.org

beginning at the start of the poster session until July 13, 2022.

About GEN-011


GEN-011 is a neoantigen-targeted peripherally derived T cell therapy candidate comprised of autologous CD4

⁺

and CD8

⁺

T cells that are specific for up to 30 ATLAS-identified neoantigens to limit tumor escape. NPTs have minimal bystander, non-tumor-specific cells, and are devoid of Inhibigen-specific cells which may be detrimental to clinical response.

About the GEN-011 TiTAN clinical trial


TiTAN is an open-label, multi-center Phase1/2a trial evaluating safety, tolerability, T cell persistence and proliferation and clinical efficacy. The TiTAN clinical trial is testing two dosing regimens, a repeated fractional dose regimen of GEN-011 without lymphodepletion and a single dose administration of GEN-011 after lymphodepletion. Both groups will receive interleukin-2 after GEN-011 dosing to maximize the tumor-killing potential of the infused cells.

About Genocea Biosciences, Inc.


Genocea’s mission is to identify the right tumor targets to develop life-changing immunotherapies for people suffering from cancer. Our proprietary ATLAS™ platform can comprehensively profile each patient’s T cell responses to potential targets, or antigens, on that patient’s tumor. ATLAS zeroes in on both antigens that activate anti-tumor T cell responses and inhibitory antigens, Inhibigens™, that drive pro-tumor immune responses. We have two ATLAS-enabled programs: GEN-009, our neoantigen vaccine for which we are conducting a Phase 1/2a clinical trial and GEN-011, our adoptive T cell therapy comprising neoantigen-targeted peripheral cells for which we are conducting a Phase 1/2a clinical trial. In addition to our two clinical programs, we are conducting research in several areas where we believe ATLAS could be a key tool in optimizing antigen selection for therapies across a number of diseases. To learn more, please visit

https://www.genocea.com

.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act, including statements related to GEN-011 and the anticipated timing of top-line results from its Phase 1/2a clinical trial, the PLANET manufacturing process and research efforts, including with regard to ATLAS and Inhibigens. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. These factors include, but are not limited to, risks related to our substantial dependence on GEN-011 where any failure to successfully develop GEN-011, or any significant delays in doing so, will have a material adverse effect on Genocea; the potential failure of GEN-011, which is in an early stage of clinical development; potential delays in enrolling patients in the GEN-011 study; our reliance on third parties to conduct technical development, non-clinical studies and clinical trials for our product candidates; our reliance on third parties to conduct some or all aspects of our product manufacturing; that GEN-011 is uniquely manufactured for each patient and the potential difficulties in production, particularly with respect to scaling our manufacturing capabilities; our ability to obtain or protect intellectual property rights related to our product candidates; the potential impacts of COVID-19 on our business and financial results; changes in law, regulations, or interpretations and enforcement of regulatory guidance; our need for additional financing and the risks listed under “Risk Factors” in our annual report on Form 10-K for the year ended December 31, 2020 and any subsequent filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements, except as may be required by law.