On March 8, 2022 Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, reported that it will present clinical, preclinical, and manufacturing data at next month’s American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 to be held from April 8-13 in New Orleans (Press release, Genocea Biosciences, MAR 8, 2022, View Source [SID1234609742]). 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.

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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 (Free AACR Whitepaper) 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.