Genocea Biosciences, Inc. Doses First Patient in Phase 1/2a TiTAN Clinical Trial for GEN-011 Neoantigen-Targeted T cell Therapy
July 13, 2021 at 12:30 pm
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Genocea Biosciences, Inc. announced the dosing of the first patient in its TiTAN study, a Phase 1/2a clinical trial testing its GEN-011 therapy. GEN-011 represents a new category of autologous solid tumor cell therapy: neoantigen-targeted peripheral T cells (“NPTs”). GEN-011: GEN-011 is a next-generation solid tumor therapy comprised of NPTs CD4+ and CD8+ which are specific for up to 30 antigens 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. 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 lower dose regimen of GEN-011 without lymphodepletion and a single high 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. Initial data from the TiTAN trial is expected in late fourth quarter of 2021 or first quarter of 2022.
Genocea Biosciences, Inc. is a biopharmaceutical company. The Company is engaged in discovering and developing cancer immunotherapies using its proprietary ATLAS platform. The ATLAS platform can profile each patient's CD4+ and CD8+ T cell immune responses to every potential target or antigen identified by next-generation sequencing of that patient's tumor. ATLAS zeroes in on both antigens that activate anti-tumor T cell responses and inhibitory antigens, or Inhibigens, that drive pro-tumor immune responses. Its GEN-009 is an investigational neoantigen vaccine delivering adjuvanted synthetic long peptides from ATLAS-identified neoantigens. The Company has a license agreement with Harvard College (Harvard), granting the Company a sublicensable license to one patent family, to develop, make, use, market licensed products, and perform licensed services related to the ATLAS discovery platform.