GNCA - FDA accepts Genocea' application to initiate early-stage study for GEN-011 in cancer

Genocea Biosciences' (GNCA) +11% in premarket in reaction to the FDA acceptance of investigational new drug application ((IND)) for GEN-011, an adoptive T cell therapy targeting neoantigens.The IND allows to commence a Phase 1/2a trial for GEN-011, in patients who have failed standard-of-care checkpoint inhibitor therapy.The trial will evaluate safety, T cell proliferation and persistence as well as clinical activity.Genocea plans to enroll up to 24 patients. In one cohort, patients will receive multiple low doses of GEN-011 with low-dose IL-2 and without lymphodepletion (destruction of lymphocytes and T cells, normally by irradiation). In the other cohort, patients will receive a single GEN-011 dose after lymphodepletion and a high dose of IL-2.

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FDA accepts Genocea' application to initiate early-stage study for GEN-011 in cancer