Genocea Biosciences, Inc. reported significant progress in the Phase 1/2a TiTAN clinical trial for its lead program GEN-011, a neoantigen-targeted peripheral T cell (NPT) therapy candidate. GEN-011 is comprised only of CD8+ and CD4+ T cells, extracted from the patient's peripheral blood, specific for ATLAS-prioritized neoantigens. GEN-011 has the potential to be differentiated from other cell therapies because of the breadth of surface-presented neoantigens it targets and the ease of manufacturing tumor-relevant T cells extracted from readily accessible peripheral blood.

Patients receive either GEN-011 in multiple fractional doses without lymphodepletion and with intermediate doses of IL-2, or as a single dose after lymphodepletion and with intermediate or high doses of IL-2. ATLAS performance: The GEN-011 NPTs are specific for neoantigens prioritized using ATLAS, Genocea's proprietary neoantigen discovery platform. To date, Genocea has completed screening 19 patient samples with ATLAS in the TiTAN trial. On average in these samples, ATLAS has prioritized 12 neoantigens (range 0-43) and identified 14 Inhibigens (range 1-55) per patient.

T cells specific for only the prioritized neoantigens (and therefore not the Inhibigens) are expanded in the PLANET™ process. PLANET performance: These T cells are grown in PLANET, Genocea's robust and rapidly scalable cell expansion process. Of the 16 patient samples entering the PLANET manufacturing process, 100% have either successfully yielded a released drug product (10) or are in process (6).

TiTAN update: Of the 10 manufactured GEN-011 drug products, five have been administered to patients across both the multidose and single dose cohorts, with the remaining five available for dosing upon patient need. Genocea expects to have initial data from the first five patients later this quarter or early Second Quarter 2022. With eight sites currently accruing patients, Genocea expects to continuously enroll and dose patients throughout the year.