Genocea Biosciences Inc (NASDAQ: GNCA) announced yesterday that it has kicked off phase I/IIa TiTAN study and has dosed its first patient. The study is meant for the investigation of T-cell therapy, which is a neoantigen-targeted therapy called GEN-011. The company underscored that the FDA has earlier accepted GEN-011’s NDA or new drug application for starting phase I/IIa study. The study was approved for patients who missed inhibitor therapy at the standard-of-care checkpoint. The study aims to evaluate GEN-011’s safety while also promoting T cell persistence, proliferation, and clinical activity boosting.
About the TiTAN study
TiTAN is pitched as the multi-center, open-label trial for evaluating T cell persistence, clinical efficacy, tolerability, and safety.
During the study, the company aims at evaluating two regimens for dosing for the GEN-011 drug. These include single-dose administration for GEN-011 after the process of lymphodepletion and a repeated lower dose in cases where lymphodepletion hasn’t yet occurred. In addition, the two groups are supposed to take interleukin-2 followed by dosing with GEN-011 so that the potential for tumor-killing is maximized. Top-line data from this study is to be presented in Q4-2021 or by the first quarter of 2022.
About Genocea Biosciences Inc
The company develops immunotherapies directed to help cancer patients. The therapies aim at the identification of the correct tumor targets. For this purpose, the company has also developed a proprietary ATLAS platform, which optimizes antigen selection. Additionally, it also identifies comprehensive profile antigens on tumors. With the help of ATLAS, the company employs precise targeting for the selection of optimal neoantigen targets, which can work for anti-tumor immune responses.
Besides GEN-011, Genocea Biosciences Inc is also arranging another study, phase I/IIa study, for GEN-009. This is pitched as the investigational neoantigen vaccine. In addition, the company is researching various indications where ATLAS could optimize antigens for therapies.