XILIO THERAPEUTICS, INC.
We are a biotechnology company focused on harnessing the immune system to achieve deep and durable clinical responses to improve the lives of patients with cancer. We have built our geographically precise solutions (GPS) platform to rapidly engineer novel molecules, including cytokines and other biologics, that are designed to optimize their therapeutic index by geographically localizing their activity inside tumors. Current immuno-oncology, or I-O, therapies have curative potential for patients with cancer; however, their potential is significantly curtailed by systemic toxicity that results from activity of the therapeutic molecule outside the tumor microenvironment, or TME. Our molecules are engineered to localize activity within the TME with minimal systemic effects, resulting in the potential to achieve enhanced anti-tumor activity.
We are advancing a number of geographically precise, or tumor-selective, agents through various stages of development. Our most advanced product candidates are:
-XTX101, an anti-cytotoxic T-lymphocyte-associated protein 4, or anti-CTLA-4, monoclonal antibody, or mAb, which received IND (investigational new drug) clearance from the FDA in June 2021; we recently initiated a Phase 1/2 trial to evaluate XTX101 in patients with solid tumors, and
-XTX202, -an interleukin 2, or IL-2, therapy, which received IND clearance from the FDA in October 2021, and we anticipate initiating a Phase 1/2 trial in the first quarter of 2022 to evaluate XTX202 in patients with multiple solid tumor types.
We are also advancing our tumor-selective IL-12 product candidate, XTX301, with the goal of submitting an IND in the second half of 2022, and we are currently pursuing preclinical studies for our tumor-selective IL-15 product candidate, XTX401. We also plan to continue to leverage our GPS platform to develop additional immunotherapies, including product candidates with a range of tumor-targeting approaches.