Xilio is focused on developing cytokines with exemplary clinical activity and tolerability. We are developing XTX301, a tumor-activated, engineered IL-12, for the treatment of advanced solid tumors.


About IL-12

IL-12, or Interleukin-12, has emerged as one of the most potent cytokine mediators of antitumor activity because of its multiple effects on different immune cells in the tumor microenvironment (TME). IL-12 has the ability to activate and bridge both innate (natural killer or NK cell) and adaptive (cytotoxic CD8+ T and CD4+ T cells) immunity for tumor cell killing while further coordinating additional anti-cancer defenses such as regulatory T-cell suppression and anti-angiogenic effects. Despite research across the field suggesting that IL-12 can significantly benefit patients in fighting cancer, there are currently no approved IL-12 agents due to severe systemic toxicity with unmodified IL-12.


XTX301, a tumor-activated, engineered IL-12

XTX301 is an investigational tumor-activated, engineered IL-12 molecule designed to potently stimulate anti-tumor immunity and reprogram the TME of poorly immunogenic “cold” tumors towards an inflamed or “hot” state.

XTX301 is currently being evaluated in an ongoing Phase 1 clinical trial as a monotherapy in patients with advanced solid tumors. Significant potential also exists to explore the development of XTX301 in combination with other agents and modalities.

About the Phase 1 Clinical Trial for XTX301

The Phase 1 clinical trial for XTX301 is a first-in-human, multi-center, open-label trial designed to evaluate the safety and tolerability of XTX301 as a monotherapy in patients with advanced solid tumors. Please refer to NCT05684965 on www.clinicaltrials.gov for additional details.

XTX301 Presentations and Publications

XTX301 Publication in Molecular Cancer Therapeutics
XTX301, a tumor-activated Interleukin-12 has the potential to widen the therapeutic index of IL-12 treatment for solid tumors as evidenced by pre-clinical studies

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XTX301 Poster Presentation at the 2023 Society for Immunotherapy of Cancer’s (SITC) 38th Annual Meeting
XTX301, a tumor-activated, half-life extended IL-12 promoted potent anti-tumor immunity and activity across multiple syngeneic tumor models

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XTX301 Poster Presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting
A first-in-human study of XTX301, a masked, tumor-activated interleukin-12 (IL-12) in patients with advanced solid tumors

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XTX301 Poster Presentation at the American Association for Cancer Research (AACR) 2023 Annual Meeting
A half-life extended, tumor-activated IL-12 increased the infiltration of effector immune cells into the tumor microenvironment and demonstrated anti-tumor activity in syngeneic mouse models

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XTX301 Poster Presentation at the New York Academy of Sciences’ Frontiers in Cancer Immunotherapy 2022 Conference
A half-life extended, tumor selective IL-12 activated tumor infiltrating immune cells and demonstrated anti-tumor activity in the MC38 syngeneic mouse model

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XTX301 Poster Presentation at the Society for Immunotherapy in Cancer’s 36th Annual Meeting (SITC)
XTX301, A Protein-engineered IL-12, Exhibits Tumor-selective Activity In Mice Without Peripheral Toxicities And Is Well Tolerated In Non-Human Primates

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