Xilio is focused on developing cytokines with exemplary clinical activity and tolerability. We are developing XTX202, an investigational tumor-activated, beta-gamma biased, engineered IL-2, as monotherapy for the treatment of advanced solid tumors, including melanoma and renal cell carcinoma. Significant potential also exists to explore the development of XTX202 in combination with other agents and modalities.

 

About IL-2

IL-2, or Interleukin-2, is a type of cytokine that regulates the activities of white blood cells by binding to IL-2 receptors. IL-2 is currently used as a biological response modifier to boost the immune system in cancer therapy. Drug development of and treatment with IL-2 therapies has been limited due to severe systemic toxicity, including fatal outcomes.

 

XTX202, a tumor-activated, beta-gamma biased, engineered IL-2

XTX202 is an investigational tumor-activated, beta-gamma biased, engineered IL-2 molecule designed to potently stimulate CD8+ effector T cells and natural killer (NK) cells without concomitant stimulation of regulatory T cells when activated (unmasked) in the tumor microenvironment.

XTX202 is currently being evaluated as a monotherapy in an ongoing Phase 1/2 clinical trial in patients with advanced solid tumors, including melanoma and renal cell carcinoma. XTX202’s monotherapy dose escalation (Phase 1A) is continuing and it is also being evaluated at the initial recommended Phase 2 dose (RP2D) of 1.4 mg/kg once every three weeks in monotherapy dose expansion (Phase 1B). XTX202 monotherapy is also being evaluated in Phase 2 at the initial RP2D of 1.4 mg/kg once every three weeks in patients with advanced melanoma and advanced renal cell carcinoma.

 

About the Phase 1/2 Clinical Trial for XTX202

The Phase 1 clinical trial for XTX202 is a first-in-human, multi-center, open-label trial designed to evaluate the safety and tolerability of XTX202 as a monotherapy in patients with advanced solid tumors. The Phase 2 clinical trial for XTX202 is a multi-center, open-label trial designed to evaluate the safety and efficacy of XTX202 as a monotherapy in patients with unresectable or metastatic melanoma and metastatic renal cell carcinoma who have progressed on standard-of-care treatment. Please refer to NCT05052268 on www.clinicaltrials.gov for additional details.

XTX202 Presentations and Publications

11/10/2022
XTX202 Poster Presentation at the 2022 Society for Immunotherapy of Cancer’s (SITC) 37th Annual Meeting
XTX202, a tumor-selective protein-engineered IL-2, exhibited enhanced anti-tumor activity in combination with checkpoint inhibition in mice

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06/05/2022
XTX202 Poster Presentation at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting
A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of XTX202, a Tumor-Selective Interleukin-2 (IL-2), in Patients with Advanced Solid Tumors

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06/08/2021
XTX202 (IL-2) Poster Presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting
XTX202, a protein-engineered IL-2, exhibits tumor-selective activity in mice without peripheral toxicities in non-human primates

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11/12/2020
XTX201 (IL-2) Poster Presentation at 35th Annual Meeting of The Society for Immunotherapy of Cancer
XTX201, a protein-engineered IL-2, exhibits tumor-selective activity in mice without peripheral toxicities in non-human primates

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