Xilio Announces Initial Monotherapy Safety and Anti-Tumor Activity Data for XTX202, a Tumor-Activated, Engineered, Beta-Gamma IL-2, in Late Line Patients with Advanced Solid Tumors

Xilio Therapeutics, Inc.
Xilio Therapeutics, Inc.
Xilio Therapeutics, Inc.
13 min read

In This Article:

Initial evidence of dose-dependent disease control rate with 50% disease control rate at higher doses (≥2.8 mg/kg) and 31% disease control rate across all dose levels in a range of solid tumor types, including cold tumors

Treatment-related adverse events primarily Grade 1-2 at doses up to 4 mg/kg administered once every three weeks in outpatient setting, with no reported signs or symptoms of vascular leak syndrome

Two patients continuing treatment for more than 1 year, demonstrating XTX202 was well-tolerated with repeated, long-term dosing

Plan to evaluate XTX202 as a monotherapy in ongoing Phase 2 proof-of-concept trial at
4.0 mg/kg in patients with advanced melanoma and renal cell carcinoma

Xilio Therapeutics to host investor conference call and webcast on Monday, November 6, 2023 at 8:00 a.m. ET

WALTHAM, Mass., Nov. 03, 2023 (GLOBE NEWSWIRE) -- Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, today announced initial safety, pharmacokinetic (PK), pharmacodynamic (PD) and anti-tumor activity data from its ongoing Phase 1/2 clinical trial evaluating XTX202, an investigational tumor-activated, engineered, beta-gamma IL-2, in late line patients with advanced solid tumors. The data were presented at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting in San Diego, CA being held on November 1-5, 2023.

“The newly reported data from our Phase 1/2 clinical trial for XTX202 expands the evidence across our programs supporting clinical validation of our tumor-activated technology. We observed a disease control rate of 50% at higher doses (≥2.8 mg/kg) and 31% across all dose levels in a variety of advanced and IO refractory solid tumors, including cold tumors. Importantly, treatment-related adverse events were primarily Grade 1-2 with no evidence of vascular leak syndrome reported at any dose level, and two patients are continuing on treatment for more than one year, highlighting XTX202’s potential for long-term tolerability at high doses,” said Katarina Luptakova, M.D., chief medical officer of Xilio. “In addition, an analysis of an on-treatment biopsy from a patient receiving 2.8 mg/kg of XTX202 demonstrated evidence of activation in the tumor with minimal active drug in peripheral circulation and also suggests that monotherapy doses at or above 2.8 mg/kg are approaching the optimal range to engage CD8+ T effector cell and NK cell expansion while continuing to avoid stimulation of regulatory T cells. Overall, these encouraging data support continued evaluation of XTX202 at a dose of 4.0 mg/kg in our Phase 2 trial of patients with metastatic renal cell carcinoma and unresectable or metastatic melanoma and the exploration of opportunities for combination therapy.”

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