Xilio doses first patient in Phase 1/2 trial of PD-1/IL-2 bispecific XTX501
Xilio reported third-quarter 2026 results alongside pipeline updates, including dosing in the XTX501 lung cancer trial and two preclinical programs advancing toward 2027 IND filings.
Xilio Therapeutics announced on November 10, 2026 that it dosed the first patient in the Phase 1 portion of its trial for XTX501 in patients with metastatic non-small cell lung cancer (NSCLC) and select advanced solid tumors.1 XTX501 is a novel, investigational PD-1/masked IL-2 (alpha-optimized) bispecific antibody fusion protein that combines two complementary mechanisms in a single molecule: selective inhibition of the PD-1/PD-L1 pathway and potent IL-2-driven expansion of T cells.1 The company plans to report initial Phase 1 data in patients with metastatic NSCLC in the fourth quarter of 2027.1 Xilio also presented a trial-in-progress poster highlighting the design of the Phase 1/2 clinical trial of XTX501 at the Society for Immunotherapy of Cancer (SITC) 41st Annual Meeting.1
On the preclinical side, IND-enabling studies for XTX602 are ongoing, and Xilio plans to submit an IND for XTX602 in the fourth quarter of 2027,1 while IND-enabling studies for XTX701 are ongoing, and Xilio plans to submit an IND for XTX701 in the fourth quarter of 2027.1 Separately, Xilio is evaluating efarindodekin alfa as a monotherapy in an ongoing Phase 2 clinical trial in patients with advanced solid tumors and expects to deliver an option data package to Gilead Sciences, Inc. in the first half of 2027.1
In corporate updates, Xilio appointed Yariv Houvras, M.D., Ph.D., as its chief medical officer in September 2026.1
On finances, cash and cash equivalents were $122.2 million as of September 30, 2026, compared to $137.5 million as of December 31, 2025.1 The company said it anticipates that its existing cash and cash equivalents will be sufficient to enable it to fund its operating expenses and capital expenditure requirements into the first quarter of 2028.1 That estimate excludes up to $36.2 million in additional gross proceeds in the fourth quarter of 2026 if all outstanding Series C warrants are exercised at their current exercise price and any potential additional milestone payments, option-related fees or other contingent payments under Xilio's collaboration and license agreements with AbbVie and Gilead, including up to $31.0 million in near-term milestones and option extension fees that could be achieved under the AbbVie collaboration through the first half of 2027.1
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