Xilio Therapeutics Showcases Progress and Safety in Tumor-Activated Cancer Therapies

Xilio Therapeutics, a clinical-stage biotechnology firm, has made significant progress in its clinical pipeline, focusing on immuno-oncology therapies for cancer patients. The company has reported promising preliminary safety data from the Phase 1 trial of XTX301, an innovative IL-12 therapy, which has been administered at doses nearly 100 times higher than the maximum tolerated dose of rhIL-12 without any dose-limiting toxicities observed.

René Russo, CEO of Xilio, emphasized the importance of IL-12's potential to treat immunologically cold tumors, a challenge that has been pursued for over two decades. The company's approach to tumor-activated therapies has allowed for higher doses without the associated lethal toxicities, marking a significant advancement in the field.

Xilio's clinical-stage programs include XTX101, a tumor-activated, Fc-enhanced anti-CTLA-4, which is currently in a Phase 1/2 trial in combination with atezolizumab for advanced solid tumors. The company has also initiated dosing for XTX101 and plans to select a recommended Phase 2 dose in 2024, contingent on securing additional capital.

Another program, XTX202, a tumor-activated, beta-gamma biased IL-2, is being evaluated in a Phase 2 trial for patients with metastatic renal cell carcinoma or unresectable or metastatic melanoma. Enrollment has been accelerated, and Xilio intends to report Phase 2 data by the end of the first quarter of 2024.

XTX301's Phase 1 trial has shown that the therapy is well-tolerated across all tested dose levels. The company aims to report safety, pharmacokinetic, and pharmacodynamic data for XTX301 in the second half of 2024, again, subject to obtaining sufficient funding.

Financially, Xilio anticipates that its existing cash reserves will support its operations into the second quarter of 2024. The company's focus is on developing therapies that can significantly improve outcomes for cancer patients without the systemic side effects associated with current immuno-oncology treatments. Xilio's proprietary GPS platform is utilized to create a pipeline of novel, tumor-activated molecules designed to enhance therapeutic efficacy while minimizing side effects.

The company's commitment to advancing multiple programs in clinical development, as well as those in preclinical stages, reflects its dedication to innovation in cancer treatment. Xilio's approach to targeting the tumor microenvironment with precision is a key strategy in its mission to improve patient outcomes.