Xilio initiates phase 2 trial for tumor-activated IL-12 therapy

Published 09/09/2025, 12:38
Xilio initiates phase 2 trial for tumor-activated IL-12 therapy

WALTHAM, Mass. - Xilio Therapeutics, Inc. (NASDAQ:XLO), a clinical-stage biotech company with a current market capitalization of $36 million, has begun dosing patients in the Phase 2 portion of its ongoing clinical trial evaluating efarindodekin alfa (XTX301), a tumor-activated IL-12 therapy for advanced solid tumors, the company announced Tuesday.

The milestone triggered a $17.5 million payment from Gilead Sciences, Inc. under their license agreement established in March 2024. Xilio expects to receive the payment by the fourth quarter of 2025.

Phase 1 data for efarindodekin alfa showed promising results, including two partial responses in patients with advanced solid tumors. The therapy has been generally well-tolerated, with most treatment-related adverse events classified as Grade 1 or 2, according to the company.

"The achievement of this important milestone highlights the promising Phase 1 data demonstrated for efarindodekin alfa to date," said René Russo, president and chief executive officer of Xilio, in a press release statement.

The Phase 2 portion of the trial is expected to enroll approximately 40 patients with specific tumor types across multiple U.S. sites. Xilio recently completed enrollment in the Phase 1A monotherapy dose escalation portion and continues to enroll patients in the Phase 1B monotherapy dose expansion.

Under the license agreement, Xilio is responsible for conducting clinical development through the initial Phase 2 portion of the trial. Following delivery of specified clinical data, Gilead can elect to transition development and commercialization responsibilities by paying a $75 million fee.

Xilio reported cash and cash equivalents of $121.6 million as of June 30, 2025. According to InvestingPro data, the company maintains a healthy current ratio of 2.32 and holds more cash than debt on its balance sheet, though it is quickly burning through its reserves. The company stated that with the addition of the $17.5 million milestone payment, it expects to fund operations into the first quarter of 2027.

Efarindodekin alfa has not been approved by any regulatory agency, and its efficacy and safety have not been established. InvestingPro analysis reveals the company has achieved impressive revenue growth of over 536% in the last twelve months, with gross profit margins of 86.8%. Analysts maintain a Strong Buy consensus on the stock, which currently trades at $0.70 per share. Get access to 8 more exclusive InvestingPro Tips and comprehensive financial metrics to make informed investment decisions.

In other recent news, Xilio Therapeutics has seen several noteworthy developments. Leerink Partners initiated coverage on Xilio Therapeutics with an Outperform rating, setting a price target of $2.00. The firm’s optimism is driven by Xilio’s lead clinical program, vilastobart, which has demonstrated efficacy in certain colorectal cancer cases when combined with atezolizumab. Additionally, Xilio Therapeutics announced the appointment of Akintunde Bello, Ph.D., to its Board of Directors, expanding the board to ten members. Dr. Bello, an oncology veteran with over 25 years of experience, will serve as a Class II director until the 2026 annual stockholders meeting. His previous role was as senior vice president at Bristol Myers Squibb, where he specialized in clinical pharmacology and bioanalysis. Dr. Bello will also contribute to the Nominating and Corporate Governance Committee at Xilio. These developments reflect ongoing strategic efforts within the company.

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