XLO

Xilio Therapeutics, Inc. (Nasdaq: XLO), a biotechnology company developing tumor-activated immuno-oncology therapies for people living with cancer, today announced that the company will host a live virtual program on Thursday, December 1, 2022, at 12:30 p.m. ET spotlighting Xilio’s clinical-stage molecule XTX301, a tumor-activated, engineered IL-12.

The event will feature Diwakar Davar, MBBS, M.Sc., a key opinion leader and assistant professor of medicine and a medical oncologist/hematologist from UPMC Hillman Cancer Center. Dr. Davar will discuss the unmet medical need in treating patients with immunologically “cold” advanced solid tumors and the differences between “cold” and “hot” tumors in the tumor microenvironment (TME), as well as the potential for IL-12 as a compelling immunotherapy target across tumor types due to its ability to activate both the innate and adaptive immune system.

Xilio executives René Russo, Pharm.D., chief executive officer, Marty Huber, M.D., president and head of R&D, and Uli Bialucha, Ph.D., chief scientific officer, will discuss the company’s clinical-stage molecule, XTX301, a unique tumor-activated, engineered IL-12 designed to potently stimulate anti-tumor immunity and reprogram the TME of poorly immunogenic “cold” tumors towards an inflamed (or “hot”) state, while limiting systemic toxicity. The Xilio team will also cover the adaptive design for the planned Phase 1 trial for XTX301 and anticipated clinical development timeline.

A live question and answer session will follow the presentation.

Webcast InformationTo register in advance for the webcast, please click here. A live webcast of the event will also be available under “Events and Presentations” in the Investors & Media section of Xilio’s website at https://ir.xiliotx.com/. A replay of the webcast will be archived on Xilio’s website for 90 days following the event.

Diwakar Davar, MBBS, M.Sc.Dr. Davar is an assistant professor of medicine and a medical oncologist/hematologist at UPMC Hillman Cancer Center. He specializes in the management of advanced melanoma and the development of early phase studies to test novel immunotherapeutic approaches to treat advanced cancers. Dr. Davar is board-certified in internal medicine and medical oncology. He received his medical degree from National University of Singapore, and he completed both his residency and fellowship at UPMC. Dr. Davar is a member of many professional organizations, including the American Association for Cancer Research, American Society of Clinical Oncology, Allegheny County Medical Society, American College of Physicians, and Singapore Medical Association.

About XTX301, a Tumor-Activated, Engineered IL-12XTX301 is an investigational tumor-activated, engineered IL-12 molecule designed to potently stimulate anti-tumor immunity and reprogram the TME of poorly immunogenic “cold” tumors towards an inflamed (or “hot”) state. IL-12 plays a key role in bridging innate and adaptive cellular immunity, making it a compelling target for immunotherapy. However, life-threatening toxicity observed with systemically active IL-12, including severe liver toxicity, have limited the therapeutic potential of IL-12 agents. In November 2022, Xilio announced that the U.S. Food and Drug Administration cleared the company’s investigational new drug application for the evaluation of XTX301 as a potential treatment for patients with advanced solid tumors.

About the Planned Phase 1 Clinical Trial for XTX301 (IL-12)The planned Phase 1 clinical trial for XTX301 is a first-in-human, multi-center, open-label trial designed to evaluate the safety and tolerability of XTX301 as a monotherapy in patients with advanced solid tumors.

About Xilio TherapeuticsXilio Therapeutics is a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology (I-O) therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current I-O treatments. The company is using its proprietary platform to build a pipeline of novel, tumor-activated molecules, including cytokines and other biologics, which are designed to optimize their therapeutic index and localize anti-tumor activity within the tumor microenvironment. Xilio is currently advancing multiple programs for tumor-activated I-O treatments in clinical development, as well as programs in preclinical development. Learn more by visiting www.xiliotx.com and follow us on Twitter (@xiliotx) and LinkedIn (Xilio Therapeutics, Inc.).

Cautionary Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding plans, timing and expectations related to the initiation of patient enrollment in the planned Phase 1 clinical trial for XTX301 and the anticipated clinical development timeline; the potential benefits of any of Xilio’s current or future product candidates in treating patients; and Xilio’s strategy, goals and anticipated financial performance, milestones, business plans and focus. The words “aim,” “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “seek,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of important risks, uncertainties and other factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties related to ongoing and planned research and development activities, including initiating, conducting or completing preclinical studies and clinical trials and the timing and results of such preclinical studies or clinical trials; the delay of any current or planned preclinical studies or clinical trials or the development of Xilio’s current or future product candidates; Xilio’s ability to obtain and maintain sufficient preclinical and clinical supply of current or future product candidates; Xilio’s advancement of multiple early-stage programs; Xilio’s ability to successfully demonstrate the safety and efficacy of its product candidates and gain approval of its product candidates on a timely basis, if at all; results from preclinical studies or clinical trials for Xilio’s product candidates, which may not support further development of such product candidates; actions of regulatory agencies, which may affect the initiation, timing and progress of current or future clinical trials; Xilio’s ability to obtain, maintain and enforce patent and other intellectual property protection for current or future product candidates; the impact of international trade policies on Xilio’s business, including U.S. and China trade policies; and Xilio’s ability to obtain and maintain sufficient cash resources to fund current or future operating expenses and capital expenditure requirements. These and other risks and uncertainties are described in greater detail in the sections entitled “Risk Factor Summary” and “Risk Factors” in Xilio’s filings with the U.S. Securities and Exchange Commission (SEC), including Xilio’s most recent Quarterly Report on Form 10‑Q and any other filings that Xilio has made or may make with the SEC in the future. Any forward-looking statements contained in this press release represent Xilio’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, Xilio explicitly disclaims any obligation to update any forward-looking statements.

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For Investor Inquiries:

Myles CloustonVice President, Investor Relationsinvestors@xiliotx.com

For Media Inquiries:

Julissa VianaVice President, Corporate Communicationsmedia@xiliotx.com