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Xilio Therapeutics to Host Live Virtual Program Spotlighting XTX301, a Tumor-Activated IL-12

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Xilio Therapeutics, Inc. (Nasdaq: XLO) will host a live virtual program on December 1, 2022, at 12:30 p.m. ET to discuss its clinical-stage molecule, XTX301, an engineered IL-12 aimed at treating immunologically 'cold' tumors. Dr. Diwakar Davar from UPMC Hillman Cancer Center will explain the significance of IL-12 in stimulating anti-tumor immunity and the differences between cold and hot tumors. Xilio executives will also outline the Phase 1 trial for XTX301 and its anticipated timeline. The event will include a Q&A session.

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WALTHAM, Mass., Nov. 23, 2022 (GLOBE NEWSWIRE) -- 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 Information
To 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-12
XTX301 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 Therapeutics
Xilio 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 Statements
This 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.

This press release contains hyperlinks to information that are not deemed to be incorporated by reference in this press release.

For Investor Inquiries:

Myles Clouston
Vice President, Investor Relations
investors@xiliotx.com

For Media Inquiries:

Julissa Viana
Vice President, Corporate Communications
media@xiliotx.com


FAQ

What is XTX301 and how does it work?

XTX301 is an investigational tumor-activated, engineered IL-12 molecule designed to stimulate anti-tumor immunity specifically in 'cold' tumors.

When is the live virtual program about XTX301?

The live virtual program will take place on December 1, 2022, at 12:30 p.m. ET.

Who will be speaking at the XTX301 virtual event?

Dr. Diwakar Davar from UPMC Hillman Cancer Center will discuss the medical need for IL-12 in treating cold tumors.

What is the goal of the Phase 1 trial for XTX301?

The Phase 1 trial aims to evaluate the safety and tolerability of XTX301 as a monotherapy in patients with advanced solid tumors.

How can I register for the XTX301 webcast?

You can register for the webcast through the link provided in the press release or by visiting Xilio’s website.

Xilio Therapeutics, Inc.

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