Vilastobart

Studies Selected for Presentation at Global Gathering FORT MYERS, Fla., Nov. 7, 2024 /PRNewswire/ -- Clinical research conducted with participation from Florida Cancer Specialists & Research Institute, LLC (FCS) continues to advance science and breakthroughs in cancer immunotherapy, which uses the body's immune system to find, target and fight many forms of the disease. FCS physician investigators are co-authors of research results being presented this week at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in Houston, the largest cancer immunotherapy conference of international leaders in the field. Continue Reading FCS physician investigators are co-authoring research being presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in Houston, the world’s largest gathering of leaders in immunotherapy research. FCS President & Managing Physician Lucio N. Gordan, MD said, "Our shared aim is to make immunotherapy a standard of care to improve outcomes for cancer patients. Each discovery achieved through our robust clinical trials research program is bringing us closer to that reality." The following FCS physician investigators are co-authors of research results being presented during oral and/or poster abstract presentations: FCS Director of Drug Development Manish Patel, MD: Phase 1B/2, multicenter dose escalation and expansion of muzstotug (ADG126, a masked anti-CTLA-4 SAFEbody®) in combination with Pembrolizumab in advanced/metastatic MSS CRC (abstract #744); Noted as a "Top 100" Evaluation of immunomodulatory effects of ifinatamab deruxtecan (I-DXd) in the IDeate-Pantumor01 phase 1/2 study in patients with advanced solid tumors (abstract #629) A phase 1/2 clinical trial of anti-VISTA KVA12123 alone and in combination with Pembrolizumab in patients with advanced solid tumors (abstract #625) Triple blockade of DNAM-1 axis with COM701 (anti-PVRIG) + COM902 (anti-TIGIT) + pembrolizumab shows preliminary antitumor activity in patients with platinum resistant ovarian cancer, interim results of a phase I trial (abstract #985) Peripheral Blood and Tumor Gene Expression as Biomarkers and Potential Predictors of Clinical Outcome with HST-1011, an Oral CBL-B inhibitor (abstract #1310) Director of Drug Development, Lake Nona DDU Cesar Perez, MD – the late-breaking abstract: Phase 1 study of XTX101, a tumor-activated, Fc-enhanced anti-CTLA-4 monoclonal antibody, in combination with atezolizumab in patients with advanced solid tumors (abstract #1455) Alexander Philipovskiy, MD, PhD – Abequolixron (RGX-104), a first-in-class oral immunotherapy targeting the liver-X receptor (LXR), in combination with docetaxel in recurrent advanced/metastatic non-small cell lung cancer (NSCLC) (abstract #657). FCS Associate Director of Drug Development Judy Wang, MD: CONSORTIUM-IO: A phase 1 study evaluating a combination of an 11-strain bacterial consortium (VE800) and Nivolumab in treatment of select refractory or metastatic cancers (abstract #607); Noted as a "Top 100" Pharmacodynamic activities of the anti-MICA/B monoclonal antibody CLN-619, evaluated as a monotherapy, support the proposed mechanisms of action and correlate with response (abstract #195) "Immunotherapy clinical trials continue to play a large role in oncology drug development," notes Dr. Manish Patel. "In ongoing studies conducted at our three drug development units, we continue to uncover critical new information about the body's response to immunotherapy, which is improving effectiveness and offering new hope for cancer patients worldwide." As one of the largest clinical research programs in the country, FCS provides access to more than 300 clinical trials at any given time within its 32 late-phase designated FCS clinics and three Drug Development Units, where research is conducted on new treatments when they are first developed, prior to FDA approval. In fact, the majority of new cancer drugs approved for use in the U.S. have been studied in clinical trials with FCS participation. Learn more about clinical trials and advance research conducted a FCS here: . About Florida Cancer Specialists & Research Institute, LLC: (FLCancer.com) Florida Cancer Specialists & Research Institute (FCS) offers patients access to more clinical trials than any private oncology practice in Florida. The majority of new cancer drugs recently approved for use in the U.S. were studied in clinical trials with FCS participation.* Recognized for our research, FCS is a recipient of the national Clinical Trials Participation Award presented by the American Society of Clinical Oncology (ASCO). FCS physicians, trained in prestigious medical schools and research institutes, are consistently ranked nationally as Top Doctors by U.S. News & World Report. Celebrating its 40th year in 2024, FCS has built a national reputation for excellence that is reflected in exceptional and compassionate patient care, driven by innovative clinical research, cutting-edge technologies and advanced treatments, including targeted therapies genomic-based treatment and immunotherapy. Our highest values are embodied by our outstanding team of highly trained and dedicated physicians, clinicians and staff. *Prior to approval SOURCE Florida Cancer Specialists & Research Institute WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Will present initial Phase 1C dose escalation data for vilastobart (XTX101), a tumor-activated, Fc-enhanced anti-CTLA-4, in combination with atezolizumab, in a late-breaker poster presentation at the SITC Annual Meeting Expect to report initial Phase 2 data in microsatellite stable colorectal cancer (MSS CRC) for vilastobart in combination with atezolizumab in the fourth quarter of 2024 Expect to report Phase 1 data for XTX301, a tumor-activated IL-12, in the fourth quarter of 2024 WALTHAM, Mass., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, today announced pipeline progress and business updates and reported financial results for the third quarter ended September 30, 2024. “Throughout the third quarter, our team continued to drive execution across all stages of our pipeline, including advancing our clinical development programs for vilastobart, a tumor-activated, Fc-enhanced anti-CTLA-4, and XTX301, a tumor-activated IL-12, toward key data milestones and potential value inflection points,” said René Russo, Pharm.D., president and chief executive officer of Xilio. “We look forward to sharing initial data from our Phase 1C dose escalation trial of vilastobart in combination with atezolizumab as part of a late-breaker poster presentation at the SITC Annual Meeting. In addition, we continue to advance multiple promising research-stage programs, including XTX501, our tumor-activated PD-1/IL-2, and tumor-activated immune cell engagers.” Pipeline and Business Updates Vilastobart (XTX101): tumor-activated anti-CTLA-4 Vilastobart is an investigational tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4 antibody designed to block CTLA-4 and deplete regulatory T cells when activated in the tumor microenvironment (TME). Xilio will present initial Phase 1C dose escalation data for vilastobart in combination with atezolizumab in a late-breaker poster presentation at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting taking place in Houston, Texas, from November 6-10, 2024.In addition, Xilio continues to enroll patients in its ongoing Phase 2 clinical trial evaluating vilastobart in combination with atezolizumab in patients with metastatic MSS CRC, including patients with and without liver metastases.Xilio expects to report initial Phase 2 data for vilastobart in combination with atezolizumab in approximately 20 patients with MSS CRC in the fourth quarter of 2024 and in a total of approximately 40 patients with MSS CRC in the first quarter of 2025. XTX301: 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. Xilio continues to enroll patients in Phase 1A monotherapy dose escalation and Phase 1B monotherapy dose expansion of its ongoing Phase 1 clinical trial of XTX301 in patients with advanced solid tumors.Xilio plans to report safety, pharmacokinetic and pharmacodynamic data from the ongoing Phase 1 clinical trial for XTX301 in the fourth quarter of 2024. Tumor-Activated Bispecific and Immune Cell Engager Programs Xilio is leveraging its proprietary platform to advance a pipeline of research-stage programs for tumor-activated bispecific and immune cell engager molecules, including tumor-activated immune cell engagers and tumor-activated effector-enhanced immune cell engagers. XTX501 is a tumor-activated bispecific PD-1/IL-2 designed to selectively stimulate PD-1 positive antigen-experienced T cells and enhance their function. XTX501 incorporates masking designed to overcome IL-2 receptor-mediated clearance and peripheral activity. Xilio is currently advancing initial investigational new drug (IND)-enabling activities for XTX501.Xilio will present preclinical data from its tumor-activated SELECTIVE EFFECTOR-ENHANCED CELL ENGAGER (SEECR) format in a poster session at the SITC Annual Meeting. Details on the poster presentation can be found here. Third Quarter 2024 Financial Results Cash Position: Cash and cash equivalents were $61.3 million as of September 30, 2024, compared to $44.7 million as of December 31, 2023.License Revenue: License revenue was $2.3 million for the quarter ended September 30, 2024, which consisted of revenue recognized under the license agreement and stock purchase agreement with Gilead. No license revenue was recognized for the quarter ended September 30, 2023.Research & Development (R&D) Expenses: R&D expenses were $10.8 million for the quarter ended September 30, 2024, compared to $11.1 million for the quarter ended September 30, 2023. The decrease was primarily driven by decreased clinical development activities for XTX202, a tumor-activated, IL-2, decreased spending related to early-stage programs and indirect research and development costs and decreased personnel-related costs, partially offset by increased clinical development activities for vilastobart and XTX301.General & Administrative (G&A) Expenses: G&A expenses were $6.3 million for each of the quarters ended September 30, 2024 and September 30, 2023.Net Loss: Net loss was $14.0 million for the quarter ended September 30, 2024, compared to $16.7 million for the quarter ended September 30, 2023. Financial Guidance Based on its current operating plans, Xilio anticipates that its existing cash and cash equivalents as of September 30, 2024, will be sufficient to fund its operating expenses and capital expenditure requirements through the end of the second quarter of 2025. About Vilastobart (XTX101) and the Phase 1/2 Combination Clinical Trial Vilastobart is an investigational tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4 monoclonal antibody designed to block CTLA-4 and deplete regulatory T cells when activated in the tumor microenvironment (TME). In 2023, Xilio entered into a co-funded clinical trial collaboration with Roche to evaluate vilastobart in combination with atezolizumab (Tecentriq®) in a multi-center, open-label Phase 1/2 clinical trial. Xilio is currently evaluating the safety of the combination in Phase 1C dose escalation in patients with advanced solid tumors and the safety and efficacy of the combination in Phase 2 in patients with metastatic microsatellite stable colorectal cancer with and without liver metastases. Please refer to NCT04896697 on www.clinicaltrials.gov for additional details. About XTX301 and the Phase 1 Clinical Trial XTX301 is an investigational tumor-activated IL-12 designed to potently stimulate anti-tumor immunity and reprogram the tumor microenvironment (TME) of poorly immunogenic “cold” tumors towards an inflamed or “hot” state. In March 2024, Xilio entered into an exclusive license agreement with Gilead Sciences, Inc. for Xilio’s tumor-activated IL-12 program, including XTX301. Xilio is currently evaluating the safety and tolerability of XTX301 as a monotherapy in patients with advanced solid tumors in a first-in-human, multi-center, open-label Phase 1 clinical trial. Please refer to NCT05684965 on www.clinicaltrials.gov for additional details. 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 advance a pipeline of novel, tumor-activated clinical and preclinical I-O molecules that are designed to optimize the therapeutic index by localizing anti-tumor activity within the tumor microenvironment, including tumor-activated cytokines, antibodies, bispecifics and immune cell engagers. Learn more by visiting www.xiliotx.com and follow us on 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, expectations and anticipated milestones for vilastobart (XTX101) and XTX301, including plans and timing for reporting clinical data for each of these programs; the potential for Xilio to leverage its research platform to develop tumor-activated bispecific and immune cell engager molecules; Xilio’s plans and expectations for advancing initial IND-enabling activities for XTX501; the potential benefits of any of Xilio’s current or future product candidates in treating patients as a monotherapy or combination therapy; Xilio’s estimated cash and cash equivalents and the period in which Xilio expects to have cash to fund its operations; 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, general market conditions; risks and uncertainties related to ongoing and planned research and development activities, including initiating, conducting or completing preclinical studies, including IND-enabling activities, 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 immune cell engager programs, including tumor-activated immune cell engagers and tumor-activated effector-enhanced immune cell engagers; initial, preliminary or interim preclinical or clinical data or results, which may not be replicated in or predictive of future preclinical or clinical data or results; 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; Xilio’s ability to obtain and maintain sufficient cash resources to fund its operations; the impact of international trade policies on Xilio’s business, including U.S. and China trade policies; Xilio’s ability to maintain its clinical trial collaboration with Roche to develop vilastobart (XTX101) in combination with atezolizumab; and Xilio’s ability to maintain its license agreement with Gilead to develop and commercialize XTX301. 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 is not deemed to be incorporated by reference in this press release. TECENTRIQ is a registered trademark of Genentech USA, Inc., a member of the Roche Group. Xilio Investor and Media Contact Scott YoungVice President, Investor Relations and Corporate Communicationsinvestors@xiliotx.com XILIO THERAPEUTICS, INC.Condensed Consolidated Balance Sheets(In thousands) (Unaudited) September 30, December 31, 2024 2023Assets Cash and cash equivalents $61,259 $44,704Other assets 13,399 16,222Total assets 74,658 60,926Liabilities and Stockholders’ Equity Liabilities Deferred revenue 34,504 —Other liabilities 19,180 24,099Total liabilities 53,684 24,099Stockholders’ equity 20,974 36,827Total liabilities and stockholders’ equity 74,658 60,926 XILIO THERAPEUTICS, INC.Condensed Consolidated Statements of Operations and Comprehensive Loss(In thousands, except share and per share data) (Unaudited) Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2024 2023 2024 2023License revenue $2,263 $— $4,620 $— Operating expenses (1) Research and development 10,759 11,051 32,375 40,400 General and administrative 6,307 6,310 18,261 20,603 Restructuring (41) — 937 — Total operating expenses 17,025 17,361 51,573 61,003 Loss from operations (14,762) (17,361) (46,953) (61,003)Other income, net 742 613 1,805 2,254 Net loss and comprehensive loss $(14,020) $(16,748) $(45,148) $(58,749)Net loss per share, basic and diluted $(0.22) $(0.61) $(0.91) $(2.14)Weighted average common shares outstanding, basic and diluted 63,465,063 27,523,821 49,762,800 27,475,579 (1) Operating expenses include the following amounts of non-cash stock-based compensation expense: Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023Research and development expense $384 $548 $1,275 $1,670General and administrative expense 1,190 1,313 3,643 3,782Total stock-based compensation expense $1,574 $1,861 $4,918 $5,452