CTLA4

WALTHAM, Mass., Oct. 30, 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 that initial data from its Phase 1C dose escalation of XTX101 (vilastobart) in combination with atezolizumab in patients with advanced solid tumors will be presented in a late-breaker poster session at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting taking place in Houston, Texas, from November 6-10, 2024. Poster presentation details: Title: Phase 1/2 Study of Vilastobart (formerly XTX101), a Tumor-Activated, Fc-enhanced Anti-CTLA-4 Monoclonal Antibody, in Combination with Atezolizumab in Patients with Advanced Solid TumorsAbstract Number: 1455Presentation Date: Friday, Nov. 8, 2024Poster Hall Hours: 9 a.m. – 7 p.m. CSTLocation: George R. Brown Convention Center 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 a Phase 1C dose escalation in patients with advanced solid tumors and the safety and efficacy of the combination in a Phase 2 clinical trial in patients with microsatellite stable colorectal cancer (MSS CRC), including both patients with and without liver metastases. Please refer to NCT04896697 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 to present clinical data from Phase 1C dose escalation for vilastobart (XTX101) in combination with atezolizumab in patients with advanced solid tumors; and Xilio’s strategy, goals, 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 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; interim or preliminary 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 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. Investor and Media Contact Scott YoungVice President, Investor Relations and Corporate Communicationsinvestors@xiliotx.com

Coya Therapeutics’ stock price $COYA fell more than 20% on Tuesday after the company reported Phase 2 data for its Alzheimer’s disease program, called COYA 301. Though Coya de-emphasized COYA 301 as part of an R&D reorganization last year, the company is still testing whether the program can work in combination with other therapies. COYA 301 is an IL-2 designed to “enhance the anti-inflammatory function of regulatory T cells,” or Tregs, Coya says . Researchers were measuring the drug’s safety and ability to expand the amount of Tregs in a patient’s system. The study enrolled 38 patients, with 22 in a cohort looking at every-four-week dosing and 16 in another cohort evaluating every-two-week dosing. Both cohorts had placebo arms. After 30 weeks, the every-four-week dose of COYA 301 induced significant increases in certain regulatory T cells, specifically CD4+ FOXP3+CD25 high Tregs, the company said. The p-value was p<0.05. The other dose did not see any statistically significant differences between the therapy and placebo. Whether those results translate to improvements in cognition — a more traditional Alzheimer’s biomarker — remains an open question. Coya looked at an Alzheimer’s measurement called the ADAS-Cog14 and, while it didn’t power the study for statistical significance, found a “slight” improvement of a 4.93-point difference between the every-four-week dose and placebo arms. That result was not statistically significant, clocking in with a p-value of 0.061. Coya is still evaluating the different combination therapies with which COYA 301 can best be utilized, execs said on a conference call Tuesday morning. In addition, the company is working on an IL-2/CTLA-4 program, COYA 302, that is being tested in ALS, frontotemporal dementia and Parkinson’s disease.

PARIS, France I October 25, 2024 I Egle Therapeutics, a biotechnology company focused on advancing the next generation of regulatory T cell-focused therapies for oncology and auto-immunity, will present at the Society for Immunotherapy of Cancer Meeting taking place in Houston, Texas from November 6 th to 10 th , 2024. The presentation, entitled “ Preferential tumor retention of EGL-001, a CTLA-4/CD25 antagonist fusion protein, to selectively deplete tumor Tregs and minimize peripheral toxicities: towards a first-in-human clinical study ”, will highlight the development and promising preclinical results of EGL-001, a humanized antibody designed to selectively target regulatory T cells (Tregs) within the tumor microenvironment. The data showcases EGL-001’s potential as single-agent and to enhance the effectiveness of immune checkpoint blockade therapies by depleting tumor-associated Tregs, leading to increased CD8+ T cell activation and anti-tumor responses in preclinical models. The SITC presentation will include key findings from studies in mouse models and cynomolgus monkeys, demonstrating the safety, tolerability, and efficacy of EGL-001, as well as its preferential tumor accumulation and rapid clearance from peripheral organs. These promising results leading Egle Therapeutics to conduct a first-in-human open-label, phase I/II trial evaluating the safety, tolerability, PK and preliminary activity of EGL-001 in patients with selected solid tumors, with the goal to address the critical need for more effective immunotherapies in cancer treatment. Session Date Saturday, Nov. 9 ; Location : George R. Brown Convention Center – Level 1 – Exhibit Halls AB ; Poster Board Number : 674 About Egle Therapeutics SAS (Egle) Egle Therapeutics is a clinical-stage biotechnology company focused on developing immunotherapies targeting suppressive regulatory T cells. Egle is leveraging a proprietary discovery platform to unveil novel Treg specific targets and to develop innovative Treg-focused drug candidates for oncology and autoimmune diseases. Egle is evaluating its most advanced drug candidate in oncology, EGL-001 (a Treg-selective anti-CTLA4-IL-2m), in a Phase I/II clinical trial. In auto-immunity, Egle aspires to advance toward the clinic its most advanced drug candidate, EGL-003 (non-targeted IL-2 Treg engager), currently in IND-enabling studies. Find out more at www.egle-tx.com . SOURCE: Egle Therapeutics