Exhibit 99.1
Xilio Therapeutics Announces Pipeline and Business Updates and Fourth Quarter and Full Year 2024 Financial Results
Additional Phase 2 data for vilastobart, a tumor-activated, Fc-enhanced anti-CTLA-4, in combination with atezolizumab in patients with MSS CRC anticipated in the middle of 2025
Advancing masked T cell engager programs in novel ATACR and SEECR formats for PSMA, CLDN18.2 and STEAP1
Announced collaboration with AbbVie in the first quarter of 2025 to develop novel tumor-activated, antibody-based immunotherapies, including
masked T cell engagers
WALTHAM, Mass., March 11, 2025 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 fourth quarter and full year ended
December 31, 2024.
We started 2025 with multiple promising updates across our pipeline, including encouraging initial Phase 2 combination data
for vilastobart, our tumor-activated anti-CTLA-4, in patients with late-line MSS CRC, a difficult to treat, immunologically cold tumor type that is increasing in incidence, particularly in younger
people, said René Russo, Pharm.D., president and chief executive officer of Xilio. These data included a preliminary 27% objective response rate in patients without liver metastases and continue to support a differentiated safety
profile, including a low incidence of immune-related adverse events and only 5% of patients reporting colitis. We look forward to reporting additional data from the ongoing Phase 2 trial in the middle of this year.
Dr. Russo added, In addition, we are excited to be advancing multiple novel masked T cell engager programs internally and as part of our recently
announced collaboration with AbbVie. Each of these programs leverages our clinically-validated, tumor-activation technology, which we believe has great potential to enhance the activity and tolerability of T cell engagers and open up promising new
targets within this class of immunotherapies.
Pipeline and Business Updates
Vilastobart: tumor-activated, Fc-enhanced, high affinity binding
anti-CTLA-4
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).
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In January 2025, Xilio announced encouraging initial data from its ongoing Phase 2 clinical trial evaluating
vilastobart at a dose of 100 mg once every six weeks (Q6W) in combination with atezolizumab (Tecentriq®) at 1200 mg once every three weeks (Q3W) in patients with metastatic microsatellite
stable colorectal cancer (MSS CRC). As of a data cutoff date of January 13, 2025, these data demonstrated a preliminary 27% objective response rate in patients without liver metastases, and responses were accompanied by decreases in levels of
serum tumor biomarkers (carcinoembryonic antigen and circulating tumor DNA) as well as improvement in clinical symptoms. In addition, as of the data cutoff date, the combination was generally well-tolerated, with patients experiencing a low
incidence of immune-related adverse events and only 5% of patients reporting colitis. These safety data continue to support the potential for vilastobart to be a differentiated next-generation anti-CTLA-4 in
combination with PD-(L)1 inhibitors. For more information, read the press release here. |