Xilio Therapeutics Announces Positive Phase 2 Data for Vilastobart in Combination Therapy

Xilio Therapeutics, Inc., a clinical-stage biotechnology company, recently shared encouraging news from its ongoing Phase 2 clinical trial evaluating vilastobart (XTX101) in combination with atezolizumab. The trial focuses on patients with advanced solid tumors. The company revealed initial data on January 21, 2025, which will be presented at the American Society of Clinical Oncology (ASCO) 2025 Gastrointestinal Cancer Symposium.

The combination therapy demonstrated promising results, including a 27% preliminary response rate in heavily pre-treated patients with microsatellite stable colorectal cancer (MSS CRC) who did not have liver metastases. Notably, the responses were linked to reduced levels of tumor biomarkers and an enhancement in clinical symptoms. Xilio Therapeutics plans to further discuss the findings in a poster session at the upcoming medical symposium.

Chief Medical Officer of Xilio, Katarina Luptakova, commented positively on the data, emphasizing the importance of vilastobart in the combination. This juxtaposition is significant as PD-(L)1 inhibitors alone have shown limited efficacy in MSS CRC patients previously. The early signs of anti-tumor activity and the continued safety profile of the regimen suggest potential benefits in challenging cancer types resistant to conventional immunotherapy.

An independent expert, J. Randolph Hecht, involved in the study, highlighted the initial data as a beacon of hope for patients with MSS colorectal cancer, a group facing significant unmet medical needs. He expressed enthusiasm for the clinical benefit that vilastobart, as a tumor-activated anti-CTLA-4, in combination with PD-(L)1 inhibitors could offer to these patients.

In addition to the positive response rates, preliminary safety data showcased the potential for vilastobart to offer a differentiated profile, with a low incidence of immune-related adverse events. This emphasizes the compound’s selectivity towards tumor cells, reducing collateral damage to healthy tissues.

Xilio Therapeutics’ plans for the future involve reporting updated data from the Phase 2 trial later in 2025, encompassing additional response assessments. Subsequent to this encouraging data, the company will aim to advance collaborative opportunities to broaden the development scope beyond MSS CRC.

The company also intends to expand its clinical development efforts, with ongoing enrollment in Phase 1C dose escalation trials. The overarching goal remains to improve patient outcomes in cancer treatment without compromising on safety or efficacy.

Investors and interested parties will have the opportunity to gain deeper insights into the findings through an investor conference scheduled by Xilio Therapeutics. This presentation will cover the initial Phase 2 data and provide a platform for discussion on the future implications of the combination therapy.

As with any forward-looking statements, investors are advised to consider the inherent risks and uncertainties associated with clinical trials and drug development processes, as specified in regulatory filings made by Xilio Therapeutics with the U.S. Securities and Exchange Commission. The company retains the flexibility to refine its strategies and goals in light of evolving developments and regulatory requirements.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Xilio Therapeutics’s 8K filing here.

Xilio Therapeutics Company Profile

Xilio Therapeutics, Inc, a clinical-stage biotechnology company, engages in the discovery and development of tumor-activated immuno-oncology therapies. The company’s checkpoint inhibitor program includes XTX101, an investigational Fc-enhanced, tumor-activated anti-CTLA-4 mAb that is in Phase 2 clinical trial for patients with advanced solid tumors.