Xilio Therapeutics Updates Pipeline, Business, and Q1 2024 Financials

Xilio Therapeutics, Inc., a clinical-stage biotechnology company, has recently shared significant updates on its pipeline and business progress, as well as financial results for the first quarter ending March 31, 2024. The company, focused on developing tumor-activated immuno-oncology therapies, is advancing several key programs with anticipated milestones in the near future.

Pipeline and Business Developments

XTX101: Tumor-Activated Anti-CTLA-4
XTX101 is an investigational Fc-enhanced anti-CTLA-4 designed to block CTLA-4 and target regulatory T cells within the tumor microenvironment. Currently, it is being tested in combination with atezolizumab in a Phase 1 trial involving patients with advanced solid tumors. Xilio plans to determine a recommended Phase 2 dose and initiate a Phase 2 trial for patients with microsatellite stable colorectal cancer (MSS CRC) by the third quarter of 2024. Initial clinical data for XTX101 are expected in the fourth quarter of 2024 and early 2025.

XTX301: Engineered IL-12
XTX301 is an IL-12 molecule engineered to stimulate anti-tumor immunity and convert “cold” tumors into “hot” ones. In March 2024, Xilio entered an exclusive license agreement with Gilead Sciences, securing $43.5 million upfront and potentially $592.5 million in contingent payments for their IL-12 program. XTX301 is in Phase 1 trials, and safety and pharmacodynamic data are expected in the fourth quarter of 2024.

Tumor-Activated Bispecifics and Immune Cell Engagers
Xilio is also focusing on research-stage development of tumor-activated bispecifics and immune cell engagers. In April 2024, they presented preclinical data on XTX501, a PD-1/IL-2 bispecific, at the AACR Annual Meeting. Early findings suggest that XTX501 may enhance anti-tumor activity of existing PD-1/PD-L1 therapies.

XTX202: Engineered IL-2
XTX202 is designed to stimulate CD8+ T cells and natural killer cells in the tumor microenvironment. Xilio released additional data from its Phase 2 trial targeting metastatic renal cell carcinoma and melanoma in March 2024. However, the company has decided to halt monotherapy investment in XTX202 but continues to seek collaborative opportunities for combination therapies.

Corporate Updates

In March 2024, Xilio streamlined its portfolio to concentrate resources on the rapid development of XTX301 and XTX101. The company also completed a private placement equity financing of approximately $11.3 million in April 2024.

Financial Overview

Cash Position
Xilio held $34.0 million in cash and equivalents as of March 31, 2024, a decrease from $44.7 million at the end of 2023. In April 2024, the company received an additional $44.6 million from Gilead and other private placements.

Research and Development Expenses
R&D expenses were $10.4 million for Q1 2024, down from $16.1 million in Q1 2023. This reduction was mainly due to decreased spending on early-stage research, reduced manufacturing activities for XTX301, and lower personnel-related costs.

General and Administrative Expenses
G&A expenses decreased to $6.1 million in Q1 2024 from $7.4 million in Q1 2023, driven by reduced personnel and consulting fees.

Net Loss
The net loss for Q1 2024 was $17.2 million, compared to $22.6 million in Q1 2023.

Financial Guidance

Xilio anticipates that its current cash, including recent investments, will fund operations into the second quarter of 2025.

Program Summaries

XTX101
XTX101, an Fc-enhanced anti-CTLA-4 antibody, is currently in Phase 1 trials with planned Phase 2 trials for MSS CRC patients expected to start in the third quarter of 2024.

XTX301
XTX301, an engineered IL-12, is under an exclusive license with Gilead and is in Phase 1 trials to assess safety and tolerability in patients with advanced solid tumors.

XTX202
XTX202, an engineered IL-2, is in Phase 2 trials for metastatic melanoma and renal cell carcinoma.

About Xilio Therapeutics
Xilio Therapeutics is dedicated to developing tumor-activated immuno-oncology therapies that target the tumor microenvironment, aiming to improve cancer treatment outcomes significantly. The company utilizes a proprietary platform to advance a pipeline of innovative clinical and preclinical I-O molecules.

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