Xilio Therapeutics Announces Pipeline and Business Updates and Third Quarter 2024 Financial Results

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 $(IND.AU)$-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 $(TME.AU)$. In 2023, Xilio entered into a co-funded clinical trial collaboration with Roche to evaluate vilastobart in combination with atezolizumab (Tecentriq$(R)$) 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

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November 07, 2024 09:05 ET (14:05 GMT)