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Xilio Therapeutics, Inc. (Nasdaq: XLO) is a biopharmaceutical company based in Waltham, Massachusetts, dedicated to pioneering tumor-activated immuno-oncology (I-O) therapies aimed at significantly improving outcomes for cancer patients. The company's name, Xilio, is derived from the Latin term 'ex nihilo,' meaning creation or big bang, symbolizing its innovative approach.
Xilio leverages its proprietary platform to develop a pipeline of novel, tumor-activated clinical and preclinical I-O molecules. These include engineered antibodies, cytokines, and chemokines, all designed to localize anti-tumor activity within the tumor microenvironment, thus optimizing the therapeutic index and minimizing systemic side effects.
Key Products and Developments:
- XTX202: An investigational tumor-activated, engineered IL-2 molecule designed to stimulate CD8+ effector T cells and natural killer (NK) cells without stimulating regulatory T cells. Recent Phase 1/2 data showed a 50% disease control rate at higher doses, and it is currently being evaluated in a Phase 2 trial for melanoma and renal cell carcinoma.
- XTX101: A tumor-activated, Fc-enhanced anti-CTLA-4 monoclonal antibody designed to block CTLA-4 and deplete regulatory T cells within the tumor microenvironment. It is being evaluated in combination with atezolizumab in a Phase 1/2 clinical trial for advanced solid tumors.
- XTX301: An engineered IL-12 molecule designed to boost anti-tumor immunity and convert 'cold' tumors into 'hot' ones. XTX301 is in a Phase 1 clinical trial, and Xilio has recently entered into an exclusive license agreement with Gilead Sciences for its development.
Recent Achievements:
- XTX202 Phase 1 monotherapy dose-escalation success at a dose level of 4.0 mg/kg, with plans to explore combination therapy opportunities.
- The company announced a strategic partnership with Gilead Sciences to accelerate the development of XTX301.
- Financial results indicate that Xilio's existing cash and cash equivalents can fund operations into the second quarter of 2025, bolstered by recent private placements and upfront payments from strategic partnerships.
For more detailed information on Xilio Therapeutics and its pipeline of tumor-activated I-O therapies, visit www.xiliotx.com.
Xilio Therapeutics (Nasdaq: XLO) announced three preclinical programs for masked T cell engagers targeting PSMA, CLDN18.2, and STEAP1. The company also entered into a collaboration agreement with AbbVie, receiving $52.0 million in upfront payments ($42.0M cash and $10.0M equity investment).
The collaboration includes an exclusive option for AbbVie to develop masked cell engager molecules and a license for masked antibody-based immunotherapy, with potential additional payments up to $2.1 billion plus tiered royalties. Xilio's technology aims to improve T cell engager tolerability through tumor-selective activation.
Development timelines include: PSMA candidate nomination in Q3 2025 (IND in Q1 2027), CLDN18.2 candidate in Q4 2025 (IND in Q2 2027), and STEAP1 candidate in H1 2026 (IND in H2 2027). The company's cash runway has been extended into Q1 2026.
AbbVie (ABBV) and Xilio Therapeutics (XLO) have announced a collaboration and option-to-license agreement to develop novel tumor-activated immunotherapies. The partnership leverages Xilio's proprietary technology for tumor-activated biologics, focusing on masked T-cell engagers and antibody-based immunotherapies.
The agreement includes $52.0 million in total upfront payments, with a $10.0M equity investment from AbbVie. Xilio is eligible to receive up to $2.1 billion in contingent payments for option-related fees and milestones, plus tiered royalties. The collaboration aims to combine AbbVie's oncology expertise with Xilio's tumor-activation technology to develop next-generation cancer treatments with minimized systemic adverse events.
AbbVie (ABBV) and Xilio Therapeutics (XLO) have announced a collaboration and option-to-license agreement to develop novel tumor-activated immunotherapies. The partnership leverages Xilio's proprietary technology platform for developing tumor-activated biologics, including masked T-cell engagers.
The collaboration aims to combine AbbVie's oncology expertise with Xilio's technology to create next-generation cancer treatments focused on tumor-selective activation while minimizing systemic adverse events. Under the agreement terms, Xilio will receive $52.0 million in total upfront payments, including a $10.0M equity investment, and will be eligible for up to $2.1 billion in contingent payments plus tiered royalties.
Xilio Therapeutics (Nasdaq: XLO), a clinical-stage biotechnology company focused on tumor-activated immuno-oncology therapies, has granted stock options to four new employees. The grants, effective February 1, 2025, consist of non-qualified stock options to purchase 83,400 shares of common stock at an exercise price of $0.705 per share, matching the closing price on January 31, 2025.
The options have a ten-year term with a vesting schedule of 25% after the first year of employment, followed by the remaining 75% vesting in 36 monthly installments. These grants were made under Xilio's 2022 Inducement Stock Incentive Plan as employment inducements in accordance with Nasdaq Listing Rule 5635(c)(4).
Xilio Therapeutics (Nasdaq: XLO) announced initial Phase 2 data for vilastobart (XTX101) combined with atezolizumab in treating metastatic microsatellite stable colorectal cancer (MSS CRC). The trial showed a 27% preliminary response rate in patients without liver metastases, with three partial responses including two confirmed ones.
Key findings include decreased levels of carcinoembryonic antigen (CEA) and circulating tumor DNA (ctDNA), along with improved clinical symptoms. Among 40 treated patients, the combination demonstrated a favorable safety profile with low immune-related adverse events and only 5% reporting colitis. Of the 18 patients evaluable for response, 11 without liver metastases showed promising results, with responses ongoing at data cutoff.
The company plans to report updated Phase 2 data in mid-2025 and is seeking partnership opportunities to expand development beyond the initial MSS CRC trial.
Xilio Therapeutics (Nasdaq: XLO), a clinical-stage biotechnology company focused on tumor-activated immuno-oncology therapies, has granted a non-qualified stock option to a new employee. The option, effective January 1, 2025, allows for the purchase of 60,000 shares of common stock at an exercise price of $0.955 per share, matching the company's closing price on December 31, 2024.
The stock option has a ten-year term with a vesting schedule of 25% after the first year of employment, followed by the remaining 75% vesting in 36 monthly installments. This grant was made under Xilio's 2022 Inducement Stock Incentive Plan and complies with Nasdaq Listing Rule 5635(c)(4).
Xilio Therapeutics (Nasdaq: XLO), a clinical-stage biotechnology company focused on tumor-activated immuno-oncology therapies, has granted a non-qualified stock option to its new Chief Legal Officer, Caroline Hensley. The option, effective January 1, 2025, allows for the purchase of 375,000 shares of common stock at an exercise price of $0.955 per share, matching the company's closing price on December 31, 2024.
The stock option has a ten-year term with a vesting schedule where 25% of shares vest after the first year of employment, followed by the remaining 75% vesting in 36 monthly installments. This grant was made under Xilio's 2022 Inducement Stock Incentive Plan and complies with Nasdaq Listing Rule 5635(c)(4).
Xilio Therapeutics (XLO) announced plans to present initial Phase 2 data for vilastobart (XTX101), their tumor-activated anti-CTLA-4 therapy, in combination with atezolizumab for metastatic microsatellite stable colorectal cancer at ASCO GI in January 2025. The company also reported preliminary Phase 1 data for XTX301, their tumor-activated IL-12 therapy, showing improved tolerability with no dose-limiting toxicities across 34 patients treated at doses from 5 µg/kg to 60 µg/kg.
The company completed an additional $8.2 million private placement with Gilead, reaching the maximum $25 million investment under their March 2024 agreement. With these proceeds, Xilio expects to fund operations into Q3 2025.
Xilio Therapeutics (Nasdaq: XLO) has appointed Caroline Hensley as chief legal officer. Hensley joins from Seres Therapeutics, where she served as senior vice president, assistant general counsel and chief compliance officer, overseeing corporate legal and compliance matters. Her experience includes managing capital markets transactions, clinical development activities, commercial launches, and FDA regulatory compliance. Previously, she worked as a corporate associate at Latham & Watkins, representing biotechnology companies in various transactions. Hensley holds a B.A. in economics from the University of Texas at Austin and a J.D. from Boston University School of Law.
Xilio Therapeutics (Nasdaq: XLO), a clinical-stage biotechnology company focused on tumor-activated immuno-oncology therapies, has granted stock options to a new employee. The grant, effective December 1, 2024, consists of non-qualified stock options to purchase 8,400 shares of common stock at an exercise price of $1.09 per share, matching the closing price on November 29, 2024.
The options have a ten-year term with a vesting schedule of 25% after the first year and the remaining 75% vesting monthly over three years. These grants were made under Xilio's 2022 Inducement Stock Incentive Plan in accordance with Nasdaq Listing Rule 5635(c)(4).
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