Xilio Therapeutics, Inc. is pioneering a novel approach in immuno-oncology by developing tumor-activated therapies that aim to enhance the efficacy of cancer treatments while minimizing systemic side effects. Their proprietary platform technology focuses on engineering a range of immune-modulatory molecules, including monoclonal antibodies, cytokines, bispecifics, and cell engagers, to be selectively activated within the tumor microenvironment (TME). This strategy is designed to optimize the therapeutic index of these agents, allowing for potent anti-tumor activity while limiting adverse effects on healthy tissues. By utilizing mechanisms such as matrix metalloprotease (MMP) activation, Xilio's therapies can effectively target and treat solid tumors, transforming the treatment landscape for patients.

One of the key products in Xilio's pipeline is XTX301, an engineered form of Interleukin-12 (IL-12) that is designed to stimulate anti-tumor immunity specifically within the TME. IL-12 is recognized for its powerful ability to activate various immune cells, but traditional forms have been hindered by severe toxicity. XTX301 aims to overcome these challenges by being tumor-activated, thus reprogramming "cold" tumors into a more immunogenic "hot" state. Currently undergoing a Phase 1 clinical trial, XTX301 has shown promise in enhancing immune cell infiltration and anti-tumor responses, with potential applications in combination therapies. This innovative approach underscores Xilio's commitment to developing effective and tolerable cancer treatments that could significantly improve patient outcomes.

United States

Xilio is a Waltham, Massachusetts-based clinical-stage biopharmaceutical company focused on defeating cancer. The company’s proprietary technology enables the explosion of therapeutic activity specifically within the tumor while reducing toxicity throughout the body – a nod to the company name, Xilio, derived from the Latin term, Ex Nihilo, meaning creation or big-bang. Xilio is applying its technology to build a broad pipeline of engineered antibodies, cytokines and chemokines as potential new options for people living with cancer.

Cancer

Xilio Therapeutics, Inc.

Solid tumor/s

XTX101+atezolizumab

Antibodies

Biologics

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. 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.

XTX301

Colorectal cancer

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).

Vilastobart (XTX101)+ atezolizumab

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)-enabling activities for XTX501.

XTX501

Melanoma

Renal cell carcinoma

XTX202 is an investigational tumor-activated, beta-gamma biased IL-2 designed to potently stimulate CD8+ effector T cells and natural killer (NK) cells without concomitant stimulation of regulatory T cells when activated (unmasked) in the TME. The Phase 2 clinical trial is a multi-center, open-label trial designed to evaluate the safety and efficacy of XTX202 as a monotherapy in patients with unresectable or metastatic melanoma and metastatic renal cell carcinoma who have progressed on standard-of-care treatment.

Xilio Therapeutics, Inc.

Company Details