TRex Bio TRXB

TRex Bio, Inc. is a clinical-stage biopharmaceutical company focused on tissue Treg biology for the discovery and development of immunoregulatory medicines designed to restore immune balance and promote tissue repair for autoimmune and inflammatory diseases. The company leverages its Deep Biology platform to decode Treg functionality in human tissue, identify novel targets, and develop therapeutic candidates aimed at addressing unmet medical needs in conditions such as atopic dermatitis, alopecia areata, and inflammatory bowel disease. TRex Bio integrates tissue-level insights with proprietary computational and functional assays to advance a pipeline of wholly-owned and collaborated product candidates.

TRex Bio generates revenue through strategic collaborations and licensing agreements with pharmaceutical partners, including upfront payments, development milestones, commercial milestones, sales milestones, and tiered royalties on net sales of licensed programs. The company has an ongoing collaboration with Eli Lilly and Company for TRB-051, under which it received a $55.0 million upfront payment in 2023 and a $15.0 million development milestone in July 2024, with eligibility for additional payments totaling up to $777.5 million upon achievement of specified milestones. Revenue is derived from the advancement of therapeutic candidates through these partnerships, with no current product sales as all candidates remain in preclinical or clinical development.

The company operates through the following segments:

• TRB-061: This segment focuses on the development of an investigational tumor necrosis factor receptor 2 (TNFR2) agonist Fc-fusion protein designed to expand and activate tissue Tregs in inflamed tissues. TRB-061 is being developed for autoimmune and inflammatory diseases with an initial focus on moderate-to-severe atopic dermatitis, and is currently in Phase 1b clinical development with topline data expected in mid-2027. The candidate has shown selective expansion of immunoregulatory Tregs and increased IL-10 production in preclinical and Phase 1a studies, supporting its mechanism of immune balance and tissue repair.
• TRB-071: This segment involves the development of an investigational monoclonal antibody agonist targeting CD30 (TNFRSF8) to augment tissue Tregs and block inflammatory signaling via CD30L. TRB-071 is designed for inflammatory bowel disease and is currently in IND-enabling studies, with plans to initiate a Phase 1 trial in the first half of 2027, subject to regulatory allowance. Preclinical studies in non-human primates and colitis models demonstrated Treg activation, expansion, and reduced inflammation, supporting its dual mechanism of immunoregulation and inflammation modulation.
• TRB-051: This segment represents a collaboration with Lilly for a modulator of immune effector cells first identified and advanced using TRex Bio’s Deep Biology platform. Lilly initiated a Phase 1 first-in-human study for TRB-051 in June 2024 and announced plans to move it into a Phase 2a clinical trial in lupus with cutaneous involvement in the second half of 2026. The candidate emerged from a multi-year discovery collaboration and is being developed by Lilly under an exclusive worldwide license, with TRex Bio eligible to receive milestone payments and royalties upon commercialization.

TRex Bio occupies a niche position in the biotechnology industry as a pioneer in tissue-targeted Treg biology, differentiating itself from competitors that rely on broad immunosuppression or peripheral blood-based approaches. The company’s competitive advantage lies in its Deep Biology platform, which combines human tissue analysis, computational mapping, a Treg Atlas, and functional assay cascades to identify targets with high translational potential. This approach enables TRex Bio to develop therapeutics that restore immune homeostasis and tissue repair, addressing limitations of current therapies such as JAK inhibitors and biologics that often require chronic treatment and fail to induce durable remission.

TRex Bio serves patients suffering from autoimmune and inflammatory diseases, with initial clinical focus on individuals with moderate-to-severe atopic dermatitis, alopecia areata, and inflammatory bowel disease. The company’s therapeutic candidates are intended for use by individuals seeking disease-modifying treatments that address underlying immune dysregulation and tissue barrier dysfunction, particularly those who have inadequate response or intolerance to existing therapies such as dupilumab or JAK inhibitors.