Lilly Initiates Phase 1 Study of TRB-051 for Autoimmune and Inflammatory Diseases in Collaboration with TRexBio

SOUTH SAN FRANCISCO, CA, USA I June 26, 2024 I TRex Bio, Inc. ("TRexBio"), a biotechnology company focused on decoding human tissue immune biology to create groundbreaking therapeutics, announced that its collaboration partner, Eli Lilly and Company ("Lilly"), has commenced a Phase 1 first-in-human study of TRB-051. This investigation targets the modulation of immune effector cells for the treatment of autoimmune and inflammatory diseases. This program is part of a broader research collaboration and exclusive worldwide license agreement between TRexBio and Lilly. The collaboration utilizes TRexBio’s Deep Biology platform to identify and develop innovative therapies for immune-mediated diseases. As a result of the agreement, TRexBio has received a milestone payment in the double-digit million dollar range and stands to gain more than $1.1 billion contingent upon achieving specific development, regulatory, and commercial milestones. Additionally, TRexBio will receive tiered royalties on product sales.

Alison Budelsky, Ph.D., Vice President of Immunology Research at Lilly, expressed enthusiasm about TRB-051's potential to provide lasting clinical benefits for patients requiring new treatments for immune system dysregulation. She highlighted the promising preclinical work carried out in collaboration with TRexBio, which has driven a translational hypothesis now set to be tested in clinical settings with TRB-051.

Melanie Kleinschek, DVM, Ph.D., Chief Scientific Officer of TRexBio, regarded the initiation of the TRB-051 study by Lilly as a milestone that further validates the efficacy of TRexBio’s Deep Biology Platform. Kleinschek emphasized that their central goal is to restore homeostasis at inflammation sites across various immune-mediated diseases. The platform's capability to map essential regulatory pathways in both healthy and diseased tissues has been pivotal in their drug discovery efforts, showing early signs of success through the progress of their Lilly-partnered programs and TRexBio’s own pipeline of wholly-owned assets advancing towards clinical trials.

The Deep Biology Platform has also been crucial in the identification and progression of TRexBio’s lead program, TRB-061. This program involves an agonist targeting the TNF receptor 2 (TNFR2), aimed at enhancing regulatory T cells (Tregs) at inflammation sites. TRB-061 is currently undergoing IND-enabling studies, with the company planning to move it into clinical trials in the first half of 2025.

TRexBio is a biotechnology company utilizing advanced computational biology tools, a focus on human tissue, and expertise in immunobiology to pioneer revolutionary therapeutics for immune-mediated diseases. Their powerful Deep Biology platform charts human tissue regulatory T cell behaviors in relation to disease processes, helping to identify and characterize innovative targets for therapeutic intervention. Using this platform, TRexBio is developing a broad portfolio of novel therapies designed to modulate the immune system and restore immune homeostasis in human tissues. Founded and initially funded by SV Health Investors in 2018, TRexBio is headquartered in South San Francisco, California. The company was among the first occupants at Lilly Gateway Labs, a collaborative innovation space that supports early-stage biotechs in advancing groundbreaking scientific research.

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