Mozart Therapeutics Announces Publication of MTX-101 Preclinical Data Demonstrating Modulation of Regulatory CD8 T Cell Network to Restore Immune Homeostasis

Preclinical Data Show MTX-101 Selectively Binds CD8 Treg, Restores Elimination of Autoreactive Cells, and Confirms Therapeutic Potential in Multiple Autoimmune Disease Models

Phase 1 Clinical Study Underway to Evaluate MTX-101 in Healthy Adults and Patients with Celiac Disease and Type 1 Diabetes

SEATTLE, Nov. 7, 2024 /PRNewswire/ -- Mozart Therapeutics, a clinical-stage biopharmaceutical company focused on the development of CD8 Treg modulators in autoimmune disease, announce today the publication of its first peer-reviewed publication entitled "Preclinical characterization of MTX-101: a novel bispecific CD8 Treg modulator that restores CD8 Treg functions to suppress pathogenic T cells in autoimmune diseases" in the journal Frontiers in Immunology. The publication extends on seminal work (Saligrama et al, 2019; Li et al, 2022) describing a cytolytic CD8 T cell subset (CD8 Treg) with anti-inflammatory effects that is dysfunctional in autoimmune diseases. The work furthers the understanding of the mechanisms underpinning CD8 Treg dysfunctions, as well as preclinical data for the Company's novel bispecific antibody, MTX-101. The data illustrate that MTX-101 selectively binds to human CD8 Treg, restoring their cytolytic functions, resulting in pathogenic CD4 T cell elimination in the periphery and disease-affected tissues ex vivo. Importantly, data demonstrate that the effects of MTX-101 are not broadly immunosuppressive and do not impair responses to viral and bacterial antigens. The full manuscript is available online (doi: 10.3389/fimmu.2024.1452537).

"The publication of our first manuscript is a significant milestone for Mozart Therapeutics. It highlights the hard work and commitment of our entire team to develop novel therapeutics with disease-modifying potential for patients with autoimmunity, and is in line with our mission to share our work with the scientific community. Collectively, our preclinical data provides a strong rationale for our ongoing clinical development of MTX-101 and confirms its broad therapeutic potential in early stage and/or indolent autoimmune diseases", said Courtney Crane, Ph.D., Senior Vice President of Biology and Translational Medicine at Mozart Therapeutics. 

The publication comes at an important time as the Company is evaluating MTX-101 in a Ph1 study in healthy adults and patients with T1D and celiac disease. Mozart Therapeutics remains committed to understanding and correcting CD8 Treg dysfunctions as it advances a pipeline of therapeutic molecules that provide effective and durable solutions to clinicians and patients with autoimmunity.

About MTX-101

MTX-101 is a bispecific antibody targeting inhibitory KIR and CD8 expressed on regulatory CD8 T cells. This autoimmune checkpoint inhibitor aims to restore the intrinsic functions of regulatory CD8 T cells, acting early in the autoimmune disease process to suppress and eliminate pathogenic cells, halt downstream inflammation, and prevent tissue destruction. MTX-101 is currently being evaluated in a randomized, blinded, placebo-controlled Phase 1 trial (NCT06324604) in healthy adults (study Part A; enrollment complete) and in patients with type 1 diabetes mellitus or celiac disease (study Part B). The clinical study is evaluating the safety, pharmacokinetics, and pharmacodynamics of MTX-101; in Part B, disease-specific biomarkers will also be assessed.

About Mozart Therapeutics

Mozart Therapeutics is focused on developing first-in-class disease-modifying therapies for autoimmune diseases, utilizing a novel approach to restoring immune system function by targeting the CD8 T regulatory network. The company is headquartered in Seattle, WA. For more information, visit www.mozart-tx.com and follow the company on LinkedIn @Mozart–tx.com.

SOURCE Mozart Therapeutics