Seattle, WA March 17, 2025: Mozart Therapeutics, the leading developer of CD8 Treg modulators for the treatment of autoimmune disease, today announce the successful completion of their Phase 1a study of MTX-101 in healthy adults. The randomized, blinded, placebo-controlled study evaluated MTX-101—a first-in-class autoimmune checkpoint inhibitor—at single and multiple doses in an ascending-dose design (NCT06324604).

Data from the study in healthy adults show MTX-101 is well tolerated. Most adverse events were low-grade and there were no serious adverse events. Participants receiving MTX-101 experienced transient and self-limited decreases in lymphocytes, which the Company believes are consistent with the study drug’s mechanism of action and indicative of target engagement.

Data further demonstrate that MTX-101 has predictable, dose-dependent pharmacokinetics (PK) and receptor occupancy that are expected to enable a convenient and competitive dosing regimen. Pharmacodynamic data support proof of mechanism and show that MTX-101 is highly selective for regulatory CD8 T cells, and that engagement with MTX-101 results in CD8 Treg activation.

Mozart plans to present full data from the Phase 1a study at upcoming medical symposia.

“We are thrilled that the initial MTX-101 phase 1 data in healthy adults confirm the mechanistic and safety findings from our pre- and nonclinical studies. This represents not only an important milestone for Mozart, but also a significant achievement as we work to advance a class of CD8 Treg modulators to restore durable immune homeostasis in autoimmune disease”, said Katie Fanning, President and Chief Executive Officer of Mozart Therapeutics.

“Our observations from the healthy adults hold great promise for patients with autoimmune disease,” echoed Jason Chien, M.D., M.S., Mozart’s Chief Medical Officer. “The well-tolerated safety profile, antibody-like PK, and clear evidence of target engagement and activation represent an exciting novel class of therapeutics that has the potential to deliver substantial clinical benefit. With these data, we are quickly advancing MTX-101 in patients with type 1 diabetes and celiac disease.”

The first patients with type 1 diabetes and celiac disease have been enrolled in Part B of the study, which is being conducted at multiple clinical sites in Australia. “MTX-101 has a novel mechanism of action that has great potential to improve the lives of people living with autoimmune disease,” said Professor John Wentworth, M.D.; Endocrinologist, The Royal Melbourne Hospital Department of Medicine; Senior Clinical Research Fellow, St Vincent’s Institute of Medical Research; Director, ANZ Type 1 Diabetes TrialNet. “This is why our type 1 diabetes community is so excited to participate in the MTX-101 development program and help determine its ability to decrease dependance on insulin injections.”
MOZART THERAPEUTICS

About MTX-101
MTX-101 is an antigen-agnostic bispecific antibody targeting inhibitory KIR and CD8 expressed on regulatory CD8 T cells. This autoimmune checkpoint inhibitor aims to restore the intrinsic functions of CD8 Treg, acting early in the autoimmune disease process to suppress and eliminate pathogenic T cells, halt downstream inflammation, and prevent tissue destruction.

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.

Egle Therapeutics, a clinical-stage biotechnology company advancing the next generation of regulatory T cell (Treg)-focused therapies for oncology and autoimmune diseases, today announced the appointment of experienced biotechnology industry executive, Christophe Quéva, Ph.D, as Chief Executive Officer (CEO). With over 20 years of experience in the biotechnology industry, Dr. Quéva brings a wealth of expertise as Egle transitions into the clinic its two lead drug candidates, EGL-001 and EGL-003.

“I am thrilled to join Egle Therapeutics and collaborate with a team renowned for its deep scientific expertise in regulatory T cells and its strong track record in developing innovative drug candidates for immunology and oncology” said Christophe Quéva, Ph.D. “Egle is uniquely positioned to demonstrate the therapeutic potential of harnessing regulatory T cells for treating both cancer and autoimmune diseases.”

“As we transition from a company with preclinical assets to a fully-fledged clinical-stage biotech, we will benefit greatly from Christophe’s deep operational and strategic expertise. We are delighted to welcome Christophe to the Egle team and look forward to the successes he will drive.” said Vincent Brichard, M.D., EGLE’s Interim CEO and Board member.

“Christophe’s appointment marks a pivotal moment for EGLE, as we focus on clinical development and advancing our technology platform, his experience, knowledge and networks of the sector will ensure Egle continues to shape its future.” said Michel Detheux, Chairman of the board.

Christophe Quéva, Ph.D.

Dr. Christophe Quéva brings over two decades of experience in immuno-oncology, spanning portfolio development from target identification to clinical trials and regulatory approvals. Before joining Egle, he founded and led Ovie Therapeutics, a company focused on an innovative treatment for brain cancer. Since 2022, he has also served as Chief Scientific Officer at DEM BioPharma, driving the development of cancer macrophage-targeting therapies. Prior to this, Dr. Quéva was Chief Scientific Officer at Oncorus, where he advanced next-generation immunotherapies using oncolytic viruses and RNA therapeutics. He also held the same role at iTeos Therapeutics, overseeing the development of a groundbreaking immuno-oncology portfolio.

Earlier in his career, Dr. Quéva held leadership roles at Gilead Sciences, Amgen, and AstraZeneca, contributing to oncology and inflammation drug discovery. He holds a Ph.D. in Life and Health Sciences from the University of Lille in France and completed postdoctoral research in cancer biology at the Fred Hutchinson Cancer Research Center. Dr. Quéva’s extensive career includes numerous patents and publications in the oncology field, reflecting his commitment to advancing patient care through innovative science and leadership.

About Egle Therapeutics SAS (Egle)

Egle Therapeutics is a biotechnology company focused on developing immunotherapies targeting suppressive regulatory T cells. Egle is leveraging a proprietary discovery platform to unveil novel Treg specific targets and to develop innovative Treg-focused drug candidates for oncology and autoimmune diseases. Egle is evaluating its most advanced drug candidate in oncology, EGL-001 (a Treg-selective anti-CTLA4-IL-2m), in a Phase I/II clinical trial. In autoimmunity, Egle has completed IND-enabling studies for, EGL-003 (an IL-2 Treg engager), and is poised to commence a clinical trial in 2025.

Find out more at www.egle-tx.com.

Contacts:
contact@egle-tx.com / +33 (0)1 86 64 08 57
investor.relations@egle-tx.com / +33 (0)1 86 64 08 57