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Monopteros Therapeutics Initiates Clinical Trial to Reprogram Regulatory T Cells in Solid Tumors

BOSTON–()–Monopteros Therapeutics Inc. (“Monopteros”), a clinical-stage biotechnology company developing MPT-0118, a first-in-class MALT1 inhibitor for the treatment of solid tumors, today announced that it has dosed the first patient in its Phase 1/1b dose escalation and cohort expansion clinical trial. The trial aims to evaluate the safety, efficacy, and pharmacology of MPT-0118 and to demonstrate the reprogramming of regulatory T cells.

Monopteros’ clinical program is based on research by Thorsten Mempel, MD, of Massachusetts General Hospital and Harvard Medical School and published in Nature in 2019.1 He discovered that regulatory T cells (“Tregs”) located in the tumor microenvironment have an increased dependence on the MALT1 enzyme. Inhibition of MALT1 results in the selective reprogramming of the tumor-associated Tregs, characterized by the loss of their immunosuppressive function and pro-inflammatory interferon-gamma production. The resulting tumor inflammation is recognized as essential for the success of checkpoint inhibitor therapy. Treg reprogramming through MPT-0118 therefore has the potential to enable a powerful anti-tumor immune attack in cancer patients that are otherwise not responsive to checkpoint inhibitor therapy.2,3

“Immunosuppressive regulatory T cells are preventing many patients with solid tumors from realizing the durable benefit from cancer immunotherapy currently achieved by a minority of patients,” commented Keith Flaherty, MD, director of developmental therapeutics at the Massachusetts General Hospital Cancer Center and chairman of the Monopteros clinical advisory board. “MPT-0118 demonstrates the potential to reprogram Tregs, which can be an essential mechanism for increasing the response rates of checkpoint inhibitors for patients with these common cancer types.”

Monopteros started its operations in the first quarter of 2019 following a $20 Million Series-A commitment by Medicxi and recruited a team of experienced drug developers and advisors to advance MPT-0118 to the clinic.

“We have achieved our goal of expeditiously bringing Dr. Mempel’s breakthrough research to the clinic while both confirming and expanding on his results,” said Peter Keller, CEO. “We now shift our focus to the clinical development of MPT-0118 and to bringing the benefits of immunotherapy to more patients with solid tumors.”

In the Phase 1/1b clinical trial, MPT-0118 is provided to patients as a tablet formulation for oral dosing.

About Monopteros Therapeutics

Monopteros Therapeutics is a clinical-stage biotechnology company developing a first-in-class inhibitor of MALT1 protease. The company’s first asset, MPT-0118, is undergoing a Phase 1/1b clinical trial to investigate reprogramming regulatory T cells in solid tumors.

Monopteros operates under Series-A funding from Medicxi and holds exclusive patent licenses from the Massachusetts General Hospital and Helmholtz Zentrum München.

Please see monopterostx.com for more information, and connect with the company on LinkedIn and Twitter.

1Targeting the CBM complex causes Treg cells to prime tumours for immune checkpoint therapy,” Nature 2019, Di Pilato et al.

2 Interferon-gamma production by regulatory T cells is required for response to cancer immunotherapy,Journal of Immunology 2020, Gocher et al.

3CTLA-4 blockade drives loss of Treg stability in glycolysis-low tumours,” Nature 2021, Zappasodi et al.

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