On April 22, 2021 Monopteros Therapeutics Inc. ("Monopteros"), a clinical-stage biotechnology company developing MPT-0118, a first-in-class MALT1 inhibitor for the treatment of solid tumors, reported that it has dosed the first patient in its Phase 1/1b dose escalation and cohort expansion clinical trial (Press release, Monopteros Therapeutics, APR 22, 2021, View Source [SID1234578347]). The trial aims to evaluate the safety, efficacy, and pharmacology of MPT-0118 and to demonstrate the reprogramming of regulatory T cells.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.