ME-344

P1, N=40, Active, not recruiting, MEI Pharma, Inc. | Trial primary completion date: Apr 2024 --> Jul 2024

P1, N=40, Active, not recruiting, MEI Pharma, Inc. | Recruiting --> Active, not recruiting

In a CT26 colon carcinoma syngeneic murine model, ME-344 in combination with regorafenib showed significantly reduced tumor growth compared to regorafenib alone (Navarro et al... This is an open-label phase 1b study in patients ≥18 years old with metastatic colorectal cancer after failure of standard therapies, including fluoropyrimidine-, irinotecan-, and oxaliplatin-based regimens, anti-EGFR if RAS wild-type, PD/L-1-blocking antibody if MSI-H/dMMR, and BRAF-targeted therapy if BRAF V600E mutated...The study is actively enrolling, funded by MEI Pharma, and registered under NCT02100007. Clinical trial information: NCT02100007.

P1, N=40, Recruiting, MEI Pharma, Inc. | Phase classification: P1b --> P1

P1b, N=40, Recruiting, MEI Pharma, Inc. | Not yet recruiting --> Recruiting

This key metabolic hallmark of leukemia was recently reported as a feature of resistance to Cytarabine (AraC)-based therapy. Ongoing in vivo studies in AML PDX models will address the impact of ME-344 in the context of acquired AraC- and Bcl-2- resistance. In summary, our findings indicate ME-344 alone or in combination with Bcl-2 inhibition constitutes an important therapeutic modality that targets a unique metabolic vulnerability of AML.

Other mitochondrial proteins are also affected resulting in interference in tumor cell redox homeostasis and mitochondrial function. These factors contribute to a beneficial therapeutic index and support continued clinical development of ME-344.