Initial Clinical Trial Results: ME-344 Combined with Avastin® for Relapsed Metastatic Colorectal Cancer Treatment

In a recent Phase 1b clinical trial, MEI Pharma's drug candidate ME-344, when combined with bevacizumab, demonstrated positive results in treating patients with relapsed metastatic colorectal cancer (mCRC). The study showed that 25% of patients experienced no disease progression by the 16-week mark, surpassing the trial's target threshold of 20%. The combination treatment was well-tolerated, with no observed overlapping toxicities. 

MEI Pharma has chosen to focus on the development of a new formulation of ME-344, which aims to enhance biological activity, improve patient convenience, and expand commercial prospects, rather than adding a new cohort to the study. The company has already begun R&D on this new formulation and has seen promising initial results. 

ME-344 is an inhibitor of mitochondrial oxidative phosphorylation (OXPHOS), a process critical for ATP production in cells. By inhibiting OXPHOS, ME-344 can induce cancer cell death. The drug is particularly effective when paired with bevacizumab, an anti-angiogenic agent, which can shift tumor metabolism towards OXPHOS, making the cancer cells more susceptible to ME-344's effects. The Phase 1b study, conducted at the Academic GI Cancer Consortium (AGICC) centers, included patients with mCRC who had exhausted standard treatment options. The primary endpoint was 16-week progression-free survival, with secondary endpoints including overall survival, response duration, and safety. 

In the trial, 5 out of 20 evaluable patients completed 16 weeks of treatment without disease progression. The median progression-free survival was 1.9 months, and 45% of patients had stable disease. The treatment was generally well-tolerated, with fatigue and abdominal pain being the most common drug-related adverse events. 

MEI Pharma is dedicated to developing innovative cancer therapies to overcome resistance to existing treatments. The company's pipeline includes voruciclib, a CDK9 inhibitor, and ME-344. MEI Pharma's strategy involves evaluating drug candidates in combination with standard therapies to address unmet medical needs and enhance patient outcomes.

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