SAN DIEGO - MEI Pharma, Inc. (NASDAQ:MEIP), a clinical-stage pharmaceutical company, has commenced enrollment for a 12-patient expansion cohort in an ongoing Phase 1 trial. The study is examining the efficacy of voruciclib in combination with venetoclax in treating relapsed and refractory acute myeloid leukemia (AML) patients.
This development follows promising responses observed in heavily pretreated patients, including no overlapping toxicity and no dose-limiting toxicities in earlier cohorts.
The combination therapy, which pairs voruciclib, a selective oral cyclin-dependent kinase 9 (CDK9) inhibitor, with venetoclax, a B-cell lymphoma 2 (BCL2) inhibitor, has shown anti-leukemic activity and expected decreases in myeloid leukemia cell differentiation protein (Mcl-1), a marker associated with poor prognosis and resistance in AML.
Yesid Alvarado-Valero, M.D., from the University of Texas MD Anderson Cancer Center, noted the combination's lack of added toxicity and early signs of clinical activity. Richard Ghalie, M.D., Chief Medical Officer of MEI Pharma, highlighted the significant need for new treatments for AML patients who have relapsed after venetoclax, as current salvage therapies have a low response rate.
The Phase 1 study is evaluating various dosages of voruciclib alone and in combination with venetoclax. The 12-patient expansion cohort is being enrolled to further assess voruciclib at 300 mg daily for two weeks in a four-week cycle alongside venetoclax.
Out of 29 patients enrolled in the dose escalation stage of the study, two achieved a complete response with incomplete hematologic recovery (CRi), and one achieved a morphologic leukemia-free state (MLFS). Additionally, 14 patients experienced stable disease, with some lasting over 90 days.
MEI Pharma plans to provide additional updates on the study in the second half of 2024. The primary objectives are to determine the safety and biologic effective dose of voruciclib, with secondary objectives including assessing preliminary efficacy, pharmacokinetics, pharmacodynamics, and biomarkers.
Voruciclib is a CDK9 inhibitor with the potential to treat hematological malignancies and solid tumors, targeting proteins dysregulated in cancer cells, such as Mcl-1 and the MYC proto-oncogene protein.
This news is based on a press release statement from MEI Pharma.
InvestingPro Insights
As MEI Pharma, Inc. (NASDAQ:MEIP) continues to advance its clinical trials for voruciclib, a deeper look at the company's financial health and market performance provides valuable context for investors monitoring this biopharmaceutical player. With a focus on the development of therapies for cancer, MEIP's financial metrics and market data, as reported on InvestingPro, offer a snapshot of its current standing.
InvestingPro Data reveals that MEI Pharma has a market capitalization of $25.8 million and holds a Price/Earnings (P/E) ratio of 1.31, which slightly adjusts to 1.34 when considering the last twelve months as of Q2 2024. This low P/E ratio could suggest that the stock is undervalued relative to its earnings. Additionally, the company has demonstrated a robust revenue growth of 16.1% during the same period, signifying a positive trajectory in its financial performance.
From an operational standpoint, MEI Pharma's Gross Profit Margin stands at an impressive 135.73%, reflecting efficient management and a strong pricing strategy. The Operating Income Margin at 20.67% further underscores the company's profitability in its core operations.
InvestingPro Tips highlight that MEI Pharma currently holds more cash than debt, indicating a solid balance sheet and financial flexibility, which is crucial for funding ongoing research and development activities. Furthermore, analysts predict that the company will be profitable this year, a significant milestone for MEIP and its stakeholders.
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