The BULL case for MEIP. The Market (finally) starts to take notice.
Send Message|Dr. Tran BioSci Advisory Please Note: Blog posts are not selected, edited or screened by Seeking Alpha editors. MEI Pharma: Pioneering New Cancer Therapeutics Jun. 10, 2018 7:15 AM ET|About: MEI Pharma, Inc. (MEIP), Includes: AGN, GERN, ROG
Summary MEI Pharma is an up-and-coming biopharmaceutical company with a robust cancer therapeutics pipeline.
Pracinostat can cut into the blockbuster market and its lead asset, pracinostat, is under investigation as a combination therapy with azacitidine for treating acute myeloid leukemia and myelodysplastic syndrome.
Pracinostat can cut into the blockbuster market and is a worthwhile development.
In a recent phase Ib study, ME-401 demonstrated an objective response rate of 90% for patients with relapsed or refractory follicular lymphoma, chronic lymphocytic lymphoma, and small lymphocytic lymphoma.
MEI Pharma had a $75M private placement with Vivo Capital, CAM Capital, and other investment firms. These proceeds will fund ongoing clinical development of ME-401.
Move only when you have an advantage. It’s very basic. You have to understand the odds and have the discipline to bet only when the odds are in your favor. We just keep our heads down and handle the headwinds and tailwinds as best we can, and take the result after a period of years. - Charlie Munger
MEI Pharma (NASDAQ:MEIP) recently announced several clinical and corporate milestones, including: presentation of clinical data for ME-401 in patients with indolent B cell malignancies, presentation of clinical data for ME-344 in patients with HER2-negative breast cancer, successful interim analysis of pracinostat + azacitidine phase II study for patients with higher risk myelodysplastic syndrome, and $75M private placement. At present, MEIP stock is priced at $4.95 and has a market cap of $348M (Figure 1).
Figure 1: MEI Pharma stock chart. (Source: StockCharts)
About The Company MEI Pharma, located in San Diego, is a biopharma company focused on developing cancer therapeutics. The management team consists of: Daniel Gold (President and CEO at MEI) was former President and CEO of Prospect Therapeutics and founder and CSO of Favrille; Robert Mass (CMO at MEI) held numerous management positions at Genentech (VTX:ROG) including Head of Medical Affairs, BioOncology, a member of the Executive Development Review Committee, and clinical science leader for Herceptin, Tarceva, and Avastin; Brian Drazba (CFO at MEI) was formerly VP of Finance and CFO at Heron Therapeutics and VP of Finance and CAO at ISTA Pharmaceuticals; David Urso (Senior VP of Corporate Development & General Counsel at MEI) served as COO and General Counsel at Tioga Pharmaceuticals, Principal at Forward Ventures, and Director of Corporate Development and Legal Affairs at DNA Sciences; Karen Potts (Senior VP of Regulatory Affairs at MEI) was formerly Senior VP of Regulatory affairs at Trius Therapeutics and Senior Director of Regulatory Policy at Allergan (NYSE:AGN); Richard Ghalie (Senior VP of Clinical Development at MEI) was formerly CMO at Denovo BioPharma, HemaQuest Pharmaceuticals, Novalar Pharmaceuticals, and Favrile.
Cancer Therapeutics Pipeline MEI has a robust cancer therapeutics pipeline and is investigating several drug candidates (Figure 2), including pracinostat (HDAC inhibitor), ME-401 (PI3K delta inhibitor), voruciclib (CDK inhibitor), and ME-344 (mitochondrial inhibitor).
Figure 2: Therapeutic pipeline. (Source: MEI Pharma)
Pracinostat The lead asset is pracinostat, a small molecule histone deacetylase (“HDAC”) inhibitor, is under investigation for use in combination with azacitidine for treating acute myeloid leukemia and myelodysplastic syndrome. We presented in the prior research on Geron Corporation (NASDAQ:GERN),
“Having defects in the lymphoid lineage (WBCs like B or T cells), some lymphoblastic or lymphocytic cancers include acute lymphoblastic leukemia, chronic lymphocytic leukemia, lymphomas and multiple myeloma. Conversely, myelogenous or myeloid cancers took root in the malignant precursors to RBCs, platelets, and WBCs (granulocytes). Examples of myelogenous cancers are acute myelogenous leukemia (“AML”), chronic myelogenous leukemia, myelodysplastic syndromes (“MDS”) and the myeloproliferative neoplasms, such as essential thrombocythemia (“ET”), polycythemia vera, and myelofibrosis (“MF”).”
Figure 3: Blood disorders (Source: Geron)
Compared with other oral HDAC inhibitors, pracinostat has favorable pharmacokinetic properties and longer half-life. Pracinostat is better able to accumulate in tumors and induce sustained inhibition of histone acetylation. This results in accumulation of acetylated histones, chromatin remodeling, transcription of tumor suppressors, and apoptosis of tumor cells. Importantly, it has great selectivity for HDACs over Zn-binding non-HDAC proteins. Pracinostat has demonstrated antiproliferative activity against cancer cell lines and tumors in xenograft mice models. In August 2016, the FDA granted Breakthrough Therapy Designation for this asset.
Back in August 2016, Mei entered into an exclusive agreement with Helsinn for Pracinostat in AML and other potential indications. Re the deal specificity, Helsinn is granted a worldwide exclusive license to develop, manufacture, and commercialize Pracinostat, and is responsible for funding its global development and commercialization. Mei received the $15M in upfront payment in August 2016 and another $5M in March 2017. Moreover, Mei can earn up to $444M in regulatory and sales-based milestones. Furthermore, the company is able to enjoy the royalty payments on the net sales of Pracinostat in the US in the high teens.
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