MEI Pharma Grabs $75 Million Private Placement to Drive Registration Study for P13K Inhibitor Program


Shares of MEI Pharma, Inc. are up nearly 9 percent this morning after the company snagged $75 million in a private placement that was led by Vivo Capital and CAM Capital. The funds will be used to treat adults with relapsed or refractory follicular lymphoma with a P13K inhibitor.

San Diego-based MEI Pharma said it will use the proceeds from the private financing round to fund continued clinical development of MEI-401, a selective oral inhibitor of phosphatidylinositol 3-kinase (PI3K) delta. The company’s program is expected to enter a single-agent registration study in 2018 for the treatment of adults with relapsed or refractory follicular lymphoma, MEI Pharma said this morning.

Daniel Gold, president and chief executive officer of MEI Pharma, said the addition of the $75 million provides the company with enough funds to “progress a robust portfolio of potential first-in-class and best-in-class oncology drugs.”

“With the start of a planned registration study of ME-401, we anticipate having two programs in pivotal trials by the end of 2018. In addition we have two other clinical stage programs, including voruciclib, an oral CDK9 inhibitor that we believe may have potential across a number of oncology indications, particularly in combination with venetoclax,” Gold said in a statement.

The company plans to present data from its Phase Ib ME-401 study in relapsed/refractory CLL and FL at the American Society of Clinical Oncology meeting next month in Chicago. In addition, the company said it will present data from an investigator-initiated study of ME-344 in HER2-negative breast cancer at ASCO 2018.

MEI isn’t the only company to push a P13K program. Last month SignalRx Pharmaceuticals Inc. announced its dual PI3K/BRD4 inhibitor SF2523 suppresses HIV-1 replication and eliminates the latent infectious state. There are some concerns with P13K inhibitors. Gilead Sciences secured approval for its blood cancer drug, Zydelig, a P13K inhibitor, but that approval came with a Boxed Warning regarding serious and fatal toxicities including liver toxicity, diarrhea and colon inflammation (colitis), lung inflammation (pneumonitis) and intestinal perforation.

MEI though is undaunted and is pushing forward with its program. This morning the company said it entered into an agreement for the sale of 33,003,296 shares of its common stock and warrants stock in a private placement led by Vivo Capital and CAM Capital. Other participants included New Enterprise Associates, Perceptive Advisors, The Biotechnology Value Fund, Boxer Capital of Tavistock Group, and Amzak Health, as well as other new and existing investors.

In addition to driving its P13K program, MEI said it will use a portion of the funding for general corporate purposes.   

Last week MEI released its quarterly financial report that showed that the U.S. Food and Drug Administration cleared the company's Investigational New Drug Application (IND) for voruciclib. MEI said it expects to initiate a Phase 1 single-agent study in relapsed/refractory B cell malignancies in the first half of 2018.

MEI closed out its quarter with $36.2 million in cash, cash equivalents and short-term investments and no outstanding debt.

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