Targeting the tricky PI3K pathway in cancer, MEI gets $75M to push program through registration study
MEI Pharma $MEIP, a small public company in San Diego, has raised $75 million in a private sale of stock to push forward its PI3K inhibitor — a class of drugs with a mixed history — to treat a common non-Hodgkin lymphoma.
The company acquired the program back in 2013 from San Francisco-based Pathway Therapeutics, and has brought the oral drug to clinical proof-of-concept trials in both follicular lymphoma and indolent lymphoma and diffuse large B-cell lymphoma.
MEI’s president and CEO Daniel Gold said the new funds will get its PI3K inhibitor (called ME-401) into a registration study.
The PI3K field — once a hot prospect in R&D — has lost a bit of its allure in recent years. The pathway is one of the most frequently dysregulated pathways in cancer, and therefore more than 40 compounds targeting the pathway have been tested in clinical trials involving patients with a range of different cancers. The clinical development of many of these agents, however, has stymied before reaching late-stage trials. Plus, the antitumor activity observed thus far has been limited, and some toxicities were found to be prohibitive.
Not to mention, Gilead’s Zydelig got slapped with a black box warning for dangerous side effects, and the rest of the field is still quite early in development.
Still, the FDA has approved some PI3K’s that have enjoyed success. Just last fall, Bayer’s Aliqopa (copanlisib) got the FDA OK, setting itself up as a potential rival to Imbruvica. In addition, Verastem, a company near Boston, has filed for approval of AbbVie’s castoff duvelisib, tackling chronic lymphocytic leukemia, small lymphocytic lymphoma, and follicular lymphoma.
MEI Pharma — along with several others — doesn’t appear to be cowed by challenges in the space.
“With this financing involving leading healthcare investment firms, we are well funded to progress a robust portfolio of potential first-in-class and best-in-class oncology drugs,” Gold said in a statement. “With the start of a planned registration study of ME-401, we anticipate having two programs in pivotal trials by the end of 2018.”
The company’s private placement was 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.