Rushville Republican

March 25, 2014

Purdue University discovery leads to Endocyte drug

Receives positive opinion from EU regulatory body


Rushville Republican

---- — WEST LAFAYETTE - A cancer targeting innovation discovered more than two decades ago by a Purdue University professor of chemistry and his then-graduate research assistant could be closer to benefiting patients with ovarian and lung cancers and other diseases after receiving positive opinions from clinical trials conducted in the U.S. and Europe.

The drug, vintafolide, is the result of research conducted over the past 24 years ago by Philip S. Low, the Ralph C. Corley Distinguished Professor of Chemistry and director of the Purdue Center for Drug Discovery, and Christopher P. Leamon, then his graduate research assistant. Low is chief science officer at Endocyte Inc., a company created to further develop and commercialize Low’s drug innovations, and Leamon is the vice president of research and development of the company.

On Friday (March 21) Endocyte Inc. and its partner Merck & Co. Inc., announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued positive opinions for the Conditional Marketing Authorizations of the cancer drug VYNFINIT® (vintafolide) and companion imaging components, FOLCEPRI® (etarfolatide), and NEOCEPRI® (intravenous (IV) folic acid), for the treatment of adult patients with folate receptor-positive, platinum-resistant, ovarian cancer, in combination with pegylated liposomal doxorubicin (PLD), a standard treatment.

Low and Leamon’s innovation attaches a drug or imaging agent to a modified form of the vitamin folic acid, which acts as a “homing device” to seek out and attach to ovarian cancer cells. Most ovarian cancer cells require large amounts of the vitamin to grow and divide, and special receptors on the cell’s surface grab the vitamin - and whatever is linked to it - and pull it inside. Not all cancer cells express the folate receptor, and a simple test is necessary to determine if a specific patient’s cancer expresses the receptor in large enough quantities for the technique to work, Low said.

Ovarian cancer has one of the highest rates of folate receptor expression at about 85 percent. Approximately 80 percent of endometrial, lung and kidney cancers, and 50 percent of breast and colon cancers also express the receptor, Low said.

Leamon added that the positive opinions from the CHMP show the importance of persistence in developing cancer-fighting therapeutics, since many obstacles have been encountered and then solved along this rocky pathway to success.

“It takes a lot of resources, including time, to bring research from the laboratory to clinical trials, and then be considered for approval by national and international agencies,” Low said. “There is a strong team at Endocyte, Merck and Purdue University that has worked well together to develop new therapies for people affected by cancer.”

“It is always good news when promising new pharmaceuticals move one step closer to the market, and this is particularly gratifying because we know how hard Phil, Chris and the whole Endocyte team are working to bring vintafolide to the public where it can help people,” said Purdue University President Mitch Daniels. “This is just one of many medical advancements that Phil and other Purdue researchers are developing, and that is one reason why Purdue is investing $29 million in a new drug discovery building. We anticipate there will be many other companies like Endocyte originating from Purdue innovations.”

The drug discovery building and Low’s work are part of the Purdue Moves drug discovery initiative to translate basic research into life-changing treatments.

The CHMP positive opinions will be reviewed by the European Commission. If approved, the European Commission will grant a centralized marketing authorization with unified labeling that is valid in the 28 countries that are members of the European Union, as well as European Economic Area members Iceland, Liechtenstein and Norway. The European Commission usually issues a final legally binding decision within three months of a CHMP opinion.

About Endocyte Inc.

Endocyte is a biopharmaceutical company and leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy in cancer and other serious diseases. Endocyte uses its proprietary technology to create novel SMDCs and companion imaging agents for personalized targeted therapies. The company’s SMDCs actively target receptors that are expressed or over-expressed on diseased cells, relative to healthy cells. This targeted approach is designed to enable the treatment of patients with highly potent drugs into these cells. The companion imaging agents are designed to identify patients whose disease expresses the molecular target of the therapy and who therefore may be more likely to benefit from treatment.

About Purdue Moves

Drug discovery is among 10 targeted priorities spelled out in Purdue Moves, an initiative designed to broaden the university’s global impact and enhance educational opportunities for its students. All of the moves fall into four broad categories: science, technology, engineering and math (STEM) leadership; world-changing research; transformative education; and affordability and accessibility. Additional information about Purdue Moves is available online at http://www.purdue.edu/purduemoves