• Company Expects to File IND for Therapeutic Agent in 2013
  • Human Study of Companion Imaging Agent EC0652 Demonstrates Safety and Binding Specificity

WEST LAFAYETTE, IN, USA I January 29, 2013 I Endocyte, Inc. (ECYT), a biopharmaceutical company developing targeted small molecule drug conjugates (SMDCs) and companion imaging diagnostics for personalized therapy, today announced the achievement of key objectives in a Phase 0 study of EC0652, a diagnostic imaging agent targeting prostate specific membrane antigen (PSMA), a protein expressed on cancer cells originating from the prostate as well as on tumor neovasculature. Based on the observed safety of the agent and its specificity for binding to diseased cells, Endocyte is advancing the development of both the diagnostic imaging agent, EC0652, and the corresponding therapeutic agent, EC1069, a proprietary PSMA-targeted SMDC linked with the potent anti-cancer drug tubulysin. Endocyte expects to file an Investigational New Drug (IND) application for EC1069 by the end of 2013.

The new prostate cancer imaging agent EC0652, also termed DUPA-99mTc, is a conjugate of a high affinity PSMA-targeting ligand, 2-[3-(1, 3-dicarboxy propyl)-ureido] pentanedioic acid (DUPA) to technetium 99m (99mTc). The discovery process utilized a unique structure-based drug design approach to synthesize the ideal targeting ligand for binding to PSMA. The corresponding SMDC, EC1069, utilizes the same targeting ligand.

"DUPA has demonstrated excellent localization to prostate cancer regionally and at distant sites," said Thomas A. Gardner, M.D., professor of urology at Indiana University Health. "These results encourage us to investigate this novel agent for both imaging and therapeutic applications for prostate cancer."

"We have generated a number of unique development methods to optimize the design of our targeting ligands and maximize specificity, and our approach is yielding superior results with new ligands of much higher specificity than other methods," commented Philip Low, Ph.D., Endocyte’s chief science officer. "We are also using this approach to develop ligands to target several other diseases as we continue to expand our SMDC platform."

The imaging study is being led by the Purdue University Center for Cancer Research and performed at the Department of Urology at the Indiana University School of Medicine. Detailed results of this study are anticipated to be presented at an upcoming medical conference.

About Endocyte

Endocyte is a biopharmaceutical company developing targeted therapies for the treatment of cancer and inflammatory diseases. Endocyte uses its proprietary technology to create novel SMDCs and companion imaging diagnostics for personalized targeted therapies. The company’s SMDCs actively target receptors that are over-expressed on diseased cells, relative to healthy cells. This targeted approach is designed to enable the treatment of patients with highly active drugs at greater doses, delivered more frequently, and over longer periods of time than would be possible with the untargeted drug alone. The companion imaging diagnostics are designed to identify patients whose disease over-expresses the target of the therapy and who are therefore more likely to benefit from treatment.

SOURCE: Endocyte