WEST LAFAYETTE, Ind., April 4, 2014 (GLOBE NEWSWIRE) -- Endocyte, Inc. (Nasdaq:ECYT) 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, today announced that three posters will be presented by Endocyte scientists at the 2014 Annual Meeting of the American Association for Cancer Research (AACR) to be held in San Diego, April 5-9, 2014.
"We continue to advance our pipeline of wholly-owned candidates based on our SDMC technology platform, and we look forward to discussing these exciting new findings at the AACR Annual Meeting," said Christopher Leamon, Ph.D., vice president of research. "For the first time we are disclosing the preclinical data for Endocyte's folate-targeted tubulysin SMDC, named EC1456, which is specifically targeted to folate receptor-expressing tumors and produces curative activity in 100 percent of animals treated under conditions that do not cause appreciable toxicity. EC1456 was further confirmed to be highly active against folate receptor-positive tumors resistant to vintafolide, paclitaxel and cisplatin. EC1456 is currently being evaluated in a Phase 1 trial in patients with advanced solid tumors along with etarfolatide, which is Endocyte's companion imaging agent for anatomically assessing tumor-associated folate receptor expression in real time. In a second presentation we will reveal a structure-activity relationship analysis that resulted in the discovery of a highly potent prostate-specific membrane antigen (PSMA)-targeted tubulysin SMDC. Preclinical development for this new agent, called EC1169 (previously named EC1719), was recently completed, and clinical development is expected to begin in the near term. Finally, we will present data in a third poster which demonstrate that both vintafolide and etarfolatide are specifically transported by the folate receptor and are not substrates for the reduced folate carrier or the proton-coupled folate transporter, two proteins commonly expressed on normal tissues."
Presentations are as follows:
|Title:||Pre-clinical development of EC1456: A potent Folate targeted Tubulysin SMDC|
|When:||Sunday, April 6, 1 p.m. – 5p.m. PDT|
|Session Title:||Novel Cytotoxic Strategies|
|Location:||Hall A-E, Poster Section 34, Poster Board 19|
|Title:||Structure-activity relationship studies for PSMA-targeted tubulysin conjugates|
|When:||Tuesday, April 08, 1 p.m. – 5p.m. PDT|
|Session Title:||Drug Delivery|
|Location:||Hall A-E, Poster Section 26, Poster Board 4|
|Title:||The folate receptor-targeted agents, vintafolide and etarfolatide, are not substrates for the reduced folate carrier or the proton-coupled folate transporter|
|When:||Tuesday, April 8, 1 p.m. – 5p.m. PDT|
|Session Title:||Novel Drug Discovery and Delivery Systems|
|Location:||Hall A-E, Poster Section 33, Poster Board 21|
About Vintafolide, Etarfolatide and IV Folic Acid
Vintafolide is an investigational conjugate of folic acid (vitamin B9) linked to an anti-cancer agent, the potent vinca alkaloid desacetylvinblastine hydrazide (DAVLBH). Since cancer cells generally consume higher levels of folate than normal cells to fuel their growth, some cancer cell types - including ovarian and NSCLC - have high concentrations of the folate receptor on their surface. Vintafolide is designed to selectively target the folate receptor to deliver the anti-cancer agent to the cancerous tissue. Tumors that have high concentrations of the folate receptor are identified by etarfolatide, a non-invasive imaging diagnostic agent. Intravenous folic acid is used with 99mTc-etarfolatide for the enhancement of image quality.
Vintafolide, etarfolatide and IV folic acid have been granted orphan drug status by the EMA, and the EMA's Committee for Medicinal Products for Human Use (CHMP) has issued positive opinions for the Conditional Marketing Authorisations of vintafolide, etarfolatide and IV folic acid for the treatment of adult patients with folate receptor-positive on all target lesions, platinum resistant ovarian cancer (PROC), in combination with pegylated liposomal doxorubicin (PLD). The U.S. Food and Drug Administration has also granted orphan drug status to vintafolide and etarfolatide. Further evaluation is ongoing in the global PROCEED Phase 3 clinical trial in folate receptor-positive (FR 100%) platinum-resistant ovarian cancer (ClinicalTrials.gov Identifier: NCT01170650). The randomized TARGET Phase 2b study of vintafolide in non-small cell lung cancer has completed enrollment (ClinicalTrials.gov Identifier: NCT01577654), and a Phase 2 study in triple-negative breast cancer is expected to be initiated in Q2 (ClinicalTrials.gov Identifier: NCT01953536).
EC1456 is an investigational proprietary, injectable, SMDC consisting of folate (vitamin B9) linked to a potent cytotoxic agent, tubulysin B hydrazide (TubBH). EC1456 is wholly owned by Endocyte. TubBH is a member of the tubulysin class of anti-neoplastic agents that inhibit the polymerization of tubulin into microtubules, a critical component during cell division. The targeting ligand folate, essential for cell division, has been investigated with vintafolide. EC1456 is currently being evaluated in a Phase 1 study in patients with advanced solid tumors (ClinicalTrials.gov Identifier: NCT01999738).
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. For more information, visit http://www.endocyte.com.
Endocyte Forward-Looking Statement
Certain of the statements made in this press release are forward-looking, such as those, among others, relating to the company's expectations for seeking regulatory approval and commercial launch of its products, including any conditional marketing authorization from the EMA, initiation of future clinical trials, and expectations for the receipt of milestones, royalties or other profits from the company's partnership with Merck. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include risks that the company may experience delays in the completion of its clinical trials (whether caused by competition, adverse events, patient enrollment rates, unavailability of clinical trial materials, regulatory issues or other factors); risks that data from its clinical trials may not be indicative of subsequent clinical trial results; risks related to the safety and efficacy of the company's product candidates, the goals of its development activities, estimates of the potential markets for its product candidates, estimates of the capacity of manufacturing and other facilities required to support its product candidates, projected cash needs, and expected financial results. More information about the risks and uncertainties faced by Endocyte, Inc. is contained in the company's periodic reports filed with the Securities and Exchange Commission. Endocyte, Inc. disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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