endocyte inc (ECYT) Key Developments
Endocyte to Present Data on EC1456 at the European Cancer Congress 2015
Sep 21 15
Endocyte, Inc. announced that data from ongoing phase 1 trials of Endocyte's SMDC EC1456 will be presented at the European Cancer Congress 2015, being held Sept. 25 - 29, 2015, in Vienna, Austria. 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.
Endocyte, Inc. Announces Final Overall Survival Results From Phase 2b TARGET Trial in Non-Small Cell Lung Cancer Patients
Sep 7 15
Endocyte, Inc. presented the final overall survival analysis from the Phase 2b TARGET trial evaluating its small molecule drug conjugate (SMDC) vintafolide in combination with docetaxel in patients with FR positive recurrent NSCLC at the World Conference on Lung Cancer in Denver, Colorado. Vintafolide plus docetaxel improved overall survival by 2.7 months in NSCLC regardless of histology (Median OS 11.5 vs. 8.8 months, OS HR=0.86, 95% CI [0.58, 1.26]). In the predefined subset analysis of patients with adenocarcinoma, which expresses higher levels of folate receptor, vintafolide plus docetaxel improved OS by 5.9 months (12.5 vs. 6.6 months, HR=0.72, 95% CI [0.44, 1.16]). OS for vintafolide as single agent was similar to docetaxel (OS 8.4 vs. 8.8 months, HR=1.02, 95% CI [0.70, 1.50]). The study previously reported that the PFS primary endpoint was met, (HR=0.75, 95% CI [0.52, 1.09]) regardless of histology and in the adenocarcinoma subgroup (HR=0.73, 95% CI [0.46, 1.16]). The safety profile of the combination arm was consistent with those observed with docetaxel alone and vintafolide alone, though a higher rate of hematologic and peripheral neuropathy adverse events were observed in the combination arm. EC1456 is a second generation folate-targeted SMDC, which delivers a more potent drug payload at higher doses than vintafolide.
Endocyte, Inc. Presents at Ladenburg Thalmann 2015 Healthcare Conference, Sep-29-2015 03:30 PM
Sep 3 15
Endocyte, Inc. Presents at Ladenburg Thalmann 2015 Healthcare Conference, Sep-29-2015 03:30 PM. Venue: Sofitel Hotel, New York, New York, United States.
Endocyte, Inc. Announces Unaudited Consolidated Financial Results for the Second Quarter and Six Months Ended June 30, 2015; Reiterates Cash Guidance for 2015; Provides Update on Clinical Progress
Aug 4 15
Endocyte, Inc. announced unaudited consolidated financial results for the second quarter and six months ended June 30, 2015. For the quarter, collaboration revenue was $0.013 million against $49.168 million a year ago. Loss from operations was $10.782 million against income from operation of $22.210 million a year ago. Interest income, net was $0.185 million against $0.168 million a year ago. Net loss was $10.604 million or $0.25 per diluted share against net income of $22.356 million or $0.52 per diluted share a year ago. Research and development expenses were $6.7 million for the second quarter of 2015, compared to $19.0 million for the same period in 2014. Research and development expenses were $6.7 million for the second quarter of 2015, compared to $19.0 million for the same period in 2014. The decrease in research and development expense was primarily attributable to a decrease in expenses related to the TARGET trial, which is now completed, and the PROCEED trial, which was terminated in May 2014 and for which a termination charge of $4.7 million was recorded in the second quarter of 2014, along with a decrease in manufacturing expenses for vintafolide and etarfolatide related to pre-commercial activity.
For the six months, collaboration revenue was $0.025 million against $66.437 million a year ago. Loss from operations was $21.747 million against income from operation of $18.991 million a year ago. Interest income, net was $0.337 million against $0.253 million a year ago. Net loss was $21.474 million or $0.47 per diluted share against net income of $19.215 million or $0.51 per diluted share a year ago.
The company reiterated its expectation that its 2015 year-end cash balance will exceed $155 million. Spending is expected to increase from current levels as the trials for EC1456 and EC1169 are expanded once the maximum tolerated doses are determined.
The company also announced that the final overall survival results from the Phase 2 TARGET trial of EC145 in NSCLC have been accepted for oral presentation at the IASLC World Conference on Lung Cancer to be held in Denver from September 6-9, 2015. While development efforts have focused on the second generation SMDCs, results of this trial provide insights into the effectiveness of the SMDC platform, particularly in targeting the folate receptor.
Endocyte, Inc. Appoints Dr. Alison A. Armour as Chief Medical Officer
Aug 4 15
Endocyte, Inc. announced that Alison A. Armour has been appointed as chief medical officer. Prior to joining Endocyte, Dr. Armour served as vice president of oncology at Novartis and GSK, where she led the global strategic TYKERB development team in breast cancer and was accountable for a large matrix team composed of clinical, medical, regulatory, statistics, medical affairs, science and commercial colleagues based in multiple sites in the US, UK and Japan.