WEST LAFAYETTE, Ind., May 26, 2016 (GLOBE NEWSWIRE) -- Endocyte, Inc. (NASDAQ: ECYT ), a leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy, today announced that two posters will be presented on its lead, clinical-stage assets, EC1456 and EC1169, at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting being held June 3 - 7, 2016, in Chicago.
Updated data will be presented on EC1456-01, a phase 1 dose escalation study in patients with advanced solid tumors who were imaged to assess folate receptor expression with 99m Tc-etarfolatide (FR expression not an eligibility criteria). Findings include:
- EC1456 is generally well tolerated in previously treated cancer patients at the doses administered to date. Fifty-eight patients have been treated and are evaluable for cycle 1 toxicity. To date, the maximum tolerated dose (MTD) has not been determined. Dose escalation is ongoing at 12.5 mg/m 2 on the weekly (QW) schedule and at 7.5 mg/m 2 on the twice weekly (BIW) schedule.
- Anti-tumor activity is suggested with lesion-level responses and 20 patients demonstrating stable disease (SD) and SD ≥ 3 months being observed in 5 BIW patients and 5 QW patients.
An update also will be provided for EC1169-01, a phase 1 dose escalation study in patients with metastatic, castration-resistant prostate cancer (mCRPC) who failed prior chemotherapy. All patients were imaged to assess PSMA expression with 99m Tc-EC0652 (PSMA expression not an eligibility criteria). Findings include:
- 99m TC-EC0652 uptake was observed in all patients in both bone and soft tissue lesions. Both positive and negative lesion uptake was observed.
- EC1169 is well tolerated in mCRPC patients at the doses administered to date. Twenty-eight patients have been treated and are evaluable for cycle 1 toxicity (TIW: 5 patients; QW: 23 patients). To date, the MTD has not been determined. Dose escalation is ongoing at 6.5 mg/m 2 on the QW schedule.
- Anti-tumor activity is suggested with lesion-level reductions. Furthermore, fifteen patients have demonstrated stable disease, and 2 patients have demonstrated a ≥50% max decline in PSA.
The posters will be available on Endocyte’s website following presentation at the conference.
Presentations are as follows:
| Abstract #: | 2585 | ||
| Title: | A phase 1 dose-escalation study of the folic acid-tubulysin small molecule drug conjugate (SMDC) folate-tubulysin EC1456 in advanced cancer patients | ||
| Presenter: | Jasgit C. Sachdev, MD, Scottsdale Healthcare | ||
| When: | Sunday, June 5, 8 a.m. – 11:30 a.m. EDT | ||
| Session Title: | Developmental Therapeutics – Clinical Pharmacology and Experimental Therapeutics | ||
| Location: | Hall A | ||
| Abstract #: | 2586 | ||
| Title: | Phase 1 study of the PSMA-targeted tubulysin small-molecule drug conjugate EC1169 in patients with metastatic castrate-resistant prostate cancer (mCRPC) | ||
| Presenter: | Michael J. Morris, MD, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College | ||
| When: | Sunday, June 5, 8 a.m. – 11:30 a.m. EDT | ||
| Session Title: | Developmental Therapeutics – Clinical Pharmacology and Experimental Therapeutics | ||
| Location: | Hall A | ||
About EC1456
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 ).
About EC1169
EC1169 is an investigational, proprietary, injectable SMDC consisting of a PSMA targeting ligand (DUPA analog) linked to a potent cytotoxic agent, tubulysin B hydrazide (TubBH). EC1169 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. EC1169 is currently being evaluated in a phase 1 study in patients with metastatic, castration-resistant prostate cancer (mCRPC) (ClinicalTrials.gov Identifier: NCT02202447 ).
About Endocyte
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 .
Contacts: Stephanie Ascher, Stern Investor Relations, Inc., (212) 362-1200, stephanie@sternir.com
