On May 26, 2016 Endocyte, Inc. (NASDAQ:ECYT), a leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy, reported that two posters will be presented on its lead, clinical-stage assets, EC1456 and EC1169, at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held June 3 – 7, 2016, in Chicago (Press release, Endocyte, MAY 26, 2016, View Source [SID:1234512816]).

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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 99mTc-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/m2 on the weekly (QW) schedule and at 7.5 mg/m2 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 99mTc-EC0652 (PSMA expression not an eligibility criteria). Findings include:

99mTC-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/m2 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).