On September 22, 2017 Eleven Biotherapeutics, Inc. (NASDAQ:EBIO), a late-stage clinical oncology company advancing novel product candidates based on its Targeted Protein Therapeutics (TPTs) platform, reported that it has completed the manufacturing of all Vicinium necessary for its ongoing Phase 3 registration trial in patients with non-muscle invasive bladder cancer (NMIBC), and for its Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (Press release, Eleven Biotherapeutics, SEP 22, 2017, View Source [SID1234520610]). In conjunction with this achievement, Eleven is ending its large-scale manufacturing activities and redirecting resources toward completing its Phase 3 trial and preparing for discussions with the U.S. Food and Drug Administration (FDA) regarding, as appropriate, the submission of a Biologics License Application (BLA) for Vicinium in patients with NMIBC. This change will include a reduction of headcount and associated cost savings. For commercialization, the Company plans to engage an external, Current Good Manufacturing Practice (cGMP) compliant, contract manufacturer.
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"We are pleased to have completed the manufacture of all Vicinium necessary for our clinical trials, which marks another key achievement on our path to registration," said Stephen Hurly, Chief Executive Officer of Eleven Biotherapeutics. "Ending our large-scale manufacturing operations will result in significant cost savings and enable a refocus of our resources toward completing our clinical trials and preparing to meet with the FDA. We are very thankful to our manufacturing team for their hard work and dedicated service, which played a key role in maturing Eleven into a late-stage company, and brought us closer to our goal of delivering transformational medicines to patients."
About Vicinium
Vicinium is manufactured as a single protein anti-epithelial cell adhesion molecule (anti-EpCAM) fusion protein fused with Pseudomonas Exotoxin A (ETA) designed to specifically target and deliver a potent anti-cancer payload directly into tumor cells. It is constructed with a stable, genetically-engineered linker to ensure its potent protein payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues thereby improving the compound’s safety. Vicinium’s one-step manufacturing process offers significant cost advantages and results in the production of a homogenous product, with less batch-to-batch variability than most antibody drug conjugates. Vicinium is currently in a Phase 3 registration clinical trial for the treatment of high-grade non-muscle invasive bladder cancer (NMIBC) in patients who have previously received two courses of Bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Eleven Biotherapeutics intends to enroll 134 subjects in the trial, including 77 subjects with carcinoma in situ (CIS), at over 70 centers in the United States and Canada. Primary and secondary endpoints include complete response (CR) in CIS subjects, time to disease recurrence and event free survival. The Company expects to complete patient enrollment in the first quarter of 2018 and to report topline three-month data in mid-2018.