CAMBRIDGE, Mass.--(BUSINESS WIRE)--Eleven Biotherapeutics, Inc. (NASDAQ: EBIO), a late-stage clinical company developing next-generation antibody-drug conjugate (ADC) therapies for the treatment of cancer, today announced that preliminary efficacy and safety data from its ongoing Phase 3 VISTA trial of Vicinium™ in patients with non-muscle invasive bladder cancer (NMIBC) who have been previously treated with bacillus Calmette-Guérin (BCG) have been selected for presentation during a plenary session currently scheduled for Monday, May 21, 2018 at 11:00 a.m. PT at the American Urological Association Annual Meeting taking place in San Francisco. Vicinium is a fusion protein, designed to be a next-generation ADC, that targets the epithelial cell adhesion molecule (EpCAM) antigens on the surface of bladder cancer cells to deliver a potent cytotoxin into those cells.
Data, as reported in the abstract published online today, are from a subgroup of the first 75 evaluable carcinoma in situ patients. Within these patients, preliminary findings show that greater than 95 percent expressed EpCAM on the surface of tumor cells, the target of Vicinium. Efficacy data as measured by complete response rates at three-months will be reported during the plenary session. Vicinium has been well-tolerated. Treatment-related adverse events (AEs) were reported in 46 percent of patients, the majority of which were Grade 1 or 2. The most common of these were dysuria (12%), UTI or pollakiuria (10%) and hematuria (7%), which are often associated with catheter-delivered treatments into the bladder and bladder cancer itself. As of the December 2017 data cut off, three treatment-related serious AEs were reported, including renal failure (CTCAE Grade 5) with cholestatic hepatitis (Grade 4) in one patient and acute kidney injury (Grade 3) in a second patient who recovered.
In March 2018, recruitment was completed in the VISTA trial, a single-arm registration study designed in accordance with U.S. Food and Drug Administration’s final guidance for developing treatments for BCG-unresponsive NMIBC.
“When treatment with today’s standard of care, BCG, is no longer an option, the next treatment option is typically removal of the patient’s bladder, a challenging, life-altering procedure that many patients elect not to undergo,” said Stephen Hurly, president and chief executive officer of Eleven Biotherapeutics. “Vicinium has demonstrated that it is a well-tolerated and active agent in patients with BCG unresponsive NMIBC in studies to-date. We are excited to be presenting the first preliminary data from our Phase 3 VISTA trial of Vicinium for patients with NMIBC at this year’s AUA meeting. During our plenary presentation, we will share initial efficacy findings and data supporting the favorable safety we have observed so far with Vicinium. We believe Vicinium holds tremendous potential as a treatment for bladder cancer, and we look forward to sharing these and additional data later in the year.”
The company plans to host a conference call in conjunction with the data presentation, with details to follow.
About the VISTA Clinical Trial
The VISTA trial is an
open-label, multicenter, single-arm Phase 3 clinical trial evaluating
the efficacy and tolerability of Vicinium™ in patients with high-risk
non-muscle invasive bladder cancer (NMIBC) that is carcinoma in situ
(CIS, cancer found on the inner lining of the bladder that has not
spread into muscle or other tissue) or papillary (cancer that has grown
from the bladder lining out into the bladder but has not spread into
muscle or other tissue), who have been previously treated with bacillus
Calmette-Guérin (BCG). The primary endpoint of the trial is the complete
response rate in patients with CIS with or without papillary disease and
durability of that response. Patients in the study receive locally
administered Vicinium twice a week for six weeks, followed by
once-weekly treatment for another six weeks, then treatment every other
week for up to two years. Topline data assessing responses and
durability of responses at three-months on treatment are expected in
mid-2018, with 12-month data anticipated in mid-2019.
About Vicinium™
Vicinium™, Eleven Biotherapeutics’ lead
product candidate, is a next-generation antibody-drug conjugate
developed using the company’s proprietary Targeted Protein Therapeutics
platform. Vicinium is comprised of a recombinant fusion protein that
targets epithelial cell adhesion molecule (EpCAM) antigens on the
surface of tumor cells to deliver a potent protein payload, Pseudomonas
Exotoxin A (ETA). Vicinium is constructed with a stable, genetically
engineered linker to ensure the 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 its safety. In prior
clinical studies conducted by Eleven Biotherapeutics, EpCAM has been
shown to be overexpressed in non-muscle invasive bladder cancer (NMIBC)
cells with minimal to no EpCAM expression observed on normal bladder
cells. Eleven Biotherapeutics is currently conducting the Phase 3 VISTA
trial, designed to support the registration of Vicinium for the
treatment of NMIBC in patients who have previously received two courses
of bacillus Calmette-Guérin (BCG) and whose disease is now
BCG-unresponsive. Topline, three-month data from the trial are expected
in mid-2018. Additionally, Eleven Biotherapeutics believes that
Vicinium’s cancer cell-killing properties promote an anti-tumor immune
response that may potentially combine well with immuno-oncology drugs,
such as checkpoint inhibitors. The activity of Vicinium in
BCG-unresponsive NMIBC is also being explored at the US National Cancer
Institute in combination with AstraZeneca’s immune checkpoint inhibitor
durvalumab.
About Eleven Biotherapeutics
Eleven Biotherapeutics, Inc. is
a late-stage clinical company advancing next-generation antibody-drug
conjugate therapies for the treatment of cancer based on the company’s
Targeted Protein Therapeutics platform. The company’s lead program,
Vicinium™, is currently in a Phase 3 registration trial for the
treatment of non-muscle invasive bladder cancer, with topline data
expected in mid-2018. Vicinium incorporates a tumor-targeting antibody
fragment and a protein cytotoxic payload into a single protein molecule
designed to selectively and effectively kill cancer cells while sparing
healthy cells. For more information, please visit the company’s website
at www.elevenbio.com.
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uncertainties inherent in the initiation and conduct of clinical trials,
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interim results from a clinical trial will be predictive of the final
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