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Eleven Biotherapeutics Inc’s (EBIO) Positive Phase 3 Trial Data in NMIBC Sends Investors on a Buying Frenzy


Eleven Biotherapeutics Inc (NASDAQ:EBIO) shares are jumping up like wildfire today on back of an encouraging Phase 3 trial data preview in bladder cancer. The stock has gained 25% in value in high anticipation of the American Urological Association Annual Meeting thanks to an abstract that shows EBIO’s lead candidate has been tolerated well by patients in the study.

Vicinium, the biotech player’s asset in non-muscle invasive bladder cancer (NMIBC) is being investigated in patients who had prior treatments with bacillus Calmette- Guérin (BCG). Preliminary efficacy and safety data from the pivotal Phase 3 Vista trial has been chosen for presentation during a plenary session presently set for Monday, May 21, 2018 at 11:00 a.m. PT at the American Urological Association Annual Meeting taking place in San Francisco. For context, 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.

Analyst Ratings

According to TipRanks, EBIO just won over a bull: Swayampakula Ramakanth of H.C. Wainwright rates a Buy rating on the stock with a $2 price target, which implies a nearly 54% upside from where the stock is currently trading.