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Last Post: 10/16/2019 9:17:06 AM - Followers: 147 - Board type: Free - Posts Today: 0



https://www.businesswire.com/news/home/20180516005210/en/Eleven-Biotherapeutics-Announces-Corporate-Change-Sesen-Bio ;                                                                                            
 
ABOUT SESEN

Sesen Bio is a late-stage company developing next-generation antibody-drug conjugate (ADC) therapies for patients with cancer. Our approach aims to overcome limitations of traditional ADCs by incorporating a tumor-targeting antibody fragment and a protein cytotoxic payload into a single protein molecule designed to selectively, effectively and broadly kill cancer cells while sparing healthy cells. These single protein molecules are known as fusion proteins.

Our lead program, Vicinium™, is a novel fusion protein currently in Phase 3 development for the treatment of patients with non-muscle invasive bladder cancer who have been previously treated with bacillus Calmette-Guérin (BCG).

 
 
                                           
 
 

VICINIUM™

Our lead product candidate, Vicinium (VB4-845), is a next-generation ADC called a fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent cytotoxin, Pseudomonas Exotoxin A (ETA) directly to cancer cells. Unlike many ADC payloads, ETA can efficiently kill both replicating and non-replicating cancer cells and is not subject to the multidrug resistance pumps that can protect cancer cells from small molecule drug payloads.

Vicinium is constructed with a stable, genetically-engineered, peptide linker to ensure its potent protein payload remains attached until it is successfully delivered into the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. We believe this design will significantly reduce the potential for systemic toxicities and increase the probability of killing replicating and non-replicating cancer cells. Historically, separation of payload and the antibody has been a common issue with ADCs, which can cause off-target toxicities and decrease the amount of drug that ultimately reaches the target cancer cells.

Vicinium is currently being evaluated in the Phase 3 VISTA trial for the treatment of patients with non-muscle invasive bladder cancer (NMIBC) who have been previously treated with bacillus Calmette-Guérin (BCG), which is the current standard of care for NMIBC. While BCG is effective in many patients, challenges with tolerability have been observed and many patients will experience recurrence of disease. If BCG is not effective or a patient can longer receive BCG, the recommended option for treatment is radical cystectomy, the complete removal of the bladder.

In a Phase 2 clinical trial, Vicinium demonstrated a complete response rate of 40 percent at three months, with no drug-related serious adverse events observed in the trial. In addition to its Phase 3 development for NMIBC, Vicinium is being evaluated in a Phase 1 trial in combination with durvalumab, AstraZeneca’s PD-L1 checkpoint inhibitor, in patients with NMIBC.


About the VISTA Trial for NMIBC
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 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 lumen of 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. 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. The trial was fully enrolled in March 2018 and 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.


Expanding Vicinium’s Benefit in Oncology
We also believe Vicinium may have potential treating additional cancers, including squamous cell carcinoma of the head and neck (SCCHN). We are developing an injectable form of Vicinium for the treatment of SCCHN, with Phase 1 trials completed in Russia and Brazil, that have demonstrated anti-tumor activity and safety. Data from these trials also demonstrated that certain patients who were injected with Vicinium in one tumor had responses in non-injected tumors as well, suggesting that Vicinium may promote an anti-tumor immune response and combine well with immunotherapies.

In addition to the Phase 1 trials, we completed a Phase 2 trial in the United States, which demonstrated a reduction in the bidirectional size of the principle targeted tumor observed in 71 percent (10/14) of patients evaluated in the study.


EBIO Investor Relations


 
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SESN News: Current Report Filing (8-k) 09/10/2019 07:02:28 AM
SESN News: Initial Statement of Beneficial Ownership (3) 09/05/2019 05:27:56 PM
SESN News: Sesen Bio to Present at the H.C. Wainwright 21st Annual Global Investment Conference 09/03/2019 07:00:00 AM
SESN News: Current Report Filing (8-k) 08/26/2019 04:46:21 PM
SESN News: Sesen Bio Announces CFO Transition as Company Drives Towards Anticipated Initiation of BLA Submission in 4Q 2019 08/26/2019 04:05:00 PM
PostSubject
#5777   You betcha mrplmer 10/16/19 09:17:06 AM
#5776   SESN would love to see Buyout! swanlinbar 10/16/19 09:09:27 AM
#5775   Excellent presentation by the way, impressive proffetti 10/15/19 03:28:09 PM
#5774   $7.00 that's a hoot. mrplmer 10/15/19 11:46:49 AM
#5773   Sesen Bio 2019 Business Update Presentation 9/10/2019 swanlinbar 10/15/19 11:05:57 AM
#5772   Lots of Big Bidders EOD for SESN-Merck$7.00 swanlinbar 10/14/19 03:45:47 PM
#5770   $4B market mrplmer 10/09/19 11:19:36 AM
#5769   It would depend on when a deal was ElevenWall 10/09/19 11:07:32 AM
#5768   I think you're a little bit light on mrplmer 10/09/19 06:09:16 AM
#5767   Merck. $8.00 ElevenWall 10/09/19 01:22:00 AM
#5766   20 dma crossing the 50 dma. Keeps BooDog 10/07/19 12:00:15 PM
#5765   So who will be the Lucky winner here? mrplmer 10/06/19 02:30:35 PM
#5764   SESN Volume Always Precedes Price swanlinbar 10/03/19 01:47:28 PM
#5763   Not yet. Someone front loaded near a $1 MD3 10/03/19 11:18:41 AM
#5762   Could also be whoever was loading in the MD3 10/02/19 07:02:38 PM
#5761   someone's selling it seems proffetti 10/02/19 06:51:35 PM
#5760   Today we saw the top ... proffetti 10/02/19 06:09:20 PM
#5759   * * $SESN Video Chart 10-02-2019 * * ClayTrader 10/02/19 04:13:39 PM
#5758   SESN lots of volumne last few days,i think swanlinbar 10/02/19 03:42:13 PM
#5757   * * $SESN Video Chart 10-01-2019 * * ClayTrader 10/01/19 06:03:46 PM
#5756   SESN swanlinbar 09/30/19 03:31:00 PM
#5755   Looks that way. MD3 09/29/19 02:47:29 PM
#5754   Chart might attract algo traders just as we ElevenWall 09/29/19 02:38:22 PM
#5753   We might be due for a bit of MD3 09/29/19 02:03:09 PM
#5752   Nope. https://finance.yahoo.com/calendar/earnings?from=2019-09-22&to=2019-09-28& BooDog 09/27/19 02:18:42 PM
#5751   Jenn Nieto ? AugustaFriends 09/27/19 02:03:29 PM
#5750   Interesting. Not seeing it anywhere. I BooDog 09/27/19 02:02:11 PM
#5749   twitter user posting earnings today for this company AugustaFriends 09/27/19 02:00:20 PM
#5748   Been doing well! Thanks for asking. Liking BooDog 09/27/19 01:53:51 PM
#5747   how you been? AugustaFriends 09/27/19 01:45:48 PM
#5746   how you been? AugustaFriends 09/27/19 01:45:47 PM
#5745   some volume today and break 1.21 could spark AugustaFriends 09/27/19 01:45:35 PM
#5744   Looks like not until November. Cheers Augusta, BooDog 09/27/19 01:34:02 PM
#5743   are earnings today? or soon AugustaFriends 09/27/19 12:47:44 PM
#5742   Looks like there's some buying pressure building. BooDog 09/27/19 12:31:50 PM
#5741   Getting some decent premarket volume. BooDog 09/27/19 08:47:46 AM
#5740   took a bite of this at 2 pm........not dirtydozen911 09/20/19 07:28:56 PM
#5739   * * $SESN Video Chart 09-16-2019 * * ClayTrader 09/16/19 05:56:52 PM
#5738   SESN On September 10, 2019, the Company gave swanlinbar 09/16/19 07:49:36 AM
#5737   To call this volume level anemic would be ElevenWall 09/13/19 01:05:18 PM
#5736   Of course it takes time, which is why ElevenWall 09/09/19 09:43:44 AM
#5735   Part of it is dead money. But a Ryoko 09/09/19 09:08:19 AM
#5734   NO you can speak for yourself but NOT mrplmer 09/09/19 08:32:46 AM
#5733   Same reason as everyone else... don’t like being ElevenWall 09/08/19 10:49:59 PM
#5732   Why do you care? I'm sure nothing happens mrplmer 09/06/19 10:56:43 AM
#5731   More news about more shares for management. Are ElevenWall 09/06/19 09:09:20 AM
#5730   Don't think it'll be testing the 52wk low BooDog 09/05/19 09:44:42 AM
#5729   SP falling. Quick Tom, hire some more ElevenWall 09/03/19 01:56:37 PM
#5728   How many more cronies does Sneaky Tom, Featherer ElevenWall 08/28/19 11:45:37 AM
#5727   Sneaky Tom sure is in a hurry to ElevenWall 08/27/19 10:52:17 AM
PostSubject