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Sesen Bio (SESN)

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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) 10/09/2018 04:54:19 PM
SESN News: Sesen Bio to Present Three-month VISTA Trial Data at Global Congress on Bladder Cancer 2018 09/20/2018 08:27:00 AM
SESN News: Current Report Filing (8-k) 08/17/2018 05:05:37 PM
SESN News: Quarterly Report (10-q) 08/14/2018 07:41:13 AM
SESN News: Sesen Bio Reports Second Quarter 2018 Financial Results and Pipeline Updates 08/14/2018 06:30:00 AM
PostSubject
#5101   Low volume manipulation, stack the ask, take out the gipper 10/01/18 03:30:07 PM
#5100   Article on checkpoint inhibitors. https://www.washingtonpost.com/national/heal grich1 10/01/18 09:33:38 AM
#5099   I am glad I learned about this one. KC01905 09/21/18 08:20:53 AM
#5098   I've been looking around some myself this evening. dwh 09/20/18 09:41:17 PM
#5097   I am super new to this stock. Like KC01905 09/20/18 09:26:55 PM
#5096   maybe this will help dwh 09/04/18 09:13:17 PM
#5095   There are quite of few companies engaged in playofthedivine 09/04/18 02:04:54 PM
#5094   Volume 1.7 MLL @ 10:00!! Oh my!! the gipper 09/04/18 10:02:35 AM
#5093   Pentium - Same here..(almost) all weekend. From what Ocnswm 09/03/18 02:02:19 PM
#5092   Potential for VISTA P3 and company overall. Pentium 09/03/18 01:10:42 PM
#5091   https://www.smarteranalyst.com/stock-news/healthcare-wiz-mitchell-blutt-bets-big grich1 08/31/18 11:11:49 AM
#5090   Why the green today? Not complaining lol discodave1 08/31/18 10:48:52 AM
#5089   Seeking Alpha Article dwh 08/28/18 09:07:55 PM
#5088   Appreciate all this but holy mother.. I’m an brockcdavison 08/26/18 07:01:39 AM
#5087   SESN buy 1.7700 stocktrademan 08/25/18 10:43:27 PM
#5086   Totally agree. Extremely undervalued here especially now that jimmy667 08/15/18 04:18:20 PM
#5085   No the shorts are not in charge but the gipper 08/15/18 08:58:17 AM
#5084   The shorts are in charge now. onin2downin2 08/14/18 11:04:44 AM
#5083   SESN PR looks excellent. It sure looks like the gipper 08/14/18 08:41:04 AM
#5082   moosebms on the ST. Don't post much. AngryMoose 08/10/18 08:56:32 PM
#5081   No doubt! I actually didn’t find this room brockcdavison 08/10/18 08:51:38 PM
#5080   It is. Thought I'd give reviving it AngryMoose 08/10/18 02:57:46 PM
#5079   Thanks moose! Thought this blog was dead! brockcdavison 08/10/18 02:56:09 PM
#5077   Crossing fingers on the news you suggest. AngryMoose 08/09/18 10:45:22 AM
#5076   The CEO switch is definitely a good thing. AngryMoose 08/09/18 10:42:43 AM
#5075   Agree brock! I see your posts over AngryMoose 08/09/18 10:41:37 AM
#5074   It's good news but I don't expect the AngryMoose 08/09/18 10:40:14 AM
#5073   Would not be surprised to see news later the gipper 08/09/18 10:16:50 AM
#5072   Must not be, people are giving shares away ...pathetic Lenard 08/09/18 09:13:20 AM
#5071   Huge news for SESN!! Fast Track granted the gipper 08/09/18 08:24:08 AM
#5070   Fast track and new deeply experienced CEO from Sugarplum 08/09/18 08:18:03 AM
#5069   Sesen Bio Announces Vicinium Granted Fast Track Designation dockside130 08/09/18 06:44:54 AM
#5068   New CEO appointed Thomas Cannelloni DMV was involved dockside130 08/07/18 07:08:20 PM
#5067   This has been manipulated for months.. but we’ll brockcdavison 07/25/18 02:41:52 PM
#5066   Volume 80,300 at 11:10 AM. What does the the gipper 07/25/18 11:10:42 AM
#5065   Nice upgrade from Jefferies. Could see some the gipper 07/23/18 09:29:43 AM
#5064   Thanks Canaccord for the Nice PT of $5 Moonlapse 07/10/18 08:41:28 AM
#5063   Just sitting here on the sidelines watching the AngryMoose 07/06/18 09:24:15 AM
#5062   Where is everybody? the gipper 07/06/18 08:36:05 AM
#5061   Quite interesting https://endpts.com/sound-familiar-china-us-biotech-hybrid-land brockcdavison 06/10/18 11:41:10 AM
#5060   My prediction based on the massive increases in jimmy667 06/08/18 01:38:42 PM
#5059   Agree. Where did the info regarding SESN AngryMoose 06/08/18 01:05:33 PM
#5058   Good digging jimmy667!! That certainly explains the the gipper 06/08/18 12:41:08 PM
#5057   Where did you see that information? KnBrown 06/08/18 12:29:38 PM
#5056   June 15 it will be put on the jimmy667 06/08/18 11:42:27 AM
#5055   Shorts busy this am premkt filling the orders the gipper 06/06/18 09:28:53 AM
#5054   I'm looking to pick up a few more KnBrown 06/06/18 09:09:53 AM
#5053   The size of some of the buys has the gipper 06/05/18 10:12:34 PM
#5052   when I jumped aboard on the 30th, I dirtydozen911 06/05/18 07:09:46 PM
#5051   Not sure myself if anything new was announced. matt24d 06/05/18 04:21:24 PM
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