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Last Post: 9/20/2020 3:06:00 PM - 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) 09/15/2020 08:03:35 AM
SESN News: Sesen Bio to Provide Business Update at the H. C. Wainwright 22nd Annual Global Investment Conference 09/08/2020 07:00:00 AM
SESN News: Current Report Filing (8-k) 08/24/2020 07:16:09 AM
SESN News: Quarterly Report (10-q) 08/10/2020 04:21:26 PM
SESN News: Sesen Bio Reports Second Quarter 2020 Financial Results and Business Update 08/10/2020 07:30:00 AM
PostSubject
#6005   Ya it is mrplmer 09/20/20 03:06:00 PM
#6004   It might be time to add more before grich1 09/20/20 02:22:08 PM
#6003   * * $SESN Video Chart 09-18-2020 * * ClayTrader 09/18/20 04:12:34 PM
#6002   gonna take out yearly highs $$$$$ MHOP kingsransome 09/18/20 12:33:04 PM
#6001   Assuming the full $35 mil ATM is used Tex18 09/16/20 07:31:46 PM
#6000   Good Presentation. I'd like to see this taken mrplmer 09/16/20 12:45:31 PM
#5999   I have no specific knowledge of any trading Ryoko 08/18/20 07:30:09 PM
#5998   Right, but Tom is an insider and just Tex18 08/18/20 07:26:15 PM
#5997   When I'm referring to insiders, I generally mean Ryoko 08/18/20 07:25:34 PM
#5996   Speaking of insiders, I’m not up to speed Tex18 08/18/20 07:11:33 PM
#5995   Smells of insiders. Very strange trading today. Ryoko 08/18/20 06:42:57 PM
#5994   Saw that too. No clue. Prolly bs, but Tex18 08/18/20 05:39:49 PM
#5993   What's up with AH? Up to $1.37, Dodgeball 08/18/20 05:17:31 PM
#5992   This should have been taken out already. Conditional mrplmer 07/31/20 11:33:49 AM
#5991   Palmer, what’s your timeline on that, 2years out Tex18 07/31/20 11:21:35 AM
#5990   After doing the math using $100,000 it would mrplmer 07/31/20 10:35:25 AM
#5989   Added here RiskyRewards 07/31/20 10:05:01 AM
#5988   loading the dip $$$$$$ MHOP kingsransome 07/31/20 09:57:28 AM
#5987   Making a move on nice volume this morning. On watch. PENNYBUSTER 07/31/20 09:21:31 AM
#5986   https://ih.advfn.com/stock-market/NASDAQ/sesen-bio-SESN/stock-news/82960101 Dodgeball 07/30/20 02:13:27 PM
#5985   Finally the almighty dollar. Let’s see if it’ll Tex18 07/24/20 02:14:04 PM
#5984   If I didn't know better I'd think there BlindSquirrelFindsNuts 07/23/20 08:35:49 PM
#5983   I cannot private reply to you anymore SEGN MakinBank 07/10/20 05:47:10 PM
#5982   I didn't have L2 open on it so BlindSquirrelFindsNuts 06/17/20 01:07:26 PM
#5981   Yup and didn't move the price one iota. Bill_ENG 06/17/20 12:56:38 PM
#5980   Not sure it means anything but a 700k BlindSquirrelFindsNuts 06/17/20 12:22:07 PM
#5979   Ya that sounds good to me. mrplmer 05/25/20 05:04:56 PM
#5978   Would be nice if Sanofi used a portion Bill_ENG 05/25/20 04:51:36 PM
#5977   Big Pharma wants to squeeze the price for mrplmer 05/11/20 02:53:13 PM
#5976   And we're down lol. What the hell is MD3 05/11/20 01:37:58 PM
#5975   Great News!! Dwilli_2 05/11/20 07:59:55 AM
#5974   This is a $4B market opportunity. mrplmer 05/10/20 08:51:36 AM
#5973   * * $SESN Video Chart 05-08-2020 * * ClayTrader 05/08/20 04:21:46 PM
#5972   Tommy boy is untested and has a terrible CoolSoupy 05/08/20 07:55:18 AM
#5971   Let's go back to $1 land. This time MD3 05/07/20 10:49:58 AM
#5970   Also possible the pending news from the upcoming Tex18 05/06/20 05:44:51 PM
#5969   It's off per press release The proposal seeking stockholder MD3 05/06/20 05:21:20 PM
#5968   Looks like the NO Votes sent a very MD3 05/06/20 05:20:28 PM
#5967   I would not bet money on that. If Ryoko 05/06/20 04:25:25 PM
#5966   From what I see, yes it’s off. On Tex18 05/06/20 03:53:15 PM
#5965   Was the RS canceled. I missed the SH MD3 05/06/20 02:17:05 PM
#5964   Can the FDA at any point just give mrplmer 05/05/20 01:00:11 PM
#5963   Anymore B.S. by Tom we need to get CoolSoupy 05/05/20 10:22:08 AM
#5962   * * $SESN Video Chart 05-04-2020 * * ClayTrader 05/04/20 06:31:49 PM
#5961   Who let the dogs out? CoolSoupy 05/04/20 12:27:20 PM
#5960   It takes $2.50 in margin balance to short jimmy667 04/26/20 07:24:02 PM
#5959   Then let's get the BOD involved mrplmer 04/26/20 10:45:10 AM
#5958   It is being fast tracked by the FDA CoolSoupy 04/24/20 12:00:06 PM
#5957   Well, then let us sell this issue to mrplmer 04/24/20 09:42:24 AM
#5956   I also voted no. They have until Nov 12 Bill_ENG 04/21/20 06:51:03 PM
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