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Last Post: 3/4/2021 1:23:46 AM - Followers: 154 - 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: Sesen Bio Announces Conference Call with Neal Shore, M.D., FACS to Provide Clinical Perspective on the Company’s Lead Produ... 03/02/2021 08:00:00 AM
SESN News: Current Report Filing (8-k) 03/01/2021 08:43:39 AM
SESN News: Statement of Changes in Beneficial Ownership (4) 02/23/2021 05:26:26 PM
SESN News: Statement of Changes in Beneficial Ownership (4) 02/23/2021 05:24:43 PM
SESN News: Statement of Changes in Beneficial Ownership (4) 02/23/2021 05:23:19 PM
PostSubject
#6172   I’ll agree the atm doesn’t help anything but Tex18 03/04/21 01:23:46 AM
#6171   Value is still there. Really didn't think Dodgeball 03/03/21 11:41:48 PM
#6170   Added low $2.50s this morn. A shaky market BlindSquirrelFindsNuts 03/03/21 10:47:52 AM
#6169   We are only 5 months out from likely BlindSquirrelFindsNuts 03/02/21 10:46:02 PM
#6168   You think buyout will happen so soon? May DavidW2 03/02/21 10:20:21 PM
#6167   Added several times below $2.60 today on low BlindSquirrelFindsNuts 03/02/21 08:35:06 PM
#6166   Man, this guy and his dilution. Big Dodgeball 03/02/21 07:47:52 PM
#6165   Very significant good news. Looks like the Dodgeball 03/01/21 12:52:46 PM
#6164   just got severely burned by CRMD--their catheter solution voisybay123 03/01/21 12:29:44 PM
#6163   Anyone dig into the updated corporate presentation subject Dodgeball 03/01/21 12:06:03 PM
#6162   I'm definitely a believer long term, just tired MD3 02/27/21 03:36:01 PM
#6161   I've held a long position for some time Dodgeball 02/26/21 10:52:11 PM
#6160   This is exactly why I didn't hold through MD3 02/26/21 07:19:15 AM
#6159   Great timing, too. Right into a crappy Dodgeball 02/25/21 11:46:57 PM
#6158   Are they short on cash rolling into the BlindSquirrelFindsNuts 02/25/21 08:55:44 PM
#6157   Yea I think that expected. They have the Tex18 02/25/21 07:53:29 PM
#6156   Yes from 129 mil shares outstanding to itwentdwnhwmch 02/25/21 07:47:01 PM
#6155   Saying got added? Tex18 02/25/21 07:38:46 PM
#6154   29 mil shares outstanding showed up today itwentdwnhwmch 02/25/21 06:12:13 PM
#6153   I turned loose about $50k in underwater positions BlindSquirrelFindsNuts 02/24/21 12:12:16 AM
#6152   Good move. Didn't think TC would pull Dodgeball 02/23/21 11:44:59 PM
#6151   I think so too Tex18 02/23/21 10:52:18 PM
#6150   They were not exercised, they were granted. Bill_ENG 02/23/21 10:51:45 PM
#6149   4 form 4’s just filed totaling just shy Tex18 02/23/21 10:22:59 PM
#6148   C E O, Big Chief, TC WITH THE Tex18 02/23/21 10:19:35 PM
#6147   CTO exercised option for 300k shares. LFG GLEN! https://www.sec.gov/Archives/ Tex18 02/23/21 10:12:30 PM
#6146   You can’t overlook Roche. Already have a side Tex18 02/23/21 08:41:49 PM
#6145   what about the potential pps if a buyout occurs? voisybay123 02/23/21 08:34:38 PM
#6144   I think there are two potential "suitors"-Merck makes voisybay123 02/23/21 08:32:59 PM
#6143   I held an average of $1.02 and sold MD3 02/23/21 01:24:18 PM
#6142   That might be overly optimistic given the pipeline BlindSquirrelFindsNuts 02/23/21 12:24:45 PM
#6141   Looking to jump back in around $2, possibly MD3 02/23/21 11:52:30 AM
#6140   Sesen Bio: Problems Of Main Competitor Make Vicinium Dodgeball 02/23/21 08:41:56 AM
#6139   The list of Institutional holders, which can be Dodgeball 02/22/21 07:53:16 PM
#6138   Looks like its stock the shelves for tutes mrplmer 02/22/21 01:24:24 PM
#6137   Much more effective than Keytruda mrplmer 02/21/21 06:48:49 PM
#6136   $SESN likely to get a boost tomorrow. It BlindSquirrelFindsNuts 02/21/21 02:31:17 PM
#6135   Tex18, I appreciate that information. Now criqsus 02/21/21 08:00:03 AM
#6134   The CEO was granted options in 2018 for Tex18 02/20/21 06:35:02 PM
#6133   Individuals/Insiders only own 76,661 shares in this company. criqsus 02/20/21 11:34:22 AM
#6132   The Feb 3 call premiums are out of nsomniyak 02/17/21 10:11:56 PM
#6131   Jefferies moves price target from $3 to $6. Dodgeball 02/17/21 09:49:31 PM
#6130   Guessing there is a wall from the ATM, Dodgeball 02/17/21 11:13:33 AM
#6129   They have "more than enough," yet they do Dodgeball 02/17/21 09:43:37 AM
#6128   Major manipulation here. This things only trades high ipo_dude 02/17/21 09:28:55 AM
#6127   Agree. But there was $44 million left on Dodgeball 02/17/21 08:31:22 AM
#6126   SESN has more than enough to get to voisybay123 02/16/21 07:43:02 PM
#6125   * * $SESN Video Chart 02-16-2021 * * ClayTrader 02/16/21 05:50:31 PM
#6124   Guessing they punched the ATM pig hard today. Dodgeball 02/16/21 03:48:56 PM
#6123   They are determined to fill the gap from Dodgeball 02/16/21 12:04:07 PM
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