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Last Post: 3/19/2020 2:20:37 PM - Followers: 146 - 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: Statement of Changes in Beneficial Ownership (4) 02/18/2020 05:15:13 PM
SESN News: Statement of Changes in Beneficial Ownership (4) 02/18/2020 05:09:55 PM
SESN News: Statement of Changes in Beneficial Ownership (4) 02/18/2020 05:02:06 PM
SESN News: Statement of Changes in Beneficial Ownership (4) 02/18/2020 04:58:17 PM
SESN News: Statement of Changes in Beneficial Ownership (4) 02/18/2020 04:54:30 PM
PostSubject
#5947   Is $SESN finally going to have it's day... MD3 03/19/20 02:20:36 PM
#5946   Best of luck to you and your coworkers BooDog 03/16/20 12:37:11 PM
#5945   No disrespect intended, but I work in O&G. Tex18 03/16/20 12:30:42 PM
#5944   Filled some in the .48's. Imo we're BooDog 03/16/20 12:14:46 PM
#5943   Question is how much of it is due Tex18 03/16/20 11:13:36 AM
#5942   Just when you think it can't go any lower... MD3 03/16/20 10:32:39 AM
#5941   Dilute at will, while there's still sucker buyers proffetti 03/13/20 05:13:32 PM
#5940   They have not even submitted the final application accipiterr 03/04/20 02:29:28 PM
#5939   expect a 8k by friday related to a accipiterr 03/04/20 02:28:08 PM
#5938   FDA approval is not expected until early April. Ryoko 03/04/20 08:39:17 AM
#5937   Biotech investors need patience. The FDA is a mrplmer 03/04/20 08:04:48 AM
#5936   Is this thing dead in the water or KC01905 03/02/20 04:43:44 PM
#5935   sounds positive lets hope joe a 02/25/20 02:42:02 PM
#5934   Sounds like a legit retirement. And a BooDog 02/25/20 02:05:08 PM
#5933   is this change in upper management a good joe a 02/25/20 07:54:51 AM
#5932   Surprised not to see more volume. 52wk BooDog 02/19/20 02:23:01 PM
#5931   SP in the toilet is always a great ElevenWall 02/19/20 01:04:03 PM
#5930   whatever's about to happen, they wanted to lock BooDog 02/19/20 09:09:38 AM
#5929   Kinda looks like they're optioning up. But the Ryoko 02/19/20 09:05:50 AM
#5928   Looks like everyone loaded up on their options. BooDog 02/19/20 06:41:17 AM
#5927   Maybe he announces approval. mrplmer 02/14/20 09:28:02 AM
#5926   Wonder what Sneaky Tom is up to now. ElevenWall 02/13/20 07:28:57 PM
#5925   They would only have to report if their Bill_ENG 02/13/20 01:06:51 PM
#5924   If you noticed I simply compared to the BooDog 02/12/20 01:41:50 PM
#5923   If They added, wouldn’t their aggregate increase instead ElevenWall 02/12/20 11:43:33 AM
#5922   Looks like CVI added and Kingdon took some BooDog 02/12/20 08:59:59 AM
#5921   New 13 g/a filed. If reading correct, ElevenWall 02/10/20 04:45:31 PM
#5920   The market is $4B going the surgical route. mrplmer 01/28/20 05:33:36 PM
#5919   Was thinking soon myself. The adx has BooDog 01/28/20 02:11:02 PM
#5918   RE: chart depicts close over a buck. proffetti 01/28/20 02:04:44 PM
#5917   yesterday shake? enticing traders with volatility? proffetti 01/28/20 02:01:35 PM
#5916   classic bullish intraday chart - bodes well proffetti 01/28/20 01:54:23 PM
#5915   buy If you can!!! this stock is going crocodile007 01/28/20 12:16:40 PM
#5914   and down it goes, .82 now, SAD! proffetti 01/27/20 03:41:43 PM
#5913   I was about to sell this stock until joe a 01/26/20 08:09:31 AM
#5912   Wondering what Sneaky Tom did this time. ElevenWall 01/21/20 03:06:44 PM
#5911   What's causing the sell off this time. Short attack? MD3 01/21/20 02:37:55 PM
#5910   I think you have a good shot, just Tex18 01/21/20 02:18:42 PM
#5909   I bought more at .97 on Friday to SavhDawg 01/21/20 02:12:06 PM
#5908   Now holding 10k with just a few cents Tex18 01/21/20 01:36:49 PM
#5907   Unfortunately, with that and some of the financing ElevenWall 01/15/20 03:55:44 PM
#5906   If it’s a material event for the company, murocman 01/15/20 11:51:07 AM
#5905   Assuming TC’s “term sheets” are indeed rolling in, Tex18 01/15/20 09:40:49 AM
#5904   Agree. But the shorts used the Keytruda news MD3 01/14/20 02:16:43 PM
#5903   Don't see the Keytruda news as bad, per ElevenWall 01/14/20 01:43:24 PM
#5902   V for Vicinium V for Victory Tex18 01/13/20 01:56:57 PM
#5901   so what's better Keytruda or Vincinium? mrplmer 01/13/20 01:46:12 PM
#5900   https://www.fiercepharma.com/marketing/keytruda-wins-fda-nod-to-tackle-new-bladd MD3 01/10/20 04:56:14 PM
#5899   Selling was due to the Keytruda news MD3 01/10/20 04:42:58 PM
#5898   Damned if I know, lol. Selling on the ElevenWall 01/10/20 02:22:00 PM
PostSubject