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Sesen Bio (SESN)

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Last Post: 5/21/2019 9:01:22 PM - Followers: 142 - Board type: Free - Posts Today: 10

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

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).



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: Securities Registration: Employee Benefit Plan (s-8) 04:53 PM
SESN News: Sesen Bio Announces Acceptance of Analytical Comparability Plan by the U.S. Food & Drug Administration to Support the BLA & C... 07:00 AM
SESN News: Current Report Filing (8-k) 05/13/2019 07:03:39 AM
SESN News: Sesen Bio Reports First Quarter 2019 Financial Results & Updated, Preliminary Primary & Additional Secondary Endpoint Data fr... 05/13/2019 07:00:00 AM
SESN News: Quarterly Report (10-q) 05/10/2019 04:06:02 PM
News News Alert: Securities Registration: Employee Benefit Plan (s-8) 05/21/2019 04:53:40 PM
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#5316   Agreed even though I see you as a jimmy667 05/21/19 09:01:21 PM
#5315   Tom mentioned we could start hearing about some Tex18 05/21/19 07:40:09 PM
#5314   I don't think a $1 pps is going Ryoko 05/21/19 06:54:17 PM
#5313   * * $SESN Video Chart 05-21-2019 * * ClayTrader 05/21/19 05:38:26 PM
#5312   You think so?!? KC01905 05/21/19 04:50:22 PM
#5311   Okay back down to a Dollar for a mrplmer 05/21/19 04:33:04 PM
#5310   $2.50+ today JJGl 05/21/19 11:17:42 AM
#5309   https://seekingalpha.com/news/3465594-sesen-bio-19-percent-premarket-advancement TheBigTicket 05/21/19 08:30:04 AM
#5308   News: $SESN Sesen Bio Announces Acceptance of Analytical whytestocks 05/21/19 08:01:29 AM
#5307   74 million jimmy667 05/21/19 06:51:34 AM
#5306   Anyone know the fully diluted share count off hand? Selett 05/20/19 09:01:57 PM
#5305   Wow. The after hours is on fire. Going Ryoko 05/20/19 08:48:15 PM
#5304   Options mrplmer 05/20/19 05:48:10 PM
#5303   * * $SESN Video Chart 05-20-2019 * * ClayTrader 05/20/19 05:32:38 PM
#5302   Do the math mrplmer 05/20/19 04:05:12 PM
#5301   I'd love to see this thing hit 1.20 KC01905 05/20/19 04:02:58 PM
#5300   $35 buyout? Really? I'd love to see it, Ryoko 05/20/19 03:34:03 PM
#5299   Patience they have the goods and are a mrplmer 05/20/19 03:26:37 PM
#5298   Not to sound crazy but is this going KC01905 05/20/19 01:47:06 PM
#5297   Here is last Friday’s article over Sesen in Tex18 05/20/19 12:02:44 PM
#5296   Haha - you added good info about a MaineMan5 05/20/19 12:00:34 PM
#5295   Beat me to it MaineMan! Tex18 05/20/19 11:30:18 AM
#5294   Meeting today is to discuss the technology transfer Tex18 05/20/19 11:29:36 AM
#5293   Today's meeting is about manufacturing, the June 6 MaineMan5 05/20/19 11:25:05 AM
#5292   Ya 4 Billion dollar market. AstraZenica will take mrplmer 05/20/19 11:01:45 AM
#5291   I'd be ok with that number and pumped KC01905 05/20/19 10:57:20 AM
#5290   The meetings will discuss what the FDA is Ryoko 05/20/19 10:56:35 AM
#5289   The purpose is to discuss submission for their mrplmer 05/20/19 10:53:26 AM
#5288   True. But there's got to be some purpose KC01905 05/20/19 10:47:22 AM
#5287   It's just a meeting. mrplmer 05/19/19 11:22:24 AM
#5286   What time should we hear any news on KC01905 05/19/19 07:41:45 AM
#5285   Meeting with FDA Monday. mrplmer 05/18/19 05:01:12 PM
#5284   Lookin good for a higher high here. Pyramid2 05/18/19 04:33:52 PM
#5282   * * $SESN Video Chart 05-17-2019 * * ClayTrader 05/17/19 05:15:28 PM
#5281   More nice action today. Not sure what's going Ryoko 05/17/19 02:45:30 PM
#5280   * * $SESN Video Chart 05-16-2019 * * ClayTrader 05/16/19 05:41:30 PM
#5279   Nice action today. Looking forward to FDA approvals Ryoko 05/16/19 10:20:56 AM
#5278   News: $SESN Sesen Bio Reports First Quarter 2019 whytestocks 05/13/19 03:00:37 PM
#5277   I was kinda thinking that. But on the Ryoko 05/13/19 10:29:32 AM
#5276   Doesn’t help that the entire market is red. Tex18 05/13/19 10:21:23 AM
#5275   Well, this is unexpected. Nothing but good news Ryoko 05/13/19 10:02:49 AM
#5274   https://www.businesswire.com/news/home/20190513005207/en/Sesen-Bio-Reports-Quart dockside130 05/13/19 08:41:02 AM
#5273   CC sounds pretty strong for FDA Approval. mrplmer 05/13/19 08:21:42 AM
#5272   Wow. Wasn't expecting the 10Q until Monday morning. Ryoko 05/10/19 05:06:18 PM
#5271   Ya mrplmer 05/08/19 08:12:11 PM
#5270   Lets hit em both!! TheBigTicket 05/08/19 08:11:11 PM
#5267   If this works it goes into AVXL and PRED mrplmer 05/08/19 04:40:04 PM
#5266   Im locked in... I believe you are in another TheBigTicket 05/08/19 04:25:01 PM
#5265   Monday is COMING! BAMM mrplmer 05/08/19 11:32:31 AM
#5264   Summary "An upcoming data readout for the phase 3 mrplmer 05/07/19 08:23:23 PM