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Sesen Bio (SESN)

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Last Post: 3/12/2019 2:58:15 PM - Followers: 127 - Board type: Free - Posts Today: 0

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: Confidential Treatment Order (ct Order) 03/19/2019 04:40:18 PM
SESN News: Current Report Filing (8-k) 03/04/2019 07:33:53 AM
SESN News: Sesen Bio Reports Fourth Quarter and Full-Year 2018 Financial Results and Additional Preliminary Data from Phase 3 VISTA Trial 03/04/2019 07:30:00 AM
SESN News: Annual Report (10-k) 03/01/2019 05:52:19 PM
SESN News: Current Report Filing (8-k) 02/25/2019 04:22:18 PM
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#5153   Time to buy to close shorty. mrplmer 03/12/19 02:58:15 PM
#5152   I'd like to hear to hear the short mrplmer 03/04/19 12:33:15 PM
#5151   Oh Boy. Helping lots of people while making mrplmer 03/04/19 08:41:34 AM
#5150   Smart move by the company. Every three month jimmy667 02/27/19 08:04:06 PM
#5149   http://secfilings.com/searchresultswide.aspx?TabIndex=2&FilingID=13250561&compan 907money 02/27/19 03:36:45 PM
#5148   Insanely undervalued and not one piece of evidence brockcdavison 02/27/19 09:31:49 AM
#5147   Sure be my guest. I think SESN jimmy667 02/27/19 08:54:54 AM
#5146   Would you mind if I shared this? Just brockcdavison 02/27/19 08:22:46 AM
#5145   I already answered the same question for some jimmy667 02/27/19 12:46:07 AM
#5144   If this is the case, in your opinion, J_Dean 02/27/19 12:19:02 AM
#5143   Very well said. Very. brockcdavison 02/26/19 09:47:20 PM
#5142   * * $SESN Video Chart 02-26-2019 * * ClayTrader 02/26/19 05:58:01 PM
#5141   Wow, the chase has begun! the gipper 02/26/19 01:52:05 PM
#5140   Just lookin for a $3-5/share price by end Tex18 02/26/19 10:51:27 AM
#5139   Sounds like could be. Short rumor, their in deep the gipper 02/26/19 08:27:41 AM
#5138   Hearing Cannell got 1 million shares today and Tex18 02/25/19 09:14:26 PM
#5137   Breaking into .90 now; c.94 buy ; buy the gipper 02/25/19 05:20:47 PM
#5136   Popped 86 AH. otterman 02/25/19 04:50:23 PM
#5135   This is a pretty awesome price right now. Trader_415 02/25/19 04:12:58 PM
#5134   I am new thinking about buying here 100k StrategyTrader 02/25/19 01:02:40 PM
#5133   A low ball figure would be less than jimmy667 02/23/19 10:47:09 PM
#5132   What do you consider a lowball buyout? Price J_Dean 02/23/19 06:40:02 PM
#5131   SESN has roughly 50 million in cash at jimmy667 02/23/19 04:58:34 PM
#5130   JimmyJimJim,. That was me making a joke because mrplmer 02/15/19 02:57:05 PM
#5129   Given your track record we can expect the jimmy667 02/15/19 01:05:57 PM
#5128   This will start the run up next week. mrplmer 02/08/19 08:48:10 PM
#5127   Looking for a big drop today to mid sixties. mrplmer 01/31/19 11:12:21 AM
#5126   N...@.725 for the reversal. Will continue to add makingbiigdough 01/22/19 11:37:28 AM
#5125   I figure atleast $10, can’t come quick enough lol jimbo69 01/11/19 08:01:14 PM
#5124   Geez. I took it down to $.75 $.74 mrplmer 01/11/19 06:52:56 PM
#5123   100% brockcdavison 01/04/19 04:58:18 PM
#5122   Cash position $57 million at last count with jimmy667 01/04/19 10:36:45 AM
#5121   Bad day for traders jimbo69 01/03/19 02:26:25 PM
#5120   As soon as I noticed they were reporting grich1 01/03/19 10:29:00 AM
#5119   Happy New Year lol. Bad day to sleep KC01905 01/03/19 10:11:34 AM
#5118   Nice to see some really nice days. Glad grich1 12/28/18 04:05:24 PM
#5117   I find it odd that SESN has a jimmy667 12/22/18 04:20:11 AM
#5116   * * $SESN Video Chart 11-23-18 * * ClayTrader 11/23/18 02:30:18 PM
#5115   Hedge funds/shorts seem to be spooked about something. the gipper 11/16/18 11:49:56 AM
#5114   Something is up! Pps surging on volume. the gipper 11/16/18 11:21:03 AM
#5113   Truth Sugarplum 11/14/18 12:32:02 PM
#5112   all noted... agreed.... experienced ... and a believer Timing101 11/08/18 09:19:27 PM
#5111   99% of all penny stocks are scams and cjstocksup 11/08/18 06:36:36 PM
#5110   Yep .... Timing101 11/08/18 06:33:51 PM
#5109   CLAY does charts he would be a fool cjstocksup 11/08/18 06:27:03 PM
#5108   Thanks CJ Timing101 11/08/18 06:14:01 PM
#5107   * * $SESN Video Chart 11-08-18 * * ClayTrader 11/08/18 05:40:59 PM
#5106   Wow!! Pps and volume exploding!! If we get the gipper 11/08/18 10:57:06 AM
#5105   When SESN moves over $2.00 it should really cjstocksup 11/08/18 10:56:27 AM
#5104   Many that I know personally and past family Timing101 11/08/18 10:47:38 AM