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Sesen Bio (SESN)

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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: Current Report Filing (8-k) 06/15/2018 04:06:23 PM
SESN News: Statement of Changes in Beneficial Ownership (4) 06/14/2018 04:49:48 PM
SESN News: Statement of Changes in Beneficial Ownership (4) 06/14/2018 04:29:50 PM
SESN News: Statement of Changes in Beneficial Ownership (4) 06/14/2018 04:28:06 PM
SESN News: Statement of Changes in Beneficial Ownership (4) 06/14/2018 04:22:26 PM
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#4962  Sticky Note Company name changes today, May 16, 2018: confident StonewallPatriot 05/16/18 05:25:56 AM
#4957  Sticky Note Preliminary efficacy and safety data from the pivotal OTC-Jesus311 05/12/18 05:40:34 AM
#5064   Thanks Canaccord for the Nice PT of $5 Moonlapse 07/10/18 08:41:28 AM
#5063   Just sitting here on the sidelines watching the AngryMoose 07/06/18 09:24:15 AM
#5062   Where is everybody? the gipper 07/06/18 08:36:05 AM
#5061   Quite interesting brockcdavison 06/10/18 11:41:10 AM
#5060   My prediction based on the massive increases in jimmy667 06/08/18 01:38:42 PM
#5059   Agree. Where did the info regarding SESN AngryMoose 06/08/18 01:05:33 PM
#5058   Good digging jimmy667!! That certainly explains the the gipper 06/08/18 12:41:08 PM
#5057   Where did you see that information? KnBrown 06/08/18 12:29:38 PM
#5056   June 15 it will be put on the jimmy667 06/08/18 11:42:27 AM
#5055   Shorts busy this am premkt filling the orders the gipper 06/06/18 09:28:53 AM
#5054   I'm looking to pick up a few more KnBrown 06/06/18 09:09:53 AM
#5053   The size of some of the buys has the gipper 06/05/18 10:12:34 PM
#5052   when I jumped aboard on the 30th, I dirtydozen911 06/05/18 07:09:46 PM
#5051   Not sure myself if anything new was announced. matt24d 06/05/18 04:21:24 PM
#5050   Was anything actually new released in the conference Manonb 06/05/18 02:30:12 PM
#5049   100k buy @ 2.795 just went through! That the gipper 06/05/18 01:13:21 PM
#5048   Wow what a day. Dip it hard at matt24d 06/04/18 04:01:03 PM
#5047   I just looked at the am graph. discodave1 06/04/18 02:23:24 PM
#5046   The manipulation this am was epic....I don't know the gipper 06/04/18 12:29:59 PM
#5045   Looks like healthy consolidation. Dip and rip. This jimmy667 06/04/18 12:02:24 PM
#5044   seems to be unlimited for sale @ dirtydozen911 06/04/18 11:42:10 AM
#5043   Decent volume for pm discodave1 06/04/18 07:59:38 AM
#5042   Wow....after hours heating up! 10k on the the gipper 06/01/18 05:04:37 PM
#5041   I personally have a small position but I matt24d 06/01/18 11:43:23 AM
#5040   Agreed Matt! $3 plus is my exit goal. playofthedivine 06/01/18 11:39:32 AM
#5039   Chart wise this is starting to set up matt24d 06/01/18 11:33:46 AM
#5038   nice ride ..last few days...hope it continues...glta! dirtydozen911 06/01/18 10:54:52 AM
#5037   I agree! This market cap seems pretty cheap matt24d 05/31/18 01:43:53 PM
#5036   How does a $83 mill market cap company jimmy667 05/31/18 01:35:09 PM
#5035   I got scalped a little bit by selling jimmy667 05/31/18 12:59:39 PM
#5034   Agree with you 100% matt24d 05/31/18 12:31:17 PM
#5033   The Data was accelerated approval worthy. You farm jimmy667 05/31/18 12:18:10 PM
#5032   Absolutely. Remember this is public offering not PIPE. jimmy667 05/31/18 12:16:31 PM
#5031   At the end of the day there was matt24d 05/31/18 11:51:17 AM
#5030   Third time try to break 2.20 Let’s see jimmy667 05/31/18 11:51:04 AM
#5029   Thanks brother I had no fear of the jimmy667 05/31/18 11:29:39 AM
#5028   we've all done it. Good times coming the gipper 05/31/18 10:49:55 AM
#5027   I lost money on the insurance trade of jimmy667 05/31/18 10:34:27 AM
#5026   2.20$s stock1ace1 05/31/18 10:33:24 AM
#5025   I agree a just bought all back higher jimmy667 05/31/18 10:31:18 AM
#5024   The manipulation of the shorts was pretty horrendous. the gipper 05/31/18 10:28:59 AM
#5023   2.10$s going ! stock1ace1 05/31/18 10:28:47 AM
#5022   If it does not pull back I am jimmy667 05/31/18 10:11:07 AM
#5021   Jaw dropping? Panties are dropping NOW! Haha jimmy667 05/31/18 10:03:06 AM
#5020   4.4 mil shares first 30 min jimmy667 05/31/18 10:01:21 AM
#5019   Ha ha yea I should have stood pat. jimmy667 05/31/18 09:58:30 AM
#5018   That PR indicates to me that there is the gipper 05/31/18 09:57:14 AM
#5017   Sens $2.05 breakout stock1ace1 05/31/18 09:53:37 AM
#5016   22 million shares plus 15% puts the company jimmy667 05/31/18 09:02:49 AM
#5015   I agree 100% also if I remember correct matt24d 05/31/18 08:11:13 AM