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Post by nateb on Nov 24, 2018 21:12:32 GMT
Biposter,
Correct there is a maintenance dosing regimen with the phase 3 trial , so most are expecting responses to remain durable longer.
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Post by biposter on Nov 24, 2018 21:58:41 GMT
Yes, nateb, thanks. I now see that on slide 10: “Dosing: 30mg Vicinium… Once CR, proceed to maintenance every other week for 2 years.” So I guess that bi-weekly maintenance dosing was not the case in their Ph2 trial, and so the drop-off in the CRR. ir.sesenbio.com/static-files/2d9ff213-04b5-47e2-a373-44d387be1a7f Btw, looking at slide 4, it’s interesting that it says “Begin Commercial and Manufacturing Readiness” in Q3-Q4 2018, and “Begin preparing BLA submission” in 4Q18. And according to that slide, it has the 12-mo. data readout set for mid-2Q19. They kept guiding for “mid-2019,” so I was expecting mid/end of summer, but, per their slide, maybe we see it as early as May? They did PR enrollment completion for their Ph3 registration Vista trial on 3/12/18. And as you posted, in their Nov PR a few weeks ago, they mention that they entered into an agreement with Fujifilm in October “to provide supply services in support of the manufacturing of Vicinium…” So it looks like they’re getting ready for their BLA submission and commercialization. But other than their slide deck, I haven’t found any comment from the CEO with any timeline about their BLA filing. Even that slide deck doesn’t include an estimated filing date on milestones timeline. So maybe sometime in 2H19. |
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Post by biposter on Nov 26, 2018 21:16:41 GMT
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Post by nateb on Nov 27, 2018 19:27:10 GMT
Biposter,
Interesting news on Merck. My thoughts are that Merck will be in a similar situation that they are in with all the other cancers Keytruda is approved in: the majority of patients don't respond to checkpoint inhibitors. Likely that some of the checkpoint inhibitor failures in BCG will be responsive Vicinium. Just my thoughts of course. You are right, there is a bit of a mixed message on BLA filing. My hope is next month when they present data, that BLA filing becomes a bit more clear, if the data is good that will of course be supportive of a filing. I think it is likely good: I don't think they would present this data now but would rather wait for 12 month data if data was poor. I guess we will see, good luck to you.
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Post by nateb on Dec 28, 2018 1:45:17 GMT
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Post by biposter on Jan 4, 2019 21:00:04 GMT
Hey, nateb, looks like data came out yesterday. So it seems there was that same drop-off in CRR as seen in the Ph2 trial, even with the continuous Tx. So for data on the pooled cohorts: @3mo: 39% CRR; 6mo: 27%; 9mo: 20%; 12mo: 14%. I thought the 9 & 12 mo. data were going to be released in in Q2/Q3? They already have the 9mo & 12mo data?
Anyway, it does drop off significantly. And though Merck is behind, it seems their data is about the same. So I haven’t been following too closely. Is SESN still expecting to file for a BLA/NDA later this year with this data? Or does this data mean it’s Game Over? I mean, 14% CRR @12 mo. is still great for that 14% of bladder cancer patients who failed SOC, right? But does it continue to drop off at 15, 18, and 24 mo.? Anyway, too bad the data didn’t hold up, even with continuous Tx.
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Post by nateb on Jan 4, 2019 21:08:35 GMT
Data looked good to me considering this is a refractory population with no other option besides bladder removal. Yes on the BLA filing, I haven't had a chance to listen to the conference call though. Kinda feels like ONCS with encouraging data but market doesn't get it or appreciate it. I will listen to the conference call in next day or so and let you know what I think.
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Post by nateb on Jan 6, 2019 0:16:05 GMT
Listed to the conference call, it appears they are very confident that vicinium will be approved based on fact that this a refractory population and that their results are better than the already approved Valstar treatment for BCG refractory cancer. I remain bullish on SESN long term. Shares at this level are I think a significant bargain.
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Post by nateb on Feb 27, 2019 18:29:37 GMT
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Post by nateb on May 14, 2019 17:14:00 GMT
ir.sesenbio.com/news-releases/news-release-details/sesen-bio-reports-first-quarter-2019-financial-results-andCo updated on latest data for their Phase III trial for BCG refractory Non-muscle invasive Bladder Cancer. I listened to their CC yesterday. CEO confident on their approval chances the Pre-BLA meeting with the FDA will be in early June with more updates to follow. There is also a worldwide shortage of BCG Vaccine(current standard of care for Bladder Cancer), FDA is keenly looking for solutions. CEO also expects to begin announcing Ex-US partnerships in early 2020. This one is really worth digging into I think.
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Post by nateb on May 20, 2019 0:48:14 GMT
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Post by nateb on May 22, 2019 3:13:48 GMT
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Post by JHam on May 22, 2019 3:33:34 GMT
Been watching this one scream upwards the past few days. I don't own any but it is on my watchlist. Probably not going to jump in now, but congrats on the good news and good luck. |
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Post by nateb on Jun 11, 2019 17:45:03 GMT
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Post by nateb on Aug 11, 2019 16:30:16 GMT
Been a while since I have posted but SESN just announced updated data on their phase 3 trial: ir.sesenbio.com/news-releases/news-release-details/sesen-bio-reports-positive-preliminary-data-update-phase-3-vista:Data continues to look good in my opinion(for this population): OS: 96%, PFS:90%, over 75% of responders estimated to remain cystectomy free two years and over, 12-month CRR at 17%. Important to remember this is for patients who the first line treatment (BCG Vaccine) has failed and the next option is bladder removal. Vicinium is intended to extend the time patients can keep their bladders(huge impact on quality of life). They have about 65 million of cash on hand and they are submitting the BLA in quarter 4 for accelerated approval. |
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Post by nateb on Aug 15, 2020 22:38:34 GMT
ir.sesenbio.com/news-releases/news-release-details/sesen-bio-announces-exclusive-license-agreement-qiluStill holding this one and they finally closed on an Ex-US Partnership, with Qilu Pharma. Qilu will assume development costs for China, Taiwan and Hong Kong. Sesen gets an up front payment of 12 million dollars and up to 23 million more as milestones are completed. Once the drug is on the market, Qilu will pay Sesen double digit royalties on sales revenue. CEO expects 6-10 more EX-US partnerships within the next year or so. FDA approval expected around mid next year.
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Post by nateb on Aug 15, 2020 22:43:31 GMT
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Post by nateb on Feb 16, 2021 15:09:34 GMT
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Post by nateb on May 31, 2021 15:54:24 GMT
About 2 1/2 months away from PDUFA. Seems early for a runup but we might be seeing that now.
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