RE:RE:RE:RE:RE:RE:RE:RE:Cannaccord 42nd With the emphasis on flexibility from this point forward I see it more about data AND decisions. I think it's going to be the decision making process that controls when announcements happen. So for example if one cancer hits it's go/no go point (either from 10 patients or feasibly before 10) then I expect talking to the FDA could trigger an expansion to 25. I don't see any merit in holding back that decision for other cancers to catch up. Where I see you'd want to hold is at the end of 1b (which includes expanded cohorts) to wait for all the data to come in before moving to pivotal trials. In a super positive scenario you might see more than one cancer type expand to 25 but I think each of those decisions can occur independently. I think this is the potential where we see a decision occurring in 2022 and that a shift in the protocol as being the trigger for an announcement. Timing probably depends on Paul's 3 options (few, some or maybe many).
The protocol atm is 10 patients so that's what they continue to talk about but it looks like the real target (for a promising cancer type) is 25 patients at the end of 1b. To me realistically that is the lowest number of patients were you start to get a sense of where ORR might land in the pivotal trial. But there is a process to get to that 25 where I can see some interim data and an announcement.
SPCEO1 wrote: Exactly - it is all about the data and it is not clear from the presentation exactly how we will hear about that data - piecemeal or all in one big PR. The timing was narrowed down to between now and Christmas. And while it is his job to be optimisitc, I did sense a positive vibe on cancer from Paul.
I was also not clear about the full enrollment target. In theory, the trial is supposed to be over by March 2023 which would mean enrollment is finalized by the end of this year. But he expects us to have some data, maybe a lot of data by Christmas. I am guessing that enrollment is completed around the end of the year and 12 week data for all patients is available by the end of the first quarter if there is no protocol extension(s). If there are, it sounded to me that t he timelines get stretched out due to the need to r ecruit more patients, but that is a high class problem. Let's hope we get an announcement of such an extension sooner rather than later. He said theywere going to be strategic in which cancer they choose to run with so, even if they have data warranting a protocol amendment in one type of cancer tomorrow, maybe they pass on that as they are hoping to get a better cancer type to pursue and need more time to get the patients in that more strategic cancer type past whatever bar they need to get past.
qwerty22 wrote: So we have Q1 next year as a target for full enrolment. But we also have a large degree of flexibility on the path forward which doesn't necessarily rely on full enrolment. Presumably that means some decisions being made prior to Q1 2023. You have to think that something like expansion in one particular cancer type is a material event. I'd expect it to be announced and the reasoning behind it to be part of the @nnouncement. Seems to me like these are the types of events we are now waiting for. It all depends on the data.
realitycheck4u wrote:
JFM,
Not testing for Sortilin at this stage is smart. I simply do not understand why you do not understand this. Did you see their new slides? They will get there.
Here is the one slide for you to calm you down.
SORT1+ TechnologyTM: Future Opportunities
1: Explore conjugation with a variety of anti-cancer agents (cytotoxics, TKIs etc) and potential synergistic new partnerships (proprietary molecules).
2: Explore rational combinations of SORT1+ TechnologyTM with other treatments, especially immunotherapies.
3: Gain better understanding of the exact MOA, impact on surrounding tissue/tumor microenvironment (TME) and fate of conjugate once it enters the cell and is degraded.
4: Explore different dosing schedules (weekly, intermittent vs continual) in order to increase the therapeutic window in terms of efficacy and safety.
5: Explore the need for a companion diagnostic for SORT1 to determine correlation of sortilin expression with response, improve patient selection, track treatment efficacy and identify early metastases.
qwerty22 wrote:
What he was confident about was the ability for 1b (or an extended 1b) to move them forward sans Sortilin testing. Try to get your head around that.
jfm1330 wrote: Nothing new on cancer. No question on ortilin testing.