Great post from Bioposter over at Biotech Investor site:
Of course the market has to tank during “ONCS run-up month” lol. So we should get the ONCS SITC PR on 11/1 and data on 11/6, which I think will be very good, if not great -- and I think the company has clearly telegraphed this:
+ This is open-label, not double-blinded, so insiders already know the data results. So what actions have they taken with this knowledge...
+ The primary endpoint is 30% BORR @24wk
+ In the original Simon two-stg design, they had to get at least 4/23 responses, or it would’ve been stopped for futility.
+ But they scrapped the Simon 2-stg design, and increased the trial size from 48 to 80, and in their 10-K, they explicitly say they did this after seeing data (“Since preliminary tumor responses...data have been observed, we believe eliminating the formal analysis and expanding the sample size is warranted.”). So if they did because of poor data, then this 10-K statement is an intentional misdirect and purposefully misleading, which is doubtful. Plus, as morangie stated, Merck would’ve had to agree to now provide Keytruda gratis for 80 patients. Doubt they would do that on bad data. So 4/23 means, at minimum, we have 17% ORR.
+ In both their 10-K and latest presentation pdf, they publicly state their intention to file for accelerated/conditional approval in late 2019/early 2020. So up till now (we’ll have to wait for confirmation from all 80 patients), they must be meeting their primary endpoint for positive data. So we must have at least a 30% BORR up to now.
+ Though this was just before Pisces start, the PI for the prior combo trial, Dr. Algazi, didn’t hesitate when he said this last year (from RLC’s transcript, p. 142 on this thread):
Q: (Robert Andtbacka?) What about the patient populations in the existing Phase 2b combo study and the upcoming PISCES study... are they different or are they similar
A: (Dr. Algazi) I think it's going to be exactly the same. It's really a validating study. Because I think the assay is a good one. ...I predict we're going to see exactly the same thing.
A (Robert Andtbacka?): It's one thing to have an assay that's highly predictive, it's another to have actual non-responding patients and that's why we're doing the PISCES now.
A (Dr. Algazi): It's really a validation. It's a really robust validation. We talked a lot about how the trial is designed and I think it's going to be a really robust test of the technology and I think this is going to be pretty definitive....
+ So since last year’s data on predicted non-responderd had a BORR of 50% (technically, 42% based on RECIST), with Dr. Algazi’s confidence, I think we’ll have at least a 42%-50% BORR! That’s my WAG! We’ll see.
Here’s the rest of my kool-aid reasons for great data:
+ If data was mediocre/poor, they wouldn’t release it at the “Super Bowl” of IO conferences -- SITC (and as a late-breaking abstract). They’d probably delay it till next year, hoping for better responses, and if still weak, then bury it at a smaller conference.
+ Though early on in Pisces, ONCS’ CSO Chris Twitty says this in person to poster waitforit last April:
"just wait very soon; this is going to be taking off," and ‘waitforit’ adding that he used “a hand gesture like a rocket taking off.”
+ Alpha Holding stakes $15M cold, hard cash at the market on ONCS, right before data, Steve Cohen is in. As well as venBIO, Nexthera (I think they were in ECYT, CPXX), so some smart money is definitely here.
+ And, of course, so far monotherapy data from all the various trials have been compelling. The science works.
+ Plus, they just filed requesting 10m preferred shares, I’m assuming, as a poison pill, so data must be compelling. So no low-ball takeover attempts after SITC data results. At least that’s my story!
So while I’m on this wild confirmation bias expedition, might as well share my WAG pps predictions. On these actual anti-PD-1 non-responders, if we see data results of...
* 30% BORR (w/20% CRs)(a little lower than last year’s results): meets the primary endpoint, so $3.50-$4 pps
* 42%-50% BORR (w/38%-41% CRs)(replicating last year’s data): $5+ pps
* If >50% BORR and >40% CRs: to da moon!
The wildcard is if BioTwitter jumps in on this -- hopefully with comments/write-ups by Timmerman, Herper, Loncar, Endpts, and an AF follow-up article, then who knows? Well, we’ll see if downing a gallon of kool-aid was too much!
