When the chief clinical officer for two years leaves / is replaced a month before supposedly big data for the company, you know it’s a big red flag. Have been out of this stock for months now thankfully but feel bad for investors.
Other red flags:
—Using a “we are seeing great results on Tavo (monotherapy) alone” narrative in recent weeks when their main trial is a combo trial.
—Announcing an ATM funding agreement two days before data(!)
Not sure why they chose to present premature data that is worse than their previous data on predicted nonresponders. Being absent from SITC would have had a smaller hit on SP than presenting this data. The things said about O’Connor have been spot on.
> Holding a CC to tout these interim data was probably a bad idea.
Very much so. As well, everybody seems to have expected apples (results as for a PD-L1 naive population), but we got oranges (results for PD-L1 refractory). See here:
I think the data is too immature to make any comparison. But even if the final BORR was 22%, this would be at least on par with Dynavax results in a refractory population (see the post above)!
I still believe in the very basic approach of an in-situ vaccination with the patient's own antigens (electroporation alone does create some a little inflammatory environment and can be used as an adjuvant, e.g. see here https://www.nature.com/articles/s41598-017-04547-2, and there is lots of literature about the role of IL-12 in the immune system).
The targeted trial is a difficult one (real PD-L1 non-responders, probably even some with prior failed other immunotherapies). But as I have written, this is very much the only population in which an accelerated approval can be gained at all (real "unmet need", no other approved therapies!). So I would not say that the choice of the trial population was wrong.
All in all, science: ok to good (two people "refractory to anti-PD-1 monoclonal antibodies" and "progressive disease after anti-PD1 mAb" starting to react! ... it's a little bit more proven, that the treatment can convert non-responders into responder - this is why it's a late-breaker poster and conference organizers don't throw late-breaker acceptance letters like candy)
The ORR is now 23.8% (5/21); inasmuch as the ORR was 22.2% (2/9) at the 2018-SITC interim (#msg-144697253), there have been 3 new responders among the 12 newly evaluable patients.
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