Biotech Values

[dangerM]

Sigh.

> 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:

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=144689549

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)

Management communication: very mehh/ugh