Avid Bioservices Inc (CDMO)

[Protector]

alvaroc, all depends on how much the difference is.

All PD-1, PD-L1, CTLA-4 etc anti's resemble each other in performance and response. However their clinical trial results in a SAME indication with a SAME or at least COMPARABLE trial set-up do vary some.

The difference will mostly already be explained by the ECOG groups, their distribution (randomizing) over the arms and possibly dosage (but I would then maybe not call it a comparable trial if the dosage is different).

For your statement to be true the difference in performance must come from the workings of the molecule because having identically sick patients in two clinical trials, distributed identically over the arms is impossible in randomized trials. And we know from Pancreatic that randomizing and ECOG distribution can make a HUGE difference.

The working of the molecule MUST be the same because an anti-PD-1 for instance is FOR ALL something that binds the PD-1 and hence the main effect is the same.

However, small differences could occur based on for instance the different size of the molecule (and hence the cell surface it covers when bound to the cell or T-cell for the PD-1). It could also come from what we would for simplicity call the exposed terminals of the molecule on the sides it is not bound. What do they do in the tumour environment? What interaction, with what?

But currently there is no prove that shows WHERE the differences come from and again this is only true for meaningful differences.

Next it all depends on what Bavituximab will do in the combinations. That is hard to say if the differences are due to the above last category. Bavituximab may work better or worse due to the molecule differences. It is not because for instance an anti-PD-L1 molecule works better then another anti-PD-L1 molecule, BOTH on their own, that in combinations the difference cannot be a strength or weakness for the combo.

Finally all depends with HOW MUCH for instance Docetaxel+Durvalumab+Bavituximab beats the SOC because Docetaxel+Keytruda+Bavituximab would have to beat it meaningfully. And for that a clinical trial would be needed and if it beats the SOC it would in ALL CASES include Bavituximab again.

So I'd take this statement with reserves for now.

Should AZN launch before MRK, the competitive edge could be short lived if Keytruda continues to show better efficacy than Durvalumab.