Avid Bioservices Inc (CDMO)

[biopharm]

3) Early HALT
PPHM does NOT expect an early halt of the clinical trial for the 1st look-in (not for safety or futility problems but neither for efficacy).
They do not expect, but explicitly did not exclude, the possibility that an early halt for efficacy would be possible for the 2nd look-in.

Keep in mind that the IDMC only gives an advice and that PPHM is under NO obligation to early stop the clinical trial for efficacy. One motivation to NOT do this could be to work towards a stronger result and become SOC in 2nd ln NSCLC that is harder to beat. Opdivo (BMY) for instance runs alone against Docetaxel (no combo) and had better results but for a very small foot-print of patients (about 30%). Bavituximab has the ability to increase that foot-print but the SUNRISE results will very probably influence at what extend competitors will be/have to be motivated to run PD-1/PD-L1 combo's with Bavituximab to become SOC. AstraZenaca (Durvalumab) is the Bavi combo leader in the PD-L1 arena for now.

So an early halt at 2nd look-in is possible but there is no guarantee that PPHM will stop the trial before DEC 2016. Waiting 6 extra months could make them A LOT of money.

CP, just taking one small part of your post .... this is what has run through my mind several times.

A Big Pharma may be on the hunt for Peregrine and they (the BP) sort of has no intention of wanting Docetaxel to become the #1 SOC and beat the current BMS current SOC.... so is it possible that some Big Pharma (not BMS) would try and make a deal with Peregrine, in order to convince them with $$$ upfront and convince them to stop that Bavituximab+Docetaxel trial as early as possible (so long as it just barely beats out BMS and Bavi+Docetaxel becomes the new SOC...

but all this is done so the new Big Pharma stepping in can run a trial with possibly a drug under their own pipeline + Bavituximab and run it early on ( like almost now !!) in order for them to stretch that trial out as long as possible (like PPHM could do with Bavi+Docetaxel till end of Dec 2016)...

but all this would be done because that new Big Pharma with big $$$ for PPHM just wants to secure their own pipeline drug for many years to come to be #1 in NSCLC in combo with Bavituximab, especially since now lung cancer may double its current rate since the FDA can (possibly) soon predict and declare one has lung cancer due to technology (blood tests to pick up the hint of cancer and then MRI to detect it at the EARLIEST STAGE.

Hopefully this all made sense.... either way, I think Peregrine Pharmaceuticals has induced much of Big Pharma BOD member meetings into talking about this little, unknown in Tustin just yet...

though things can change any day, especially when 2 or 3 Big Pharmas may feel like they must move together and offer Peregrine something better or at least match what some of the top tier Big Pharmas could offer Peregrine and in this way.... Peregrine could think of something even more strategic in not setting a percentage evenly for royalties for 2 or 3 mid-size pharmas working together to pick up Peregrine, but pit them against one another but at the same time... all good for Peregrine.