Thursday, June 09, 2016 5:10:49 PM
So it is official now!
By now you all know what my last sentence in the back linked post was about since it is public.
Now I have another puzzle peace, to use biopharm's vocabulary.
The company will pursue a clinical development strategy focused on conducting small, early stage studies of bavituximab in combination with I-O agents. These trials may be conducted as part of ongoing collaborations with AstraZeneca and the National Comprehensive Cancer Network (NCCN). The goal of these trials will be to generate compelling data capable of driving partnering interest. As part of this new strategy, the company has discontinued plans to initiate further Phase II and Phase III trials.
If you want to understand where this is going (I mean the text above) you will have to find back a post of mine from shortly after the SUNRISE stop in which I suggested that PPHM would change strategies.
The general idea was that since Bavituximab performed again as expected and remained safe on more then 1000 patients now and since it seems to work in many combinations if we are looking at clinical and pre-clinical data, they should play BPs against each other by making Bavituximab available PER COMBO PER CONDITION.
Now if you want to do that it comes in handy to have some condition specific data. Furthermore you want to deploy your weapon where it makes a difference.
For now, and we have seen the poster cheynew posted with the pathways for PD-1 combo's, it is clear that the immune oncology market is dominated by the PD (programmed death) anti's.
The 4 meaningful players at this moment, BMY, Merck, Roche and AstraZeneca all have an anti PD-1 or anti PD-L1. So with a SAME WEAPON, that by the way has the SAME shortcomings in tremendous side effects and limited responders, it will be something else that will make the difference.
I will PREDICT (SPECULATION) something. PPHM does NO LONGER intend to run any PII or PIII clinical trial themselves ever, or at least for the coming years. They will, based on the PI data close partnerships. AstraZeneca PAYS for the Durvalumab (a PD-L1) and will for sure get some priority on any continuation of future trials following the PI's. I think PPHM is writing a modified version of what I have suggested they should do and I think their approach is SPLENDID.
Those that think that it is going to take 5 years before the cash starts running in from the Bavituximab program think again.
By now you all know what my last sentence in the back linked post was about since it is public.
Now I have another puzzle peace, to use biopharm's vocabulary.
The company will pursue a clinical development strategy focused on conducting small, early stage studies of bavituximab in combination with I-O agents. These trials may be conducted as part of ongoing collaborations with AstraZeneca and the National Comprehensive Cancer Network (NCCN). The goal of these trials will be to generate compelling data capable of driving partnering interest. As part of this new strategy, the company has discontinued plans to initiate further Phase II and Phase III trials.
If you want to understand where this is going (I mean the text above) you will have to find back a post of mine from shortly after the SUNRISE stop in which I suggested that PPHM would change strategies.
The general idea was that since Bavituximab performed again as expected and remained safe on more then 1000 patients now and since it seems to work in many combinations if we are looking at clinical and pre-clinical data, they should play BPs against each other by making Bavituximab available PER COMBO PER CONDITION.
Now if you want to do that it comes in handy to have some condition specific data. Furthermore you want to deploy your weapon where it makes a difference.
For now, and we have seen the poster cheynew posted with the pathways for PD-1 combo's, it is clear that the immune oncology market is dominated by the PD (programmed death) anti's.
The 4 meaningful players at this moment, BMY, Merck, Roche and AstraZeneca all have an anti PD-1 or anti PD-L1. So with a SAME WEAPON, that by the way has the SAME shortcomings in tremendous side effects and limited responders, it will be something else that will make the difference.
I will PREDICT (SPECULATION) something. PPHM does NO LONGER intend to run any PII or PIII clinical trial themselves ever, or at least for the coming years. They will, based on the PI data close partnerships. AstraZeneca PAYS for the Durvalumab (a PD-L1) and will for sure get some priority on any continuation of future trials following the PI's. I think PPHM is writing a modified version of what I have suggested they should do and I think their approach is SPLENDID.
Those that think that it is going to take 5 years before the cash starts running in from the Bavituximab program think again.
Peregrine Pharmaceuticals the Microsoft of Biotechnology! All In My Opinion. I am not advising anything, nor accusing anyone.
