1. Are we seeking the OBD in order to give us the best therapeutic outcome or for an outcome which puts us in a position for a commercial deal?
My thoughts: The simple answer is that they should be one and the same thing. OBD (Optimum Biologic Dose) is generally defined as being the lowest dose with the highest rate of efficacy while still being safe. ie. Once effectiveness plateaus out - then you have the OBD. The OBD is the point at which the effectiveness curve flattens (assuming the drug is still "safe" at that level). No need to go to higher dosages - it's just a waste of material.
That's a bit over simplified, because the terms (eg safety) are subject to a bit of variable interpretation, but it's good enough for me.
So the OBD is a scientific goal, not a commercial goal, and the Clinical Trial is pursuing scientific goals through scientific method - but I think this is a situation where the scientific goal and the commercial goal are pretty much the same. The combination of "highest efficiency with lowest dose to achieve that, while maintaining safety" - should be what is best for the patient (ie a medical/scientific and social outcome) but it should also be what "puts us in a position for a commercial deal" - because any commercial partner will want to be seeing optimum effectiveness with safety.
commercial deal. It's just a minimum requirement for a deal.
What I mean is: The best you can get out of a Phase 1 trial is a determination of OBD, and confirmation of safety - with
some data indicating clinical effectiveness/benefit. OBD and safety are essential minimum requirements for anyone to make a commercial offer - but the
size and the
value of that offer, and the way it is structured, will be determined by the extent and reliability of the clinical benefit data. (Plus quite a few other things such as comparison with competitor drugs; IP protection - length and coverage of patents; ease of manufacture; cost of manufacture; ease of administration; durability/shelf life/storage requirements of the drug etc etc).
At the end of the MAST Phase 1 we should have a firm idea of OBD, and safety (which so far looks to be outstandingly good for a cancer treatment). The very exciting part is that we are already seeing excellent clinical benefit outcomes, with a high likelihood that the clinical benefit data at OBD/end of Phase 1 will be even better - very possibly massively better. Yay!
But it will still be a limited data set - due to limited number of patients spread across a wide range of cancer types.
So any "offers" will be tempered by big Pharma's risk assessment of that - much the same way investors "value" a company like IMU.
We could till get some very high offers!! But that would be if Big Pharma is prepared to take extra "risk" and/or if multiple BP players try to outbid each other.
As we progress our trials, and the data becomes better/more statistically reliable, the risk that the early data was just an "anomaly" decreases - and our perceived value will go up (depending upon the extent of the clinical benefit we can prove).
Additional milestones/achievements - eg. FDA Breakthrough or Fast Track; or even Accelerated Approval - would add further value.
This is true for all our products.
( For a very interesting detailed discussion of OBD I suggest this journal article:
https://bmccancer.biomedcentral.com/articles/10.1186/s12885-021-07782-z )
2. At what dose do either of you believe would trigger enough results to warrant a deal from BP assuming safety & efficacy exponentially improve per the dosing?
My thoughts: Like friend
@Outlander2 - I have no idea. I suspect /hope that the results at 10
8 will be seriously exciting - and would be sufficient to excite big Pharma, but by the time they release any data on results at that level they may well be already dosing even higher. I don't think anyone will actually offer a deal until they see data on effectiveness at OBD.
Any offers become more likely - and probably better - if they are based on data from the expansion cohort of Biliary Cancer patients - assuming that the data nd the patient outcomes are good - because that will be raising the chances of FDA Breakthrough/Fast Track or Accelerated Approval.
Along the way though, as the data improves, the market will also be factoring in an assessment of reducing risk of failure, and an increasing likelihood of commercial success - and the SP will go up, and up, and up (with the usual fluctuations). Again - assuming the results are good.
Cheers
Dave