Continuing our STING mini series, the third part looks at a company with a next generation agonist that is heading into the clinic soon.
What sort of challenges have the overcome, what can we expect to learn more about? Are they thinking narrowly or broadly?
One of the most exciting times for me in new product development is not when they move from phase 2 to approval, launch, and subsequent commercialisation, but that window between preclinical studies and first-in-man trials. The IND-enabling phase is an intense period with much to get done that can make or break subsequent advanced solid tumour dose finding trials.
Get your various key predictions wrong and you could be looking at a spate of unwanted severe side effects that will rapidly grind your trial to a halt. Sometimes they are a predicted risk at a much higher dose, for example, other times the PK/PD predictions don’t turn out as expected at all (oops). Then there’s scheduling and timing issues to think about on top of dosing and therapeutic window for combination trials.
Despite a lot of research, it’s still a very imperfect science. As one of my mentors used to say, “Better to be lucky than pedantically dotting all the i’s and t’s!”
So imagine a young up and coming IO biotech in that window between preclinical and clinical development – what are they going to do and where do they see themselves fitting in the broader landscape?