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?
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We first wrote about this innate pathway back in early 2015 – before it became famous and controversial – when things seemed much simpler then.
Imagine the basic concept… add an immune agonist – this targets the innate immune system to jumpstart or wake up the immune system in colder tumours – to an established adaptive immune therapy such as checkpoint blockade and see whether any magic happens. In practice, this turned out to be much easier said than done, because in reality mouse and man have quite different immune systems and do not react in the exactly same way, which makes extrapolation from one to the other challenging at the best of times.
Still, back in 2015 there were barely a handful of STING agonists that anyone could really put a name too, now there’s 18 compounds in early pipelines and counting.
Not all the players are small biotechs either, as big Pharma is certainly paying attention to the smaller biotechs (both private and public) generating molecules, especially now that early clinical data (alone and in combination) is beginning to dribble out.
Aside from collaborations and licensing deals, there’s also an increase in patents in this niche, which is often a sign of competitive activity.
Four years on, how has the landscape changed, what does the data look like and what sort of issues need to be addressed?
In the first of our latest three-part mini series, we look at the competitive landscape and how it has changed (quite drastically since 2015, I can assure you!). In parts two and three, we look at two different up and coming players in the STING space with very different approaches.
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