Stacy Lindborg
๐ค SpeakerAppearances Over Time
Podcast Appearances
It's actually hitting on to the two main arms of the immune system, adaptive and innate immunity.
And even for some of our clinicians, when we're having conversations, you know, and we're talking about critical points to make, they'll emphasize how critical it is that look, we're not just delivering a cytokine or protein.
we're really activating both arms of the immune system.
And when you think about the distinct advantages, you know, from a safety standpoint, that's obviously a critical part of the delivery of how we're delivering our product, the stability, the scalability that we can actually go beyond.
There are many solid tumors that we've studied preclinically that we know will be rapid growth for our company and added value we can bring to patients.
you know, really it becomes about the uniqueness of this product and how we can grow.
We have a novel design, but one that's really predicated in the FDA that will allow us to move very quickly if we see an effect in women that are HRD positive, meaning they have mutations that suggest based on our data that they would respond quickly.
So we'll be able to do interim analyses.
If we see an effect, we'll be able to get the BLA, so the biologic license application, to the FDA quickly for review and full approval in that subgroup.
But it would match the urgency that I think the population demands.
while we study this broader all-comers population.
So two, in the protocol and really even the ongoing phase two study, it is amazing how consistent every single endpoint and subgroup points to an immunotreatment effect over the standard of care.
And that consistency gives us just such confidence as we go into this phase three trial.
This very well-powered 500 patient
trial that allows for early action for success and access to the public that needs it.
It has truly been a highlight of my day.