RE: RDE Cohorts slide 4014 Dec 2024 20:11
'RDE Cohorts Phase 1 AVA6000 FPI'
I researched to find a better understanding of this acronym - FPI, but did not succeed, at least I found nothing I could hang my hat on.
However, I searched my notes for 'basket trial', as that is what CC called the phase 1a trial, looking for evidence of prior breast cancer intent. - Data to show FDA / MHRA with a request to include breast cancer in phase 1b studies.
Here is part of a transcription of the 30.09.2024 Investor Meet presentation Q/A session:
Question 3:
Considering the extremely consistent data observed in the Phase 1a dose escalation study, is there now a firm intention to fast-track Phase 2 with a focus on a single indication, and if so, which indication is likely to be prioritised and which route sought?
Answer 3
The short answer is no. This might feel like the right path to take given that we are now seeing exciting responses, the duration of response is quite nice – the durability, but we wouldn’t fast track to phase 2 for two reasons.
One, we have multiple options on the table as we talked about during the presentation there isn’t a clear winner right now having the best data.
Two, we haven’t tested in the breast cancer indication. You’ll recall that in the phase two we select one indication. The phase two is a large investment of cash time and resource, so at the current time, because we have at least three indications that we’re thinking about, we need some more data to select that one. I can tell you if we made a decision now on both tumour type and line of therapy which together form that indication, the chances are that we would be wrong. So the expansion cohorts, small number of patients, specific line of therapy allowing us to design and foreshadow that phase two trial. Drug development is about a series of decisions that are all derisked by our prior knowledge. So what we know from the phase one both safety efficacy and the biology is now helping us to derisk where we go with AVA6000 now. But also, it’s now helping to plan and derisk additional pipeline assets and this is how we set the company and the pipeline up to succeed.
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