Risks to AVA6000 success16 Nov 2023 11:01
This is something of a summary of where we are. Risks can be: change in disease; approval; adverse events; patent protection; litigation; and competitors. If you think of others, please add.
CHANGE IN DISEASE - Cancer is not going to change, so nothing to see there.
APPROVAL - Approval will need a successful pivotal Phase 2 trial and will be based on an improved side-effect profile and/or increased efficacy. I would rate the chances of failing on either of these as miniscule and on both as zero. The side-effects profile has already been shown to be much improved over straight doxorubicin and they (Avacta, clinicians AND the FDA) would have to really mess up to not select treatable STS sub-types for Phase 2.
ADVERSE EVENTS - Spoiler: this is the most concerning to me but the issue should not be insurmountable. (Remember that Fiona told the TG people that Avacta is learning a lot about FAP. The oft-cited table of FAP concentrations was a one-off piece of work, and may be out-of-date now.) AVA6000 gets converted to doxorubicin when it encounters active FAP. For some epithelial cancer sufferers it may be obvious whether there is or isn't active FAP elsewhere but for others it likely won't be obvious or, more specifically, it won't be obvious that there is a distinct differential between active FAP in the TME and active FAP elsewhere, including background FAP if the amount in the TME is very low. This would become apparent as adverse events during larger scale (post-approval) Phase 3 trials for STS and subsequently for other indications - that is a large part of the purpose of such trials. The solution to this would seem to me to be an incrementally increasing dosage regimen and/or a diagnostic test, one that is preferably cheaper and more accessible than FAPi-PET scans currently are, to quantify active FAP in the TME and its distribution elsewhere in the body - an opportunity for Avacta Dx to file IP perhaps?
PATENT PROTECTION - The US and other patents have been granted and the inventive step (cleavable D-Ala-L-Pro-drug) was definitely novel.
LITIGATION - Following on from the above, challenges of the validity of our patent by competitors are extremely unlikely. More possible are infringements of our IP coverage if competitors make similar compounds but we should win any litigation due to the unique inventive step (as above). Or a competitor may just ignore our IP and make AVA6000. A Western company wouuldn't do that as they would be bound to lose in court (plus loss of reputation) but a Chinese, Indian, Brazilian, etc organisation may not feel bound by our commercial laws. Litigation action would then be taken at the point of import or use with loss of potential revenue in untouchable China, India or wherever.
COMPETITORS - There are no competitor compounds anywhere near enough to approval to be a challenge to AVA6000.
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