Ayala Pharmaceuticals Inc (ADXS)

[hovacre]

Hmmm, I don't think this is on quite the right track. Remember that neither NEO nor HOT are intended to be used in HPV-positive tumors in the near future. The point being that targeting HPV in cervical cancer, a traditionally "cold" tumor, may simply be the more cost-effective route to targeted immunotherapy in these tumor types.

So the logic that Axal is going to be a failure where HOT/NEO are more likely to succeed is not quite in line with reality, as far as we know. There are no results out there right now to suggest that targeting neoantigens will be effective at all, let alone more effective than other treatment strategies.

The fact is that Axal has demonstrated potential in an area of high unmet need. ADXS-PSA might be there too, with some more observation (but that is not guaranteed).

This is not a computer, Bourbon. v1.0 products are separate products with separate rationales and methods, with different likelihoods of helping specific patients. There may never come a day where we say that Axal has been replaced by neoantigen constructs. And it is definitely too soon to tell whether HOT/NEO deserve this moniker of "v2.0" in the way you describe.

More importantly, only one of these products has late-stage clinical data. And it's the only one that will have late-stage data for at least 3 or 4 more years at the earliest. If I happen to be a pharma that feels good about what I see from GOG-0265, then I may take that bite on cervical cancer, which kills some 14,000 women in Europe yearly. Figures taken from Canada suggest that the cost of treatment for women who die of cervical cancer ranges from $30,000-$69,000 per year, meaning a current cost to healthcare each year ranging from $450 million to $1 billion. (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4835018/)

So we're not talking chump change, which is why Merck has seen fit to go capture a small subset of patients (PD-L1-positive) with pembrolizumab.

All that is intended to say that cervical has the potential to be a big enough market to be worth tackling on its own. And Axal appears to be active in this population in terms of extending life. NEO/HOT will not be making it to cervical anytime soon.