RE: My Thoughts on a takeover !20 Nov 2025 16:12
What CC actually said about STS during the Preliminary Results, 6 June 2025: https://www.investormeetcompany.com/meetings/preliminary-results-77 (Q&A, Q13)
Q13: The strategy for FAP-Dox appears to be changing. We don't hear updates on the sarcoma arm anymore. Is this changing and why?
CC: "So we have placed three bets on the table with our expansion cohorts as we, you know, described their design and the dose in the presentation. Those three bets are salivary gland cancer triple, negative breast cancer and soft tissue sarcoma.
"There are two things that happened late in 2024 outside of Avacta and inside of Avacta that essentially defined the strategy. Now, we have to be very in tune to anything that happens out there in the public domain in oncology and how it impacts our programs and that's the first thing that I'll describe is the indication of soft tissue sarcoma did take, I'll call it a little bit of a regulatory influence that happened in that there was a data set that was published late 2024 with the Boehringer Ingleheim MDM2 inhibitor in dedifferentiated liposarcoma. It was a randomised Phase III trial that failed to meet its primary endpoint and the comparator arm in that trial, important to note, was monotherapy doxorubicin and the progression free survival there was over 8 months. That is an important development because it is much better than anyone anticipated and so the regulatory bar then in that indication, it's elevated, and our probability of regulatory success drops because that will be the comparator for AVA6000, for FAP-Dox.
"Now, at the same time, we started to see some really nice activity in a rare tumour type, salivary gland cancer, and our investigators that were working with us on that continued to, I'll call it beat the drum, tell us, like "This drug seems to really be working in this rare tumour type and the unmet need here is huge." I've mentioned before that, if you open up the NCCN Guidelines which drive the therapies that are administered in a given setting in the United States, the preferred regimen for this tumour type is 'none', there isn't one, and that's regulatory speak, kind of, for, you know, we would then be able to use something called an investigator choice arm. We wouldn't have to necessarily compare to doxorubicin alone. Doxorubicin alone isn't actually used.
"And so, it's both of those, sort of an external factor with the data in doxorubicin in soft tissues sarcoma, but also our own data in salivary gland cancer that, yes, we will always adapt to both external data but also things that we are seeing and so our probability of success, we think, with salivary gland cancer is just much higher based on both of those factors that I mentioned, and so, the expansion cohorts are ongoing and we look forward to those data really helping us to drive the next steps."
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