RE: Certainly a STS treatment but may be much much more ? 🤔19 Sep 2023 10:04
It was never limited to STS. It is only limited to solid tumours expressing FAPalpha.
There MUST, by Science Day, have been responses in cancers other than STS since the wording of the RNS of 21 June at the conclusion of C5 stated "... several patients in cohort 5 and earlier cohorts remain on treatment as their disease has not progressed." Earlier cohorts, plural, and by Science Day, when C4 had been concluded, only one patient (in C3) was listed as having STS.
Clinical development will initially be limited to STS because of the ODD and the FDA benefits that go with that and any possible other FDA schemes that would make development cheaper and regulatory approval quicker.
These from today's RNS are absolutely crucial: "... in parallel with the completion of cohort 7, the Company intends to begin a short study to explore more frequent dosing (fortnightly) of AVA6000 as a first line treatment in patients with soft tissue sarcoma. The study is expected to begin in Q4 2023 subject to receipt of approval of a protocol amendment from the US Food & Drug Administration (FDA)" and "The study will replace the much longer planned Phase 1b efficacy study, and is expected to allow the Company to bring forward the start of the potentially pivotal Phase 2 efficacy study into 2024" as they clearly show that Avacta is working closely with the FDA to progress AVA6000 to market asap. Expect announcements in the coming months about any number of Fast Track, Breakthrough Therapy, Accelerated Approval and Priority Review (https://www.fda.gov/patients/learn-about-drug-and-device-approvals/fast-track-breakthrough-therapy-accelerated-approval-priority-review).
Avacta must be confident that the data in Phase 1a show that the side-effects seen in the 3-weekly cycle will not adversely affect patients on a 2-weekly cycle. That is, recovery time would be sufficient or accumulated damage wouldn't be limiting.
I shouldn't be surprised to see this trial extension dosing at the C6 level (310mg/m²) which over 6 weeks (three 2-weekly doses of 310mg/m² of AVA6000 vs two 3-weekly doses of 75mg/m² of straight doxorubicin) works out as the (maximum) amount of doxorubicin in AVA6000 being given at the rate of 4.185 times the standard doxorubicin dose.
If they were to use the C7 level for two-weekly dosing (which would show extreme confidence that MTD won't be found!), then the rate would be 5.2 times the standard doxorubicin dose. That would just be out of this world!
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