RE: FOR BE BOLD - buying in20 Jul 2025 14:56
@COLDWATER, for the benefit of yourself but more for other board members...
A lot of the issues around funding and market interest are, as Thompi wrote, to do with the mess that the previous CEO created with hype, the Dx venture and the associated Heights bond. I say 'a lot' and not 'all' because Avacta is still an early stage clinical biopharma company with neglible income and an appetite for cash. In that respect it is no different from all the other early stage clinical biopharma companies that have been struggling due to market and financing conditions these past few years post-Covid.
As regards the Phase 1a trial, it has been very successful in its aims: AVA6000 is safe and well tolerated, which is the aim of any Phase 1a trial, and has shown early signs of efficacy at various dosing levels in a variety of cancers. It is important to bear in mind that:
1) Phase 1a cancer patients are, almost by definition, terminally ill - it would be unethical to test an uncharacterised drug on patients whose lives could be saved by receiving the standard of care treatment.
2) The cancers treated, at least in the Q3W cohorts, were chosen to maximise recruitment of patients with solid tumours where FAP is present - they were chosen to test proof of concept without regard to whether doxorubicin was an effective drug for the cancer type.
3) Patients had had various prior therapies that would be expected to affect the efficacy of doxorubicin - again, safety and tolerability were the aims here, not treatment.
4) The dose level increased during the trial from cohort to cohort - twice, once for Q3W dosing and then again for Q2W dosing - and with that the likelihood of efficacy as well as side-effects increased but no maximum tolerated dose was identified and the trial was stopped as there were signs of efficacy and with higher dose levels came considerations about the maximum lifetime cumulative dose (MLCD)- some AVA6000 for a time or more for a shorter time. Such a relatively small diverse collection of terminally ill, pre-treated patients, diverse by cancer type, dose level and prior treatment, doesn't make for any sort of statistical reliability with respect to successful efficacy - that will be looked for in Phase 1b and beyond.
5) Some trial results have been given along the way and the final results should be presented in peer-reviewed form in a journal when the trial has completed, remembering that measurements continue until at least one year post cessation of treatment for any survivors. This is normal. As the patients were terminally ill, had cancers that weren't treatable with doxorubicin, had refractory tumours, etc., they are unlikely to survive (unless AVA6000 was a wonderdrug for them) but for as long as any do they will continue to receive AVA6000 until MLCD.