The best things in life are worth waiting for. Indeed, for Avacta (AVCT) - a 'smart chemo' diagnostics and drug development firm - the R&D news seems to get better and better.
Today the company reported outstanding safety data for its lead AVA6000 therapeutic (albeit from a relatively small patient size) in a 3-week dosing Phase 1a trial across 7 cohorts - the last one being conducted at a concentration 3.5x greater than standard doxorubicin.
It had recently commenced US testing of AVA6000 in a new fortnightly dose escalation study (1.45x concentration) in order to see whether this shorter cycle time improves efficacy without impacting toxicity. Regulatory approval has also been granted in the UK with 1st data from Cohort 1 hopefully being available by the end of April.
Either way, the combined 2 and 3 week studies will be used to help design a potentially pivotal Phase II trial planned for late 2024.
CEO Alastair Smith commenting: "We are extremely pleased with the continued excellent progress of AVA6000 in the Phase 1a dose escalation study. These emerging data clearly demonstrate that the preCISION platform is functioning in the way it was designed, and is capable of targeting the release of a cancer therapy to the tumor. Targeted therapy that spares healthy tissues is a holy grail of oncology drug development and we believe we have a unique platform to target FAP-rich tumor tissues to deliver significantly better outcomes for patients and substantial value to our shareholders."
"We are looking forward to providing a further detailed update on the clinical trial at the American Association for Cancer Research meeting in April."
Elsewhere, AVCT’s next candidate AVA3996, a FAP-activated proteasome inhibitor, is slated to enter clinical trials in 2024/25, adding another possible multi $bn per year addressable market to the drug pipeline.
And there are plenty of other exciting 3rd party licensing agreements (e.g. with LG Chem, POINT Biopharma, a wholly-owned subsidiary of Eli Lilly and Company and AffyXell Therapeutics), alongside a fast growing European diagnostics arm and a high-potential Affimer therapeutic platform.
Finally, in terms of commercialisation - whilst Avacta intends to have an active in-house clinical development team for its own assets (e.g. AVA6000), I believe it would consider partnering with Big Pharma for larger Phase 3 trials, and may also have nearer-term options with regards to licensing out preCISION's FAP activated tech to other 3rd parties.
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