The investor theme of 2023 so far has been generative AI, with defensive sectors like healthcare put to the sword. But this looks unfair, especially given there's been several notable advancements in medical science such as blockbuster drugs to treat obesity - from Eli Lilly - and Biogen's breakthrough with Alzheimer's.
There has been further significant today in respect of the clinical development of a novel next generation, targeted chemotherapy from Avacta (AVCT) for the treatment of soft tissue sarcomas, AVA6000. It's still early days, but I don't think I’ve ever seen such favourable Phase 1a trial data.
The company said that it had completed its 5th cohort dose escalation, to 2.25x stronger than standard doxorubicin, and that AVA6000 had not only continued to demonstrate a “very positive safety profile” but also that “several patients remain on trial in different cohorts, as their disease has not progressed”.
This is fabulous news, not least because it means extremely sick cancer patients might soon be able to safely receive higher dosages of chemotherapy for longer periods and across more treatment cycles, extending life expectancies with a much improved quality, too.
In fact, the results to date have been so good that Avacta has decided to further extend Phase 1a to a 6th dose cohort, at an even higher 310 mg/m2, equivalent to 2.7x the standard dose of doxorubicin.
The aim is to identify a maximum tolerated dose (MTD) which can then be used for the Phase 1b and future studies. Moreover by having a higher MTD, it might also ultimately enable regulators to approve AVA6000 for usage across a broader patient population - a higher total addressable market assuming the drug makes it to market.
CEO Alastair Smith commenting: "The continued positive safety profile of AVA6000 at these dose levels compared with standard doxorubicin is remarkable. We are seeing a significant reduction in the incidence and severity of all doxorubicin side effects. Analysis of the tumour biopsies to date also confirms that enough doxorubicin is being released in the tumour to have a therapeutic effect. If even higher doses of AVA6000 are tolerated then this may make a significant difference to the outcomes for patients in the upcoming efficacy study.”
"We are keen to progress onto the Phase 1b efficacy study as soon as possible following completion of the dose finding Phase 1a study. The dose expansion Phase 1b study will provide an initial evaluation of efficacy and of the relative improvement in patient outcomes and quality of life of different dosing regimens of AVA6000 compared with the standard doxorubicin regimen."
Avacta shares leap on "remarkable" trial results
Jun 21, 2023Disclaimer & Declaration of Interest
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