6 September 2022 - - UK-based clinical stage oncology drug company Avacta Group plc (AIM: AVCT), a developer of diagnostics based on its Affimer and pre|CISION platforms, has launched first-in-human Phase I trial (ALS-6000-101) of AVA6000 Pro-doxorubicin will advance to the fourth dose cohort of patients following a positive review of the safety and tolerability data from the dosing of the third cohort, the company said.

Avacta's Safety Data Monitoring Committee, comprised of clinicians currently recruiting patients, has completed its review of the safety data from the third cohort dosed with AVA6000 at 160mg/m2 in the ongoing Phase I trial.

Following this review, the SDMC has recommended that the clinical trial continues as planned and escalates to the next dose of AVA6000 at 200mg/m2.

AVA6000 is a novel form of doxorubicin that has been modified with Avacta's pre|CISION FAP-activated delivery platform to improve its safety and therapeutic index.

AVA6000 has been designed to limit cell penetration of the drug, and therefore its cell killing effect, until it is specifically activated by fibroblast activation protein α which is in high concentration in many solid tumours compared with healthy tissues.

The resulting reduced exposure of healthy tissues to active doxorubicin has the potential to significantly increase its therapeutic index by reducing the incidence of adverse effects, including cardiotoxicity and myelosuppression.

Anthracyclines such as doxorubicin, a generic chemotherapeutic agent, with a market size that is expected to grow to USD 1.38bn by 20241, are widely used as part of standard of care in several tumour types, but its use is limited by cumulative dose toxicity associated with cardiomyopathy.