Avacta Group PLC has announced the successful completion of the first cohort and dosing of three patients in the second cohort in the dose escalation study of Arm 2 of its Phase 1 trial for AVA6000, a peptide drug conjugate form of doxorubicin chemotherapy. The Phase 1 trial is evaluating the safety and tolerability of AVA6000, leveraging its proprietary pre|CISION™ technology. The company has also initiated a sub-study utilizing FAPI-PET scanning at baseline to further characterize the full burden of FAP-positive disease in patients.

The dosing of the second cohort in Arm 2 has commenced, with three patients successfully dosed. The sub-study, in partnership with SOFIE, utilizing baseline [18F]FAPI-74 PET scanning in the AVA6000 Phase 1 trial, aims to better characterize the whole-body tumor expression of the target of the pre|CISION™ molecule and levels of fibroblast activation protein ("FAP") expression. These data will inform on various indications for further efficacy studies.

Christina Coughlin MD, PhD, Chief Executive Officer of Avacta, expressed delight in the progress of the two-weekly dosing schedule arm of the Phase 1 trial of AVA6000, stating that it supports their continued confidence in AVA6000 and the wider pre|CISION™ platform. The introduction of a new diagnostic approach of [18F]FAPI-74-PET scanning into the program will help to better characterize the FAP expression among patients, potentially assisting in indication selection.

Data from Arm 1 of the trial, presented at the American Association for Cancer Research (AACR) meeting in April, demonstrated that AVA6000 delivers high concentrations of doxorubicin to the tumor microenvironment relative to plasma, resulting in significant antitumor activity in patients whose tumors have over-expression of FAP. A significant reduction in the frequency and severity of the known doxorubicin toxicities was observed across the dosing range in Arm 1.

Avacta is on track for stated goals in the second half of 2024, including the commencement of the dose expansion Phase 1b efficacy study and presenting further data from the AVA6000 trial. The data from this expansion study will be used to inform the optimal choice of a single indication for a Phase 2 efficacy study which will follow the expansions.