(Sharecast News) - Avacta Group announced the successful completion of the first cohort and the start of dosing for three patients in the second cohort of the second arm in its phase one trial of AVA6000, a peptide drug conjugate form of doxorubicin chemotherapy, on Thursday.
The AIM-traded company also initiated a FAPI-PET sub-study within the trial to better characterise the FAP-positive disease burden at the study entry for selected patients.
It said the phase one trial aimed to evaluate the safety and tolerability of AVA6000, leveraging Avacta's proprietary preCISION technology.
Following positive data from the first arm, arm two was designed to optimise the dosing schedule and efficacy, using a two-weekly dosing regimen.
The first cohort in the second arm was completed without any adverse safety signals, and the second cohort had started dosing, with three patients already treated.
In addition to the main trial, Avacta said it had initiated a sub-study in partnership with SOFIE, using baseline FAPI-74 PET scanning.
The sub-study aimed to better characterise whole-body tumour expression of the preCISION molecule's target and levels of fibroblast activation protein, or FAP, expression - an enzyme found in high concentrations in many solid tumours.
It said the insights from the sub-study would inform on various indications for further efficacy studies, and represent an ongoing collaboration between Avacta and SOFIE.
Avacta said it remained on track to achieve its goals for the second half of 2024, including the start of the dose expansion phase 1b efficacy study and the presentation of further data from the AVA6000 trial.
The outcomes of the expansion study would guide the selection of an optimal single indication for a subsequent phase two efficacy study.
"This is an important milestone which supports our continued confidence in AVA6000 and in the wider preCISION platform," said chief executive officer Christina Coughlin.
"The introduction of a new diagnostic approach of [18F]FAPI-74 -PET scanning into the programme will help to better characterise the FAP expression among patients, potentially assisting in indication selection.
"We're excited to be working with our investigators to integrate these tools to accelerate our efforts to optimise indications, dosing and schedule, as we bring this promising program through clinical studies."
At 1606 BST, shares in Avacta Group were up 5.25% at 43.15p.
Reporting by Josh White for Sharecast.com.
Avacta Group (AVCT)