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(Alliance News) - Avacta Group PLC on Thursday said it dosed the third patient in the first cohort of its phase 1a dose escalation study for its lead preCision drug AVA6000.
AVA6000 is a peptide drug conjugate designed to target the release of the chemotherapy doxorubicin to tumour tissue.
The Wetherby, England-based life sciences company developing oncology drugs and diagnostics said the safety and tolerability of AVA6000 is continuing to be assessed.
In December 2023, data from the three-weekly dosing arm of the trial demonstrated that the preCISION platform targets the release of the chemotherapy to the tumour as intended, and that AVA6000 "significantly improved the safety and tolerability" of doxorubicin and is "already showing encouraging preliminary clinical signs of anti-tumour activity".
Based on this "very favourable" three-weekly dosing safety profile, Avacta said it began a two-weekly dosing safety study in the US "on the basis that this is likely to lead to better efficacy".
Three patients have now been dosed in cohort 1 of the two-weekly dose escalation study in the US, Avacta said, while it has received regulatory and ethics approval to open sites in the UK in the two-weekly arm.
Avacta anticipates that the safety data monitoring committee will review the two-weekly cohort 1 data by the end of April. The combined data from the three-weekly and two-weekly studies will provide information towards defining the dose and schedule to be used in future efficacy studies.
Patients can be dosed in parallel in the two-weekly dose escalation study, Avacta said, saying it remains on track to begin the dose expansion efficacy study in the second half of 2024.
The data from the expansion study will be used to inform the optimal choice of a single orphan indication for the phase 2 efficacy study, Avacta added, which will follow on immediately.
"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 peptide drug conjugate platform is functioning in the way it was designed and is capable of targeting the release of a cancer therapy to the tumour. 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 tumour tissues to deliver significantly better outcomes for patients and substantial value to our shareholders," said Avacta Chief Executive Officer Alastair Smith.
"The continuing validation of the preCision platform we are seeing in the clinic underlines our confidence in the significant opportunity to apply preCision to a range of warheads, including those much more potent than doxorubicin. We are now in a very strong position to deliver significant clinical and commercial milestones relating to AVA6000 and the wider preCision platform, and we are looking forward to providing a further detailed update on the clinical trial at the American Association for Cancer Research meeting in April."
Shares in Avacta were up 1.7% to 53.61 pence each in London on Thursday morning.
By Greg Rosenvinge, Alliance News senior reporter
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