Five of the ten trial subjects who received doses of 250mg/m² or higher experienced tumour shrinkage. Credit: Andrey_Popov / Shutterstock.

UK-based biotechnology company Avacta Therapeutics has reported outcomes from the Phase Ia trial of AVA6000, a drug candidate for solid tumours.

AVA6000 is designed to treat fibroblast activation protein-positive (FAP-positive) solid tumours, with a particular focus on salivary gland cancer (SGC) treatment.

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Of the ten trial subjects who received a dose of 250mg/m² or higher, five have experienced tumour shrinkage, including one partial and four minor responses.

Six of these subjects are still receiving treatment, with two additional ones being monitored for progression-free survival after completing the maximum treatment cycles.

Encouraged by these ‘favourable‘ safety and efficacy data, Avacta has begun three Phase Ib expansion cohorts to explore the therapy in soft tissue sarcoma, SGC, and triple-negative breast cancer.

Subject screening for these cohorts is ongoing, with the first US patients expected to begin treatment soon.

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Preliminary evidence from the trial suggests ‘durable’ anti-tumour activity, backed by ongoing RECIST responses in a disease setting lacking a standard care approach.

AVA6000’s tolerability has been confirmed in both dosing schedules, with a significant reduction in toxicities and no maximum tolerated dose identified.

Avacta Therapeutics CEO Christina Coughlin said: “These data highlight the transformative potential of our pre|CISION peptide drug conjugates in expanding the efficacy of highly potent therapeutics and support our growing optimism in this programme.

“We are thrilled to begin enrolment in the expansion cohorts, and this part of the trial will also be conducted in less heavily pre-treated patients, which will allow us to better understand the potential of AVA6000 in these disease settings with high unmet need.”

In April 2023, Avacta Group dosed the first subject in the dose-escalation portion of its Phase I trial of AVA6000 in the US, which enrolled individuals with locally advanced and/or metastatic solid tumours known to be FAP-positive.