Avacta, a UK-based clinical-stage biotechnology company focused on oncology, has reported initial Phase 1a safety and pharmacokinetic (PK) data from the FOCUS-01 trial evaluating AVA6103, its lead second-generation pre|CISION tumour-activated Peptide Drug Conjugate (PDC) programme.

AVA6103, also known as FAP-EXd, is an FAP-activated, controlled-release exatecan designed to selectively localise payload activity within the tumour microenvironment (TME).

According to the initial data, the programme has provided early clinical evidence supporting the targeted tissue localisation observed in preclinical studies. Initial dose-escalation cohorts demonstrated an approximately three-fold reduction in systemic payload exposure compared with benchmarks for existing Antibody-Drug Conjugates (ADCs).

The company said the findings also indicated an absence of the severe myelosuppression typically associated with free topoisomerase 1 inhibitors. The data remain exploratory, but Avacta said they support the potential of its engineered capping group to retain the parent conjugate within the TME and establish a localised, slow-release drug reservoir.

The Phase 1a dose-escalation portion of FOCUS-01 is continuing through the remaining cohorts, with full safety findings expected by late 2026.

The Phase 1b expansion is planned to begin in early 2027 and will evaluate AVA6103 across six high-prevalence solid tumour indications. The study is designed to assess objective response rates and disease control, with initial efficacy data expected in the first half of 2027.

Avacta said the upcoming clinical data will help determine whether the pharmacokinetic and safety characteristics observed in the early cohorts can translate into measurable clinical benefit and support the broader development of the pre|CISION platform.

The early proof-of-mechanism findings have also led Trinity Delta to revise its valuation assumptions for Avacta, citing potential expansion of the platform through multiple payloads targeting FAP-expressing solid tumours. Trinity Delta’s revised risk-adjusted net present value (rNPV) model values Avacta at Euro 525 million, equivalent to 111 pence per share, or 105 pence on a fully diluted basis, compared with its previous valuation of Euro 475 million, or 101 pence per share, and 94 pence on a fully diluted basis.

Avacta had Euro 16.4 million in cash at the end of April 2026, which Trinity Delta said provides a runway into the first quarter of 2027 and covers several anticipated value inflection points. Potential future funding routes identified by Trinity Delta include licensing or partnering transactions, an additional NASDAQ listing and further equity raises.

Trinity Delta is an issuer-paid equity research provider focused on healthcare and life sciences. Its research covers biotechnology, medical technology, specialty pharmaceuticals and consumer health, and is provided under the non-monetary minor benefit category of MiFID 2, according to the firm.