Avacta Highlights pre|CISION® Platform Data and Ongoing FOCUS-01 Trial Design with FAP-Exd (AVA6103)
The company reported preclinical findings and an update on its Phase 1 peptide-drug conjugate program; efficacy claims remain company-reported and largely preclinical.
TL;DR
- Avacta said it presented preclinical AVA6103 findings and the ongoing FOCUS-01 Phase 1 trial design at the ESMO Congress.
- The company reported tumor responses in mouse models, including models that had progressed after Enhertu treatment.
- FOCUS-01 remains an ongoing early-stage study, and Avacta expects initial efficacy data in H1 2027.
Avacta said it presented new preclinical data on AVA6103 and the FOCUS-01 Phase 1 trial design at the ESMO Congress. The investigational drug is a FAP-activated peptide-drug conjugate designed to release the exatecan payload in the tumor environment. [1] [2]
The company reported that AVA6103 showed tumor-growth inhibition and partial responses in patient-derived mouse models, including models that had progressed after Enhertu treatment. These are sponsor-reported preclinical findings and do not establish benefit in patients. [1]
Avacta described FOCUS-01 as a first-in-human, multicenter dose-escalation study enrolling people with selected solid tumors. It said enrollment was ongoing in both arms and that the study was intended to examine safety, pharmacokinetics and early activity. [1] [2]
The company said it expects the first efficacy data in H1 2027 while the Phase 1 trial continues. Sharecast separately covered the program’s first-quarter milestones, but available reports do not provide independently verified patient efficacy results or establish whether the preclinical findings will translate clinically. [1] [2]
Why it matters
The update puts a peptide-drug conjugate in active early clinical development, an area where delivery design and target biology are central to the program’s thesis. The immediate evidence remains sponsor-reported preclinical work; patient-level efficacy data are still pending.
Editor's note
The principal findings and timelines are from Avacta, the program sponsor; Sharecast provides separate coverage of company milestones. Mouse-model results are not clinical efficacy. TODO-review: confirm preferred Korean rendering for “peptide-drug conjugate.”