Avacta Group (AIM:AVCT) presented the design of its FOCUS-01 Phase 1 trial and new preclinical data on AVA6103 at the American Association for Cancer Research Conference on Pancreatic Cancer in San Diego, running from 25 to 28 September.
The AIM-listed life sciences company is developing AVA6103, its first Next-Generation pre|CISION peptide-drug conjugate, as a treatment for pancreatic ductal adenocarcinoma and other exatecan-sensitive tumours including cervical, breast, lung, gastric and colorectal cancers.
Preclinical studies using a dose-dense, two-week dosing regimen in patient-derived xenograft mouse models of pancreatic cancer produced durable complete and partial responses that persisted for weeks after dosing stopped.
Researchers also found high expression of fibroblast activation protein (FAP) in pancreatic tumours, with FAP-expressing cancer-associated fibroblasts positioned close to blood vessels and tumour cells, supporting the drug's targeted delivery mechanism.
"The robust preclinical efficacy, combined with the high FAP expression in PDAC, further strengthens our confidence in AVA6103 as a promising therapeutic candidate to improve treatment options for patients", said Christina Coughlin, Avacta's chief executive.
Preliminary safety and pharmacokinetic data from the first three dose levels of FOCUS-01, reported earlier this month, showed AVA6103 was well tolerated at a payload dose roughly 50% above the maximum tolerated dose of conventional exatecan.
Patients are now being dosed at dose level four, more than double that threshold and approaching the equivalent payload dose used in Enhertu's approved breast cancer regimen.
Avacta is targeting an initial efficacy readout from FOCUS-01 in the first half of 2027.
News Intelligence what this means for the company
Avacta presented preclinical efficacy data and Phase 1 trial design for AVA6103 at a pancreatic cancer conference, showing durable responses in mouse models and high target (FAP) expression in patient tumours. The company is now dosing patients at levels more than double the conventional exatecan maximum tolerated dose, with proof-of-mechanism already reported across the first three dose levels in 19 patients on 16 September, and an initial efficacy readout targeted for H1 2027—a near-term catalyst that could validate the drug's therapeutic potential.
The data reinforce confidence in AVA6103's mechanism and tolerability ahead of the H1 2027 efficacy readout, the company's most material near-term value inflection point. However, Avacta remains clinical-stage and raised £10.0m in March 2026 to extend cash runway into early Q1 2027, so efficacy results will be critical to funding the path to potential approval.
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