Avacta Therapeutics reported progress across its oncology pipeline during the first half of 2026, highlighted by early clinical data showing proof of mechanism for lead next-generation pre|CISION candidate AVA6103.
AVA6103 is a fibroblast activation protein-enabled drug designed to release the topoisomerase I inhibitor exatecan within tumors.
Avacta said Phase 1a data from patients with selected solid tumors demonstrated a clean safety profile through the first three dose levels.
At the third dose level, patients received an exatecan payload dose approximately 50% higher than the maximum tolerated dose of conventional exatecan.
The company also reported that clinical pharmacokinetic results have closely matched its preclinical modeling through the first three dose levels.
The data showed controlled release of exatecan in patients for several days after dosing, supporting the mechanism underlying the pre|CISION platform.
Avacta also completed a head-to-head preclinical comparison of AVA6103 with Enhertu, an approved antibody-drug conjugate targeting HER2.
The company said AVA6103 demonstrated better antitumor activity than Enhertu in the preclinical comparison, with deep and durable responses using the dose-dense regimen being applied in the FOCUS-01 clinical trial.
The FDA cleared Avacta’s Investigational New Drug application for AVA6103 in January, and the first patient entered the study in March.
Avacta expects to report the first efficacy data from FOCUS-01 during the first half of 2027. The company also expects clinical tumor biopsies to provide additional information on whether AVA6103 is retained inside tumors as a drug reservoir.
The company’s next-generation pipeline also includes AVA6207, a dual-payload pre|CISION program.
Avacta presented initial in vivo efficacy and exposure pharmacology for AVA6207 at the 2026 AACR Annual Meeting and subsequently presented additional in vivo studies during its Science Day.
Payload selection and supporting data for the AVA6207 clinical candidate are expected during the fourth quarter of 2026.
Avacta also continued development of first-generation asset AVA6000, or faridoxorubicin.
Updated Phase 1a and Phase 1b data presented at the 2026 ASCO Annual Meeting showed early efficacy signals in salivary gland cancers.
Following an end-of-Phase 1 meeting, Avacta said it reached agreement with the FDA on certain elements of a potential pivotal trial and the regulatory pathway that could follow Phase 1b data.
The FDA also agreed to protocol changes removing the maximum dosing limit and providing additional flexibility to identify a dose for further development.
Avacta raised approximately £19 million during 2026 through two financings. An oversubscribed placing and subscription raised £10 million in March, followed by approximately £9 million in gross proceeds from an equity raise in June.
Cash and short-term deposits totaled £20.27 million as of June 30, compared with £16.9 million at the end of 2025. Cash stood at £10.59 million as of August 31.
The company separately announced plans for another capital raise alongside its interim results to strengthen its balance sheet and fund upcoming development milestones.
Avacta also strengthened its board during 2026 through the appointments of Richard Hughes as non-executive Chairman, Patrick Vink as Deputy Chairman and Mats Blom as Chair of the Audit Committee.
KEY QUOTES:
“This has been a transformative first half for Avacta, with compelling clinical validation of our pre|CISION platform delivering robust and durable tumor responses and demonstrating the clear advantages of our approach over conventional ADCs. The controlled-release mechanism of our Next Gen pipeline with AVA6103 as the lead asset is now working in patients, exactly as modelled, and we are moving towards initial efficacy data in 2027.
“This progress is underpinned by a strong and complementary leadership team. We have further reinforced the expertise and governance at Avacta with several senior appointments in 2026 to management and our Board, who bring the benefit of their scientific, industry, markets and financial acumen to the Company as we advance our proprietary pipeline and explore partnering opportunities to maximize the potential of our pre|CISION platform.
“Our financing activities have raised approximately £19.0 million in 2026 to date, which together with the anticipated proceeds of our planned capital raise being launched today, will ensure funding is in place to execute on multiple value inflection milestones, including the efficacy data on AVA6103 in H1 2027, as well as payload selection for our dual-payload program AVA6207 later this year.”
Christina Coughlin, CEO of Avacta Therapeutics
