On April 21, 2026 Avacta Therapeutics (AIM: AVCT, "the Company", "Avacta"), a clinical stage biopharmaceutical company developing pre|CISION, a tumor-activated oncology delivery platform, reported two presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026. These presentations include the first in vivo efficacy and exposure pharmacology for the pre|CISION dual payload technology program and updated pharmacology and preclinical exposure data analyses highlighting the favorable delivery profile of AVA6103 (FAP-EXd), its second clinical candidate, which has recently entered Phase 1 development. Updates to the ongoing Phase 1 clinical trial are also being presented.
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Christina Coughlin, CEO of Avacta, commented:
"The data being presented at AACR (Free AACR Whitepaper) underline the potential of our pre|CISION technology and AVA6103 to make a considerable difference to cancer patients. These observations could significantly increase the probability of success with AVA6103, given both the ability of FAP-Exd to deliver more payload selectively to the tumor in the preclinical setting, and the success of Enhertu in the clinic. The FOCUS-01 Phase 1 clinical trial of AVA6103, now underway in the US, is designed to demonstrate the benefits of pre|CISION in unlocking the full potential of exatecan while minimizing systemic toxicity.
Furthermore, we have shown how pre|CISION delivers a therapeutically relevant combination of payloads specifically to the tumor microenvironment while reducing systemic dose-limiting toxicities, broadening its utility in the delivery of novel medicines. The dual delivery mechanism of pre|CISION shows its potential to dramatically increase the therapeutic window and reduce systemic toxicities, offering improved outcomes for patients with cancer."
Details of the Two Presentations:
AVA6103 (FAP-EXd) Preclinical and Clinical Trial in Progress Highlights (Rink, C. et al.)
This presentation includes updated preclinical data from the Company’s second clinical candidate, AVA6103, a novel FAP-activated pre|CISION peptide-drug conjugate (PDC) delivering the topoisomerase I inhibitor (TOP1i) exatecan directly to the tumor-stroma interface, as well as details of the ongoing FOCUS-01 Phase 1 trial of this agent.
The data demonstrate that AVA6103 has robust activity in multiple patient-derived xenograft (PDX) models with FAP levels ranging from very low to high, suggesting excellent antitumor effects even at the lowest levels of FAP expression in stromal cells only. This presentation also includes a data analysis comparing pre|CISION FAP-cleavable payload delivery with that of the leading marketed ADC Enhertu (an AstraZeneca/Daiichi Sankyo product).
The data analysis used a synthetic comparator arm that was generated using AI to recreate a published AstraZeneca data set[1] and compare to experimental data generated with AVA6103 in a similar experimental design using a FAP-high animal model with two drugs using similar payloads (exatecan and deruxtecan). It demonstrated three key differences in the pharmacokinetics (PK) of the payload: more rapid tumor penetration and payload release with AVA6103, tumor Cmax of more than one log higher with AVA6103, and Tumor Selectivity Index (TSI: AUCtumor / AUCplasma) three times higher with AVA6103.
AVA6103 has recently entered the clinic, with the first patient receiving treatment in the FOCUS-01 study in March. FOCUS-01 (NCT07454642) is a multicenter, open-label Phase 1 clinical trial of AVA6103 in adults with selected advanced cancers, and the initial clinical data readout from the study is anticipated later this year. Based on favorable preclinical activity and biomarker readouts from the strategic collaboration with Tempus, two indications have been added to the trial: colorectal cancer (CRC) and hormone receptor-positive breast cancer (HR+ BC)
Abstract Number and Title: Abstract #5846, AVA6103 is a FAP-enabled pre|CISION peptide-drug conjugate delivering sustained release of exatecan in the tumor microenvironment with potent antitumor activity.
Poster number and Location: 5846, Section 17, Board 15
Session: Tumor Microenvironment, Multi-specifics, and Immunomodulation
The pre|CISION dual payload technology (AVA6207) update (Juskaite, V. et al.)
This presentation includes the description of how pre|CISION delivers a therapeutically relevant combination of payloads specifically to the tumor microenvironment while reducing systemic dose-limiting toxicities, broadening its utility in the delivery of novel combinations of medicines.
The AVA6207 dual payload is designed to simultaneously release a TOP1i and a DNA Damage Repair (DDR) inhibitor by FAP cleavage, resulting in synthetic lethality in two genetic models of TOP1i resistance: tumor cells harboring either (1) ATM-deficiency or (2) loss of SLFN11. These studies demonstrate the ability of AVA6207 to overcome key mechanisms of TOP1i resistance and mediate synergistic tumor cell killing.
The first in vivo data with this novel combination mechanism are presented, with tumor and plasma pharmacokinetic studies demonstrating the robust tumor-selective release of both payloads with a highly potent TSI. In addition to the robust exposure data, antitumor efficacy is demonstrated in a patient-derived xenograft (PDX) model of HER2+ gastric cancer with low FAP expression with optimal activity of AVA6207 over the HER2-targeted TOP1i ADC (Enhertu)
Abstract Number and Title: Abstract #5656, Characterization and translational development of novel pre|CISION technology compounds delivering complementary dual payloads to the tumor microenvironment following FAP cleavage
Session: Antibody-Drug Conjugates and Linker Engineering 4
Section: Experimental and Molecular Therapeutics
(Press release, Avacta Life Sciences, APR 21, 2026, View Source [SID1234664660])