AVA6000 Phase 1b expansion cohorts continue to enroll with encouraging initial signals of efficacy
Avacta strengthens the Executive Management Team and Board of Directors with multiple additions
LONDON AND PHILADELPHIA – July 2, 2025 – Avacta Therapeutics (AIM: AVCT, ‘the Company’), a life sciences company developing innovative, targeted oncology drugs, today provides a business update ahead of the Annual General Meeting of Shareholders outlining progress against its strategic objectives for 2025 and a review of upcoming milestones.
Christina Coughlin, M.D., Ph.D., Chief Executive Officer of Avacta, said: “The Company is focused on advancing our promising peptide drug conjugate pipeline with our innovative pre|CISION® technology. We are making strong progress with the clinical development of FAP-Dox (AVA6000), with patient enrollment ongoing in multiple dose expansion cohorts of our ongoing Phase 1b study, including triple negative breast cancer.
“The data continue to show a favorable tolerability profile and increasingly durable responses in salivary gland cancers. The AVA6103 program is progressing towards the start of a Phase 1 trial early next year, reflecting efforts to develop a new class of medicines aimed at improving drug delivery and patient outcomes. These advances in pre|CISION® will continue to drive value in the Company for shareholders.”
pre|CISION® Medicine Pipeline
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FAP-Dox (AVA6000), a pre|CISION®-enabled form of doxorubicin chemotherapy, continues to progress in Phase 1b studies. During the second quarter, patient enrollment continued across the expansion cohorts, with early signs of efficacy observed, including a robust partial response in a patient with salivary gland cancer, with a nearly 50% reduction in tumor diameters. We remain on track to release the initial data in salivary gland cancer in late 2025 and in triple negative breast cancer in H1 2026. |
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FAP-EXd (AVA6103), a pre|CISION®-enabled PDC comprised of the pre|CISION® peptide linked to exatecan, continues preclinical development. AVA6103 is currently in investigational new drug (IND)-enabling studies with a Phase 1 trial anticipated to begin in the first quarter of 2026. |
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Multiple Data Presentations at the American Association for Cancer Research (AACR) Annual Congress. In April Avacta presented three posters at the AACR Annual Meeting, showcasing continued progress across its pipeline. These included an update from the salivary gland cancer cohort of the Phase 1a trial of FAP-Dox (AVA6000), with sustained durable responses observed in multiple patients. Notably, median progression free survival (PFS) had not yet been reached after a follow-up of 5.9 months, nearly double that reported in published benchmark data (Licitra et a. ESMO 2024). The two additional presentations featured preclinical data from Avacta’s second agent, FAP-EXd (AVA6103), along with translational work with the proprietary pre|CISION® platform. Further updates on the next generation peptide drug conjugates (PDCs) are expected later in 2025. |
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We continue to engage with third parties across a range of commercial opportunities reflecting the breadth of the pre|CISION® platform and progressing these discussions remains a top priority. We are also discussing FAP-Dox with a range of parties who are keen to assess additional data which is due later this year and in H1 2026. |
Changes to Board and Executive Management Team
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Changes to the Board of Directors. Two directors, Richard Hughes, founder of Zeus Capital with deep UK capital markets experience, and David Bryant, with extensive commercial industry knowledge and networks, have joined the Avacta Board of Directors. Darlene Deptula-Hicks has resigned with immediate effect from the Board to enable her to focus on other business interests. |
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Strengthened Executive Management Team and Business Development. David Liebowitz was named Chief Medical Officer on July 1, 2025. David joins Avacta with deep clinical development experience and publicly traded company experience. Avacta has also appointed Yulii Bogatyrenko as a consultant in the business development team on July 1, 2025, with a focus on supporting the Company’s commercial partnership strategy. Yulii brings long experience of overseeing commercial deals in multiple senior level positions in large pharmaceutical companies in the US. |
Addition of Broker to the Company
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Zeus Capital was appointed a joint broker to the Company, along with Peel Hunt as Nomad and joint broker and Panmure Liberum as joint broker. The Company continues to develop traction with a range of investors as it assesses options to extend the Group’s cash runway and to further build value in the pre|CISION® platform. |