Completion of Dose Escalation and RDE Arms

Avacta Group plc

("Avacta" or "the Group" or "the Company")

Dose Escalation and Recommended Dose for Expansion (RDE) Arms of the AVA6000 Phase 1a Trial complete and Phase 1b Disease Specific Expansion Cohorts Open for Enrolment

LONDON - Dec. 12, 2024 - Avacta Therapeutics (AIM: AVCT), a life sciences company developing next generation peptide drug conjugates (PDC) targeting powerful anti-tumor payloads directly to the tumor, today announces the completion of the enrollment in the AVA6000 Phase 1a Dose Escalation and Recommended Dose for Expansion (RDE) cohort, and the opening of the Phase 1b disease-specific expansion cohorts in the trial. Patient screening has commenced.

The Phase 1b expansion cohorts follow the encouraging preliminary results in the trial reported earlier in 2024 demonstrating a favorable safety profile and significant antitumor activity in patients with salivary gland cancers (a subset of head and neck cancer) and high-grade soft tissue sarcoma. 

The Phase 1b cohorts will enroll patients in three disease-specific cohorts including: (1) triple negative breast cancer; (2) salivary gland cancer and (3) high grade soft tissue sarcoma. 

Updated data for the Phase 1 dose escalation cohorts and the recommended dose for expansion cohort will be presented in the first half of 2025.

Christina Coughlin, MD PhD, CEO of Avacta, commented: "We are encouraged by the anti-tumor activity observed in the Phase 1 dose escalation and RDE cohorts of the trial and the expansion cohorts are designed to build on that knowledge.  Opening of the expansion cohorts represents a significant milestone in the development of FAP-Doxorubicin (AVA6000) in that we will now be able to assess the activity in specific indications to better plan Phase 2 development."

About the pre|CISION^® Platform

The pre|CISION^® platform comprises an anticancer payload conjugated to a proprietary peptide that is a highly specific substrate for fibroblast activation protein (FAP) which is upregulated in most solid tumors compared with healthy tissues. The pre|CISION^® platform harnesses this tumor specific protease to cleave pre|CISION^® peptide drug conjugates and pre|CISION^® antibody/Affimer^® drug conjugates in the tumor microenvironment, thus releasing active payload in the tumor and reducing systemic exposure and toxicity, allowing dosing to be optimized to deliver the best outcomes for patients.

About AVA6000: FAP-enabled doxorubicin

The lead pre|CISION^® program AVA6000, a peptide drug conjugate form of doxorubicin, is in Phase 1 studies. It has shown an improvement in safety and tolerability in clinical trials to date compared with standard doxorubicin and preliminary signs of clinical activity in multiple patients.To register for news alerts by email go to https://avacta.com/investors/investor-news-email-alerts/.

About Avacta Group plc - https://avacta.com/

Avacta Group is a UK-based life sciences company focused on improving healthcare outcomes through targeted cancer treatments and diagnostics. Its clinical stage oncology biotech division Avacta Therapeutics is harnessing the proprietary pre|CISION^® platform technology to develop novel, highly targeted cancer drugs. Avacta Diagnostics focuses on supporting healthcare professionals and broadening access to diagnostics. To register for news alerts by email go to https://avacta.com/investors/investor-news-email-alerts/.