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Avacta Opens First Two US Clinical Investigator Sites for AVA6000 Phase 1 Clinical Study

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Avacta Group plc (AIM: AVCT) announces the opening on 5 April 2023 of the first two clinical investigator sites for the phase 1 clinical trial of AVA6000 under its US Investigational New Drug (IND) Application. The two sites, Memorial Sloan Kettering Cancer Center (MSK) in New York and Fred Hutch Cancer Center in Seattle, are now open for patient enrolment to ALS-6000-101. This is the first-in-human trial of AVA6000, Avacta’s lead pre|CISION drug candidate for the treatment of soft tissue sarcoma.

Active enrolment has now begun for soft tissue sarcoma patients to the phase 1 clinical trial in the US, led by Dr William D. Tap, Chief of the Sarcoma Medical Oncology Service at MSK, and Dr Lee D. Cranmer, Professor at the Clinical Research Division of Fred Hutch Cancer Center.

The opening of the US phase 1 trial sites for recruitment marks a significant milestone in Avacta’s plan to expand AVA6000 clinical studies. A phase 1a dose escalation study is currently underway in the UK and recently begun dosing patients in the fifth cohort at 250 mg/m2 as announced on 5 April 2023, following the favourable safety profile of AVA6000 generated in the study to date. The US trial sites will initially contribute patients to the dose escalation phase, while being uniquely positioned to lead the enrolment of soft tissue sarcoma patients in the phase 1b dose expansion stage of the AVA6000 study when this begins. Patients will receive the same doses at each stage of the trial as in the UK.

The Company will provide further updates in respect of the progress of the US Phase 1 trial as appropriate.

Neil Bell, Chief Development Officer for Avacta Group plc, commented: “This timely opening of these two key US sites, under the expert direction of Dr Tap and Professor Cranmer, is a major milestone in Avacta’s entry strategy into the US with our promising AVA6000 pre|CISION lead programme. We share with our US colleagues a clear vision to transform treatment outcomes for patients, and we look forward to working together as we continue to build the clinical evidence base for the safety and tolerability of AVA6000, in addition to the significant tumour-targeting potential of the pre|CISION platform.”