Avacta Group plc (AIM: AVCT), a clinical stage biopharmaceutical company developing innovative cancer therapies and powerful diagnostics based on its proprietary Affimer® and pre|CISION™ platforms announces that the next pre|CISION™ drug candidate, AVA3996, has been selected for pre-clinical development with a view to a first-in-human Phase I clinical trial beginning in the second half of 2023.

Avacta’s pre|CISION™ chemistry is used to modify chemotherapy drugs to render them inactive in the circulation until they enter the tumour micro-environment where they are activated by an enzyme called fibroblast activation protein α (FAP). This enzyme is in high abundance in most solid tumours but, crucially, not in healthy tissues. The pre|CISION™ platform therefore offers a way to reduce systemic exposure to, and improve the safety of, these effective and affordable cancer drugs. In this way the pre|CISION™ platform is intended to increase the tolerability of chemotherapies and achieve better clinical outcomes for patients.

AVA3996 is a FAP-targeted pre|CISION™ proteasome inhibitor. Proteasome inhibitors have a market that is expected to grow to $2.3bn by 2026¹, despite limited regulatory approvals of other molecules in this class due to their serious toxicities. AVA3996 has been designed to reduce these systemic toxicities by targeting the release of the proteasome inhibitor to FAP-rich tumour tissues.

Following a review of efficacy studies in several liquid and solid tumour models, safety studies and a review of manufacturability, AVA3996 has been selected as a candidate for pre-clinical development with the aim of a Clinical Trial Authorisation (CTA) and/or Investigational New Drug (IND) filing in the first half of 2023 and dosing of the first patient later in the year.

Dr Alastair Smith, Chief Executive of Avacta Group, commented: “We are excited by the early pre-clinical data for AVA3996, the second of Avacta’s pre|CISION™ pro-drugs following on from AVA6000. The pre|CISION™ platform has the potential to generate a significant pipeline of safer, better tolerated chemotherapies to treat a wide range of cancers. It represents a major commercial opportunity and the principal value driver for the Group.”

“If AVA3996 is shown to have a significantly improved safety profile in the clinic, then not only could it provide a better tolerated treatment for multiple myeloma, but it has the potential to be the first proteasome inhibitor to be suitable for treating solid tumours, thereby significantly increasing the market opportunity.”

1. Proteasome Inhibitors Market Size, Share, Trends, Report 2022-2027

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