Avacta Group Regulatory News (AVCT)

11 August 2021

Avacta Group plc

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

Avacta Announces First Patient Dosed in AVA6000 Pro-Doxorubicin Phase 1 Clinical Trial

Dose escalation phase anticipated to complete by Q2 2022

Avacta Group plc (AIM: AVCT), a clinical stage oncology drug company and developer of powerful diagnostics based on its innovative Affimer® and pre|CISION™ platforms, is pleased to announce that the first patient has been dosed in the Company's Phase I multi-centre trial evaluating AVA6000, a novel pro-drug of Doxorubicin and Avacta's first therapeutic product based on its proprietary pre|CISION™ technology.

Anthracyclines such as Doxorubicin, a generic chemotherapy for which the market is expected to grow to $1.38bn by 2024, are widely used as part of standard of care in several tumour types, but their use is limited by cumulative toxicity, and, in particular, cardiotoxicity. Avacta's pre|CISION™ pro-drug approach is designed to reduce the systemic exposure of healthy tissues to the active chemotherapy, leading to improved safety and therapeutic index, potentially resulting in improved dosing regimens, better efficacy and better outcomes for patients.

This trial of AVA6000 is a dose-escalation Phase I study in patients with locally advanced or metastatic selected solid tumours, known to be FAP-positive, in which cohorts of patients receive ascending doses of AVA6000 to determine the maximum tolerated dose and establish a recommended Phase II dose. The second part of the study is an expansion phase where patients receive AVA6000 to further evaluate the safety, tolerability and clinical activity at this recommended Phase II dose across selected tumour types. For more information visit www.clinicaltrials.com (NCT04969835).

The first patient has received their first dose of AVA6000 at The Royal Marsden NHS Foundation Trust. The Phase I study is being initiated across a small group of leading UK cancer centres with an established reputation for early cancer clinical research in the Phase I setting. The dose escalation phase is anticipated to complete by Q2 2022 followed by completion of the dose expansion phase by Q2 2023.

Dr Alastair Smith, Chief Executive Officer of Avacta Group, commented:

"The initiation of the first in human Phase I clinical study for AVA6000 marks the transformation of Avacta into a clinical stage biopharmaceutical company. It is an outstanding achievement by the team and we are extremely proud of what has already been achieved since the establishment of the collaboration with Professor William Bachovchin at Tufts University Medical School to develop the pre|CISIONTM technology for tumour targeting.

"We are delighted to be working on the AVA6000 study with global key opinion leaders in oncology drug development at world-class oncology clinical trial sites in UK on this important pro-drug approach to improving the safety and efficacy of chemotherapies.

"If the study shows that the pre|CISIONTM technology is effective in reducing systemic toxicity of Doxorubicin in humans, then that would open up an extensive and proprietary pipeline for Avacta of next-generation pre|CISIONTM pro-drug chemotherapies with significant clinical and commercial advantages in a chemotherapy market that is expected to exceed $74 billion by 2027."

Neil Bell, Chief Development Officer, Avacta Life Sciences commented:

"AVA6000 offers an exciting opportunity to improve upon the current doxorubicin treatment paradigm for patients, either as a monotherapy or in combination. We look forward to the results from our AVA6000 first-in-human clinical trial as we strive to improve the therapeutic index of doxorubicin for patients."

AVA6000 Principal Investigator Professor Udai Banerji, Deputy Director of the Drug Development Unit at The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust commented:

"I am delighted that the first patient has now received AVA6000 in the first-in-human study. This drug harnesses our understanding of the tumour microenvironment to enhance drug delivery - targeting potent anticancer therapies to tumours and potentially sparing patients debilitating side effects. It is fantastic that efforts are being made to discover and develop smarter, kinder treatments."

1. https://www.prnewswire.com/news-releases/doxorubicin-market-size-is-expected-to-reach-138-billion-by-2024-grand-view-research-inc-602613665.html

2. https://www.globenewswire.com/en/news-release/2021/02/08/2171622/0/en/Cancer-Chemotherapy-Market-Value-Anticipated-To-Reach-US-74-3-Billion-By-2027-Acumen-Research-and-Consulting.html

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

Avacta Group is developing novel cancer immunotherapies and powerful diagnostics based on its two proprietary platforms - Affimer® biologics and pre|CISION™ tumour targeted chemotherapies.

The Affimer® platform is an alternative to antibodies derived from a small human protein. Despite their shortcomings, antibodies currently dominate markets, such as diagnostics and therapeutics, worth in excess of $100bn. Affimer technology has been designed to address many of these negative performance issues, principally: the time taken to generate new antibodies and the reliance on an animal's immune response; poor specificity in many cases; their large size, complexity and high cost of manufacture.

Avacta's pre|CISIONTM targeted chemotherapy platform releases active chemotherapy in the tumour, which limits the systemic exposure that causes damage to healthy tissues, and thereby improves the overall safety and therapeutic potential of these powerful anti-cancer treatments.

The Group comprises two divisions: The therapeutics development activities are based in Cambridge, UK and the Group is generating near-term revenues from Affimer reagents for diagnostics, bioprocessing and research, through a separate diagnostics business unit based in Wetherby, UK.

Avacta's Diagnostics Division works with partners world-wide to develop bespoke Affimer® reagents for third party products. The Group is also developing an in-house pipeline of Affimer-based diagnostic assays including the AffiDX® SARS-CoV-2 Lateral Flow Rapid Antigen Test and AffiDX® BAMS™ SARS-CoV-2 Assay in partnership with Adeptrix Inc.

Avacta's Therapeutics Division is addressing a critical gap in current cancer treatment - the lack of a durable response to current immunotherapies experienced by most patients. By combining its two proprietary platforms the Group is building a wholly owned pipeline of novel cancer therapies deigned to be effective for all cancer patients. In 2021 Avacta a clinical stage biopharmaceutical company, commencing a phase 1 first-in-human, open label, dose-escalation and expansion study of AVA6000 Pro-doxorubicin, the Group's lead pre|CISION™ prodrug, in patients with locally advanced or metastatic selected solid tumours.

Avacta has established drug development partnerships with pharma and biotech, including a research collaboration with ModernaTX,Inc. (formerly Moderna Therapeutics Inc.), a multi-target deal with LG Chem worth up to $400m, a joint venture in South Korea with Daewoong Pharmaceutical focused on cell and gene therapies incorporating Affimer immune-modulators, a partnership with ADC Therapeutics to develop Affimer-drug conjugates and a collaboration with Point Biopharma to develop radiopharmaceuticals based on the pre|CISION™ platform. Avacta continues to actively seek to license its proprietary platforms in a range of therapeutic areas.

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About AVA6000 and the pre|CISION Technology

AVA6000 is Avacta's first therapeutic product based on its proprietary pre|CISION™ technology. When attached to a chemotherapy, the pre|CISION™ technology prevents the chemotherapy from entering cells and therefore renders it inert in its pre|CISION™ "pro-drug" form.

The pre|CISION™ technology is removed by an enzyme called fibroblast activation protein-alpha (FAP) which is present in high concentration in most solid tumours and only present at low background levels in healthy tissue. Removal of the pre|CISION™ technology releases the active chemotherapy, which in the case of AVA6000 is Doxorubicin. Due to the much higher levels of FAP in tumour tissue, this activation occurs predominantly in the tumour, reducing the systemic exposure of healthy tissues to the active chemotherapy.