Avacta Group Regulatory News (AVCT)

18 February 2021

Avacta Group plc

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

Phase I Clinical Trial Authorisation for AVA6000 Approved by MHRA

Approval for the phase I dose-escalation and expansion study of Avacta's novel pre|CISIONTM FAP-activated Doxorubicin pro-drug

Avacta Group plc (AIM: AVCT), the developer of Affimer® biotherapeutics and reagents, announces that it has received approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) for its Clinical Trial Authorisation (CTA) in the UK for a phase I study of its lead pre|CISIONTM pro-drug, AVA6000 pro-doxorubicin.

In AVA6000, doxorubicin has been modified with Avacta's pre|CISIONTM chemistry, which renders the modified drug inactive in the circulation until it enters the tumour micro-environment. Here it is activated by an enzyme called FAP (fibroblast activation protein), which is in high abundance in most solid tumours but not in healthy tissue such as the heart.

In animal models AVA6000 has been shown to significantly increase the amount of active drug in a tumour compared with the heart and has significant potential to improve tolerability and achieve better clinical outcomes for patients.

The MHRA CTA approval is for a phase I clinical study and is a first-in-human, open-label, multi-centre study to be carried out in the UK in patients with locally advanced or metastatic solid tumours, which are known to be FAP positive including pancreatic, colorectal, breast, ovarian, bladder and non-small cell lung cancers, squamous cell carcinoma of the head and neck and soft-tissue sarcoma.

The timing of dosing the first patient in the study may be affected by the ongoing COVID-19 pandemic and its effect on hospital resources. However, it is anticipated that the study will start around mid-year.

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

"I am delighted to receive this approval for the AVA6000 Pro-doxorubicin phase I study from the MHRA. This is a significant milestone for Avacta and opens the path to a potentially transformational clinical proof-of-concept study for AVA6000 and the pre|CISION platform.

If the AVA6000 study shows that the pre|CISION chemistry is effective in reducing systemic toxicity of doxorubicin in humans, then it can be applied to a range of other established chemotherapies to improve their safety and efficacy. This would open up a pipeline of next generation chemotherapies for the Group with significant clinical and commercial value in a chemotherapy market that is expected to grow to $56 billion by 2024.1

I look forward to updating the market on the timing of the dosing of the first patient and on the clinical data in due course."

Professor Chris Twelves, AVA6000 Study Chief Investigator, Leeds Teaching Hospitals Trust and the University of Leeds, commented:

"This is tremendous news. When I see patients with cancer I want to offer them more effective treatments with fewer side effects. My team are excited to be part of the AVA6000 Phase I first into human study and we look forward to enrolling patients into the clinical trial ."

Neil Bell, Chief Development Officer of Avacta Group, commented: 

"The AVA6000 clincial trial authorisation approval represents another important milestone for the pre|CISION platform and AVA6000 programme. Working in partnership with the UK regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA), Avacta has obtained approval to initate our first Phase I open-label clinical study to evaluate AVA6000, a novel FAP-activated doxorubicin prodrug.

By utilizing FAP activation as a selective drug delivery system the pre|CISION platform provides the capability to deliver chemotherapies to the tumour microenvironment whilst limiting severe and life-threatening toxicities in non-target tissues. pre|CISION has the potential to change future treatment paradigms for many chemotherapies which have not yet optimised their clinical utility.

The next key milestone for the AVA6000 programme is to dose our first patient, planned for mid-year 2021 in the UK. Notwithstanding Covid-19 restrictions, the team are energetically working towards achieving this milestone, which will see Avacta transform into a clinical stage company."

This announcement contains information which, prior to its disclosure, was considered inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (MAR).

[1] https://www.globenewswire.com/news-release/2019/06/19/1871180/0/en/Chemotherapy-Market-Estimated-to-Be-Valued-at-USD-56-491-59-Million-to-Register-a-Robust-CAGR-of-11-50-By-2024.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|CISION 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 Company is also developing an in-house pipeline of Affimer-based diagnostic assays including the AffiDXTM SARS-CoV-2 Lateral Flow Rapid Antigen Test and a BAMSTM 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 Company is building a wholly owned pipeline of novel cancer therapies deigned to be effective for all cancer patients. In 2021 Avacta will commence a phase 1 first-in-human, open label, dose-escalation and expansion study of AVA6000 Pro-doxorubicin, the Company's lead pre|CISIONTM 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 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|CISIONTM platform. Avacta actively seeks to license its proprietary platforms in a range of therapeutic areas.

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