Dose escalation in the phase I trial of AVA6000

RNS Number : 5357A

Avacta Group PLC

03 February 2022

 

3 February 2022

Avacta Group plc

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

Avacta Announces Dose Escalation in the Phase I Clinical Study of AVA6000 Pro-doxorubicin

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, announces that the first-in-human Phase I trial (ALS-6000-101) of AVA6000 Pro-doxorubicin will advance to the next dose cohort following a positive review of the safety data from the dosing of the first cohort.

Avacta's Safety Data Monitoring Committee (SDMC), comprised of clinicians currently recruiting patients, has completed its review of the safety data from the first cohort dosed with AVA6000 at 80mg/m² in the ongoing Phase I trial. Following this review, the SDMC has recommended that the clinical trial continues as planned and escalates to the next dose of AVA6000 at 120mg/m².

AVA6000 is a novel form of doxorubicin that has been modified with Avacta's pre|CISION™ platform to improve its safety and therapeutic index. Anthracyclines such as doxorubicin, a generic chemotherapy with a market size that is expected to grow to $1.38bn by 2024¹, are widely used as part of standard of care in several tumour types, but their use is limited by cumulative toxicity. AVA6000 has been designed to limit cell penetration of the drug, and therefore its cell killing effect, until it is specifically activated by fibroblast activation protein α (FAP) which is in high concentration in many solid tumours compared with healthy tissues. The resulting reduced exposure of healthy tissues to active doxorubicin has the potential to significantly increase its therapeutic index by reducing the incidence of adverse effects, including cardiotoxicity and myelosuppression.

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

"We are delighted with the SDMC's recommendation to move on to the next dose of AVA6000 in our dose escalation study following its positive review of the safety data from patients in the first cohort.

"We are very excited by the potential of AVA6000, and the pre|CISION platform more broadly, to deliver ground-breaking and affordable cancer treatments that have the potential to significantly improve patients' lives."

ENDS

Market Abuse Regulation (MAR) Disclosure

The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014 as it forms part of UK domestic law by virtue of the European Union (Withdrawal) Act 2018 ('MAR'). Upon the publication of this announcement via Regulatory Information Service ('RIS'), this inside information is now considered to be in the public domain.

For further information from Avacta Group plc, please contact:

Avacta Group plc Alastair Smith, Chief Executive Officer Tony Gardiner, Chief Financial Officer Michael Vinegrad, Group Communications Director	Tel: [phone] www.avacta.com
Stifel Nicolaus Europe Limited (Nomad and Broker) Nicholas Moore / Nick Adams / Fred Walsh / Nicholas Harland	Tel: [phone] www.stifel.com
FTI Consulting (Financial Media and IR) Simon Conway / Alex Shaw	Tel: [phone] [e-mail]
Zyme Communications (Trade and Regional Media) Lily Jeffery	Tel: [phone] [e-mail]

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 London and 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 is developing an in-house pipeline of Affimer-based diagnostic assays, including the AffiDX^® SARS-CoV-2 Lateral Flow Rapid Antigen Test, and works with partners world-wide to develop bespoke Affimer^® reagents for third party products.

Avacta's Therapeutics Division is working to deliver a more tolerable and durable treatment response for oncology patients who do not respond to existing immunotherapies. By combining its two proprietary platforms the Group is building a wholly owned pipeline of clinically differentiated cancer therapies, aiming to extend the therapeutic benefits to all cancer patients. In 2021 Avacta transitioned to become a clinical stage biopharmaceutical company, commencing a phase I first-in-human, open label, dose-escalation and expansion study of AVA6000, a 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 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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¹ https://www.prnewswire.com/news-releases/doxorubicin-market-size-is-expected-to-reach-138-billion-by-2024-grand-view-research-inc-602613665.html

 

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