Avacta Group (AVCT ) said the first patient from its Phase I multi-centre trial evaluating AVA6000, a therapeutic product based on the pre|CISION™ technology has been dosed.
The Company’s Phase I trial evaluating AVA6000, a pro-drug of Doxorubicin, is its first therapeutic product based on its proprietary pre|CISION™ technology. Today, Avacta said the first patient has received their first dose at The Royal Marsden NHS Foundation Trust.
The trial is a dose-escalation study in patients with locally advanced or metastatic selected solid tumours, known to be FAP-positive. The patients receive ascending doses of AVA6000 to determine the maximum tolerated dose and establish a recommended Phase II dose.
Avacta’s 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.
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 said its pre|CISION™ pro-drug approach is designed to reduce the systemic exposure of healthy tissues to the active chemotherapy for improved safety and therapeutic index, which can result in improved dosing regimens, better efficacy and better patient outcomes.
During the second part of the study, patients will receive AVA6000 to evaluate the safety, tolerability and clinical activity at this recommended Phase II dose in selected tumour types.
The second part of the study, referred to as the ‘dose escalation phase’, is anticipated to complete by 2Q22 followed by completion of the dose expansion phase by 2Q23.
Commenting on this morning’s announcement, Dr Alastair Smith, Chief Executive Officer of Avacta Group, stated: "The initiation of the first in human Phase I clinical study for AVA6000 marks the transformation of Avacta into a clinical stage biopharmaceutical company.”
Smith said the dosing of the trial’s first patient as “an outstanding achievement”. He said: "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 the 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.”
In particular, Avacta said this would come with “significant clinical and commercial advantages” in a chemotherapy market that is expected to exceed $74 billion by 2027.
Principal Investigator, Professor Udai Banerji, Deputy Director of the Drug Development Unit at The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust said:
“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."
View from Vox
Last week, Avacta began the shipment of its AffiDX® SARS-CoV-2 antigen lateral flow test, a ‘high performance’, 20-minute antigen test which uses patient-friendly nasal swabbing.
To date, the AffiDX® SARS-CoV-2 test has been shown by independent clinical evaluation to be 100% sensitive for patient samples with a PCR Ct value below 27 (indicative of a high viral load), 98.0% sensitive across a much wider range of viral loads and with 99% specificity.
Following the recent confirmation of registration from the MHRA, Avacta has been able to commercially roll-out its AffiDX® test across Europe by placing the test on the market.
In recent weeks, Avacta has entered a new agreement granting the professional use of its AffiDX® SARS-CoV-2 antigen lateral flow test in the UK and European Economic Area (EEA).
In June 2021, Avacta noted that its AffiDX® test was proven to outperform two lateral flow antigen tests currently commercially available in Europe. Following the evaluation, one of the tests only detected half the positive cases than AffiDX® while the other test detected none.
"In comparison with other lateral flow tests on the market, Avacta's rapid antigen test demonstrates better clinical performance,” said Smith, who added that this demonstration is “a further huge validation of the Affimer® reagent platform for use in in-vitro diagnostics.”
Lateral flow rapid antigen tests are intended to provide a low cost means of identifying individuals with a high viral load that means they are more likely to infect others.
Shares in Avacta Group have increased by over 10% in value since the beginning of 2021. The stock was trading 0.81% higher this morning at 124.5p following the announcement.
Reasons to AVCT
Avacta is developing cancer immunotherapies and diagnostics based on its two proprietary platforms - Affimer® biologics and pre|CISION™ tumour targeted chemotherapies.
Its 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, which is a market that is believed to be worth in excess of $100bn.
Therapeutics
The 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.
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 designed to be effective for all cancer patients.
In 2021, Avacta commenced 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.
COVID-19 Test Development
Avacta has also developed a SARS-CoV-2 lateral flow rapid antigen test aimed at identifying infectious individuals so that they can isolate promptly and reduce the spread of COVID-19.
Recent data returned in recent months from the Company’s ongoing clinical studies across Europe and the UK demonstrated an ‘excellent performance’ of the SARS-CoV-2 rapid antigen test in identifying patients with an infectious viral load and no false positive results.
As a result of ‘excellent initial data’, the Company said it will now progress to a full clinical validation with a larger number of patient samples to CE mark the test for professional use, aiming to bring the test to market in Europe around the end of the first quarter of this year.
These data from the first clinical studies will allow the Group to advance into a full clinical validation of the test, manufactured at scale, at its clinical trial sites in the UK and the EU.
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