Avacta reports ‘significant momentum’ across both its diagnostics and therapeutics divisions
(AVCT ) has highlighted its progress during the 12 months ended 31 December 2020 and post-period in a business update released this morning in which the Group stated that it now expects to deliver significant value from both its diagnostics and therapeutics divisions during 2021 and beyond.
Diagnostics
The diagnostics businesses, based on its proprietary Affimer® and platform, finished the period “well placed” for the launch of a ‘commercially valuable’ rapid coronavirus lateral flow test by the end of 1Q21.
‘Importantly,’ it said, ‘this included establishing a complex supply chain for manufacturing the test kits and the establishment of a quality management system to support the required ISO13485 accreditation for medical devices.’
To date, the recorded analytical performance of the Company’s coronavirus rapid test in the laboratory suggests that it may be the most sensitive S1 spike protein lateral flow test available, Dr Alastair Smith, Chief Executive Officer of Avacta Group noted to investors.
A recent initial clinical evaluation of this test using anterior nasal swab samples showed a sensitivity of 96.7% for samples with an infectious viral load and a specificity of 100%, meaning Avacta can now progress with significant confidence to full clinical validation to support a CE Mark.
Therapeutics
Smith also said the Company’s Therapeutics Division continues to expand its in-house preclinical pipeline, as outlined at the time of its fundraise in 2020. He said the Group has kept partnered programmes moving forwards despite the restrictions of COVID-19 safe working.
Last week, the Group received approval from the Medicines and Healthcare Products Regulatory Agency (“MHRA”) to start a phase 1 clinical trial of its pre|CISIONTM pro-drug, AVA6000 pro-doxorubicin in patients with locally advanced or metastatic solid tumours.
The Group said it had been granted Clinical Trial Authorisation (“CTA”) to initiate the phase 1 study which will be a first-in-human, open-label, multi-centre study carried out in the UK.
The trial will target patients with locally advanced or metastatic solid tumours 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.
While the timing of dosing the first patient may be affected by the COVID-19 pandemic and its effect on hospital resources, Avacta anticipates that the study will start around mid-year.
The Group expects the AVA6000 study to demonstrate that its pre|CISION chemistry is effective in reducing systemic toxicity of doxorubicin in humans and that it can be applied to a range of other established chemotherapies in order to improve their safety and efficacy.
It is expected to open up a pipeline of next generation chemotherapies with significant clinical and commercial value in a chemotherapy market that is expected to grow to $56bn by 2024.
It said it is making ‘significant progress’ with its in-house Affimer bispecific programmes towards the selection of a clinical development candidate by the end of 2021. Avacta’s cash position at 31 December 2020 was £48m, coming in slightly higher than market forecasts.
Post-period End
In recent weeks, Avacta has agreed to partner with Mologic in order to provide the Company with a faster route to market for its lateral flow rapid antigen test. This will occur by CE marking it for professional use under Mologic’s existing ISO13485 quality system.
Separately, the Group entered into a licence agreement with Point Biopharma to provide access to its ‘preCISION’ technology to develop tumour-activated radiopharmaceuticals.
Meanwhile, AffyXell Therapeutics, the JV between Avacta and Daewoong Pharmaceutical closed a Series A venture capital investment of $7.3m at the start of February which will enable the Group to develop its pipeline of next generation cell and gene therapies.
“The progress achieved during 2020 in both the Diagnostics and Therapeutics Divisions positions us to deliver significant value inflection points during 2021 and beyond”
“I am very proud indeed of the way in which the Avacta team has dealt with the unprecedented challenges that the pandemic has presented us with and that we have continued to deliver progress and significant shareholder value. I look forward to updating the market on the significant and very exciting milestones ahead of us,” commented Smith.
Whilst the valuation of Avacta is subject to much speculation, long-term sophisticated investors will take confidence in the fact management are methodically advancing plans for a CE Marked lateral flow test for professional use whilst building the therapeutics division into a profitable business in its own right.
For investors focussed on the pandemic, the Avacta share price has increased by nearly 50% since the beginning of February 2021 after returning “extremely encouraging” results from first data received for its SARS-CoV-2 rapid antigen test from its ongoing clinical studies in Europe and the UK.
However, for longer-term investors, there is potentially much more to come with the global market for AVA6000 estimated to be >$1.5bn pa before considering that if Avacta’s pre|CISION science is successful, it could be deployed across many other oncology areas.
Reasons to Follow 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
The Company 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 earlier this week 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 it 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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