Avacta Group (AVCT ) has 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 has 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.
In AVA6000, doxorubicin has been modified with 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,’ it noted.
Avacta noted that in animal models AVA6000 has previously 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.
It states that this is because AVA6000 pro-doxorubicin permits higher doses than the MTD maximum tolerable dose for doxorubicin which results in better anti-tumour activity.
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.
Commenting on the phase 1 clinical trial, Alastair Smith, Chief Executive Officer of Avacta Group said, “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.”
He highlighted that should the AVA6000 study demonstrate 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 in order to improve their safety and efficacy.
This 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.
“pre|CISION has the potential to change future treatment paradigms for many chemotherapies which have not yet optimised their clinical utility,” said Neil Bell, Chief Development Officer of Avacta Group.
He said, “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.”
The next key milestone for the AVA6000 programme is to dose its first patient, planned for mid-year 2021 in the UK. The Group said its team are “energetically working towards achieving this milestone, which will see Avacta transform into a clinical stage company."
Avacta’s ‘AVA6000 Pro-doxorubicin’, is designed to be totally ‘harmless’ to healthy tissues (vs chemotherapy). But when in direct contact with a tumour will release (re FAP enzyme) a precision-guarded ‘chemo-warhead’ dose of doxorubicin into the cancerous cells. Thus ideally killing them without causing any major side-effects.
The global market for AVA6000 is estimated to be >$1.5bn pa. But if successful, Avacta’s pre|CISION science could be deployed across many other oncology areas. Indeed the treatment has already shown great promise in pre-clinical studies, & today was given the green light to enter Phase 1 human trials by the UK’s MHRA. 1st patients are set to be dosed in the summer. While the global market for AVA6000 is estimated to be >$1.5bn pa, if successfully utilised, Avacta’s pre|CISION science could be deployed across many other oncology areas.
This, alongside its Affimer platform & #Covid testing initiatives, means that #AVTC has multiple game-changing opportunities ahead.
Shares in Avacta Group have increased by over 35% in value since the beginning of February 2021 and by over 6% in the past two days after the Group returned “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. The stock was trading 2.89% higher this morning at 192.4p.
Reasons to AVCT
Avacta is developing cancer immunotherapies and diagnostics based on its two proprietary platforms - Affimer® biologics and pre|CISION™ tumour targeted chemotherapies.
The Company’s 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, a market that is believed to be worth in excess of $100bn.
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 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.
COVID-19 pipeline
The Company has also developed a SARS-CoV-2 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.