Avacta gets approval for first-in-human study of AVA6000

(Sharecast News) - Biotherapeutics and reagents developer Avacta has received approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) for a phase 1 study of its lead 'preCISION' pro-drug, AVA6000 pro-doxorubicin, it announced on Thursday.

The AIM-traded firm said that in AVA6000, doxorubicin had been modified with its preCISION chemistry, which rendered the modified drug inactive in circulation until it entered the tumour microenvironment.

There, it was activated by an enzyme called fibroblast activation protein (FAP), which is in high abundance in most solid tumours but not in healthy tissue such as the heart.

In animal models, AVA6000 was shown to "significantly increase" the amount of active drug in a tumour compared with the heart, with the board saying it had "significant" potential to improve tolerability and achieve better clinical outcomes for patients.

The MHRA clinical trial authorisation approval was for a phase 1 clinical study, which would be a first-in-human, open-label multi-centre study carried out in the UK in patients with locally-advanced or metastatic solid tumours which are known to be FAP positive.

Such tumours include 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 could be affected by the ongoing Covid-19 pandemic and its effect on hospital resources, the board warned, but it did expect that that the study would start around mid-year.

"This is a significant milestone for Avacta and opens the path to a potentially transformational clinical proof-of-concept study for AVA6000 and the preCISION platform," said chief executive officer Alastair Smith.

"If the AVA6000 study shows that the preCISION 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 $56bn by 2024."

At 0832 GMT, shares in Avacta Group were up 1.6% at 190p.