Avacta Group has receive approval from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) to begin a Phase I trial of a pro-drug form of the chemotherapy doxorubicin.
The study will investigate Avacta’s AVA6000, a pro-drug form of the chemotherapy doxorubicin which has been modified using the company’s pre|CISION chemistry.
AVA6000 is rendered inactive in circulation until it enters the tumour micro-environment, where it is then activated by the enzyme fibroblast activation protein (FAP).
This enzyme is prevalent in most solid tumours, but is not in healthy tissues such as the heart.
The MHRA approval is for a Phase I clinical study, to be carried out in the UK, in patients with locally advanced or metastatic solid tumours which are known to be FAP-positive.
This includes pancreatic, colorectal, breast, ovarian, bladder and non-small cell lung cancers, as well as squamous cell carcinoma of the head and neck and soft-tissue sarcoma.
“The next key milestone for the AVA6000 programme is to dose our first patient, planned for mid-year 2021 in the UK,” said Neil Bell, chief development officer of Avacta.
“Notwithstanding COVID-19 restrictions, the team are energetically working towards achieving this milestone, which will see Avacta transform into a clinical stage company,” he added.