The US Food and Drug Administration (FDA) has granted approval to Avacta Group’s Investigational New Drug (IND) application for AVA6000, a new form of doxorubicin.

With this approval in place, the company will be able to expand its Phase I clinical trial, ALS-6000-101, into trial sites in the US.

The FDA approved the IND after completing its review of Avacta’s application for 30 days and concluded that the company may go ahead with its proposed clinical investigation.

Avacta submitted the application ahead of schedule last month. The company will now recruit eligible subjects into US clinical trial sites for the multi-centre trial.

Avacta Group CEO Dr Alastair Smith said: “This is a major milestone in our development of pre|CISION chemotherapies and is testament to the performance of our clinical development team and the quality of the pre-clinical data for AVA6000.

“Provided that the study shows that the pre|CISION technology is effective in reducing systemic toxicity of Doxorubicin, then that would open up an extensive and proprietary pipeline for Avacta of next-generation pre|CISION chemotherapies with significant clinical and commercial advantages in a chemotherapy market that is expected to exceed $74bn by 2027.”

Avacta has started patient recruitment and dosing for the trial at several sites in the UK, as announced in August this year.

Dose escalation phase for the trial is expected to complete by the second quarter of next year followed by the dose expansion phase completion around mid-2023.

Enrollment in clinical trial sites in the US is expected to begin early next year.

The company plans to open clinical trial sites in the US and additional centres in the UK.

Avacta Life Sciences chief development officer Neil Bell said: “We are excited to bring the first FAP-activated chemotherapeutic to the clinic in the US, which has the potential to meaningfully impact patients with difficult-to-treat tumours.”

The company develops new treatments for cancer and diagnostics based on its Affimer and pre|CISION platforms.