FDA gives Avacta the go-ahead for US chemotherapy trials

(Sharecast News) - Clinical-stage biopharmaceutical company Avacta Group announced on Monday that the US Food and Drug Administration (FDA) has approved its investigational new drug (IND) application for its chemotherapy drug 'AVA6000'.
The AIM-traded firm said that would allow it to expand its phase 1 clinical trial into sites in the United States.

It described AVA6000 as a novel form of doxorubicin, that had been modified with its proprietary 'preCISION' platform to improve its safety and therapeutic index.

Anthracyclines such as doxorubicin, a generic chemotherapy for which the market was expected to grow to $1.38bn by 2024, are widely used as part of standard-of-care in several tumour types, but their use remained limited by cumulative toxicity.

AVA6000 was designed to limit cell penetration of the drug, and therefore its cell killing effect, until it was specifically activated by fibroblast activation protein α (FAP), which is in high concentration in many solid tumours compared with healthy tissues.

The company said the resulting reduced exposure of healthy tissues to active doxorubicin had the potential to "significantly increase" its therapeutic index, by reducing the incidence of adverse effects, including cardiotoxicity and myelosuppression.

Avacta said the FDA completed its 30-day review of the IND application, which was submitted ahead of schedule in October, and concluded that the group could proceed with its proposed clinical investigation.

The decision would allow Avacta to enroll eligible patients into US clinical trial sites for the company's phase 1 multicentre study, ALS-6000-101.

As it had announced in August, the company had started recruiting and dosing patients for the study at several clinical trial sites in the UK, and continued to expect the dose escalation phase for the trial to complete by the second quarter of 2022, followed by the completion of the dose expansion phase around mid-2023.

Enrollment in US clinical trial sites was expected to begin in early 2022.

"We are delighted to have received approval from the FDA to add clinical trial sites in the United States as part of the phase 1 study for AVA6000," said chief executive officer Alastair Smith.

"This is a major milestone in our development of preCISION chemotherapies and is testament to the performance of our clinical development team and the quality of the pre-clinical data for AVA6000."

Dr Smith said, provided that the study showed that the preCISION technology was effective in reducing systemic toxicity of doxorubicin, it would open up an "extensive and proprietary" pipeline for Avacta of next-generation chemotherapies with "significant" clinical and commercial advantages, in a chemotherapy market that was expected to exceed $74bn by 2027.

"We now look forward to opening up clinical trial sites in the United States and additional clinical trial sites in the UK."

At 1021 GMT, shares in Avacta Group were up 6% at 127.2p.