FDA backs Cambridge chemotherapy push in US
Cambridge biopharma company Avacta has received crucial backing from the FDA to push ahead with chemotherapy technology in the US. The FDA has approved the company’s Investigational New Drug (IND) application for AVA6000.
This will allow the Group to expand its Phase I clinical trial, ALS-6000-101, into clinical trial sites in the US. AVA6000 is a novel form of doxorubicin that has been modified with Avacta’s pre|CISION™ platform to improve its safety and therapeutic index.
Anthracyclines such as doxorubicin, a generic chemotherapy for which the market is expected to grow to $1.38 billion by 2024, are widely used as part of standard of care in several tumour types, but their use is limited by cumulative toxicity.
AVA6000 has been designed to limit cell penetration of the drug, and therefore its cell killing effect, until it is specifically activated by fibroblast activation protein a (FAP) which is in high concentration in many solid tumours compared with healthy tissues.
The resulting reduced exposure of healthy tissues to active doxorubicin has the potential to significantly increase its therapeutic index by reducing the incidence of adverse effects, including cardiotoxicity and myelosuppression.
The FDA has completed its 30-day review of Avacta’s IND application, which was submitted ahead of schedule in October 2021, and has concluded that the Group may proceed with its proposed clinical investigation. This allows Avacta to enrol eligible patients into US clinical trial sites for the company’s Phase I multi-centre study, ALS-6000-101.
As previously announced in August 2021, the company has begun recruiting and dosing patients for this study at several clinical trial sites in the UK and continues to expect the dose escalation phase for this trial to complete by Q2 2022 followed by completion of the dose expansion phase around mid-2023. Enrolment in US clinical trial sites is expected to start in early 2022.
Avacta CEO Dr Alastair Smith says: “We are delighted to have received approval from the FDA to add clinical trial sites in the United States as part of the Phase I study for AVA6000.
“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 $74 billion by 2027.”