Presentation

Avelas Biosciences is a clinical-stage drug-device company headquartered in California, USA. The company is developing pegloprastide (“AVB-620”), a novel fluorescent imaging agent used in combination with a fluorescence camera system for real-time cancer detection and visualisation during surgery with an aim to increase the precision of cancer surgery and improve treatment outcomes for patients. Pegloprastide has FDA Breakthrough Therapy Designation and is currently under clinical development for patients undergoing breast cancer surgeries.

Recent highlights
Avelas Biosciences announced positive results of the Ph2 clinical trial with its lead asset Pegloprastide in breast cancer patients undergoing surgeries last year. The data demonstrates safety and efficacy of Pegloprastide to detect positive cancer margins in real-time during surgery and guide surgeons to remove additional tissue to achieve negative margins. The primary endpoint - the ability to detect cancer in margin-relevant tissue – was achieved with high statistical significance. Based on the findings, the company is finalising the design and protocol of the study and aims to enter registrational confirmatory Phase III trial in 2022.

Outlook
Avelas Biosciences aims to commence its registrational confirmatory Phase III trial for pegloprastide, its novel, best-in-class agent for visualising breast cancer margins, in 2022, having received constructive and helpful feedback from the US FDA.