Policy & Regulation
Avenge Bio's AVB-001 IND application receives US FDA approval for peritoneal malignancies
4 August 2022 -

Avenge Bio, Inc., a US-based biotechnology company, announced on Wednesday that it has received approval from the US Food and Drug Administration (FDA) for the Investigational New Drug (IND) application for AVB-001 in peritoneal malignancies.

AVB-001 is the first clinical application of the LOCOcyte platform, encapsulating cells designed to secrete native IL-2 in immune-activating alginate capsules. The first-in-human AVB-001 clinical trial will be an intraperitoneal administration to treat platinum resistance ovarian cancer.

The Phase one, multi-centre clinical trial is likely to commence in the second half of 2022 and is to assess the tolerability of the product, determine a recommended dose for Phase two, measure immunological changes in the blood and peritoneal environment, and evaluate anti-tumour activity.