The FDA accepted an investigational new drug application allowing for the start of a phase 1 trial to evaluate the tolerability of AVB-101 in patients with platinum resistance ovarian cancer.
The FDA has cleared the investigational new drug (IND) application for AVB-001 as treatment for patients with peritoneal malignancies with a primary focus on relapsed and refractory ovarian cancer, according to Avenge Bio, Inc.1
Based on the IND, a first-in-human clinical trial for the intraperitoneal administration of AVB-001 for the treatment of platinum resistance ovarian cancer is expected to begin in the second half of 2022.
"We are very pleased to be advancing AVB-001 into the upcoming clinical trial as a potential treatment for patients with metastatic ovarian cancer, a life threatening disease. The FDA's clearance of our IND represents a significant milestone for Avenge and the first to be cleared leveraging the LOCOcyte™ technology platform," said Michael Heffernan, chief executive officer of Avenge Bio, in the press release.
Investigators in the phase 1, multi-center clinical trial will evaluate the tolerability of AVB-001, determine a recommended dose for the phase 2 portion of the trial, measure immunological changes in the blood and peritoneal environment, and assess anti-tumor activity.
AVB-001 is the first clinical implementation of the LOCOcyte™ platform which aims to leverage immunomodulators and biomaterials for a synergistic impact in a single, controlled, allogeneic cell therapy. The platform works by encapsulating cells engineered to secrete native IL-2 in immune-activating alginate capsules.
The LOCOcyte platform being created by Avenge Bio is an immunotherapy platform administering potent immune effector molecules for the treatment of solid tumors. This is achieved by creating a controlled cell therapy leveraged by immunomodulators and biomaterials.
Treatment with the platform works as it develops an innate and adaptive immune response after localization to the primary tumor site and destroys metastasized cells without increasing toxicity levels.
If the results of this trial end up positively meeting the primary and secondary end points, patients with ovarian cancer have the potential of gaining a new treatment option in upcoming years.
Avenge bio announces FDA clearance of the AVB-001 IND for the treatment of ovarian cancer, a novel cellular therapy leveraging the LOCOcyte™ immunotherapy platform. News release. Avenge Bio, Inc. August 3, 2022. Accessed August 4, 2022. https://prn.to/3zzyeRD