Avenge Bio secures FDA orphan drug designation for mesothelioma therapy

Avenge Bio has obtained orphan drug designation from the US Food and Drug Administration (FDA) for its AVB-001 to treat mesothelioma patients.

Mesothelioma, a highly symptomatic cancer that mostly impacts adults, occurs in the cells that make up the mesothelium of the pleural [lung] and peritoneal [tissue lining the abdominal wall and pelvis] cavities, as well as the pericardium [the sac encasing the heart] and the tunica vaginalis [the sac encasing the testes].

2022 saw approximately 3,000 new cases reported in the US while approximately 2,500 people died from the disease.

Pleural mesothelioma represents 85% of new mesothelioma cases, followed by peritoneal mesothelioma and pericardium or tunica vaginalis mesothelioma.

Avenge Bio is currently adding patients in an ongoing Phase I/II trial investigating AVB-001 to treat refractory ovarian cancer.

The first-in-human, single-arm, open-label, dose-escalation and expansion trial aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumour activity of AVB-001 given intraperitoneally to people living with high-grade serous adenocarcinoma in the ovary, primary peritoneum or fallopian tube.

In March 2023, the FDA provided positive feedback on Avenge Bio’s preclinical and clinical development initiatives for pleural malignant mesothelioma.

Avenge Bio had previously unveiled preclinical data to confirm the efficacy and safety of pleurally administered AVB-001 to treat pleural malignant mesothelioma.

Producing native IL-2 immunotherapy, AVB-001 is initially being evaluated in metastatic peritoneal cancers, including ovarian cancer.

Avenge Bio is a biotechnology company developing cell-based immunotherapeutic products to treat intractable solid tumours by leveraging its LOCOcyte platform, an allogeneic cell-based immunotherapy platform that facilitates the local modulation of the immune system. This triggers a systemic immune response, enabling the treatment of previously intractable cancers.