Melbourne, Australia
Our client Arovella Therapeutics Ltd (ASX: ALA) recently announced that the U.S. Food and Drug Administration (FDA) has accepted its investigational new drug (IND) application for ALA-101 to commence first-in-human clinical trials.
This is a major operational and regulatory milestone for Arovella as they advance their invariant Natural Killer T (iNKT) cell therapy platform into the clinic. The IND approval allows the company to begin treating patients with CD19‑positive non‑Hodgkin’s lymphoma and leukaemia, and importantly, opens the door for trial sites both in the U.S. and via the CTN scheme in Australia, helping accelerate timelines.
Arovella anticipates that this successful IND application will create a framework for other pipeline products, including ALA-105 for the treatment of gastric cancer, and potentially for new technologies targeting neuroblastoma and hepatocellular carcinoma.
CTPL is proud to be supporting Arovella with manufacturing for this Phase 1 program and to play a role in helping bring this innovative therapy one step closer to patients.
To learn more about Arovella, please click here: https://www.arovella.com/
To learn more about Cell Therapies, please click here: https://celltherapies.com/
Media Contacts
Cell Therapies Pty Ltd
Name: Dr Shrinidh Joshi, Head of Commercial Business Development
Email: [email protected]
Phone: +61 3 9492 4777
For further information please contact [email protected]
