Arovella Therapeutics Ltd (ASX:ALA) has completed a key manufacturing step to progress lead product ALA-101 to clinic with its Good Manufacturing Practice (GMP)-grade lentiviral vector for ALA-101 successfully manufactured and quality release testing passed.
ALA-101 is being developed by Arovella to treat CD19+ lymphomas and leukemias.
A key requirement for the development of an iNKT cell therapy product is the establishment of the manufacturing process under GMP conditions.
Critical component
The GMP-grade lentiviral vector is a critical component for clinical manufacturing as it carries the genetic material to program iNKT cells to target and eliminate cancer cells.
ALA-101’s vector is a third-generation lentiviral vector manufactured by Lentigen Technology, Inc, a world-leading manufacturer of lentiviral vectors for cell and gene therapies.
“A tremendous step”
Arovella’s CEO and MD Dr Michael Baker said: “This is a tremendous step forward for the ALA-101 program and for Arovella.
"Producing GMP lentiviral vector is essential to developing ALA-101 and we are delighted this major step was completed on schedule.”
About Arovella and ALA-101
Arovella is a biotechnology company focused on developing its invariant natural killer T (iNKT) cell therapy platform from Imperial College London to treat blood cancers and solid tumours.
Its lead product is ALA-101, which consists of CAR19-iNKT cells that have been modified to produce a Chimeric Antigen Receptor (CAR) that targets CD19, which is an antigen found on the surface of numerous cancer types.
iNKT cells also contain an invariant T cell receptor (iTCR) that targets α-GalCer bound CD1d, another antigen found on the surface of several cancer types.
ALA-101 is being developed as an allogeneic cell therapy, which means it can be given from a healthy donor to a patient.
Arovella is also expanding into solid tumour treatment through its CLDN18.2-targeting technology licensed from Sparx Group.
Additional tumour-targeting technologies are anticipated to be used in conjunction with Arovella’s iNKT cell therapy platform.