Arovella Therapeutics Ltd, the biotechnology company specialising in iNKT cell therapy, announced that the Good Manufacturing Practice (GMP)-grade lentiviral vector for its lead product, ALA-101, has completed successful manufacturing and quality release testing.
Arovella’s focus on developing innovative therapies for CD19+ lymphomas and leukemias takes a pivotal step with the establishment of the GMP manufacturing process, the company said in an ASX announcement.
The lentiviral vector is responsible for carrying the genetic material required to program iNKT cells, enabling them to effectively target and eliminate cancer cells.
Arovella has collaborated with Lentigen Technology, a globally renowned manufacturer of lentiviral vectors for cell and gene therapies, to produce the 3rd-generation lentiviral vector for ALA-101.
Dr Michael Baker, CEO, and MD of Arovella Therapeutics, expressed his enthusiasm about the achievement, stating, “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.”
According to the company, the successful manufacturing of the GMP-grade lentiviral vector marks a crucial milestone for the ALA-101 program, positioning Arovella as a key player in advancing iNKT cell therapy for the treatment of CD19+ lymphomas and leukemias.
The adherence to GMP standards underscores the company’s commitment to quality and safety in the development of cutting-edge therapies.
As Arovella Therapeutics progresses towards clinical trials, the completion of this key manufacturing step brings ALA-101 closer to providing a potential breakthrough in the treatment of challenging hematologic malignancies.
The achievement aligns with Arovella’s dedication to addressing unmet medical needs and leveraging innovative solutions to transform the landscape of cancer therapeutics.
Arovella is also broadening its scope to include the treatment of solid tumours by leveraging its CLDN18.2-targeting technology, which has been licensed by Sparx Group.
Additional technologies for targeting tumours are expected to complement Arovella’s iNKT cell therapy platform.
The primary product in development is ALA-101, featuring CAR19-iNKT cells that have undergone modification to express a Chimeric Antigen Receptor (CAR) specifically targeting CD19 – an antigen present in various cancer types.
Furthermore, iNKT cells contain an invariant T cell receptor (iTCR) designed to target ?-GalCer-bound CD1d, another antigen found on the surface of several cancer types.
ALA-101 is being advanced as an allogeneic cell therapy, allowing it to be administered from a healthy donor to a patient.
For more information about Arovella Therapeutics and its iNKT cell therapy platform, please visit the company’s official website.
