Imugene Limited (ASX:IMU) has formally commenced cGMP (current good manufacturing practice) manufacture of the clinical batch of its cancer vaccine KEY-Vaxx.
The cGMP batch is part of the pre-clinical development for the proposed PD-1 phase I clinical trial to be conducted in 2019.
AmbioPharm Inc, a US-based peptide manufacturing company has been appointed to manufacture the vaccine.
We've commenced cGMP manufacturing of the clinical batch of cancer vaccine KEY-Vaxx for the proposed Phase 1 PD-1 clinical trial, after successfully completing pilot studies. AmbioPharm Inc. (APi), a US-based cGMP manufacturer has been appointed $IMU #ASX https://t.co/xL390CKopH pic.twitter.com/YVOYROEtbZ— Imugene Ltd (@TeamImugene) September 20, 2018
KEY-Vaxx is a B-cell peptide cancer vaccine which aims to induce the body to produce polyclonal antibodies that block PD-1 signalling, and potentially produce an anticancer effect similar to Keytruda, Opdivo and the other immune checkpoint inhibitor monoclonal antibodies that are transforming the treatment of a range of cancers.
KEY-Vaxx has shown potential in preclinical studies, outperforming an industry-standard antibody in a mouse model of HER2+ colorectal cancer.
New provisional patent
The protection of Imugene’s global position in PD-1 B-cell cancer vaccines has been strengthened with the filing of a new provisional patent in Australia titled “A vaccine composition and uses thereof”.
Imugene managing director Leslie Chong said: “Maintaining and strengthening our already strong international intellectual property position is a key area of focus in maintaining the competitive advantage of KEY-Vaxx and any future improvements, vaccine formulations and clinical uses.
“We are extremely pleased with the progress made from our expert scientific team.”