Therapeutic antibody development company Patrys (ASX:PAB) has identified and selected an optimised stable cell line for the production of its full-sized IgG deoxymab, PAT-DX3.
The company said this allows it to commence work on developing a commercial-scale manufacturing process for GMP-grade (Good Manufacturing Practice) PAT-DX3 deoxymab that is required to commence its clinical development.
"The establishment of a stable, PAT-DX3-producing cell line is an important milestone that Patrys has achieved ahead of its scheduled timeline," said the company.
"Patrys has established that the selected cell line is both stable and able to deliver reproducible and consistent production of PAT-DX3 protein over time.
"This cell line will be stored as a Master Cell Bank (MCB) which will form the basis for all future production of PAT-DX3."
The company said studies conducted to date have shown that PAT-DX3 is able to cross the blood-brain barrier in animal models of brain cancer and penetrate cancer cells.
"PAT-DX3 appears to have a higher affinity for DNA than PAT-DX1, suggesting that it has the potential to be more efficacious.
"In addition, Patrys has reported that PAT-DX3 was able to be used as a targeting agent to successfully deliver an anticancer drug in an animal model of human breast cancer."
The company said it is actively exploring partnering opportunities for PAT-DX3 to be used in antibody-drug conjugates (ADCs) for the targeted intracellular delivery of cancer drugs and a range of other payloads such as nucleic acids.
CEO and managing director Dr James Campbell said, "We are delighted to have identified a high-yielding stable cell line for the production of PAT-DX3 significantly ahead of schedule. There is a lot of interest in PAT-DX3 both as a therapeutic agent in its own right and for the intracellular delivery of therapeutic payloads into brain and other cells.
"With this key reagent now identified and in hand, we can rapidly move into developing a commercial-scale production process to support both the clinical and partnering opportunities we have for PAT-DX3. Most of the therapeutic antibodies in the market today are full-sized IgGs which should provide a rich experience base for facilitating the development of a process for the large scale production of clinical grade PAT-DX3 deoxymab."
