16 October 2018 - - US-based PCR-based DNA manufacturing specialist Applied DNA Sciences Inc.'s (NASDAQ: APDN) LineaRx, Inc. subsidiary, which is focused on next-generation biotherapeutics, has initiated pre-clinical development of a non-viral, plasmid-free chimeric antigen receptor modified T cell (CAR T) manufacturing platform which will be made available to CAR T developers worldwide, the company said.

Concurrently, LineaRx announced the signing of an exclusive North American licensing agreement and research services agreement with iCell Gene Therapeutics, Inc. (iCell) under which iCell licensed to LineaRx an anti-CD19 CAR T therapy for non-viral delivery.

LineaRx will utilise its NVPF platform, along with the in-licensed anti-CD19 CAR T therapy, to develop, manufacture and commercialize LinCART19, a non-viral, plasmid free anti-CD19 CAR T drug candidate.

The company believes its novel NVPF construction of CAR Ts provides a manufacturing format that would be attractive to many developers of these therapies.

Despite costly and inefficient manufacturing platforms, the CAR T market is currently experiencing rapid growth and investment, with over USD 20bn in recent M and A activity, and is expected to yield a CAGR of 32.5% at least through 20282.

The NVPF LineaRx CAR T manufacturing platform under development leverages Applied DNA's expertise in large-scale PCR-based production and chemical modification of DNA to produce expression vectors for CAR T therapy, without the use of viral vectors or plasmids.

CAR T therapies are a DNA based approach to destroy cancer cells by harnessing the power of a patient's own immune system. CD19 is a protein that is expressed on the vast majority of B cell cancers.

By targeting CD19 expressing B cells with CAR modified T cells, various B cell malignancies can be addressed. Since 2017, the FDA has approved two CAR T-based therapies targeting the CD19 epitope, opening a new frontier in the fight against cancer.

iCell Gene Therapeutics is developing proprietary technologies and a pipeline of Chimeric Antigen Receptor engineered cell therapies designed to be first in class, cost effective and life saving.

LineaRx seeks to commercialize the biotherapeutic value of Applied DNA's deep expertise and experience in the design, manufacture and chemical modification of DNA by large scale polymerase chain reaction.