Abnova Completes GMP Manufacturing Agreements and Appoints Aldevron and Lentigen to Manufacture the Respective Transfer Plasmid and Lentiviral Vector for its Gene-Modified T Cell Therapy Clinical Trials

Neihu, Taiwan (August 26, 2019)

Abnova announced today the completion of GMP manufacturing agreements and appointment of Aldevron and Lentigen to manufacture the respective transfer plasmid and lentiviral vector for its gene-modified T cell therapy clinical trials. Under a worldwide exclusive license of inducible tumor-infiltrating lymphocyte (iTIL) technology from MD Anderson, Abnova races ahead to develop autologous, gene modified T cell therapy for solid tumors. Its lead candidate, attIL-12, an universal tumor-targeting peptide combined with membrane anchored IL-12 cytokine, prepares the autologous T cell for deep tumor penetration while overcoming tumor microenvironment immunosuppression, tumor antigen escape, and treatment-related toxicities. So far, gene modified CAR T and NK immunotherapy have not been demonstrated to be effective against solid tumors, and still impacted by the risks of cytokine release syndrome and peripheral organ toxicities. Abnova is now completing the preclinical and IND-enabling studies, and plans entering phase I human clinical trial in 2020.

Aldevron is responsible for Abnova’s attIL-12 transfer plasmid GMP production. attIL-12 is built on a backbone of third generation lentiviral plasmid with greater efficacy and safety. The use of same batch GMP plasmid for preclinical safety studies and human clinical trials is a prerequisite for the FDA. Aldevron has an industry track-record of producing GMP plasmid for all phases of clinical development and commercialization plus a recent expansion of 14-acre gene therapy manufacturing center. Aldevron also pioneered the GMP-Source (GMP-S) quality system to allow client to reach early clinical milestones with shorter timelines and lower costs. It is followed by a seamless transition into GMP manufacturing for late phase clinical trials and commercialization. Aldevron’s GMP transfer plasmid will then be the source material for downstream lentiviral vector production.

Lentigen is a recognized leader in the GMP manufacturing of lentiviral vector by incorporating the transfer plasmid along with third generation packaging/ helper plasmids. The success of Abnova’s attIL-12 clinical deployment also relies on the critical lentiviral vector for ex vivo gene modification of T cells before reinfusion back to the patients. Lentigen has also successfully developed a large-scale chemically-defined, serum-free suspension bioreactor lentiviral vector manufacturing process which is more efficient and cost-effective than the traditional adherent cell methodology. Lentigen not only undertakes the viral vector GMP manufacturing for Abnova’s attIL-12 clinical trials but also supports its commercialization upon FDA approval. Lentigen’s in-depth expertise has attracted a cadre of cell therapy companies advancing the next generations of gene-modified immune cells to overcome solid tumors.