The study examined secukinumab biosimilar lentivirus-based gene therapy, which showed successful and prolonged expression of the recombinant antibody in rats.
Researchers say biosimilar gene therapy could become a cost-effective, long-term treatment for autoimmune diseases, according to a recent study; their work looked at secukinumab biosimilar lentivirus-based gene therapy, which showed successful and prolonged expression of the recombinant antibody in rats.
Producing, transporting, storing, and administering monoclonal antibodies is time-consuming and costly. According to the researchers, if patients’ own cells could be used to manufacture a biosimilar, manufacturing, transportation, and storage steps could be eliminated, while providing a longer-lasting source of the drug potentially at a lower cost.
Secukinumab (Cosentyx) binds to IL-17A, inhibiting its interaction with the IL-17 receptor; secukinumab is prescribed for plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis. The universality of IL-17’s involvement in autoimmune diseases made this particular drug attractive to the researchers.
Biosimilar gene therapy was tested in both ex vivo and in vivo experiments. Human chorionic villous mesenchymal stem cells (CMSCs) were isolated and transduced with a lentiviral vector containing the DNA sequences of the heavy and light chains of secukinumab, which were derived from the secukinumab protein sequence. In one group of rats, the transduced CMSCs were injected. In another group, the lentivirus was injected, and the rats were monitored for 60 days.
Expression of recombinant secukinumab at the mRNA and protein levels was confirmed in the transduced CMSCs, and the secreted antibody’s ability to inhibit IL-17 was confirmed in human fibroblasts. In both transduced CMSC and lentivirus injected rats, the presence of secukinumab in the bloodstream was confirmed at various points throughout the 60 day period.
The serum concentration of the antibody was higher in lentivirus treated rats compared to CMSC treated rats. However, the authors noted these concentrations were substantially lower than those currently approved for administration of secukinumab, and that improved serum concentrations would be necessary for human application of this therapy.
Reference
Fallah A, Estiri H, Parrish E, Soleimani M, Zeinali S, Zadeh-Vakili A. Biosimilar gene therapy: Investigational assessment of secukinumab gene therapy. Cell J. 2020;21(4):433—443. doi:10.22074/cellj.2020.6309
Partnering for Biosimilar Security: India's Role in US Health Care Savings, Supply Chain Stability
May 9th 2024As Indian pharmaceutical companies supplied 4 of every 10 prescriptions in the US in 2022, generating $1.3 trillion in health care savings, a new IQVIA report highlights concerns about supply chain risks and advocates for partnerships to bolster biosimilar security and overall supply chain resilience.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Patient Perceptions of Switching From the Reference Adalimumab to Amjevita During Its Initial Launch
April 20th 2024In a survey of patients with autoimmune arthritis who had been switched from reference adalimumab (Humira) to biosimilar adalimumab-atto (Amjevita; Amgen), most reported preferring the biosimilar and had no concerns about switching.