FDA Approval of First Plasmid DNA Immunotherapy Ignites Hope for STEMVAC
On October 30, the FDA granted accelerated approval to Voceryq, the first-ever plasmid DNA-based immunotherapy, developed by Inovio Pharmaceuticals. The treatment delivers two plasmids to help the immune system target cells infected with human papillomavirus (HPV), which are responsible for recurrent respiratory papillomatosis (RRP). The FDA’s approval marks an important milestone for DNA-based therapeutics and could help advance research in this field. Cancer Vaccine Institute (CVI) Director Dr. Nora Disis contributed to the conversation in Drug Discovery News.
“Having one therapeutic approved really lays the foundation for others to advance rapidly through the clinical investigation pipeline to approval. It always helps to have a ‘first-in-class’ lead the way,” she says.
Dr. Disis and CVI Principal Investigator Dr. Brie Chun are leading a Phase II trial evaluating STEMVAC, a plasmid DNA cancer vaccine designed to treat metastatic triple-negative breast cancer. Phase I results demonstrated that the vaccine generated immune responses against five cancer-associated proteins in patients and was well-tolerated. CVI researchers are also evaluating this vaccine in clinical trials for hormone receptor-positive breast cancer and non-small cell lung cancer.
Dr. Disis also explains why her team selected plasmid DNA as the delivery method for STEMVAC. According to Dr. Disis, advantages include easier manufacturing, more practical storage requirements, intradermal injection, and strong immune responses with relatively low-grade adverse effects.
While each DNA-based immunotherapy must demonstrate its own safety and efficacy, the approval of Voceryq represents an encouraging milestone for other DNA-based therapies. For the CVI, it also reinforces the promise of DNA-based approaches, such as STEMVAC, and the potential for these therapies to progress from clinical research to FDA approval.
Read the Drug Discovery News article here: https://www.drugdiscoverynews.com/fda-approves-first-ever-plasmid-dna-based-immunotherapy-17631
