China’s Shenzhen Geno-Immune Medical Institute has embarked on a vaccine (LV-SMENP) clinical trial centering on a genetically modified vaccine to target the SARS-CoV-2 spike protein.
Back in December 2019 during the original pandemic breakout in Wuhan, China, it became apparent how dangerous this novel coronavirus could be—many died from acute respiratory failure. The development of a safe and effective vaccine to treat and prevent severe COVID-19 pneumonia was imperative. The Shenzhen Genoimmune Medical Institute conducted a detail analysis of the viral genome and searched for prospective immunogenic targets. The team came up with a synthetic minigene engineered based on conserved domains of the viral structural proteins and a polyprotein protease. They position that the SARS-CoV-2 is mediated through binding of the spike protein to the ACEII receptor, and the viral replication depends on molecular mechanisms of all of the viral proteins.
This “synthetic mini-gene”-based product adopts a sort of multiple-weapon approach. Called LV-SMENP_DC, it actually equates to lentivirus (disabled HIV) used to deliver viral proteins (S,M,E,N, and P for polyprotein protease) and also “immune modularity genes” that trigger dendritic cells. Acting as patrols for the immune response, they alert cytotoxic T cells to attack viruses, as reported by the Genetic Literacy Project.
Who is the sponsor?
The Shenzhen Genoimmune Medical Institute. Founded in 2015 by the Shenzhen Government, they were formed to provide contract research and technical services for individually cell-based immunotherapy. Their primary focus area is the advanced lentiviral vector technologies associated with CAR-T and Gene Therapy. They hope to develop various therapeutic solutions for cancers and other genetic diseases.
They position on their website the ability to develop “4th generation CAR-T therapeutic products with safety design to control the viability of target-specific T-cells.” These are clinically proven, they tout, to be a superior solution to handle adverse effect (CRS) during CAR-T treatment. They suspect it may also be the best therapeutic strategy for clinical applications.
Who are the key players?
Their team consists of some prominent scientists with clinical translational expertise, including Dr. Lung-Ji Chang.
The government-based research entity is testing innovative COVID-19 minigenes engineered based on multiple viral genes, using an efficient lentiviral vector system (NHP/TYF) to express viral proteins and immune modulatory genes to modify dendritic cells (DCs) and additionally active T cells. They team is studying the safety and efficacy of this LV vaccine (LV-SMENP).
An interventional trial, the sponsor seeks 100 participants in this open-label, multi-center trial, which commenced on March 24, 2020 and concludes December 31, 2024.
In addition to the Medical Institute, the Shenzhen Second People’s Hospital and Shenzhen Third People’s Hospital are recruiting patients.
Lung-Ji Chang, PhD, Principal Investigator
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