NG-350A is an oncolytic adenoviral vector designed to deliver gene therapy to activate T-cells to fight cancer locally in the tumor microenvironment. The NG-350A virus bears genes coding for an agonist anti-CD40 monoclonal antibody.
Anti-CD40 antibodies are a potentially powerful activator of a patient’s immuno-inflammatory response. However, anti-CD40 antibody development has been historically challenging due to the interaction of the antibody with non-cancerous cells which can cause unintended side effects. At PsiOxus, we believe that our approach to selectively deliver antibodies to tumor cells locally will allow them to be well tolerated and more effective. Our NG-350A virus is designed to selectively produce agonist anti-CD40 antibodies in tumor cells to fight cancer in the local tumor microenvironment.
NG-350A is designed to be administered intravenously. The virus infects and replicates in tumor cells and those same tumor cell are simultaneously directed by the encoded anti-CD40 genes to produce the anti-CD40 antibodies locally. The anti-CD40 antibodies are expected to activate the patient’s own dendritic cells, macrophages and B-cells to drive CD4 and CD8 immuno-inflammatory responses and T-cell mediated tumor cell killing. (Figure 1.)
The Investigational New Drug (IND) application was approved by the FDA in December 2018 and PsiOxus intends to initiate a Phase 1 clinical trial of
NG-350A in 2019.