T-SIGn Product Platform
PsiOxus aims to be the world leading cancer gene therapy company, delivering medicines of value to patients with cancer. Our Tumor-Specific Immuno-Gene Therapy or T-SIGn platform, provides a differentiated pipeline capable of simultaneous, local expression of combinations of genes for the treatment of solid tumors.
T-SIGn is a broad product platform for gene therapy combinations. T-SIGn utilizes enadenotucirev, our proprietary first generation oncolytic virus with demonstrated intravenous delivery, as a gene delivery vector (Figure 1.).
Up to four genes can be inserted into a T-SIGn virus providing simultaneous expression of combinations of genes. Furthermore, PsiOxus’ T-SIGn viruses delivering combinations of therapy in one product may have significant commercial advantages for patients, physicians and payors.
In each case, our objective is to express the genes in the tumor at high therapeutic concentrations and to avoid exposure to non-tumor cells. T-SIGn viruses are administered intravenously and circulate in the body with potential to reach both primary and metastatic tumor tissue. During viral replication in tumors, those same tumor cells are simultaneously directed by the encoded genes to produce biologic therapies to fight the cancer locally. In effect, the T-SIGn products are designed to turn tumor cells into “drug factories”. At PsiOxus, we believe this will result in local delivery of biological anti-cancer therapeutics to the tumor microenvironment for the treatment of cancer.
PsiOxus’ T-SIGn product platform for gene therapy has broad utility to express multiple types of genes (Figure 2.):
Antibodies: genes encode for individual or combinations of antibodies or antibody fragments. NG-350A is PsiOxus’ first virus to encode a full-length antibody.
Bi-Specifics: genes encode bi-specific or multi-specific antibodies. NG-641 encodes a bi-specific antibody in combination with three additional immune enhancer genes.
Membrane integrated ligands: genes encode for T-cell engaging ligands or other ligands that are bound to the tumor cell membrane. NG-348 encodes both CD3 and CD80 membrane anchored ligands.
Secreted immunomodulators: genes encode for cytokines and chemokines. Research is ongoing in this area.
The T-SIGn pipeline reflects the gene therapy approaches above, some of which are combined in a single virus product (Figure 3.). PsiOxus announced its first T-SIGn product collaboration with Bristol-Myers Squibb on the NG-348 asset in 2016 with approval achieved for use in human clinical trials in 2017. PsiOxus is developing NG-350A in its Phase 1 FORTITUDE clinical trial. Additional gene therapy approaches to expand the above list are the subject of on-going research. PsiOxus maintains broad proprietary rights to the T-SIGn platform.
View the AACR 2016 poster on T-SIGn
Figure 1. – Arming EnAd to Deliver Immuno-Therapeutics to Local Tumor Sites of Action
Figure 2. – T-SIGn Product Platform Classifications
Figure 3. – Product Pipeline