Imugene Limited announced a clinical development update on its PD1-Vaxx cancer immunotherapy. PD1-Vaxx will be trialled in patients with non-small cell lung cancer (NSCLC), the most common type of lung cancer, accounting for around 80% of cases. The study is planned to commence in 2020 and is to be conducted at up to 6 sites in North America and Australia under a U.S. Food & Drug Administration (FDA) Investigational New Drug (IND) application. Important pre-clinical milstones have been met with GMP manufacturing, including final sterile fill and finish, processes completed by FDA inspected and qualified contract manufacturing organization's (CMO) in the U.S. The final filled and finished vials of PD1-Vaxx have completed non-human primate (NHP) safety toxicology studies at a US-based contract research organization (CRO). The NHP was chosen due to its target PD1 receptor being 100% identical to human PD1 and hence the study also provided valuable data on the antibody generating potential of PD1-Vaxx in humans. The three doses tested not only were well tolerated with no adverse findings reported, they also generated high levels of PD1-targeting polyclonal antibodies. This is an important development since it's a strong indicator that PD1-Vaxx will break tolerance in humans, generate antibodies, and may produce an anti-cancer effect similar to Keytruda, Opdivo and the other immune checkpoint inhibitor monoclonal antibodies that are transforming treatment of a range of cancers. These three doses will now be selected for the dose escalation phase of the Phase 1 trial commencing in 2020. The study was completed under Good Laboratory Practice (GLP) conditions, a standard required for regulatory submissions to the Therapeutic Goods Administration in Australia and the US Food and Drug Administration in the US. Imugene's PD1-Vaxx is a B-cell cancer immunotherapy designed to treat tumors such as lung cancer by interfering with PD-1/PD-L1 binding and interaction, and produce an anti-cancer effect similar to Keytruda, Opdivo and the other immune checkpoint inhibitor monoclonal antibodies that are transforming treatment of a range of cancers. The inhibitory immune pathway, consisting of the receptor programmed cell death 1 and its ligands, PD -L1 and PD-L2, plays a vital role in the maintenance of peripheral tolerance. Several tumors exploit this pathway by expressing PD-L1 and PD-L2 to escape T-cell­mediated tumor-specific and pathogen-specific immunity. Imugene is proposing to develop an anti-PD-1 immunotherapy to treat patients with lung tumors that over-express the ligand of PD1, PD-L1/2. The hypothesis is that a polyclonal-induced B-cell antibody response will be more effective or as effective with improved safety over current monoclonal antibody therapy. Therapies with monoclonal antibodies targeting PD-1 and its ligands are associated with remarkable response rates in various cancers and have revolutionized cancer treatment.