Imugene Limited (ASX:IMU) (OTCMKTS:IUGNF) will trial its PD1-Vaxx B-cell cancer immunotherapy on patients with non-small cell lung cancer (NSCLC) during 2020 at up to six sites in North America and Australia.
NSCLC is the most common type of lung cancer, accounting for around 80% of cases.
Important pre-clinical milestones have been met with GMP manufacturing, including final sterile fill and finish, processes completed by FDA inspected and qualified contract manufacturing organisations in the US.
“New therapeutic option”
The final filled and finished vials of PD1-Vaxx have completed non-human primate (NHP) safety toxicology studies at a US-based contract research organisation (CRO).
NHP was chosen due to its target PD1 receptor being 100% identical to human PD1 and, therefore, also provided valuable data on the antibody generating potential of PD1-Vaxx in humans.
Managing director and CEO Leslie Chong said, “We are pleased to reach both the toxicology and GMP drug product manufacturing milestones with such positive results, enabling us to progress PD1-Vaxx into Phase 1 trials in 2020 as an important next step in bringing a much-needed new therapeutic option to cancer patients”.
Three doses tested
The three doses tested were not only 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 anticancer effect similar to Keytrudaâ, Opdivoâ and the other immune checkpoint inhibitor monoclonal antibodies that are transforming the treatment of a range of cancers.
These three doses will be selected for the dose-escalation phase of the Phase 1 trial set to begin in 2020.