Imugene Limited announced the Cohort Review Committee (CRC) has confirmed its checkpoint immunotherapy candidate, PD1-Vaxx, has completed its Phase 1a monotherapy dose escalation and will proceed to combination dose escalation. The Phase 1a monotherapy dose escalation was performed with 10, 50 and 100µg of PD1-Vaxx in non-small cell lung cancer (NSCLC) patients who progressed on one or more immune checkpoint inhibitors (ICIs). After CRC review of monotherapy safety, tolerability and biomarker data, it advised Imugene to proceed to the combination phase of clinical development of PD1-Vaxx.

The primary objective of the phase 1 trial is to determine safety and optimal biological dose as monotherapy and in combination with immune checkpoint inhibitors (ICI). Plans are now being finalized to combine PD1-Vaxx with Roche/Genentech's PD-L1 targeting blockbuster ICI atezolizumab (Tecentriq) as first-line in ICI treatment naïve NSCLC patients. Dual targeting of the PD-1/PD-L1 axis is an area of considerable interest with ongoing clinical results creating strong interest inside the pharma industry¹.

Combination with PD1-Vaxx may overcome treatment resistance to ICIs² with dual inhibition of the PD-1/PD-L1 axis extending the treatment benefit of atezolizumab. In contrast to combination of two monoclonal antibodies, PD1-Vaxx has the advantage that it induces a unique polyclonal immune response which may increase response rates for the combination therapy.