Imugene Limited (ASX:IMU) 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 nonsmall 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 (Tecentriqâ) 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 industry.
Combination with PD1-Vaxx may overcome treatment resistance to ICIs with dual inhibition of the PD-1/PD-L1 axis extending the treatment benefit of atezolizumab.
Imugene MD and CEO, Leslie Chong, said that 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.
Phase 1 trials are generally designed to look for safety, tolerability and early response signals to determine the optimal dose for further development,” Mr Chong said,
“I am encouraged that we are seeing positive signals at such an early stage of our PD1-Vaxx Phase I trial and we are now progressing to the Phase 1b combination studies in treatment naïve patients. “Our Phase 1a trial has been open 12 months and I’m pleased with both the pace of development and the early responses seen.
“It’s particularly gratifying to have followed a patient in the trial for over 12 months where their tumour burden has been reduced to zero.”
Imugene’s PD1-Vaxx is a B-cell activating immunotherapy designed to treat tumours such as lung cancer by interfering with PD-1/PD-L1 binding and interaction, and produce an anti-cancer effect similar to Tecentiq, Keytruda, Opdivo and the other immune checkpoint inhibitor monoclonal antibodies that are transforming the treatment of a range of cancers.