Imugene Ltd (ASX:IMU, OTC:IUGNF) has presented findings from its PD1-Vaxx trial in non-small cell lung cancer patients at the International Association for the Study of Lung Cancer’s annual conference.
The World Conference on Lung Cancer started on August 6 in Vienna, where Professor Michael Boyer showcased a poster presentation with the early-stage data.
Essentially, Imugene’s Phase 1 study is trialling its B-Cell immunotherapy candidate, known as IMU-201 or PD1-Vaxx, to determine its safety and tolerability when treating patients with non-small cell lung cancer.
The clinical-stage immuno-oncology company will soon move to Phase 1b studies, which will test the drug candidate in combination with a monoclonal antibody medication known as Atezolizumab.
“Positive early signs”
Speaking to the data, Imugene managing director and CEO Leslie Chong said: “Phase 1 trials are generally designed to look for safety, tolerability and early response signals to determine the optimal dose for further development.
“I am encouraged that we are seeing positive signals with correlative biomarker data at such an early stage of our PD1-Vaxx Phase 1 trial and we are now progressing to the Phase 1b combination studies in treatment naïve patients.
“It’s particularly gratifying to have followed a patient in the trial for over 18 months where their tumour burden has been reduced to zero.
For such a late-stage patient, having a chemo-free alternative could mean a very real difference to their quality of life,” she added.
Phase 1 trial
Imugene’s Phase 1 trial included different dose cohorts in a bid to determine the optimal dosage.
Four patients were in the 10-microgram dose cohort, and one patient achieved a complete response, meaning all signs of cancer disappeared in response to the treatment.
Out of six patients in the 50-microgram dose cohort, two achieved stable disease, which means the tumour is neither shrinking or growing.
Finally, four patients participated in a 100-microgram dose cohort, and one patient achieved partial response, meaning their tumour shrank in response to treatment, while two more reached stable disease status.
Exploratory biomarker data indicates that IMU-201 is immunogenic and stimulates a sustained, antibody response.
Importantly, by week six, antibodies to IMU-201 were generated and sustained at high titres during treatment with 100 micrograms of PD1-Vaxx.
There was also a dose-dependent increase in antibody production in patients receiving the 100-microgram dose.
Taken together, these data support the further evaluation of IMU-201 in non-small cell lung cancer patients.