BriaCell Therapeutics has started dosing patients in a Phase I/IIa trial to evaluate Bria-IMT in combination with pembrolizumab (Keytruda) or ipilimumab (Yervoy) for the treatment of advanced breast cancer.
Keytruda is manufactured by Merck and Yervoy is developed by Bristol-Myers Squibb Company.
Both drugs are immune checkpoint inhibitors designed to overcome immune suppression in cancer patients.
As part of the open-label, non-randomised, parallel assignment, Phase I/IIa trial, BriaCell is expected to enrol 40 subjects.
During the trial, the combination of Keytruda and Bria-IMT will be provided to patients with expression of programmed death-ligand 1 (PD-L1) or PD-L2.
Patients without expression of PD-L1 or PD-L2 will receive the combination of Bria-IMT and Yervoy.
The trial’s primary endpoint is safety, while the secondary endpoints include assessment of tumour response, immune responses, tumour characteristics, quality of life (QOL), among others.
BriaCell Therapeutics president and CEO Dr Bill Williams said: “We believe that combination of Bria-IMT with immune checkpoint inhibitors should create even more potent anti-cancer immune responses, leading to our strategy of combination studies of Bria-IMT with Keytruda or Yervoy.
“BriaCell is committed to exploring additional ways to address the unmet needs of the advanced breast cancer community.”
Bria-IMT is BriaCell’s lead clinical candidate that is designed as a breast cancer cell line engineered to produce an immune-activating factor (GM-CSF).
Last month, BriaCell reported positive proof of concept data from a Phase I/IIa study evaluating Bria-IMT in advanced breast cancer.
The results showed improved levels of safety and efficacy of Bria-IMT in the enrolled patients.