BriaCell Therapeutics Corp. has received positive feedback from the FDA regarding its planned pivotal study for Bria-IMT™ in combination with an immune checkpoint inhibitor for treating advanced metastatic breast cancer. This development could significantly accelerate the path to commercialization for the company's lead immunotherapy candidate.
The FDA has agreed on the study's eligible patient population: breast cancer patients who have failed available approved therapies. These patients, who face an average survival time of less than one year, represent a population with urgent unmet medical needs. Importantly, the regulatory agency has also approved the company's preferred primary endpoint of survival improvement compared to the patient physician's choice of treatment.
"Rather than working through multi-year Phase II and Phase III trials, successful completion of the pivotal study would allow us to subsequently submit a Biologics License Application and greatly accelerate the path to commercialization," said Dr. William V. Williams, BriaCell's President and CEO.
Fast Track Designation Accelerates Development Timeline
BriaCell's Bria-IMT™ program has received Fast Track designation from the FDA, which has facilitated more frequent and responsive communication with the agency. This designation has significantly accelerated protocol review and feedback timelines. The company anticipates initiating patient dosing as early as the second quarter of 2023.
In preparation for the pivotal study, BriaCell has increased production batches of Bria-IMT™ and enhanced testing capabilities required for larger-scale patient dosing. The company reported a cash position of US$37 million, which it believes will be sufficient to drive the program forward without additional financing, pending finalization of the pivotal study protocol and associated costs.
Personalized Immunotherapy Approach
In parallel with the Bria-IMT™ development, BriaCell is advancing its Bria-OTS™ personalized treatment program. The company recently received a patent protecting the composition of matter and method of use of its personalized off-the-shelf whole-cell immunotherapies.
The Bria-OTS™ approach aims to maximize patient responses through "HLA matching." This process involves identifying each patient's human leukocyte antigen (HLA) type prior to treatment using a simple saliva test, then treating them with pre-manufactured cells that correspond to their specific HLA type.
"This novel treatment approach came about when we found that the HLA type of our previously disclosed top responders matched with the Bria-IMT™ cell-line HLA type," explained Dr. Williams. "The treatment will be 'personalized' because the cell therapy will match the HLA type of the patient, even though it is pre-manufactured."
BriaCell expects to begin dosing advanced metastatic breast cancer patients in its Bria-OTS™ Phase I/IIa clinical study in the first half of 2023.
Addressing an Urgent Medical Need
Metastatic breast cancer patients who have progressed through multiple treatment regimens face extremely limited options and poor prognoses. In some cases, survival may be measured in weeks rather than months.
"These are women in desperate need of therapy to extend their lives," Dr. Williams emphasized. "These women need help!"
The company's immunotherapy approach represents a potential new option for these patients. By targeting the immune system to fight cancer cells, BriaCell's therapies aim to provide a different mechanism of action compared to conventional treatments.
BriaCell Therapeutics Corp. is a clinical-stage biotechnology company specializing in targeted immunotherapies for cancer. The company continues to focus on developing solutions for cancer patients with unmet medical needs and expects to share additional updates on its clinical programs in the coming months.
