Metastatic breast cancer (MBC) remains incurable, with approximately only one-third of diagnosed women meeting the five year survival rate.
Subtypes like triple-negative breast cancer (TNBC) or heavily pretreated hormone receptor-positive disease often come with more treatment challenges, leading to continuous innovation in the health and medical sector.
Immunotherapy has emerged as an alternative and arguably an improvement over standard treatments, aiming to redefine survival expectations. Clinical-stage immuno-oncology company BriaCell Therapeutics (TSX:BCT,NASDAQ:BCTX) is responding to the call by proposing innovative, cell-based solutions that produce robust data and go beyond traditional clinical milestones.
Clinical challenges in MBC
The benefits of PD-1/PD-L1 checkpoint inhibitors, a class of cancer immunotherapy drugs, are minimal.
By binding specific proteins that function as “switches” for inhibiting the immune system’s ability to identify and eliminate cancerous cells, these aim to treat MBCs and improve overall patient response.
Still, these treatments show resistance and heterogeneous efficacy.
A study published by the US’ National Library of Medicine notes that while PD-1/PD-L1 expression is closely associated with tumor progression and treatment, using this as the sole predictive biomarker for cancer immunotherapy “remains problematic.” Antibody drug conjugates (ADCs) like Trastuzumab Deruxtecan and Sacituzumab Govitecan, which pair a targeted monoclonal antibody with a toxic chemotherapy payload, aim to deliver localized destruction to tumor cells and have demonstrated better progression-free survival. However, concerns about durability and toxicity persist.
The Oxford Academic also published a study that mentions how cancer cells are prone to developing resistance to ADCs by antigen loss, defective endocytosis and the activation of multidrug resistance proteins. Additionally, the toxicity resulting from the payloads causes treatment discontinuation.
Median survival among those who have received multiple previous treatments is usually less than 12 months, still close to the actual survival range for MBC. This means there remains a need for mechanisms such as cell-based immunotherapies, which are designed to train a patient’s immune system to pursue its own fight against the tumor.
BriaCell’s Bria-IMT and Bria-OTS response
BriaCell has introduced its own cell-based, targeted immunotherapy called Bria-IMT, which is “a genetically engineered human breast cancer cell line with features of immune cells.”
Along with this is Bria-OTS, a personalized, off-the-shelf immunotherapy that falls under a broader field of precision oncology and intends to create a customized immunotherapy plan rather than a one-size-fits-all treatment.
Both therapies aim to provide an option for patients who have gone through multiple standard treatments without seeing significant results.
BriaCell notes that Bria-IMT does not work in isolation and will need the power of the likes of checkpoint to eliminate barriers that cancer puts up to hide from the immune system. Together, the body’s ability to detect and destroy cancer cells can be amplified.
Bria-OTS, on the other hand, customizes the immune response and targets tumor-specific markers. This also works by counteracting resistance pathways, including those seen with checkpoint inhibitors and antibody-drug conjugates. Given its targeted nature, less healthy cells are also affected, meaning fewer side effects for patients.
Positive results from Bria-IMT Phase 2 study
Data from Bria-IMT’s Phase 2 study demonstrates significant results, especially in overall survival.
The company specifies that nine out of 25 of its patients treated since 2022 remain alive, surviving 18 to 47 months post-enrollment. Compared to standard therapies with similar patient populations, this surpasses the industry benchmark of 12 to 18 months.
BriaCell points to patient journeys, including a 66-year-old woman with ER+/PR+/HER2+ metastatic breast cancer with eight prior therapies, including an antibody-drug conjugate (Enhertu).
“She presented with metastatic involvement of the right orbit (behind the right eye), the right temporal lobe of the brain, and multiple skeletal sites (and) experienced complete resolution of the temporal lobe metastasis, substantial improvement in the orbital lesion and stable disease in the bone,” the company wrote.
BriaCell adds that she was on study 24 months after initiating treatment, receiving 35 cycles of therapy. The patient remains in survival follow-up 27 months post-enrollment.
The company also previously reported that the Bria-IMT cohort, consisting of 25 patients with hormone receptor-positive (HR+) metastatic breast cancer, demonstrated a median overall survival of 17.3 months when treated with Bria-IMT plus retifanlimab (Zynyz). This exceeds those of the current ADC standard of care, TRODELVY®, which is recorded at 14.4 months.
“Our clinical data support our hypothesis that the Bria-IMT regimen plus (checkpoint inhibition) has the potential to address the unmet medical needs of (patients with) HR-positive (breast cancer) and TNBC, and provide an effective and well-tolerated therapeutic option,” said Giuseppe Del Priore, MD, MPH, chief medical officer of BriaCell.
A promising next phase
Phase 3 clinical trial for Bria-IMT is reportedly ongoing, with BriaCell noting that more than 315 patients have been screened and over 230 patients have enrolled.
The Phase 3 clinical trial, called the Bria-ABC study, will examine Bria-IMT in combination with an immune checkpoint inhibitor versus a physician’s choice of treatment in advanced breast cancer.
Penn Medicine’s Abramson Cancer Center, a world-renowned cancer institute, has been named as one of the company’s clinical trial sites for the study.
Interim topline data is expected in 2026, while Bria-IMT continues under a fast-track designation from the US Food and Drug Administration.
Investor takeaway
Biotech market momentum is rebounding, with oncology innovations attracting renewed capital. BriaCell’s Phase 2 survival results offer clinically proven upside, alongside potential efficacy improvement from expected Phase 3 data. The company’s flagship solutions represent a high-risk, high-reward opportunity in a sector where breakthrough therapies can redefine patient outcomes and market valuations. Investors who are seeking meaningful oncology investment may find answers in the company and its strongly supported innovation.
This INNspired article is sponsored by BriaCell Therapeutics (TSX:BCT,NASDAQ:BCTX). This INNspired article provides information which was sourced by the Investing News Network (INN) and approved by BriaCell Therapeutics in order to help investors learn more about the company. BriaCell Therapeutics is a client of INN. The company’s campaign fees pay for INN to create and update this INNspired article.
This INNspired article was written according to INN editorial standards to educate investors.
INN does not provide investment advice and the information on this profile should not be considered a recommendation to buy or sell any security. INN does not endorse or recommend the business, products, services or securities of any company profiled.
The information contained here is for information purposes only and is not to be construed as an offer or solicitation for the sale or purchase of securities. Readers should conduct their own research for all information publicly available concerning the company. Prior to making any investment decision, it is recommended that readers consult directly with BriaCell Therapeutics and seek advice from a qualified investment advisor.
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