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BriaCell Therapeutics Corp. (OTCQB: BCTXF) (TSX.V: BCT) Initiates Patient Dosing in Phase I/IIa Combination Study Targeting Advanced Breast Cancer

  • Patient dosing has commenced in a combination study of Bria-IMT with KEYTRUDA or YERVOY in advanced breast cancer
  • Company recently announced positive proof of concept data in the Phase I/IIa study of Bria-IMT in advanced breast cancer patients, which indicated excellent targeted anti-tumor activity and outstanding safety and tolerability
  • KEYTRUDA and YERVOY are highly recognized for their potent immune boosting properties, which validates BriaCell’s strategy to use these therapeutics in its combination study

BriaCell Therapeutics Corp. (OTCQB: BCTXF) (TSX.V: BCT), an immuno-oncology-focused biotechnology company engaged in developing targeted and safe approaches for cancer management, recently announced (http://nnw.fm/QYox4) that it has initiated patient dosing in a Phase I/IIa study of Bria-IMT, its lead clinical candidate, in combination with pembrolizumab (KEYTRUDA, which is manufactured by Merck & Co., Inc. [NYSE: MRK]) or ipilimumab (YERVOY, which is manufactured by Bristol-Myers Squibb Company [NYSE: BMY]). This combination study is listed on ClinicalTrials.gov as NCT03328026.

BriaCell continues its commitment to exploring new methods of addressing the advanced breast cancer community’s unmet medical needs, and the company is eager to test this novel combination treatment approach and believes that it will offer significant clinical benefits to patients who have advanced breast cancer.

Bria-IMT is essentially a breast cancer cell line that has been engineered to produce an immune-activating factor (GM-CSF) and has been shown to stimulate T-cells, which are vital cells within the immune system. Earlier this year, BriaCell published these findings in a leading immunology journal (http://nnw.fm/Xg6So). Based on Bria-IMT’s published, proposed mechanism of action, BriaCell anticipates that Bria-IMT, combined with immune checkpoint inhibitors, can exert additive or synergistic tumor-directed effects resulting in even more potent anti-cancer immune responses and leading to the company’s strategy of combination studies of Bria-IMT with KEYTRUDA or YERVOY. It is important to note that pembrolizumab and ipilimumab have not been shown to work independently in breast cancer but are each approved for other indications.

On September 26, BriaCell announced positive proof of concept data in a phase I/IIa study of Bria-IMT in advanced breast cancer, which resulted in outstanding safety and efficacy in patients with HLA matches with Bria-IMT. An impressive point to note is that the safety and efficacy data appeared superior to that of other advanced or approved drugs for breast cancer when they were at a similar clinical development stage.

Analysis of blood samples collected in the phase I/IIa study showed that circulating tumor-associated cells expressed the immune checkpoint molecule programmed death-ligand 1 (PD-L1). PD-L1 molecules block immune cells from attacking cancer cells. KEYTRUDA neutralizes the blocking mechanism of PD-L1, while YERVOY blocks other aspects of immune suppression and, therefore, may also activate the immune system to destroy cancer cells.

Bria-IMT with KEYTRUDA or YERVOY Combination Study Details

  • KEYTRUDA Combination: Patients with expression of PD-L1 or PD-L2 on their cancer will be treated with the combination of Bria-IMT and the anti-PD-1 antibody KEYTRUDA.
  • YERVOY Combination: Patients without expression of PD-L1 or PD-L2 on their cancer will be treated with the combination of Bria-IMT and YERVOY, which is also expected to enhance the immune response induced by Bria- IMT.

It is hypothesized by the BriaCell team that patients in the combination therapy trial may receive particular benefit from these combinations with Bria-IMT.

Bria-IMT with KEYTRUDA or YERVOY Combination Study Rationale

Immune checkpoint inhibitors like pembrolizumab (KEYTRUDA; anti-PD-1) and ipilimumab (YERVOY; anti-CTLA-4), which are designed to overcome immune suppression in cancer patients, have become forerunners in the fight against cancer, offering substantial benefits for certain patients. The significance of immune checkpoint inhibitors was most recently recognized by the Nobel committee in awarding the 2018 Nobel Prize in Physiology or Medicine to Dr. Tasuku Honjo (PD-1) and Dr. James P. Allison (CTLA-4) (http://nnw.fm/b86sB). This greatly validated BriaCell’s decision to launch a combination therapy with immune checkpoint inhibitors.

An important preclinical study conducted in 2010 by Dr. Allison’s group showed that combination with anti-PD-1 and anti-CTLA-4 antibodies potentiated the tumor-rejection effect of irradiated melanoma cells engineered to produce immune-activating factors.

BriaCell envisions that Bria-IMT and immune checkpoint inhibitors can exert additive or synergistic tumor-directed effects. In a recent interview, company CEO Dr. William Williams discussed the company’s immunotherapies in detail, and how the company is building offerings for the $30 billion immunotherapy market (http://nnw.fm/bk8Dt).

For more information, visit the company’s website at www.BriaCell.com

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