BriaCell Therapeutics Corp. (OTCQB: BCTXF) (TSX.V: BCT) Advances Breast Cancer Therapy Trials to Patient Dosing Stage

• Breast cancer is the leading cancer diagnosed in women and the second-most common cancer overall
• BriaCell Therapeutics has begun patient dosing in clinical trials that combine its trademarked Bria-IMT technology with celebrated cancer-fighting antibodies
• The clinical trials are working on a therapy that will help the body’s own immune system fight cancerous cells

The battle against breast cancer is taking a technological turn amid an increasing drive to develop therapies that use the body’s own immune system to destroy life-threatening cancer cells. BriaCell Therapeutics Corp. (OTCQB: BCTXF) (TSX.V: BCT) is on the front line of the battle and is currently testing its immuno-oncology biotechnology in phase I and IIa trials involving advanced-stage breast cancer patients.

Last month, the company announced positive outcomes from the latest proof of concept data for the study (http://ibn.fm/36wya), in which BriaCell’s trademarked Bria-IMT immunotherapy technology was checked for safety and efficacy factors in select breast cancer patients. The company reported that patients experienced some tumor shrinkage at various sites after the introduction of Bria-IMT, building on previous Bria-IMT proof of concept testing that showed substantial tumor shrinkage in a patient whose breast cancer had metastasized. In the study, blood was tested to see if cancerous cells and associated cells expressed an “immune checkpoint” molecule dubbed “programmed death-ligand 1,” or PD-L1, that might normally suppress the immune system response to cancerous “invaders.”

Earlier this month, BriaCell announced that it is proceeding with the next stage of testing — patient dosing using Bria-IMT in combination with celebrated cancer-fighting antibodies expected to increase the power of the technology’s punch (http://ibn.fm/5QKZU).

The immune checkpoint inhibiting antibodies, known as pembrolizumab and ipilimumab and marketed as Keytruda by Merck & Co., Inc. (NYSE: MRK) and as Yervoy by Bristol-Myers Squibb Company (NYSE: BMY), respectively, gained worldwide attention after the 2018 Nobel Prize in Physiology or Medicine was awarded to Drs. Tasuku Honjo and James P. Allison. Honjo and Allison made what the Nobel committee referred to as “game-changing discoveries about how to harness and manipulate the immune system to fight cancer” by studying proteins that block the immune system from attacking dangerous cells (http://ibn.fm/S30pC).

The proteins are known as CTLA-4, which Yervoy targets, and PD-1, which Keytruda targets in an attempt to “release the brakes” on the immune system’s fight against such protected cancer cells. The scientists’ work in the 1990s led rapidly to the development of new cancer therapies designed to help the body’s immune system fight off cancerous cells, and Yervoy was the first to gain approval in 2011.

Keytruda launched in 2014 and became a bigger hit. Initially, Keytruda received FDA approval for treating a type of skin cancer, but ongoing clinical trials led to its accelerated implementation in treating other forms of cancer, such as non-small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma and bladder cancer, with priority review currently under way for treating advanced gastric or gastroesophageal junction adenocarcinoma (http://ibn.fm/bHuRa).

In this developing landscape for battling cancer, BriaCell believes Bria-IMT’s use in stimulating the immune system’s T-cell activity, working in combination with the protein-attacking virtues of Keytruda and Yervoy, may provide the trial’s advanced-stage breast cancer patients with a greater benefit than they might otherwise have known. The PD-L1 expression of blood-borne cancer cells and cancer-associated cells suggests that Keytruda may be the best combination, and this will be evaluated initially.

Thus far in 2018, more than two million new cases of breast cancer have been diagnosed, making it the most commonly occurring cancer in women and the second most common cancer overall, according to the World Cancer Research Fund International (http://ibn.fm/HUClW).

“We believe that combination of Bria-IMT with immune checkpoint inhibitors should create even more potent anti-cancer immune responses,” BriaCell President and CEO Dr. Bill Williams stated in this month’s news release. “BriaCell is committed to exploring additional ways to address the unmet needs of the advanced breast cancer community. We are very excited to test this novel combination treatment approach which we believe will offer significant clinical benefit to patients with advanced breast cancer.”

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

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