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BriaCell Therapeutics Corp. (BCTX) RSS Feed

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http://briacell.com/

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About BriaCell

Dedicated to enhance the lives of cancer patients who are facing limited therapeutic options, BriaCell Therapeutics Corp. (OTCQB: BCTXF; TSX: BCT.V)’s mission has been to develop novel immunotherapies, as the most cutting edge technology to fight cancer. Immunotherapies have become the forefront of the cancer treatments because they use the body’s immune system to destroy the cancer cells, offering higher levels of safety and efficacy than chemotherapy, with less likeliness of recurrence.

Designed by our team of scientists and clinicians, BriaCell’s proprietary whole-cell based vaccine technology platform continues to show its impressive potential to establish a new model for treating cancer patients. Our lead product candidate, Bria-IMT™ (SV-BR-1-GM), is a genetically engineered whole-cell vaccine derived from a human breast cancer cell line. Bria-IMT™ is used in combination with multiple immune-modulators to powerfully trigger the immune system to recognize and eliminate cancerous cells.

In a preliminary Phase I clinical study in metastatic (i.e., Stage IV) breast cancer patients who had failed multiple treatments, Bria-IMT™ treatment significantly reduced the tumor size, without serious side effects. Importantly, the tumor regression was observed in other sites including the lung and even the brain -a difficult site. Impressively, the median lifespan of the patients was substantially longer than that of the comparable trials.

At our laboratory facility in Berkeley, CA, we are planning to expand our pipeline of oncology immunotherapy candidates using our proprietary technology platform.

Using the clinical data from the patients from the clinical studies, we are working to identify the molecular fingerprint of the patients for which the vaccine would be highly effective, and are planning to develop diagnostic testing products to identify this group. By directing the drug to the top-responders, we expect this approach to increase the likelihood of clinical trial success of Bria-IMT™ -to bring hope to thousands of cancer patients with few-to-no treatment options.

The company is currently recruiting its Phase I/IIa trial to further test Bria-IMT™ safety and activity in metastatic breast cancer patients. BriaCell maintains global rights for Bria-IMT™.

Phase I/IIa Clinical Study of Bria-IMT™ in Advanced Breast Cancer

BriaCell is currently recruiting patients to evaluate the safety and activity of Bria-IMT™ in an additional Phase I/IIa study in 25-40 metastatic breast cancer patients who have failed at least one course of treatment.

For the details of the trial, please visit For the details of the trial, please visit https://www.clinicaltrials.gov/ct2/show/NCT03066947

Roll-Over Combination Therapy Study

FDA has approved the roll-over combination study of Bria-IMT™ with pembrolizumab (Keytruda; manufactured by Merck & Co., Inc.) or ipilimumab (Yervoy; manufactured by Bristol-Myers Squibb Company) for patients previously treated with BriaVax™ from the ongoing Phase I/IIa Clinical Trial in Advanced Breast Cancer. The study is available for patents on the SV-BR-1-GM Phase I/IIa study who develop progressive disease. These patients will be eligible to roll-over into combination therapy with Keytruda or Yervoy, depending on the type of breast cancer they have.

More information on the roll-over combination study of Bria-IMT™ with either ipilimumab or pembrolizumab will be available on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT03328026)

KEYTRUDA® (pembrolizumab)

Manufactured by Merck & Co., Inc., KEYTRUDA® (pembrolizumab) is a prescription medicine that may treat certain cancers by working with the immune system. It has been approved for the treatment of a number of cancer indications excluding breast cancer.

For more information on pembrolizumab, please see:
http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf

About YERVOY® (ipilimumab)

Manufactured by Bristol-Myers Squibb Company, YERVOY® (ipilimumab) is a prescription medicine used in adults and children 12 years and older to treat melanoma (a kind of skin cancer) that has spread (metastatic) or cannot be removed by surgery (unresectable). It is a monoclonal antibody that works to activate the immune system and enabling them to recognize and destroy cancer cells.

For more informations on Ipilimumab, please see:
https://packageinserts.bms.com/pi/pi_yervoy.pdf

 

Clinical Development Timeline – Breast Cancer

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