- The safety of a novel combined advanced breast cancer treatment has proven to be excellent, BriaCell announced at a major breast cancer conference
- The monotherapy (i.e. drug on its own) clinical trial showed positive anti-tumor activity in patients with advanced breast cancer and metastases
- Further information about the efficiency of the Bria-IMT/KEYTRUDA combined treatment will be provided in the first quarter of 2019
Initial data from a combination study of Bria-IMT and KEYTRUDA (pembrolizumab) demonstrated an excellent safety profile, BriaCell Therapeutics Corp. (OTCQB: BCTXF) (TSX.V: BCT) announced at the 2018 San Antonio Breast Cancer Symposium (http://nnw.fm/Po3A0). During the conference, the immuno-oncology focused biotechnology company also presented positive proof of concept data for Bria-IMT as a monotherapy for the treatment of advanced breast cancer.
“The robust biological activity of Bria-IMT demonstrated through the trials is very exciting,” BriaCell’s president and CEO, Dr. William Williams, said in a news release. “The findings also reinforce the product development strategy for Bria-OTS – BriaCell’s off-the-shelf personalized immunotherapy solution.”
Studies so far have demonstrated the ability of Bria-IMT to promote a powerful immune response that causes tumor regression in patients with advanced stage breast cancer. “We are highly confident of our strategy to use Bria-IMT in combination with KEYTRUDA, an approved treatment for multiple cancer indications, and expect synergistic activity of this combination in patients with advanced breast cancer. We look forward to additional clinical data and expect to share details at upcoming scientific meetings,” Dr. Williams added.
Presenting the poster was Saveri Bhattacharya (http://nnw.fm/jHE6b), DO, assistant professor of medical oncology at Thomas Jefferson University (http://nnw.fm/Rzui1), researcher at the NCI-designated Sidney Kimmel Cancer Center (http://nnw.fm/PZc8p) at Jefferson Health (http://nnw.fm/mn5DF) and principal investigator (PI) of the study.
In the combination therapeutic study, five patients were treated with Bria-IMT and Merck & Co., Inc.’s (NYSE: MRK) KEYTRUDA. The combination was tolerated very well, and the study is still ongoing to provide further data on the safety of the therapeutic approach. More information about the efficacy of the combination is to be presented in the first quarter of 2019.
Additionally, examination of Bria-IMT’s efficacy in the treatment of advanced breast cancer is ongoing. The Bria-IMT phase I/IIa monotherapy study involved 23 patients who were very heavily pre-treated (a median of four previous systemic therapy regiments per patient). The treatment with Bria-IMT was well-tolerated, with minor local irritation at the injection site being reported as the most common adverse effect.
More importantly, Bria-IMT contributed to tumor shrinkage in three of the patients. The top respondent previously received seven rounds of chemotherapy and had tumor metastases at various sites. The patient’s three-month follow-up showed shrinkage in all 20 metastatic formations in the lungs. After six months, the response was still maintained. Two other patients also showed tumor reduction. All of the patients with tumor reduction matched Bria-IMT at one or more HLA types, validating BriaCell’s approach to selecting patients most likely to respond (BriaDx). Biological activity was observed in several other of the patients, and there was a noted decrease in circulating cancer-associated cells.
Bria-IMT works by stimulating T-cell activity. T-cells are an important immune response component, and their activation is expected to increase the body’s natural ability to recognize and destroy cancer cells.
BriaCell is also focusing on the development of Bria-OTS – a personalized immunotherapy solution that matches the needs of the patient without a specialized manufacturing process. This personalized treatment is expected to be safe and highly effective while avoiding the high costs of creating personalized treatments for advanced cancer patients. In addition, Bria-OTS is created to produce a selective immune response that’s tailored to the specific needs of the cancer patient. Bria-OTS is expected to cover approximately 90 percent of the patient population.
For more information, visit the company’s website at www.BriaCell.com
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