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BriaCell Therapeutics Corp. (OTCQB: BCTXF) (TSX.V: BCT) Advances Novel Formulation of Drug Candidate in Battle against Advanced Breast Cancer

  • Development of frozen formulation of Bria-IMT completed for on-demand shipment to clinical sites
  • Novel formulation is easily transportable to distant locations, easy to use, safe and has improved potency; it accommodates higher patient volumes at reduced per-dose costs
  • Promising novel immunotherapy technology provides hope to patients with advanced breast cancer
  • Breast cancer remains the leading cancer diagnosed in women and the second-most common cancer overall

Immuno-oncology focused biotechnology company, BriaCell Therapeutics Corp. (OTCQB: BCTXF) (TSX.V: BCT) recently announced the imminent clinical use of a novel, frozen formulation of Bria-IMT, the company’s lead cancer drug candidate targeting the unmet medical needs of advanced breast cancer patients. Comprehensive data analysis is underway following completion of a Phase I/IIa clinical trial of Bria-IMT in a combination study with pembrolizumab – marketed as KEYTRUDA® by Merck & Co., Inc. (NYSE: MRK) – and listed on ClinicalTrials.gov as NCT03328026.

The company’s frozen formulation allows for the storage of cryopreserved, ready-to-inject Bria-IMT for cold-chain overnight transport to clinical sites where it will be thawed prior to injection in patients. This unique formulation of Bria-IMT has also shown improved potency compared to the old formulation in vitro. Long term, this novel, frozen formulation is expected to carry reduced per-dose costs compared to the old formulation, the company stated in a news release (http://ibn.fm/qHd1W). Bria-IMT activates the immune system to destroy cancer cells in a way that’s believed to be both unique and more effective than other, similar approaches. The frozen formulation will also be applicable to Bria-OTS, BriaCell’s personalized off-the-shelf immunotherapy, which is being developed.

“Currently, the old formulation of Bria-IMT used in the clinical trials was cumbersome to prepare, as it had to be processed the day before administration to patients. This created a great deal of inconvenience and complexities for the manufacturer, clinicians and patients,” Dr. Bill Williams, BriaCell’s president and CEO, said in a news release. “The new frozen formulation has shown improved potency and stability in vitro and, based on its constituents and injection route, is expected to be highly bioavailable. This enhances Bria-IMT’s potential to address patient needs as a ready-to-use treatment alternative that can be prepared in advance, is easily transportable to distant locations in large quantities, is easy to use, and is safe and highly effective.”

Cryopreservation is a process that preserves organelles, cells, tissues or any other biological constructs by cooling the samples to very low temperatures. The successful cryopreservation of cells and tissues is the subject of intensive research for many medical applications, as noted in a scholarly article (“Cryopreservation and its clinical applications”) published online by the National Center for Biotechnology Information, National Library of Medicine, National Institutes of Health (http://ibn.fm/vdD5Y).

“We are excited to add this novel technology to our growing immunotherapy franchise as we advance safe and effective treatment solutions for advanced breast cancer, an unmet medical need,” Williams continued. “We look forward to the efficacy data of our ongoing clinical trial, which will provide further evidence for this promising novel therapy to bring hope to patients with advanced breast cancer.”

Breast cancer is the most commonly occurring cancer in women and the second-most common cancer overall, with over two million new cases diagnosed worldwide in 2018, according to the World Cancer Research Fund International (http://ibn.fm/bvFox). Research into powerful immunotherapies for cancer, also known as immune-oncology, is growing, the Cancer Research Institute (“CRI”) noted in an article highlighting a robust international interest in the field (http://ibn.fm/huQb5). The article, titled “Trends in the global immune-oncology landscape,” appeared online in Nature Reviews Drug Discovery from Nature Publishing Group.

“The quantitative analyses from this report reveal a 67 percent increase of the number of active immuno-oncology pipeline agents in a year, showing the unprecedented enthusiasm and commitment of the field,” said Jill O’Donnell-Tormey, Ph.D., chief executive officer and director of scientific affairs at the Cancer Research Institute.

Cancer care affects not just the patient, but caregivers as well, with many concerned about the financial impact and availability of care near where they live, as the American Society of Clinical Oncology (ASCO) noted in its second annual National Cancer Opinion Survey (http://ibn.fm/wlm4g). Bria-Cell’s frozen formulation of its lead cancer drug candidate, Bria-IMT, importantly offers the ability to easily transport the cryopreserved formulation anywhere it is most needed and at an expected reduced per-dose cost.

“Patients are right to be concerned about the financial impact of a cancer diagnosis on their families. It’s clear that high treatment costs are taking a serious toll not only on patients, but also on the people who care for them,” added ASCO Chief Medical Officer Richard L. Schilsky, MD, FACP, FASCO. “If a family member has been diagnosed with cancer, the sole focus should be helping them get well. Instead, Americans are worrying about affording treatment, and in many cases, they’re making serious personal sacrifices to help pay for their loved ones’ care.”

BriaCell Therapeutics Corp. will present a poster at a 2019 Keystone Symposia scientific conference being held on January 20-24, 2019, at Fairmont Hotel Vancouver in Vancouver, British Columbia. The poster will highlight BriaCell’s recent clinical and research-focused development of Bria-IMT and BriaDX, the corresponding companion diagnostic test, which helps identify those patients most likely to benefit from Bria-IMT, as well as Bria-OTS, the first off-the-shelf personalized treatment for advanced stage breast cancer.

BriaCell management will also attend Biotech Showcase 2019, an important investor conference taking place on January 7-9, 2019, at Hilton San Francisco Union Square in San Francisco, California.

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

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