Berkeley, CA — 02/06/2018 — BriaCell Therapeutics Corp.(“BriaCell”), an immuno-oncology focused biotechnology company with a proprietary targeted immunotherapy technology, is pleased to announce the opening of a new clinical site, Jefferson Breast Care Center in Philadelphia, PA, and the appointment of Dr. Saveri Bhattacharya, a board certified medical oncologist, as the clinical site's principal investigator. Dr. Bhattacharya will work closely with Cancer Insight, LLC., BriaCell's contract research organization, to manage the clinical and regulatory aspects of the clinical trial on behalf of BriaCell.
Saveri Bhattacharya, DO, currently Assistant Professor of Medical Oncology at Thomas Jefferson University, is a board-certified oncologist experienced in clinical trials for breast cancer patients. She graduated from Touro University College of Osteopathic Medicine in 2011 and completed her Fellowship in Hematology & Oncology at the University of Pittsburgh Medical Center. She is currently focused on the clinical aspects of novel therapeutics for breast cancer at Jefferson Breast Care Center. Dr. Bhattacharya has an impressive roster of publications, including major review articles in both breast cancer chemotherapy and in immunotherapy.
“Dr. Saveri Bhattacharya's credentials, knowledge, and experience in breast cancer are impressive. We are delighted to appoint her as a principal investigator for Phase I/IIa clinical trial of Bria-IMTâ„¢ in advanced breast cancer,” stated Dr. William Williams, BriaCell's President & CEO. “Excellence in patient care is our main priority, and we are grateful to have the opportunity to work with the experts at Jefferson Breast Care Center, known for outstanding cancer care, as our 4th site for the clinical trials of Bria-IMTâ„¢. The addition of the site should improve the accessibility of Bria-IMTâ„¢ to the patients in the northeastern regions of the US and accelerate patient enrollment in the current Phase I/IIa clinical trial.”
“We are thrilled to join the BriaCell team in this opportunity to assess the safety and activity of this novel therapeutic, Bria-IMTâ„¢, in advanced breast cancer with the ultimate goal of enhancing the lives of patients afflicted with advanced breast cancer,” commented Dr. Bhattacharya. “We are impressed with the early safety and efficacy information on Bria-IMTâ„¢ treatment in patients with breast cancer and look forward to enroll additional patients in the ongoing clinical trial.”
BriaCell is an immuno-oncology focused biotechnology company developing a targeted and safe approach to the management of cancer. Immunotherapy has come to the forefront in the fight against cancer, harnessing the body's own immune system in recognizing and selectively destroying cancer cells while sparing normal ones. Immunotherapy, in addition to generally being more targeted and less toxic than commonly used types of chemotherapy, is also thought to be a potent approach with the potential to prevent cancer recurrence.
Bria-IMTâ„¢ (SV-BR-1-GM), the Company's lead product candidate, is derived from a specific breast cancer cell line. It is genetically engineered to release granulocyte-macrophage colony-stimulating factor (GM-CSF), a substance that activates the immune system. We believe that Bria-IMTâ„¢ helps the body to recognize and kill tumor cells by activating T cells that attack the tumor and B cells that produce anti-tumor antibodies.
The results of two previous proof-of-concept clinical trials (one with the precursor cell line not genetically engineered to produce GM-CSF and one with Bria-IMTâ„¢) produced encouraging results in patients with advanced breast cancer. Most notably, one patient with metastatic breast cancer responded to Bria-IMTâ„¢ with substantial reduction in tumor burden including breast, lung, soft tissue and brain metastases. The company is currently conducting a Phase I/IIa clinical trial for Bria-IMTâ„¢ in patients with advanced breast cancer. This trial is listed in ClinicalTrials.gov as NCT03066947. The trial is being conducted along with the co-development of BriaDXâ„¢, the Company's companion diagnostic test. The interim data for the first 10 patients is expected by the first quarter of 2018. Additionally, the FDA recently approved the roll-over combination study of Bria-IMTâ„¢ with pembrolizumab [KeytrudaÂ®; manufactured by Merck & Co., Inc.] or ipilimumab [YervoyÂ®; manufactured by Bristol-Myers Squibb Company] for patients previously treated with Bria-IMTâ„¢ in the Company's ongoing Phase I/IIa clinical trial in advanced breast cancer. The roll-over trial is listed in ClinicalTrials.gov as NCT03328026.
BriaCell is also developing Bria-OTSâ„¢, an off-the-shelf personalized Immunotherapy. Bria-OTSâ„¢ consists of 14 individually pre-manufactured genetic alleles. BriaCell's BriaDXâ„¢ companion diagnostic reveals a patient's specific HLA-types and the 2 best matching alleles are administered to the patient. BriaCell's 14 alleles (8 Class I and 6 Class II) cover approximately 90% of the Breast Cancer population while eliminating the complex manufacturing logistics required for other personalized immunotherapies. Bria-OTSâ„¢ is a personalized therapy without the need for personalized manufacturing.
Yet another item in the BriaCell pipeline is a novel, selective protein kinase C delta (PKC?) inhibitor. PKC? inhibitors have shown activity in a number of pre-clinical models of RAS genes' transformed cancers including breast, pancreatic, non-small cell lung cancer and neuroendocrine tumors (such as carcinoid tumors).
For additional information on BriaCell, please visit our website: http://briacell.com.
About Jefferson Breast Care Center
With its state of art equipment, and nationally-ranked cancer specialists including top oncologists, surgeons, plastic surgeons, radiation oncologists, pathologists and radiologists (subspecialized in breast imaging), Jefferson Breast Care Center provides a wide range of breast care services for women and men. The services include risk assessment, breast screening and diagnosis, to treatment and follow-up care.
The center provides comprehensive – yet highly specialized – treatment for all types and stages of breast cancer, including: Early and advanced stage breast cancer, Metastatic breast cancer, Inflammatory breast cancer, Breast cancer during pregnancy, Breast cancer in young women, Triple negative breast cancer, Breast cancer in men, and Rare breast tumors.
Additional support team includes specially trained nurse practitioners, oncology nurses, social workers, therapists and technicians to ensure a personalized and coordinated breast care.
Accreditations and Accolades in Breast Cancer Treatment include the following:
– Jefferson Kimmel Cancer Center is a National Cancer Institute (NCI) designated Cancer Center
– Jefferson Breast Care Program and Center is one of the first 30 Centers in the country to be accredited by the National Accreditation Program of Breast Centers (NAPBC)
– Jefferson University Hospital is accredited by the Commission on Cancer (CoC) for cancer services
For more information on Jefferson Breast Care Center, please visit http://hospitals.jefferson.edu/departments-and-services/breast-care-center/.
Cautionary Note Regarding Forward-Looking Information
Except for the statements of historical fact, this news release contains “forward-looking information” within the meaning of the applicable Canadian securities legislation which involves known and unknown risks relevant to the Company in particular and to the biotechnology and pharmaceutical industries in general, uncertainties and other factors that may cause actual events to differ materially from current expectation. These risks are more fully described in the Company's public filings available at http://www.sedar.com.
Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company disclaims any intention or obligation, except to the extent required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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