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BriaCell Adds New Clinical Site To Phase IIa Study in Advanced Breast Cancer and Expands R&D Team

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  • The addition of the Cancer Center of Kansas (CCK) as a new clinical trial site is expected to accelerate patient enrollment in both clinical trials.
  • The hiring of Dr. Sunkari, an experienced Scientist, is intended to speed up the development of Bria-OTS™, BriaCell's novel off-the-shelf personalized immunotherapy.

BERKELEY, Calif. and VANCOUVER, British Columbia, Aug. 08, 2018 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. ("BriaCell") (TSX-V:BCT) (OTCQB:BCTXF), an immuno-oncology focused biotechnology company with a proprietary targeted immunotherapy technology, is pleased to announce that the Cancer Center of Kansas (CCK) has been added as a new clinical trial site. BriaCell is currently conducting  an ongoing, multicenter, Phase IIa study of Bria-IMT™ (listed in ClinicalTrials.gov as NCT03066947) in advanced breast cancer, as well as the rollover combination study of Bria-IMT™ with pembrolizumab or ipilimumab (listed in ClinicalTrials.gov as NCT03328026). Dr. Shaker R. Dakhil, Board certified in Medical Oncology and Internal Medicine, will act as the clinical site's principal investigator (PI). Under the direction of Dr. Dakhil, the Cancer Center of Kansas lists 16 offices, and 13 Sub Investigators. Dr. Dakhil will work closely with Cancer Insight, LLC., BriaCell's contract research organization, to manage the clinical and regulatory aspects of the Phase IIa clinical trial in advanced breast cancer on behalf of BriaCell.

With its wide network of facilities and leading oncologists, CCK has been providing the patients in the State of Kansas with leading cancer-related research, diagnosis, and treatment since 1975. The Cancer Center of Kansas team, and its physicians, have received numerous awards for excellent patient care and expertise. The clinical site currently lists 16 offices in the State of Kansas, including their main location in Wichita, and 15 additional participating locations at McPherson, Junction City, Marysville, and Neodesha.

"We are thrilled to be working with a leading oncology team at a well-respected center such as CCK, as we continue the clinical development of Bria-IMT™ in advanced breast cancer," stated Bill Williams, BriaCell's President and CEO. "We anticipate that  multiple trial locations will provide treatment access to qualified patients in the US Midwest.  This new relationship should speed up the pace of recruiting for our Phase II clinical trial of Bria-IMT™ and the rollover study.  Our top priority is to obtain data from these studies which will enable us to make Bria-IMT™ immunotherapy available to patients as soon as possible. We believe Bria-IMT™ is a safe and effective treatment.  If data from the trial supports its effectiveness, Bria-IMT™ will fill a void in the treatment of advanced breast cancer, currently a huge unmet medical need."

Dr. Shaker R. Dakhil will serve as the lead Principal Investigator (PI) for Bria-IMT™ and rollover studies. Board certified in Medical Oncology and Internal Medicine since 1981, Dr. Dakhil has served as President of CCK since 2000. He is a clinical Professor of Medicine at the University of Kansas School of Medicine – Wichita, and has served as PI for numerous cancer clinical trials.

Dr. Dakhil has lead several earlier cancer research projects, and was part of a three-physician team which developed the first implantable central venous catheter (known as port-a-cath), used in cancer care. Dr. Dakhil is a Fellow of the American College of Physicians, and holds membership in a number of professional societies in oncology. He has served as President of the Medical Society of Sedgwick County (1997) and is Past President of staff at Via Christi Hospital. Dr. Dakhil founded Wichita Cancer Foundation, a non-profit organization which provides financial assistance for cancer patients. He has been honored with numerous awards including the Healthcare Heroes Lifetime Achievement Award by the Wichita Business Journal in 2014, and has been named each year, from 2005 to 2011, in the Top 1% of Physicians in the Nation by Castle Connolly Medical Ltd. as nationally published by Newsweek, US News and World Report.

"We are grateful to have a top oncology expert such as Dr. Dakhil as the lead PI at CCK in our Phase I/IIa clinical trials of Bria-IMT™,"  Dr. Williams said.

"Bria-IMT™ may represent a significant advance in the safe and effective treatment of advanced breast cancer patients," commented Dr. Dakhil. "Early data from the preliminary trials and ongoing trials have been encouraging, and it is our hope they will be substantiated by these clinical studies at our site. We are excited to be working with the  BriaCell team to make these treatments available to advanced breast cancer patients with poor survival prospects".

The Phase IIa clinical trial of Bria-IMT™ and the Phase I/IIa rollover combination study with Keytruda® and Yervoy® in advanced breast cancer are currently being conducted at five top cancer centers: 1) St. Joseph Health-Sonoma County, Santa Rosa, CA, 2) Everett Clinic and Providence Regional Medical Center, Everett, WA, 3) Jefferson Breast Care Center, Philadelphia, PA, 4) Sylvester Comprehensive Cancer Center, University of Miami in Miami, FL, and 5) Cancer Center of Kansas, Wichita, KS. An earlier site at Florida Cancer Care in Plantation, FL was recently closed.

BriaCell is currently enrolling advanced breast cancer patients in a Phase IIa trial (NCT03066947) with Bria-IMT™ and a rollover trial (NCT03328026) with Bria-IMT™ in combination with other immunotherapies. For further information on the Phase IIa trials, please visit https://clinicaltrials.gov/ct2/show/NCT03066947?term=BriaCell&rank=2.

About The Cancer Center of Kansas

Founded by Dr. Harry Hynes in Wichita, KS, in 1975, Cancer Center of Kansas, provides personalized, quality and innovative cancer care to patients in the mid-west. The center's mission has been to provide the latest and highest quality diagnostic and therapeutic care to cancer patients through their commitment to excellence in medical oncology and hematology. Since 1987, CCK began extending its coverage throughout the state to serve patients in rural areas such as McPherson, Junction City, Marysville, and Neodesha. Cancer Center of Kansas currently lists 16 participating offices and 14 physicians in the State of Kansas.

With its widespread network of facilities throughout the state of Kansas, top oncologists, and excellent patient care team, CCK is aiming to provide world class cancer care to patients. Their services are focused on multiple aspects of cancer treatment including– diagnosis and treatment, blood and marrow transplants, research and clinical trials, diagnostic imaging, advanced laboratory work, and an oral medications center to better serve their patients.

Throughout the years, the CCK team has received numerous distinctions, awards and recognitions at community, national, and international levels for the the center's excellence in patient care, and the expertise of its physicians. For the full list of awards, please see: https://cancercenterofkansas.com/awards-recognition/.

For more information on the Cancer Center of Kansas, please visit https://cancercenterofkansas.com/.

BriaCell Expands R&D team: Hires Vivek Sunkari, Ph.D. as Senior  Scientist

BriaCell announces the expansion of its R&D team with the addition of Vivek Sunkari, Ph.D. as Senior  Scientist. Dr. Sunkari earned his Ph.D. in Molecular Medicine from Karolinska Institute, Sweden in 2013, where he identified several new pathogenic mechanisms involved in chronic tissue repair and regeneration processes. Dr. Sunkari, completed his translational immunology postdoctoral work at Stanford University focusing on the role of extracellular matrix molecules and their influence on immune and endocrine disorders. Prior to joining BriaCell, Dr. Sunkari was an immunology scientist, at Lake Pharma Inc., where he was involved in discovering antibodies for the treatment of immune disorders including immuno-oncology, and autoimmune diseases. Dr. Sunkari has authored numerous peer-reviewed publications, reviewed multiple articles for biomedical journals, and has been a member at a number of international scientific organizations. Additionally, Dr. Sunkari is a co-founder of LymeTek Inc., a start up company that focuses on Lyme Disease treatment and prevention.

About BriaCell

BriaCell is an immuno-oncology focused biotechnology company developing targeted and safe approaches for the management of cancer. Immunotherapy has come to the forefront in the fight against cancer because it uses the body's own immune system in recognizing and selectively destroying cancer cells while leaving normal cells intact. In addition, immunotherapy is also considered to be a more potent approach than chemotherapy, and has the potential to prevent cancer recurrence.

Bria-IMT™ (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. BriaCell believes that Bria-IMT™ helps the body to recognize and kill tumor cells by activating both T cells that directly attack tumor cells, 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-IMT™) produced encouraging results in patients with advanced breast cancer. Most notably, one patient with breast cancer that had spread to other sites (metastatic cancer) responded to Bria-IMT™ with a substantial reduction in tumor size and volume in these sites, including sites in the breast, the lung, soft tissues, and even the brain. BriaCell is currently conducting a Phase I/IIa clinical trial of Bria-IMT™ in patients with advanced breast cancer.  In this trial, to date, Bria-IMT™ treatment has been safe with instances of tumor reduction observed. This trial is listed in ClinicalTrials.gov as NCT03066947. The trial is being conducted along with the co-development of BriaDX™, the Company's companion diagnostic test, to be able to predict the patients who will likely benefit the most from Bria-IMT™ treatments. Additionally, the FDA recently approved a rollover combination study of Bria-IMT™ with pembrolizumab [Keytruda®; manufactured by Merck & Co., Inc.] or ipilimumab [Yervoy®; manufactured by Bristol-Myers Squibb Company]. This study permits continuation of the Bria-IMT™ treatment for patients in the ongoing Phase I/IIa trials who stop responding to the treatment. The rollover trial is listed in ClinicalTrials.gov as NCT03328026.

Based on our observation of superior tumor shrinking responses in the patients who shared certain HLA types with Bria-IMT™, BriaCell is developing Bria-OTS™, an off-the-shelf personalized Immunotherapy, for advanced breast cancer.  Bria-OTS™ includes a set of cell lines, each being similar to Bria-IMT™, which are being engineered to express various pre-manufactured HLA types. With only 15 different HLA types, Bria-OTS™ cell line combinations are expected to cover over 90% of the United States' population. BriaCell expects to use BriaDX™ to determine the HLA types of patients, and subsequently select one or two Bria-OTS™ cell lines with matching alleles to be administered to the patient. This should produce a potent and selective immune response against the cancer of each patient while eliminating the time, expense, and complex manufacturing logistics currently used for other personalized immunotherapies. In essence, Bria-OTS™ should provide a personalized treatment without the need for personalized manufacturing.

BriaCell's small molecule program includes the development of novel, selective protein kinase C delta (PKCδ) inhibitors which have shown potent activity in a number of pre-clinical models of several different cancer indications as well as fibrotic diseases.

For additional information on BriaCell, please visit our website: http://briacell.com.

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 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.

Contact Information

For further information, please contact:
BriaCell Therapeutics Corp.:
Farrah Dean
Manager, Corporate Development
Email: farrah@BriaCell.com
Phone: 1-888-485-6340

 

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