Berkeley, CA -- (SBWIRE) -- 08/09/2018 -- BriaCell Therapeutics Corp. ("BriaCell"), 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 startup 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 (PKC?) 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 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.

For more information on this press release visit: http://www.releasewire.com/press-releases/briacell-adds-new-clinical-site-to-phase-iia-study-in-advanced-breast-cancer-and-expands-rd-team-1026729.htm

Berkeley, CA -- (SBWIRE) -- 06/12/2018 -- BriaCell Therapeutics Corp. ("BriaCell"), an immuno-oncology focused biotechnology company with a proprietary targeted immunotherapy technology, announced today that it will publish its clinical findings in the American Society of Clinical Oncology (ASCO) Annual Meeting Proceedings. ASCO's Annual Meeting, taking place June 1-5, 2018 in Chicago, IL, represents the world's largest gathering of oncology physicians, biotechnology executives, researchers, and investment analysts to discuss breakthrough clinical research and therapeutics in the field.

"We are very excited with our clinical findings and are delighted that ASCO selected our abstract to be published in their meeting proceedings," said Dr. Williams, BriaCell's President and CEO. "The inclusion of BriaCell's clinical data in the proceedings of such a prestigious meeting lends important support to our hypothesis that Bria-IMT™'s unique mechanism of action may shrink tumors in breast cancer patients who match HLA Class II molecules with Bria-IMT™. The findings also provide a strong rationale for the development Bria-OTS™, BriaCell's off-the-shelf personalized immunotherapy for advanced breast cancer to match/cover over 90% of the patient population," Dr. Williams noted.

"We are pleased to announce that we have recently initiated treatment on 7 additional patients in the study, for a total of 13 patients to date. The study continues to enroll rapidly, and we look forward to sharing the interim data in the second half of 2018."

BriaCell is currently conducting the 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 and https://clinicaltrials.gov/ct2/show/NCT03328026.

The abstract summarizes the clinical data on 6 advanced breast cancer patients dosed with Bria-IMT™ in the ongoing Phase I/IIa clinical study (NCT03066947). The clinical data showed that Bria-IMT™ treatment was safe and well-tolerated. Most importantly, tumor volumes were significantly reduced in 2 of 6 advanced breast cancer patients who have failed a number of prior treatments. These findings are highly significant because these 2 patients matched Bria-IMT™ in specific HLA molecules, providing additional support for our hypothesis for the unique mechanism of action of Bria-IMT™ which sets it apart from similar immunotherapy products, and provides the logic for further development of BriaDX™, BriaCell's companion diagnostic test.

The details of the abstract are the following:

Category: Developmental Therapeutics—Immunotherapy

Meeting: 2018 ASCO Annual Meeting

Abstract No: e15165

Section: Cancer Immunity and Immunotherapy

Title: SV-BR-1-GM a whole-cell targeted immunotherapy for breast cancer: Preliminary clinical data

The abstract can be accessed via the following link: http://abstracts.asco.org/214/AbstView_214_229215.html.

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 (PKC?) 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.

For more information on this press release visit: http://www.releasewire.com/press-releases/briacell-publishes-clinical-findings-in-2018-american-society-of-clinical-oncology-asco-meeting-986924.htm

Berkeley, CA -- (SBWIRE) -- 05/23/2018 -- BriaCell Therapeutics Corp., an immuno-oncology focused biotechnology company with a proprietary targeted immunotherapy technology, published a paper that sheds light on the potentially unique mechanism of action of BriaCell's lead product candidate, Bria-IMT™, in the journal of Frontiers in Immunology, the 5th most cited journal in Immunology.

The paper titled, SV-BR-1-GM, a Clinically Effective GM-CSF-Secreting Breast Cancer Cell Line, Expresses an Immune Signature and Directly Activates CD4+ T Lymphocytes, focuses on the mechanism of action of Bria-IMT™, also referred to as SV-BR-1-GM, and may explain the impressive early clinical data on tumor shrinkage observed in some patients with metastatic breast cancer.

As summarized in the peer-reviewed publication, a body of evidence suggests immune-stimulating actions of SV-BR-1-GM which the paper's authors believe are unique to Bria-IMT™ compared with other similar approaches. 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. Bria-IMT™ is thought to help the body recognize and kill tumor cells by activating both T cells that directly attack tumor cells, and, potentially, B cells that produce anti-tumor antibodies.

Specifically, Bria-IMT™ contains several factors, including HLA Class II molecules, molecules which typically are involved in starting an immune response. These molecules directly activate CD4+ "Helper" T cells, a key component of the immune system, which can produce a strong immune response against tumor cells resulting in tumor size reduction also known as clinical regression. Complete or even partial regressions are difficult to achieve in advanced breast cancer patients who have failed the standard of care. BriaCell has previously reported such responses in patients with metastatic breast cancer, not only in soft tissue and visceral areas, but even in the brain, a difficult site to treat.

"The publication of BriaCell's findings in such a prestigious peer-reviewed journal further validates our hypothesis that Bria-IMT™'s unique mechanism of action may be associated with a substantial tumor reduction in patients who match HLA Class II molecules with Bria-IMT™," stated Dr. Williams, BriaCell's President & CEO and one of the paper's multiple authors.

"The findings outlined in this publication are the cornerstones of our pipeline of cell-based cancer therapeutics, referred to as Bria-OTS™, our off-the-shelf personalized immunotherapy for advanced breast cancer. This strategy will allow us to match/cover over 90% of the patients with advanced breast cancer as we work tirelessly to improve patient outcomes in the fight with this deadly disease," Dr. Williams noted.

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.

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 at multiple sites, including in the breast, the lung, soft tissues, and even the brain. This patient matched Bria-IMT™ at an HLA Class II allele (HLA type) known as HLA-DR?3. The observation that Bria-IMT™ expresses HLA-DR?3, and the matching observed, imply a unique mechanism of action for Bria-IMT™ as well as a potential method to select patients most likely to respond.

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 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 patients who stop responding to the treatment with Bria-IMT™ in the ongoing Phase I/IIa trial to be continue Bria-IMT™ in combination with Keytruda® or [Yervoy®. The rollover trial is listed in ClinicalTrials.gov as NCT03328026.

BriaCell also had an abstract accepted for publication in the proceedings for the American Society of Clinical Oncology (ASCO) national meeting. The abstract discusses the clinical data on 6 patients dosed with Bria-IMT™ in 2017. The abstract notes that 2 of 6 heavily pre-treated patients showed tumor regression. An excellent safety profile was noted as well as additional support for our companion diagnostic, BriaDX™.

This abstract can be accessed at this link: http://abstracts.asco.org/214/AbstView_214_229215.html.

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

Based on their 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 alleles, Bria-OTS™ cell line combinations are expected to cover at least about 90% of the United States' population with double HLA matches while over 99% will have at least a single match. BriaCell expects to use BriaDX™ to determine HLA types of patients (to identify HLA alleles), and subsequently select one or two Bria-OTS™ cell lines with matching alleles for administration 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.

The Company is currently conducting 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.

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

The details of the publication are as following:
Journal: Frontiers in Immunology
Section: Cancer Immunity and Immunotherapy

Title: SV-BR-1-GM, a Clinically Effective GM-CSF-Secreting Breast Cancer Cell Line, Expresses an Immune Signature and Directly Activates CD4+ T Lymphocytes

The manuscript of the publication can be accessed via the following link: http://journal.frontiersin.org/article/10.3389/fimmu.2018.00776/full?&utm_source=Email_to_authors_&utm_medium=Email&utm_content=T1_11.5e1_author&utm_campaign=Email_publication&field=&journalName=Frontiers_in_Immunology&id=297974

For more information on this press release visit: http://www.releasewire.com/press-releases/new-paper-highlights-role-of-immune-stimulating-cells-that-shrink-breast-cancer-tumors-983215.htm

Berkeley, CA -- (SBWIRE) -- 04/30/2018 -- BriaCell Therapeutics Corp. ("BriaCell"), an immuno-oncology focused biotechnology company with a proprietary targeted immunotherapy technology, is pleased to announce that it has presented two posters highlighting its most recent scientific and clinical findings of BriaCell's lead product candidate, SV-BR-1-GM, also known as Bria-IMT™, at the 2018 American Association of Cancer Research (AACR) Annual Meeting.

The posters are available for viewing at http://briacell.com/category/recent-events/.

The following summarizes the important highlights from the posters:

SV-BR-1-GM, a Whole-Cell Targeted Immunotherapy for Breast Cancer: Preliminary Clinical Data

Led by Dr. Jarrod P. Holmes, of Saint Joseph Heritage Healthcare, Santa Rosa, and the clinical team at BriaCell and Cancer Insight, the poster presentation provided data from the Bria-IMT™ Phase I/IIa clinical trial (listed in ClinicalTrials.gov as NCT03066947). The presentation demonstrated that Bria-IMT™, delivered as a monotherapy regimen along with other immune system modulators, generated immune responses, and tumor reduction in some patients. Specifically, the data showed the following:

The regimen produced clinically relevant regression of metastases (i.e. cancer that has spread to other sites) in patients with advanced Stage IV breast cancer

Response was rapid and were fully developed by 3 months and durable at 6 months

The responses developed despite previous chemotherapy with multiple different regimens

The regimen appeared to be safe and well-tolerated

The tumor reduction responses appeared most pronounced in patients who match with Bria-IMT™ at one or more HLA loci

This has encouraged BriaCell to study futher the Bria-IMT™ regimen, specifically in combination therapy with immune checkpoint inhibitors such as pembrolizumab or ipilimumab. The roll-over combination study of Bria-IMT™ with pembrolizumab or ipilimumab is available for patients previously treated with Bria-IMT™ 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.

Targeted immunotherapy with SV-BR-1-GM: Mechanism of action and companion diagnostic development

Lead by Markus D. Lacher, PhD, BriaCell's Head of R&D, the poster presentation provided information regarding the mechanism of action of Bria-IMT™. The data showed the following:

Tumor regressions were observed, especially in breast cancer patients matching at HLA-DRB3 with Bria-IMT™.

Anti-SV-BR-1 antibody levels change with Bria-IMT™ treatment suggesting additional paths for tumor attack.

Interleukin (IL)-8 levels increased in HLA-DRB3 matched subjects suggesting a potentially higher-level anti-tumor activity in patients who match Bria-IMT™ at HLA-DRB3.

"We are intrigued by the initial data indicating safety and efficacy of Bria-IMT™ in patients with advanced breast cancer, and we look forward to use these findings in the development of Bria-OTS™, our off-the-shelf personalized immunotherapy treatment for advanced breast cancer, which is expected to cover about 95% of the patient population," stated Dr. Bill Williams, BriaCell's President & CEO.

About BriaCell
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-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. We believe that Bria-IMT™ 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-IMT™) produced encouraging results in patients with advanced breast cancer. Most notably, one patient with metastatic breast cancer responded to Bria-IMT™ with substantial reduction in tumor burden including breast, lung, soft tissue and brain metastases. BriaCell is currently conducting a Phase I/IIa clinical trial for Bria-IMT™ in patients with advanced breast cancer. In this trial, Bria-IMT™ treatment appeared safe with similar instances of tumor reduction as those observed in the earlier proof-of-concept trials. 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. Additionally, the FDA recently 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 Bria-IMT™ 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-OTS™, an off-the-shelf personalized Immunotherapy. Bria-OTS™ is a set of cell lines similar to Bria-IMT™ which are being engineered to express pre-manufactured HLA alleles. With a combined total of 15 different alleles Bria-OTS™ is expected to be able to match more than 90% of the US population. BriaCell's BriaDX™ companion diagnostic reveals patient HLA types. One or two Bria-OTS™ cell lines carrying matching alleles are planned to be administered per patient. Bria-OTS™ eliminates the complex manufacturing logistics required for other personalized immunotherapies and is regarded as 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.

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.

For more information on this press release visit: http://www.releasewire.com/press-releases/briacell-provides-highlights-of-scientific-and-clinical-findings-at-aacr-970912.htm

Berkeley, CA -- (SBWIRE) -- 04/24/2018 -- BriaCell Therapeutics Corp. ("BriaCell"), an immuno-oncology focused biotechnology company with a proprietary targeted immunotherapy technology, is pleased to announce that Sylvester Comprehensive Cancer Center at the University of Miami is now actively screening and enrolling patients in the ongoing, multicenter, Phase IIa study of Bria-IMT™ in advanced breast cancer. Dr. Carmen Julia Calfa, a Board-Certified breast medical oncologist, will act as the clinical site's principal investigator. Dr. Calfa 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 top oncologists and state of the art facilities, Sylvester Comprehensive Cancer Center, part of UHealth – the University of Miami Health System, has been serving as the hub for cutting edge cancer-related research, diagnosis, and treatment in the State of Florida since 1973. Sylvester Comprehensive Cancer Center has received numerous awards for its excellent patient care and is part of an elite group, the Alliance of Dedicated Cancer Centers, shown to have higher survival rates in a 2015 JAMA Oncology study. The clinical site includes one main location of Sylvester Comprehensive Cancer Center, and 4 participating locations at Deerfield beach, Coral Gables, Kendall and Plantation.

"We are very excited to include this well-established Cancer Center, and are grateful for the opportunity to work with leading oncologists as we continue to progress the clinical development of Bria-IMT™ in advanced breast cancer," stated Bill Williams, BriaCell's President and CEO. "We expect that the addition of the large clinical site (i.e., one main and 4 participating locations) will significantly improve our patient recruitment schedule, and accelerate the clinical advancement of Bria-IMT™ and the rollover clinical trials."

As a breast medical oncologist since 2008, Dr. Carmen J. Calfa, has dedicated a significant part of her clinical career to breast oncology and providing excellent care for breast cancer patients. She was awarded her Medical Doctorate in 2000, completed her Residency in Internal Medicine in 2004, and a Fellowship Program in Hematology Oncology in 2008 – both at University of Miami. She is currently Assistant Professor of Clinical Medicine, University of Miami Miller School of Medicine. Dr. Calfa has authored and co-authored numerous publications, and has participated in a number of breast cancer clinical trials.

"We are impressed with Dr. Calfa's credentials and expertise in breast cancer and look forward to working with her team in our Phase IIa clinical trial of Bria-IMT™ in advanced breast cancer patients," stated Dr. Williams.

"We look forward to being part of the clinical trial with Bria-IMT™ in advanced breast cancer. We hope to contribute to the development of safe and effective treatment options for the advanced breast cancer patients, as these patients have limited treatment options and poor survival outlook," commented Dr. Calfa.

BriaCell recently presented a formal update on its progress with its ongoing Phase IIa clinical trial at the American Association of Cancer Research (AACR) Annual Meeting 2018. To view the posters, please visit the following link: http://briacell.com/category/recent-events/.

The Phase IIa clinical trial is currently being conducted at four 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, and 4) Sylvester Comprehensive Cancer Center, University of Miami in Miami, FL. The site at Florida Cancer Care in Plantation, FL was recently closed. BriaCell is 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 Sylvester Comprehensive Cancer Center
Since 1973, Sylvester Comprehensive Cancer Center, part of UHealth – the University of Miami Health System, has been committed to providing outstanding patient care in Southern Florida.

Sylvester has been supported by generous gifts from philanthropist Harcourt Sylvester Jr. and Harcourt M. and Virginia W. Sylvester Foundation to build a 117,500 square-foot State of Art cancer center which was opened in June 1992. In 2003, another generous gift established Braman Family Breast Cancer Institute at Sylvester, which is dedicated to all aspects of breast cancer.

With its state of the art facilities, leading oncologists, research scientists, and reputation for providing excellent patient care, Sylvester has become one of the leading cancer treatment centers in the US. Sylvester was designated a Cancer Center of Excellence by the state of Florida in March 2015, and re-certified in 2017, one of only four in Florida. Additionally, Sylvester has the distinction of being one of eleven academic cancer centers shown to have better patient outcomes in a 2015 study by Memorial Sloan Kettering Cancer Center in New York. That study, published in JAMA Oncology, suggested 10 percent higher survival chances for patients treated at the elite centers including Sylvester versus those who were treated at community hospitals.

At Sylvester, patients are provided with more treatment options than most hospitals in the Southeastern US. Sylvester's main inpatient and outpatient facility is located on the central medical campus in the heart of Miami. Its physicians also care for cancer patients at University of Miami Health System Tower, Jackson Memorial Hospital, Holtz Children's Hospital, and the Miami VA Medical Center. Sylvester also provides state of the art cancer care at other participating facilities including those at Deerfield Beach, Coral Springs, Kendall, and Plantation.

For more information on Sylvester Comprehensive Cancer Center, please visit http://sylvester.org/

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 similar instances of tumor reduction have been 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 the 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 US 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 a novel, selective protein kinase C delta (PKC?) 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 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.

For more information on this press release visit: http://www.releasewire.com/press-releases/briacell-activates-a-clinical-site-in-florida-for-phase-iia-study-of-its-lead-candidate-in-advanced-breast-cancer-968153.htm

Berkeley, CA -- (SBWIRE) -- 04/03/2018 -- BriaCell Therapeutics Corp. ("BriaCell"), an immuno-oncology focused biotechnology company with a proprietary targeted immunotherapy technology, is pleased to announce the acceptance of a manuscript describing the novel mechanism of action of the Company's lead product candidate, Bria-IMT™. The findings detailed in the paper provide a rationale for the encouraging clinical results observed with Bria-IMT™ in current and past clinical testing. The publication will appear in Frontiers in Immunology, the 5th most cited journal in Immunology worldwide. Bria-IMT™, also known as SV-BR-1-GM, has caused remarkable reduction of tumor size in some patients with advanced metastatic breast cancer. Understanding Bria IMT™'s mechanism of action is extremely important, not only for developing further clinical refinements; it may shed light on basic immune mechanisms important in many other areas. BriaCell is currently enrolling patients in a Phase IIa trial (NCT03066947) with Bria-IMT™ and a rollover trial (NCT03328026) with Bria-IMT™ alone or in combination with other immunotherapies.

The peer-reviewed paper provides evidence for the unique immune-enhancing activity of Bria-IMT™, which is believed to set the Bria-IMT™ approach apart from all other similar therapies. Bria-IMT™ contains a number of factors, in particular HLA-Class II molecules, i.e., specific markers that distinguish the body's own cells from cells recognized by the body as foreign. These factors directly activate CD4+ "Helper" T cells, a key component of the immune system, which may produce a vigorous attack on tumor cells resulting in clinical tumor regressions (i.e., reduction in the tumor size). In patients with advanced breast cancer who have failed other therapies, complete or even partial regressions are difficult to achieve. BriaCell has previously reported such responses in patients with advanced metastatic breast cancer, not only in soft tissue and visceral areas, but even within the brain, responses which have not been typically seen in similar trials. BriaCell has devoted significant resources to further advance its clinical and preclinical studies.

"We are very pleased with the acceptance of our paper in this prestigious peer-reviewed immunology journal", stated Dr. Williams, BriaCell's President & CEO. "Our investigations into the mechanism of action of Bria-IMT™, addressed in the paper, support our hypothesis that direct activation of T cells by Bria-IMT™ is an important factor that contributes to the substantial tumor shrinkage we have seen in patients in whom HLA Class II molecules match with Bria-IMT™. According to the American Cancer Society, about 41,400 patients are expected to die of breast cancer in the US in 2018. With the support of our investors, we have been capitalizing on the observations in this paper to develop a novel off-the-shelf personalized immunotherapy, Bria-OTS™, which will allow us to match over 90% of the patients with advanced breast cancer. Our goal is to combat this deadly disease and improve patient outcomes".

"These findings provide a scientific rationale for why patients with an HLA-Class II version also present in Bria-IMT™ have achieved objective clinical benefits from the Bria-IMT™ regimen", stated Dr. Markus Lacher, BriaCell's Head of R&D and the lead author of the paper. "They also build the foundation for our strategy to develop Bria-OTS™, our off-the-shelf personalized immunotherapy for advanced breast cancer patients. We look forward to seeing more data in the coming months as we develop Bria-OTS™ as a new approach to treating breast cancer. We are grateful to our collaborators for their cooperation and expert advice".

The details of the upcoming publication are the following:

Journal: Frontiers in Immunology
Section: Cancer Immunity and Immunotherapy.
Article type: Original Research Title: SV-BR-1-GM, a Clinically Effective GM-CSF-Secreting Breast Cancer Cell Line, Expresses an Immune Signature and Directly Activates CD4+ T Lymphocytes

The abstract of the manuscript can be accessed via the following link:
https://www.frontiersin.org/articles/10.3389/fimmu.2018.00776/abstract

About BriaCell
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-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. We believe that Bria-IMT™ 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-IMT™) produced encouraging results in patients with advanced breast cancer. Most notably, one patient with metastatic breast cancer responded to Bria-IMT™ with substantial reduction in tumor burden including breast, lung, soft tissue and brain metastases. BriaCell is currently conducting a Phase I/IIa clinical trial for Bria-IMT™ in patients with advanced breast cancer. In this trial, Bria-IMT™ treatment appeared safe with similar instances of tumor reduction as those observed in the earlier proof-of-concept trials. 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. Additionally, the FDA recently 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 Bria-IMT™ 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-OTS™, an off-the-shelf personalized Immunotherapy. Bria-OTS™ is a set of cell lines similar to Bria-IMT™ which are being engineered to express pre-manufactured HLA alleles. With a combined total of 15 different alleles Bria-OTS™ is expected to be able to match more than 90% of the US population. BriaCell's BriaDX™ companion diagnostic reveals patient HLA types. One or two Bria-OTS™ cell lines carrying matching alleles are planned to be administered per patient. Bria-OTS™ eliminates the complex manufacturing logistics required for other personalized immunotherapies and is regarded as 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.

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.

For more information on this press release visit: http://www.releasewire.com/press-releases/briacells-lead-product-candidate-mechanism-of-action-described-in-a-major-immunology-journal-958770.htm

Berkeley, CA -- (SBWIRE) -- 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-IMT™ 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-IMT™. The addition of the site should improve the accessibility of Bria-IMT™ 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-IMT™, 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-IMT™ treatment in patients with breast cancer and look forward to enroll additional patients in the ongoing clinical trial."

About BriaCell
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-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. We believe that Bria-IMT™ 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-IMT™) produced encouraging results in patients with advanced breast cancer. Most notably, one patient with metastatic breast cancer responded to Bria-IMT™ 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-IMT™ 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 BriaDX™, 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-IMT™ with pembrolizumab [Keytruda®; manufactured by Merck & Co., Inc.] or ipilimumab [Yervoy®; manufactured by Bristol-Myers Squibb Company] for patients previously treated with Bria-IMT™ 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-OTS™, an off-the-shelf personalized Immunotherapy. Bria-OTS™ consists of 14 individually pre-manufactured genetic alleles. BriaCell's BriaDX™ 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-OTS™ 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.

For more information on this press release visit: http://www.releasewire.com/press-releases/briacell-opens-fourth-clinical-site-in-advanced-breast-cancer-928201.htm

Berkeley, CA -- (SBWIRE) -- 11/08/2017 -- BriaCell Therapeutics Corp. ("BriaCell" or the "Company"), an immuno-oncology focused biotechnology company with a proprietary vaccine technology, today released a clinical update on its ongoing Phase I/IIa study of its lead vaccine candidate, BriaVax™, in advanced breast cancer patients.

The Phase I/IIa study evaluates the safety and activity of BriaVax™ in patients with advanced breast cancer. To boost the anti-tumor effects of BriaVax™, the patients are pre-treated with low dose cyclophosphamide and post-vaccine interferon-2b {Intron A; manufactured by Merck & Co., Inc. At the request of the FDA, the first three patients were dosed sequentially with a sufficient amount of time between patients to evaluate any potential safety issues from the vaccine. That portion of the study was completed in September 2017, and the study was opened to additional patients marking the beginning of the Phase IIa portion of the study. So far, an additional 3 patients have been enrolled and dosed with BriaVax™, bringing the total number of patients dosed to date to 6.

Recruitment continues to proceed as projected, despite the challenges presented in recruiting late stage cancer patients. The study remains on track to announce data on the first 10 patients in the first quarter of 2018. The development of BriaDx™, a companion diagnostic test to identify the patients for whom BriaVax™ treatment would be most effective, is proceeding in parallel to this study. BriaCell has generated intriguing preliminary data that appears consistent with the observations from the Phase I pilot study previously performed by Dr. Wiseman, BriaCell's scientific founder.

Patients who develop progressive disease during the BriaVax™ phase I/IIa study are eligible to participate in the BriaVax™ roll-over combination study (listed in ClinicalTrials.gov as NCT03328026) which evaluates BriaVax™ in combination with either pembrolizumab [Keytruda; manufactured by Merck & Co., Inc. or ipilimumab [Yervoy; manufactured by Bristol-Myers Squibb Company. These FDA-approved immune checkpoint inhibitors are expected to boost the anti-tumor activity of BriaVax™ thereby providing additional clinical benefit to the patients. Enrollment in the roll-over study may commence as early as first quarter of 2018.

BriaVax™ is currently being investigated in three (3) US-based clinical sites, recruiting patients for the Phase I/IIa and roll-over combination studies. The sites include: 1) Santa Rosa, St. Joseph Health-Sonoma County, CA, 2) Florida Cancer Care, Plantation, FL, and 3) The Everett Clinic and Providence Regional Medical Center, Everett, WA. These sites are working closely with Cancer Insight, LLC, BriaCell's contract research organization. Additional sites are planned to be opened over the course of the coming months.

About BriaVax™
BriaVax™ is a whole-cell breast cancer vaccine genetically engineered to release granulocyte-macrophage colony-stimulating factor (GM-CSF), a substance that activates the immune system. Previously, a small Phase I study documented very prompt and near complete regression of metastatic breast cancer in the breast, lung, soft tissue, and even the brain.

About BriaVax™ Clinical Studies
Phase I/IIa Study: The ongoing open-label Phase I/IIa study evaluates the BriaVax™ regimen in up to 40 advanced stage breast cancer patients. This trial is listed in ClinicalTrials.gov as NCT03066947. The primary objective of the Phase I/IIa clinical trial is to evaluate the safety of BriaVax™, and the principal secondary objective is to assess the tumor size reduction. Tumor size is monitored every two to three months during the study. Additionally, progression-free survival (PFS) and overall survival (OS) are evaluated in the study. Interim data for the first 10 patients is expected in the first quarter of 2018.

For additional details regarding the Phase I/IIa clinical trial, please visit: https://www.clinicaltrials.gov/ct2/show/NCT03066947 (link is external)

Roll-over Combination Study: The roll-over combination study allows patients who develop progressive disease during the BriaVax™ phase I/IIa study to continue receiving the potential clinical benefits of BriaVax™ by being treated with BriaVax™ in combination with either pembrolizumab or ipilimumab. This trial is listed in ClinicalTrials.gov as NCT03328026.

For additional details regarding the roll-over combination clinical trial, please visit: https://clinicaltrials.gov/ct2/show/NCT03328026?term=BriaCell&rank=1.

About BriaCell
BriaCell is an immuno-oncology focused biotechnology company developing a targeted and safe approach to the management of cancer. BriaCell's mission is to serve late-stage cancer patients with no available treatment options.

Immunotherapy has come to the forefront of 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.

BriaVax™, the Company's lead product candidate, is a whole-cell breast cancer vaccine genetically engineered to release granulocyte-macrophage colony-stimulating factor (GM-CSF), a substance that activates the immune system by allowing the body to recognize and eliminate cancerous cells by inducing tumor-directed T cell and potentially antibody responses.

The results of two previous Phase I clinical trials (one with the precursor cell line not genetically engineered to produce GM-CSF and one with BriaVax™) have been encouraging in patients with advanced breast cancer. Most notably, one patient with metastatic breast cancer responded to BriaVax™ 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 BriaVax™ 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 BriaDx™, 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 BriaVax™ with pembrolizumab [Keytruda; manufactured by Merck & Co., Inc. or ipilimumab [Yervoy; manufactured by Bristol-Myers Squibb Company for patients previously treated with BriaVax™ 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 novel, selective protein kinase C delta (PKC) inhibitors. PKC is important for maintaining cancers transformed by mutations of the RAS gene. PKC inhibitors have shown activity in a number of pre-clinical models of RAS 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.

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 (link is external).

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.

For more information on this press release visit: http://www.releasewire.com/press-releases/briacell-provides-clinical-update-on-its-lead-vaccine-candidate-briavax-888863.htm

Berkeley, CA -- (SBWIRE) -- 10/31/2017 -- BriaCell Therapeutics Corp ("BriaCell" or the "Company"), an immuno-oncology focused biotechnology company with a proprietary vaccine technology, announced today that the FDA has approved the roll-over combination study of BriaVax™ 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.

This roll-over combination study allows the patients who did not respond to BriaVax™ (monotherapy) treatment to be treated and continue to receive the potential clinical benefits of BriaVax™ in combination with either pembrolizumab or ipilimumab. This approach is based on the hypothesis that both pembrolizumab and ipilimumab may improve the anti-tumor activity of BriaVax™ in patients with advanced breast cancer. Safety and efficacy data will be evaluated.

"We are very excited to evaluate the effects of BriaVax™ with other approved anti-tumor immunotherapeutic agents. We expect this study to extend and potentiate the clinical benefits of BriaVax™ in advanced breast cancer patients," stated Dr. Williams, BriaCell's President & CEO. "We look forward to expanding our clinical study and exploring potential immunotherapy partnerships with leading pharmaceutical companies in the future, and we are pleased with the FDA decision," Dr. Williams added.

The clinical investigators will work closely with Cancer Insight, LLC, BriaCell's contract research organization, to manage the clinical and regulatory aspects of the clinical trial for the roll-over combination study of BriaVax™ on behalf of BriaCell. More information on the roll-over combination study of BriaVax™ with either ipilimumab or pembrolizumab will be available on ClinicalTrials.gov (Study identifier: BRI-ROL-001).

About 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: https://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 information on Ipilimumab, please see: https://packageinserts.bms.com/pi/pi_yervoy.pdf

About BriaVax™
BriaVax™ is a whole-cell breast cancer vaccine genetically engineered to release granulocyte-macrophage colony-stimulating factor (GM-CSF), a substance that activates the immune system. Previously, a small Phase I study documented very prompt and near complete regression of metastatic breast cancer deposits in the breast, lung, soft tissue, and even the brain.

About BriaVax™ (Clinical Trial – Monotherapy)
The ongoing open-label Phase I/IIa study will evaluate BriaVax™ in up to 40 advanced breast cancer patients. This trial is listed in ClinicalTrials.gov as NCT03066947. The trial is being conducted along with the co-development of BriaDx™, our companion diagnostic test. The interim data for the first 10 patients is expected by the first quarter of 2018.

About BriaCell
BriaCell is an immuno-oncology focused biotechnology company developing a targeted and safe approach to the management of cancer. BriaCell's mission is to serve late-stage cancer patients with no available treatment options.

Immunotherapy has come to the forefront of the fight against cancer, harnessing the body's own immune system in recognizing and selectively destroying the 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 strong type of approach aimed at preventing cancer recurrence.

BriaVax™, the Company's lead product candidate, is a whole-cell breast cancer vaccine genetically engineered to release granulocyte-macrophage colony-stimulating factor (GM-CSF), a substance that activates the immune system by allowing the body to recognize and eliminate cancerous cells by inducing tumor-directed T cell and potentially antibody responses.

The results of two previous Phase I clinical trials (one with the precursor cell line not genetically engineered to produce GM-CSF and one with BriaVax™) have been encouraging in patients with advanced breast cancer. Most notably, one patient with metastatic breast cancer responded to BriaVax™ with substantial reduction in tumor burden including lung and brain metastases. The company is currently conducting a Phase I/IIa clinical trial for BriaVax™ in patients with advanced breast cancer whose disease has progressed following at least one prior treatment course. This trial is listed in ClinicalTrials.gov as NCT03066947. The trial is being conducted along with the co-development of BriaDx™, our companion diagnostic test. The interim data for the first 10 patients is expected by the first quarter of 2018.

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

About The Phase I/IIa Clinical Trial
In a previous Phase I setting, a patient with metastatic breast cancer responded to BriaVax™ with objective reduction in tumor burden. To expand on this finding, after updating the clinical protocol of the original investigational new drug (IND) application, an open-label Phase I/IIa clinical trial enrolling up to 40 late stage breast cancer patients with recurrent and/or metastatic disease has been launched. Patients will be administered BriaVax™ every two weeks for the first month of treatment, then monthly up to one year.

The primary objective of the Phase I/IIa clinical trial is to evaluate the safety of BriaVax™ in study subjects, and the principal secondary objective is an evaluation of the tumor size reduction. Tumor response will be monitored every three months during the study. The trial will also evaluate progression-free survival (PFS) and overall survival (OS).

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

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. Investors 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.

For more information on this press release visit: http://www.releasewire.com/press-releases/fda-approves-the-roll-over-combination-study-with-checkpoint-inhibitor-immunotherapies-to-allow-continued-access-to-briavax-in-patients-with-advanced-breast-cancer-884734.htm