Biotech

BriaCell Therapeutics Corp. a clinical-stage biotechnology company specializing in targeted immunotherapy for advanced breast cancer, announces the overall survival data of its lead product candidate, Bria-IMT™, in combination with Checkpoint Inhibitors in advanced breast cancer patients. Additional overall survival data from the clinical studies will be presented in a poster session on December 9 11 during the ...
  • Overall Survival of 13. 3 months in patients , including 14 months in patients with Grade I/II tumors , suggesting clinical benefit;
  • Comparison: 7. 2 -9. 8 months in similar patients with metastatic breast cancer in the third line setting without BriaCell's treatment;
  • Additional overall survival data will be presented at the 2020 San Antonio Breast Cancer Symposium®, December 9 – 11 .

BriaCell Therapeutics Corp. ("BriaCell" or the "Company") (TSX-V:BCT) (OTCQB:BCTXF ) a clinical-stage biotechnology company specializing in targeted immunotherapy for advanced breast cancer, announces the overall survival (OS) data of its lead product candidate, Bria-IMT™, in combination with Checkpoint Inhibitors in advanced breast cancer patients. Additional overall survival data from the clinical studies will be presented in a poster session on December 9 11 during the 2020 San Antonio Breast Cancer Symposium® (SABCS), a virtual event.

Median OS of 13.3 months has been observed in the Phase I/IIa study for patients treated with Bria-IMT™ in combination with immune checkpoint inhibitors in patients with advanced breast cancer (third line or later).  Further, median OS had reached 14 months in patients with Grade I/II tumors. Checkpoint inhibitors included pembrolizumab (KEYTRUDA®; manufactured by Merck & Co., Inc.), and more recently, Incyte's INCMGA00012 (by Incyte Corporation). This data is derived primarily from patients previously disclosed (see press release dated June 22, 2020 ). An OS of 7.2-9.8 months in similar patients with metastatic breast cancer in the third line setting has recently been published (Kazmi S, et al. "Overall survival analysis in patients with metastatic breast cancer and liver or lung metastases treated with eribulin, gemcitabine, or capecitabine." Breast Cancer Res Treat. 2020).

The SABCS® poster will also summarize the clinical and pathological data of the Bria-IMT™ monotherapy study and Phase I/IIa clinical study of Bria-IMT™ in combination with immune checkpoint inhibitors including pembrolizumab, and more recently, Incyte's INCMGA00012, in advanced breast cancer with grade I and grade II tumors.

The SABCS® presentation will be posted on https://briacell.com/novel-technology/scientific-publications/ .

The details on the SABCS® poster presentation are as follows:

Abstract Number: 1313
Presentation Title: Response to a modified whole tumor cell targeted immunotherapy in patients with advanced breast cancer correlates with tumor grade
Session Date: December 9-11, 2020
Program Number: PS17-20
Session Title: Poster Session 17

About BriaCell

BriaCell is an immuno-oncology focused biotechnology company developing targeted and effective approaches for the management of cancer.

For additional information on BriaCell, please visit: https://briacell.com/ .

About SABCS®

Since its inception in 1977, San Antonio Breast Cancer Symposium (SABCS®) has grown to a program that covers the latest research on the experimental biology, etiology, prevention, diagnosis, and treatment of breast cancer and premalignant breast disease. The Symposium is attended by a large international audience of researchers, health professionals, physicians, oncologists, and those with a special interest in breast cancer from over 90 countries.

To complement the clinical focus of the annual SABCS®, Baylor College of Medicine became a joint sponsor of SABCS® in 2005. Additionally, the Cancer Therapy & Research Center (CTRC) at UT Health Science Center San Antonio and American Association for Cancer Research (AACR), a prestigious scientific organization known for its basic, translational and clinical cancer research, began collaboration with SABC® in 2007. The Symposium was renamed the CTRC-AACR San Antonio Breast Cancer Symposium.

For additional information on 2020 SABCS®, please visit: https://www.sabcs.org .

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 (also known as "forward-looking statements") which are subject to 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 .

These forward-looking statements include, but are not limited to, BriaCell's plans, objectives, expectations and intentions. Such forward-looking statements reflect BriaCell's current beliefs and are based on information currently available to management. Although the forward-looking statements contained in this news release are based upon what BriaCell believes are reasonable assumptions, there can be no assurance that actual results will be consistent with these forward-looking statements.

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.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Contact Information

For further information, please contact:

BriaCell Therapeutics Corp.:
William V. Williams, MD
President & CEO
Phone: 1-888-485-6340

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

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News Provided by GlobeNewswire via QuoteMedia

BriaCell

BriaCell

Overview

BriaCell Therapeutics Corp. (NASDAQ:BCTX, BCTXW, TSX:BCT) is a biotechnology company with a mission to develop innovative immunotherapies for treating cancer and infectious diseases.

At the forefront of cancer treatments, immunotherapies boost the ability of the body's own cancer-fighting cells to destroy cancerous tumors. Immunotherapies also have low-toxicity, making it easier for patients to undergo treatment. Most importantly, they may offer better efficacy and less chance of recurrence for many cancer patients. In a report released by Research and Markets, the global immuno-oncology market is expected to reach $100 billion by 2022, and BriaCell continues to uncover opportunities in this space with its innovative technologies.

BriaCell's lead candidate, Bria-IMT™, is an immunotherapy currently being developed to treat advanced breast cancer, which is the expected cause of approximately 43,000 deaths in the US in 2021. Bria-IMT™ recently achieved positive proof of concept, showing outstanding safety and efficacy data. Importantly, preliminary efficacy data was similar or superior to those of other approved breast cancer drugs when they were at a similar stage of clinical development.

BriaCell currently has a non-exclusive clinical trial collaboration with Incyte Corporation (NASDAQ:INCY) to evaluate the effects of combinations of novel clinical candidates. Under the agreement, Incyte and BriaCell will be evaluating novel combinations of compounds from Incyte's development portfolio with BriaCell's drug candidates in advanced breast cancer patients.

BriaCell has been dosing patients in a Phase I/IIa clinical trial of Bria-IMT™ in combination with the immunotherapy development candidates retifanlimab, an anti-PD-1 antibody, and is planned to also combine with epacadostat, an orally bioavailable small-molecule inhibitor of indoleamine 2,3-dioxygenase 1 (both provided by Incyte). The combination study is listed in ClinicalTrials.gov as NCT03328026.

BriaCell is also developing Bria-OTS™, an off-the-shelf personalized immunotherapy, for advanced breast cancer. Bria-OTS™ immunotherapy treatments are personalized to match the patient without the need for personalized manufacturing. Bria-OTS™, which is expected to match over 99 percent of the patient population, is designed to produce a potent and selective immune response against the cancer of each patient while eliminating the time, expense and complex manufacturing logistics associated with other personalized immunotherapies.

In November 2020, BriaCell announced a Cooperative Research and Development Agreement with the National Cancer Institute (NCI, Center for Cancer Research), part of the National Institutes of Health, to investigate novel off-the-shelf personalized therapeutics for cancer.

BriaCell's management team is comprised of a team of experienced industry leaders involved in the approval of dozens of drugs.

BriaCell Therapeutics' Company Highlights

BriaCell has truly emerged in the last 13 months:

  • April 2021: Closing of Over-Allotment Option in Connection with U.S. Public Offering, Bringing Total Gross Proceeds to US$28.7 Mil
  • February 2021: BriaCell Announces Closing of US$25 Mil Public Offering
  • November 2020: BriaCell Announces Collaboration with the NCI
  • October 2020: Survival Data: 13.3 months vs. 7.2-9.8 months
  • January 13, 2020: Remarkable Responder Update
  • January 9, 2020: Additional 'Biomarker' identified; Possible predictor of high-responding patients
  • October 7, 2019: First patient dosed under Incyte Corporation collaboration

The Cancer Immunotherapy Space

There are a number of challenges that cancer immunotherapy treatments face. Approved immunotherapies work in 20 to 30 percent of patients. They depend on the patient's weakened immune system and, in some cases can cause autoimmune disease.

Other challenges include the lack of effectiveness of cancer immunotherapies to treat some solid tumors or blood cancers since they only work in certain types of cancer and not in others. Additionally, newly developed effective personalized immunotherapies such as PROVENGE® and CAR-T need to be individually manufactured for each patient. This means a complex and time-consuming manufacturing process, which is extremely expensive and might make the therapies commercially unsuccessful.

In response to these challenges, BriaCell is developing Bria-OTS™, an off-the-shelf personalized immunotherapy, for advanced breast cancer, which has been estimated to be the cause of about 43,000 deaths in the US in 2021.

The off-the-shelf approach means that the treatments are pre-manufactured and the patient will be able to receive her or his personalized, targeted treatment using an easy and common HLA test on her or his saliva sample. This approach is quick, and relatively inexpensive, and avoids the complex manufacturing process associated with other personalized immunotherapy treatments. This approach is the first of its kind for advanced breast cancer.

Bria-IMT™

Bria-IMT™, BriaCell'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 stimulate cancer-fighting T-cells, cells that directly attack tumor cells, and B-cells that produce anti-tumor antibodies.

Proof-of-concept clinical trials

The first clinical trial used the original unmodified breast cancer cell line, with low dose cyclophosphamide and GM-CSF to boost the immune response. Fourteen patients were treated and produced impressive results, including no severe drug-related side-effects and a median survival rate in patients after treatment of about twice what was expected.

The second clinical trial used Bria-IMT™ (i.e. the original cell line – modified to produce GM-CSF) along with low dose cyclophosphamide and interferon-alpha in four advanced-stage cancer patients. The treatment was tolerated very well with few side effects. The median overall survival was much longer than expected. The study also had one patient that responded extremely well to the treatment with an approximately 90 percent tumor reduction in breast cancer as well as disappearance of the cancer from the lungs and soft tissues.

Source: BriaCell Therapeutics Corp.

After the treatment stopped, as required by the study, the patient's breast cancer returned and had spread to the patient's brain, lungs and other sites. Importantly, the patient was treated again with Bria-IMT™ and the tumors were reduced at multiple sites, even in the brain. This patient-matched Bria-IMT™ for HLA genes which are used to match patients to tissues in tissue transplantation (e.g. for kidney transplants).

Recent clinical findings (Phase I/IIa proof-of-concept study with Bria-IMT™: 2017 to 2018)

BriaCell completed a Phase IIa study of Bria-IMT™ in advanced breast cancer in 23 patients that were heavily pre-treated (listed in ClinicalTrials.gov as NCT03066947) and released their initial data in September 2018. To date, Bria-IMT™ treatment has been safe with several instances of tumor reduction observed in certain patients sharing a key biomarker (HLA match) with Bria-IMT™. The treatment was safe and well-tolerated. Most importantly, initial efficacy data was similar or superior to those of other advanced or approved drugs for breast cancer when they were at a similar stage of clinical development.

Based on the recent findings related to the mechanism of action of Bria-IMT™, and the potential to produce intensified anti-tumor activity when used in combination with certain drugs, the company is now conducting the combination study of Bria-IMT™ with retifanlimab and epacadostat. The combination study is listed in ClinicalTrials.gov as NCT03328026.

Immune checkpoint inhibitors such as anti-PD-1 including pembrolizumab (KEYTRUDA®; manufactured by Merck & Co., Inc.) and, more recently, Incyte's retifanlimab (under a corporate collaboration with Incyte Corporation) , are designed to neutralize immune suppression in cancer patients. The significance of immune checkpoints has been recognized by the Nobel committee by awarding Drs. Honjo and Allison with the 2018 Nobel Prize in Physiology or Medicine. BriaCell believes that Bria-IMT™ can exert additive or synergistic tumor-directed effects with checkpoint inhibitors like KEYTRUDA®. Initial safety data for the combined approach shows that it is very safe and well-tolerated by patients. Early efficacy data for the first eleven advanced breast cancer patients dosed with Bria-IMT™ in combination with KEYTRUDA® suggested strong additive or synergistic effects on tumor regression (shrinkage).

BriaCell hypothesizes that checkpoint inhibitors act by “awakening" a component of the immune system, while Bria-IMT™ “puts the foot on the gas" of the immune system, which may lead to more powerful anti-tumor activity.

BriaCell Therapeutics' Collaboration with Incyte Corporation

In April 2019, BriaCell and Incyte Corporation formed a non-exclusive clinical trial collaboration to evaluate the effects of combinations of novel clinical candidates. Under the agreement, Incyte and BriaCell plan to evaluate novel combinations of compounds from Incyte's development portfolio with Bria-IMT™ in advanced breast cancer patients.

BriaCell initiated dosing patients with advanced breast cancer in its Phase I/IIa clinical study for Bria-IMT™ in combination with Incyte's retifanlimab and epacadostat. The goal of the program is to remove cancer-induced suppression of the immune system (taking the “foot off the breaks" that cancer puts on the immune system) and stimulating an immune response with the Bria-IMT™, putting the “foot on the gas". This is expected to allow the immune system to attack the cancer in a targeted way with the help of Bria-IMT™. The combination study is listed in ClinicalTrials.gov as NCT03328026.

BriaDX™

BriaCell has developed a companion diagnostic test that would allow a physician to prepare a personalized pre-made treatment for each patient based on the presence of certain biomarkers (HLA type). Testing is simple and done on the patient's saliva.

This diagnostic test may be used in future clinical trials to speed up the clinical development of Bria-IMT™ and will be used in trials of Bria-OTS™.

Bria-OTS™

The Bria-OTS™ treatment is based on pre-manufactured immunotherapies – each containing a specific HLA type – which can be selectively administered to patients based on the patient's HLA type. BriaCell is developing 15 unique HLA types that will allow for the treatment of over 99 percent of advanced-staged breast cancer patients. This approach provides customized cancer immunotherapy for each individual patient that doesn't require personalized manufacturing.

Source: BriaCell Therapeutics Corp.

A simple diagnostic test, BriaDX™, will determine the appropriate off-the-shelf immunotherapy for each patient. Based on the results, one or two pre-made Bria-OTS™ immunotherapy cell lines will be selected to be administered to the patient. Thus, Bria-OTS™ is expected to provide the patient with fast, inexpensive, safe and effective personalized cancer immunotherapy treatment that can be ordered readily.

BriaCell Therapeutics' Small Molecule Program

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. Protein kinase C delta (PKCδ) inhibitors may provide another shot on goal besides a potential partnership opportunity.

BriaCell Therapeutics' Management Team

William V. Williams, MD, FACP, President & CEO, Director

  • Former VP, Exploratory Development, Incyte Corporation
  • Former VP, Experimental Medicine, GlaxoSmithKline
  • Former Head, Rheumatology Research, University of Pennsylvania
  • Extensive drug development experience

Gadi Levin, CA, MBA – CFO and Corporate Secretary

  • CFO of Labstyle Innovations Ltd
  • VP of Finance for two Israeli investment houses in the fields of private equity, hedge funds and real estate
  • Financial Consultant, various firms
  • Accountant, Arthur Andersen

BriaCell Therapeutics' Board of Directors

Jamieson Bondarenko, CFA, CMT, Chairman of the Board

  • Previously Principal and Managing Director of the Equity Capital Markets group of Eight Capital
  • Previously several positions at Dundee Securities Ltd., including Managing Director, Director, Vice President and Associate

Vaughn Embro-Pantalony, MBA, FCPA, FCMA, CDir, ACC, Director

  • Current: Chair, Board of Directors, Soricimed Biopharma Inc.
  • Board and Audit Committee Member, Microbix Biosystems Inc.
  • VP, Finance & CFO, Teva Novopharm Limited
  • VP, Finance & Administration, Bayer Healthcare
  • Director, Finance and Administration & CFO, Zeneca Pharma Inc.

Marc Lustig — Director

  • Investor, entrepreneur, and corporate finance veteran with a deep understanding of the life sciences industry, including biotechnology and pharmaceuticals, as well as the legal cannabis industry.
  • Holds MSc and MBA degrees from McGill University and his professional experience includes working at Merck & Co.,
  • His capital markets career includes roles in biotech equity research, corporate finance and as Head of Capital Markets.
  • Founder and CEO of Origin House where he currently serves as a director.
  • Director of a number of public companies, and founded the Lustig Family Medical Cannabis Research & Care Fund of the Cedars Cancer Foundation that provides cannabis to palliative cancer patients.

Martin Schmieg, CPA, Director

  • Current: CEO, ClearIT, LLC
  • CFO: Sirna Therapeutics, Inc., & Isolagen, Inc.
  • CEO, Freedom-2, Inc. (now PharmaCyte, Inc.)
  • Advisor, Caladrius Biosciences, Inc., Beckman Coulter Genomics, Calimmune, Inc., Cryoport, Inc., Vetbiologics, a division of U.S. Stem Cell, Inc., Sapientia Pharmaceuticals, Inc., & Rokk3r Labs, LLC

Rebecca A. Taub, MD, Director

  • Current: CMO & EVP, Director, Founder, Madrigal Pharmaceuticals
  • Senior VP, VIA Pharmaceuticals
  • VP of Research, Metabolic Diseases, Hoffmann-La Roche Company
  • Executive Director, Bristol-Myers Squibb
  • Executive Director, Dupont Pharmaceuticals
  • Professor of Genetics and Medicine, University of Pennsylvania

Jane Gross, Ph.D., Director

  • Chief Scientific Officer and SVP, Research and Non-Clinical Development at Aptevo Therapeutics (Nasdaq: APVO)
  • VP, Applied Research and Non-Clinical Development at Emergent BioSolutions (NYSE: EBS)
  • VP, Immunology Research at ZymoGenetics
  • Independent Director for aTyr Pharmaceuticals (Nasdaq: LIFE)

Suzanne Ostrand-Rosenberg, Ph.D. - Advisor

  • 40 years of experience leading investigations focused on the immune system's response to cancer.
  • Robert & Jane Meyerhoff Professor of Biochemistry, Emeritus
  • Professor of Biological Sciences, Emeritus, University of Maryland Baltimore County, Baltimore, MD, and has been working with the University since 1977.
  • Adjunct Professor of Pathology, Huntsman Cancer Institute (HCI), University of Utah, Salt Lake City, UT, in 2018.

BriaCell Therapeutics' Management Team

William V. Williams, MD, FRCP, President & CEO

  • Seasoned biopharmaceutical executive with over 35 years of industry and academic expertise, including significant clinical management in multinational pharmaceutical companies.
  • Served as VP of Exploratory Development at Incyte Corporation from 2005 – 2016.
  • Facilitated entry of over 20 compounds into the clinic, including approvals for ruxolitinib (Jakafi) and baricitinib (Olumiant).
  • Responsible for establishing proof-of-concept in several therapeutic areas
  • Involved in numerous new drug applications (NDAs) for therapeutics that achieved marketing authorization

Gadi Levin, CA, MBA, CFO & Corporate Secretary

  • Appointed as BriaCell Therapeutics Corp.'s Chief Financial Officer in February 2016.
  • Acted as Chief Financial Officer of Labstyle Innovations Ltd, a biotechnology company focused on diabetes.
  • Served as the Vice President of Finance and Chief Financial Officer for two Israeli investment houses in the fields of private equity, hedge funds and real estate (2008 to 2009 and 2010, respectively).

Miguel A. Lopez-Lago, Ph.D., Senior Director, Research and Development

  • Working as a cancer scientist at Memorial Sloan-Kettering Cancer Center, New York (MSKCC).
  • Investigated various aspects of tumor biology, including the development of targeted therapies for Mesothelioma and the characterization of the biological mechanisms underlying cancer metastasis.
  • Interested in the study of the tumor immune-microenvironment and in the development of immunotherapies for thoracic cancers using chimeric antigen receptor (CAR) T cell technologies.
  • Since 2013, Dr. Lopez-Lago has been working as Senior Research Scientist at MSKCC. Dr. Lopez-Lago received his Bachelor of Science in Bio-Sciences and his doctorate in Molecular Biology from Santiago of Compostela University, Spain.
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