BriaCell

Developing Personalized Off-The-Shelf Immunotherapy Treatments for Cancer Patients

This profile is part of a paid investor education campaign.*

Overview

BriaCell Therapeutics Corp. (TSX:BCT, OTCQB:BCTXF) is a biotechnology company with a mission to develop innovative immunotherapies for treating cancer. 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 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 2019. 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 clinical-stage of development.

BriaCell has initiated a combination study of Bria-IMT™ with KEYTRUDA® (by Merck & Co., Inc.) and announced preliminary results, which indicated an excellent safety profile and strong evidence of rapid additive or synergistic anti-tumor activity for the combination in advanced breast cancer patients. The combination study is listed in ClinicalTrials.gov as NCT03328026.

In April 2019, BriaCell and Incyte Corporation (NASDAQ: INCY) formed a non-exclusive clinical trial collaboration 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 Bria-IMT™ in advanced breast cancer patients.

BriaCell is 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 cover 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.

BriaCell’s management team is comprised of a team of experienced industry leaders involved in the approval of dozens of drugs. Management and Board of Directors also notably hold about 27 percent of the company’s shares.

Company Highlights

  • BriaCell utilizes an immunotherapy approach – a type of cancer treatment that boosts the ability of the body’s own cancer-fighting cells to destroy cancerous tumors
  • Market focus:  Advanced breast cancer (the cause of ~43,000 deaths per year in the U.S.)
  • Bria-IMT™ Phase I/IIa  Outstanding safety & efficacy data
  • Bria-IMT™ combined with KEYTRUDA® (Merck)  Phase I/IIa combination study
  • Excellent safety and evidence of additive or synergistic activity
  • Incyte Corporation  Clinical trial collaboration and supply agreement
  • Developing Bria-OTS™, an “Off-The-Shelf Personalized” immunotherapy tailored to each patient
  • Patients are matched to 1 of 15 choices based on a simple identification test
  • CEO Dr. William Williams and his team have been involved in dozens of drug approvals

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 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 2019.

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. BriaCell expects FDA approval for Bria-OTS™ to enter the clinical trials in late 2019.

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.

BriaCell Bria IMT

Source: BriaCell Therapeutics Corp.

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) with 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 the breast cancer as well as disappearance from the lungs and soft tissues.

BriaCell clinical trialsSource: 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™: 2017-2018) 

BriaCell recently conducted 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 KEYTRUDA®. The combination study is listed in ClinicalTrials.gov as NCT03328026.

Immune checkpoint inhibitors such as anti-PD-1, KEYTRUDA® for example, 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 six 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 KEYTRUDA® acts 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.

Collaboration with Incyte Corporation

In April 2019, BriaCell and Incyte Corporation (NASDAQ: INCY) formed a non-exclusive clinical trial collaboration 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 Bria-IMT™ in advanced breast cancer patients. BriaCell expects to initiate a clinical study in collaboration with Incyte Corporation in 2019.

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 will be used in future clinical trials to speed up the clinical development success for Bria-IMT™ and 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 treatment of over 99 percent of advanced-staged breast cancer patients. This approach provides a customized cancer immunotherapy for each individual patient that doesn’t require personalized manufacturing. BriaCell expects FDA approval for Bria-OTS™ to enter the clinical trials in late 2019.

BriaCell Bria OTS

 Source: BriaCell Therapeutics Corp.

A simple and inexpensive diagnostic test, BriaDX™, will determine the appropriate off-the-shelf immunotherapy for each patient. Based on the results, one or two Bria-OTS™ pre-made 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 expects FDA approval for Bria-OTS™ to enter the clinical trials in late 2019.

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, expected to enter the clinics in 2021, may provide another shot on goal besides a potential partnership opportunity.

Management

William V. Williams, MD, FACP – President, CEO and Director

  • VP, Exploratory Development, Incyte Corporation
  • VP, Experimental Medicine, GlaxoSmithKline
  • Head, Rheumatology Research, University of Pennsylvania
  • Facilitated entry of over 30 compounds into the clinic including ruxolitinib (Jakafi), baricitinib, & epacadostat. Involved in over 10 NDAs including Jakafi, Olumiant, Tykerb, Boniva and Bexxar.
  • Author of over 120 peer-reviewed publications & over 20 patents

Markus Lacher, Ph.D – Senior Director of R&D

  • Founder, T cell Therapeutics, Inc., an immuno-oncology company
  • Clinical Scientist, Cesca Therapeutics, Inc., a clinical-stage autologous cell therapy company
  • Scientist at BioTime, Inc. and OncoCyte Corporation
  • Editorial advisory board; Recent Patents on Anti-Cancer Drug Discovery

Gadi Levin, CA, MBA – CFO

  • 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

Farrah Dean, M.Sc, MBA – Corporate Development Manager

  • Investor relations, CytRx Corporation, & CCG Investor Relations
  • Senior Associate Equity Analyst, Oppenheimer & Co., Rodman & Renshaw, & ThinkEquity LLC

Board of Directors

Jamieson Bondarenko — Chairman of the Board

  • Jamieson Bondarenko, CFA, CMT, is an active investor and provides strategic capital markets & corporate development advice to early-stage life sciences companies through his merchant capital company, JGRNT Capital Corp.
  • Jamieson was most recently Principal, Managing Director, Equity Capital Markets at Eight Capital.
  • His previous roles include Equity Capital Markets and Investment Banking positions at Dundee Capital Markets, Wellington West Capital Markets and HSBC Securities. Jamieson is a CFA Charterholder and a Chartered Market Technician.

Dr. Rebecca Taub, M.D. — Director

  • Rebecca Taub, M.D., has served as chief medical officer and executive vice president, R&D, and director of the board for Madrigal Pharmaceuticals, a clinical-stage biopharmaceutical company pursuing novel therapeutics, since 2016.
  • Previously, Dr. Taub served as senior vice president, R&D, of VIA Pharmaceuticals, and as vice president, research, metabolic diseases, at Hoffmann-La Roche where she oversaw clinical development and drug discovery programs for a number of indications including the conduct of a series of Phase I and II proof of concept clinical trials.
  • She received her Doctor of Medicine degree from Yale University School of Medicine and bachelor’s degree from Yale College.

Vaughan C. Embro-Pantalony — Director

  • Embro-Pantalony is chairman of the board of Soricimed Biopharma Inc., a private clinical-stage biopharma company developing targeted cancer therapies.
  • He is also a director of Microbix Biosystems Inc., a leading manufacturer of viral and bacterial antigens and reagents for the global diagnostics industry, where he also served as president and chief executive officer from 2012 to 2017.
  • He received his bachelor’s degree from Wilfrid Laurier University and his master of business administration degree from University of Windsor. He is a Fellow Chartered Professional Accountant and a Chartered Director (C. Dir.) and is Audit Committee Certified (A.C.C.) through the Directors College, McMaster University.

Charles L. Wiseman, MD, FACP — Co-Founder and Director

  • Director, Immunotherapy Lab, St. Vincent Medical Center
  • Chief, Breast Cancer Basic Research Lab, Univ. of Texas MD Anderson Hospital & Tumor Institute; Assist. Prof., Dept of Molecular Carcinogenesis & Virology, MD Anderson
  • Acting Chief, Div. of Oncology, White Memorial Medical Center, LA

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