Developing Personalized Off-The-Shelf Immunotherapy Treatments for Cancer Patients
This profile is part of a paid investor education campaign.*
BriaCell Therapeutics Corp. (TSX:BCT, OTCQB:BCTXF) is a biotechnology company with a mission to develop innovative immunotherapies for treating cancer. Currently, the company is in the process of developing its lead candidate, Bria-IMT™, as well as its Bria-OTS™, an off-the-shelf personalized immunotherapy, the first of its kind for advanced breast cancer.
At the forefront of cancer treatments, immunotherapies use the body’s immune system to destroy cancer cells. Immunotherapies also have low-toxicity which would make it easier for patients to undergo treatment. Most importantly, they promise to offer better efficacy and less chances 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 designed to treat advanced-stage breast cancer patients. Bria-IMT™ recently achieved positive proof of concept in the company’s Phase IIa study showing an outstanding safety and tolerability profile. Additionally, the data included demonstration of anti-tumor activity of Bria-IMT™ in heavily pre-treated advanced breast cancer patients. Importantly, preliminary Phase IIa efficacy data was similar or superior to those of other approved breast cancer drugs when at a similar clinical-stage of development. Based on these impressive results, BriaCell initiated a combination study of Bria-IMT™ with Keytruda (by Merck & Co., Inc.), and recently announced an early read indicating an excellent safety profile for the combination in advanced breast cancer patients.
The Company also confirmed that top respondent patients shared certain key biomarkers with Bria-IMT™ that would allow the Company to develop a diagnostic test, BriaDX™ to identify these patients, and also advance the company’s plans to develop Bria-OTS™, an off-the-shelf personalized immunotherapy, to cover approximately 90% of the advanced breast cancer patient population.
The Bria-OTS™ personalized immunotherapy can be prepared relatively quickly because it is pre-manufactured. Thus, it avoids the cost, time, and complex manufacturing process associated with other personalized immunotherapies.
BriaCell’s management team is comprised of a team of experienced industry leaders involved in the approval of over 10 drugs. Management also notably holds about 14 percent of the company’s shares.
- Targeting Advanced Breast Cancer, an unmet medical need (over 40,000 deaths in the US in 2017). $1 billion – $5 billion market opportunity depending on patient treatment stage.
- Impressive results in 2 proof-of-concept clinical trials. Rapid response rate; Repeated response following re-treatment. Showing an excellent, safe profile.
- Completed enrollment in Phase I/IIa clinical trials of Bria-IMT™ with outstanding safety and efficacy data. Initiated Phase IIa Combination Study of Bria-IMT™ with Keytruda® (Merck & Co., Inc.).
- Developing Bria-OTS™, the First Off-the-Shelf Personalized Immunotherapy, for advanced breast cancer, along with BriaDX™, its companion diagnostic test. Ability to treat ~90% of patient population with Off-the-Shelf personalized immunotherapy.
- Experienced management has been involved in over 10 drug approvals
- Significant Near-Term News-flow
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 the cancer immunotherapies to treat solid tumors or blood cancers since they only work in certain types of cancer and not in others, and even in responsive cancers only work in a minority of patients. Additionally, the newly developed effective personalized immunotherapies such as PROVENGE® and CAR-T need to be individually manufactured for each patient. This may mean 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. The off-the-shelf approach means that the treatments are pre-manufactured, and the patient will be able to receive her/his personalized treatment based on the results of an easy and common HLA test on her/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-OTS™ is expected to enter the clinic in 2019.
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 recognize and kill tumor cells by activating both T 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 GM-CSF, and low dose cyclophosphamide to boost the immune response. They treated 14 patients and produced some impressive results, including no severe drug related side-effects and a median survival rate in patients after treatment 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 otherwise. 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 shown below) as well as disappearance 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 certain genes called 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 (listed in ClinicalTrials.gov as NCT03066947) and announced the initial data September 26, 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™. Importantly, initial safety data appeared superior to that of the other advanced or approved drugs for breast cancer when they were at a similar stage of clinical development. 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 focusing on the combination study of Bria- IMT™ with pembrolizumab [Keytruda®; manufactured by Merck & Co., Inc.]. The combination study is listed in ClinicalTrials.gov as NCT03328026.
It is important to note that immune checkpoint inhibitors such as pembrolizumab (anti-PD-1) have come to the forefront in the fight against cancer with substantial benefits for some 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. This is highly encouraging for BriaCell because the Company is using Keytruda®, a check point inhibitor, in combination with Bria-IMTTM in its ongoing Phase IIa studies in advanced breast cancer patients.
How Bria-IMT™ works
As shown below, Bria-IMT™ is genetically engineered to secrete an immune system activator, GM-CSF, which activates antigen presenting cells that then activate the T-cells in a patient’s immune system to recognize cancer cells and eliminate them. They will also induce a humoral or antibody response to the cancer cells.
The company believes that Bria-IMT™ is also directly recognizable to the immune system’s T-cells, acting as an antigen presenting cell and boosting the immune response against the cancer cells. This key effect sets Bria-IMT™ apart from other similar targeted immunotherapies and may account for the excellent clinical responses seen to date.
Source: BriaCell Therapeutics Corp.
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™.
The Bria-OTS™ treatment is based on pre-manufactured immunotherapies – each containing a specific HLA type. When treating a patient, a physician will be able use BriaDX™, BriaCell’s companion diagnostic test, to customize the treatment (already pre-manufactured) for the patient. This approach is expected to cover approximately 90 percent of the overall breast cancer patient population with safe and effective personalized immunotherapy treatments. In short, this approach provides a customized cancer immunotherapy for each individual patient that doesn’t require personalized manufacturing. Bria-OTS™ is expected to enter the clinic in 2019.
How Bria-OTS™ Works
Based on our observation of superior tumor shrinking responses in the patients who shared certain biomarkers (i.e. HLA types) with Bria-IMT™, BriaCell is developing Bria-OTS™ for advanced breast cancer.
As shown in the following figure, 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.
As noted above, BriaDX™ is used to determine the HLA types of patients. 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 because it is pre-made.
Source: BriaCell Therapeutics Corp.
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 2020, may provide another shot on goal besides a potential partnership opportunity.
William V. Williams, MD, FACP, President & CEO, 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, Boniva and Bexxar.
- Author of over 120 peer-reviewed publications & over 20 patents
Markus Lacher, Ph.D, Senior Director, R&D
- Founder, T cell Therapeutics, Inc., an immuno-oncology company
- Sr. 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
Saeid Babaei, Ph.D., MBA — Chairman of the Board
- Entrepreneur. 20 yrs of biotech leadership roles
- Current CEO, AbCelex,
- VP, Bus. Develop @ Lorus Therap, Dir. of Corp. Develop, Northern Therapeutics
Rahoul A. Sharan, CPA — Director
- Chairman, Potash Ridge.
- Director of the Board, Ansell Capital Corp, Parallel Resources, & Galaxy Capital Corporation
Martin E. Schmieg — Director
- CFO: Sirna Therapeutics, Inc., & Isolagen, Inc.
- CEO, Freedom-2, Inc. (now PharmaCyte, Inc.)
- Advisor, Caladrius Biosciences, Inc., Beckman Coulter Genomics, Calimmune, Cryoport, Vetbiologics, Sapientia Pharma, & Rokk3r Labs
Charles L. Wiseman, MD, FACP — Co-Founder & Director
- Director, Immunotherapy Lab, St. Vincent Medical Center
- Chief, Breast Cancer Basic Research Lab, Univ. of Texas MD Anderson Hospital & Tumour Institute; Assist. Prof., Dept of Molecular Carcinogenesis & Virology, MD Anderson
- Acting Chief, Div. of Oncology, White Memorial Medical Center, LA
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