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 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 was the cause of over 40,000 deaths in the US in 2017. 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 for the combination in advanced breast cancer patients. For the combination strategy, BriaCell has developed a frozen formulation for Bria-IMT™, which shows improved potency, enables for overnight transfer to clinics and has reduced per-dose costs.
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 over 99 percent 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 dozens of drugs. Management also notably holds about 14 percent of the company’s shares.
- Targeting advanced breast cancer: $1 billion to $5 billion market opportunity depending on patient treatment stage.
- Impressive results in two 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®, with initial results showing the combination is very safe and well-tolerated by patients, preliminary efficacy expected in 1Q19.
- Developed frozen formulation of Bria-IMT™ that can be transferred more readily to the clinics, has an improved potency and reduced per-dose costs.
- Developing Bria-OTS™, the first off-the-shelf personalized immunotherapy, for advanced breast cancer, along with BriaDX™, its companion diagnostic test.
- Ability to treat over 99 percent of the patient population with off-the-shelf personalized immunotherapy.
- Briacell advancing collaboration discussions with several big pharma companies.
- Experienced management has been involved in dozens of 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 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 was responsible for over 40,000 deaths in the US in 2017.
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 based on the results of 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-OTS™ is expected to enter the clinic in the near term.
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 cells in the form of 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 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.
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™: 2017-2018)
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™. 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 KEYTRUDA®.
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.
“We are highly confident of our strategy to use Bria-IMT™ in combination with KEYTRUDA®, an approved treatment for multiple cancer indications, and expect synergistic activity of this combination in patients with advanced breast cancer,” said BriaCell’s CEO, Dr. William Williams.
BriaCell has developed a frozen formulation of their Bria-IMTTM immunotherapy that will support overnight transport to clinical sites. The frozen formulation has shown improved potency compared to the liquid formulation and is expected to reduce per-dose costs.
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 – 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. Bria-OTS™ is expected to enter the clinic in 2019.
How Bria-OTS™ Works
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 99 percent of the US population.
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. Bria-OTS™ is excepted to enter FDA clinic trials in 2019 and is expected to synergize with checkpoint inhibitors like KEYTRUDA®.
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 2021, may provide another shot on goal besides a potential partnership opportunity.
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
- 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
Jamieson Bondarenko — Director
- 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.
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 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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