Personalized Immunotherapy Could Be
the Future for Advanced Breast Cancer Treatment
NetworkNewsWire Editorial Coverage:
Personalized treatment for advanced breast cancer is a massive
global medical need. According to latest figures from the Centers
for Disease Control, in the United States alone more than 41,000
women die from breast cancer each year. Hope is on the horizon,
however, as innovative biomedical companies apply their research
and technologies to bring personalized immunotherapies to market
for this unmet medical need. Among these companies is
BriaCell Therapeutics Corp. (OTC: BCTXF) (TSX.V: BCT) (BCTXF Profile), an
immune-oncology-focused biotech company developing the first
off-the-shelf personalized immunotherapy for advanced breast
cancer. The company's technology is based on a targeted
immunotherapy regime that has seen encouraging results in clinical
trials. Other biotechs in the personalized cancer immunotherapy
space include Gilead Sciences, Inc. (NASDAQ: GILD), the
parent company of Kite Pharma; Cellectis S.A. (NASDAQ: CLLS);
Neon Therapeutics, Inc. (NASDAQ: NTGN); and
Loxo Oncology, Inc. (NASDAQ: LOXO).
Personalized Immunotherapy for Advanced Breast Cancer:
Rationale
The global market for breast cancer treatment reached an
estimated $12 billion in 2017 and is on pace to reach approximately
$19 billion by 2025. Within this market, precision medicine
shows considerable promise. Personalized immunotherapy, an example
of precision medicine in which a treatment is tailored to the individual
patient, broadly aims to stimulate a patient's own immune
system to combat cancer. This personalized approach allows a
physician to tailor the treatment to each individual patient,
thereby potentially achieving higher effectiveness and fewer side
effects.
Focused on revolutionizing advanced breast cancer treatment
aligned with this approach, BriaCell's (OTC: BCTXF) (TSX.V: BCT) off-the-shelf
personalized immunotherapy treatment can be quickly prepared for
each individual patient and is designed to safely kill the tumor
cells while saving time, high cost and manufacturing complexities
associated with making personalized immunotherapies.
The need for this caliber of technology is significant in the
field of oncology, considering that one in eight women will develop
invasive breast cancer over the course of their lifetime. Aside
from skin cancer, breast cancer is the most commonly diagnosed
cancer among women in the United States, and breast cancer death
rates are higher than those for any other cancer except lung
cancer. Advanced breast cancer, also called metastatic or stage IV
breast cancer, is the most advanced and deadly form of the disease,
causing the majority of breast cancer-related deaths.
Predictable Anti-Tumor Response in Phase IIa Clinical
Studies in Advanced Breast Cancer
BriaCell's novel technology is being developed based on the
recent
positive proof-of-concept clinical findings of phase IIa
studies of the company's lead product candidate, Bria-IMT™, in
heavily pretreated advanced breast cancer patients.
Bria-IMT is derived from a specific breast cancer cell line and
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 phase IIa study (listed in ClinicalTrials.gov as
NCT03066947) showed potent anti-tumor activity of Bria-IMT in
certain patients who shared certain HLA types with Bria-IMT. (HLA =
Human Leukocyte Antigen typing is used to match patients and donors
in transplants.) HLA biomarkers, found on most cells, are
recognized by the immune system to determine self versus foreign
cells. Importantly, preliminary phase IIa efficacy data in these
patients, with the same HLA type as those on Bria-IMT, were similar
or superior to those of other approved breast cancer drugs when at
a similar clinical-stage of development.
Click here to view a slide presentation of the
results.
Leading the advancement of Bria-IMT and BriaCell's pipeline is
the company's president and CEO, Dr. Bill Williams, who has been
personally involved in the development of 10 drugs in the
market.
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, BriaCell is
now focusing on the combination study of Bria-IMT with
pembrolizumab (Keytruda®, manufactured by Merck & Co., Inc.) or
ipilimumab (Yervoy®, manufactured by Bristol-Myers Squibb Company).
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) and ipilimumab (anti-CTLA-4) 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
(PD-1) and Allison (CTLA-4) with the 2018 Nobel Prize in Physiology or
Medicine. This is highly encouraging for BriaCell because the
company is using these check point inhibitors in combination with
Bria-IMT in its ongoing Phase IIa studies in advanced breast cancer
patients.
"We believe that combination studies with immune checkpoint
inhibitors should create even more potent anti-cancer immune
responses, leading to our strategy of combination studies of
Bria-IMT with Keytruda or Yervoy," Williams stated in the press
release announcing the results. "In our view, the combination of
Bria-IMT with Keytruda or Yervoy has the potential to provide a new
therapeutic option and substantial clinical benefit in heavily
pre-treated advanced breast cancer patients where there remains a
significant unmet need."
Preliminary 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. In the trial, 14 patients were treated.
Among positive results, no severe drug-related side effects were
reported, and the treatment produced a post-treatment median
survival rate about twice what was expected.
The second clinical trial used Bria-IMT (i.e., the original cell
line modified to produce GMCSF) with cyclophosphamide and
interferon-alpha in four advanced-stage cancer patients. The
treatment was tolerated well with few side effects. The median
overall survival was much longer than expected. The study also had
one patient who responded extremely well to the treatment with an
approximately 90 percent tumor reduction in the breast cancer.
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, such as for kidney transplants.
Recent Clinical Findings (Phase I/IIa Study:
2017-2018)
As earlier noted, BriaCell achieved proof-of-concept in its
phase IIa study of Bria-IMT with positive safety and excellent,
predictable efficacy in patients with HLA matches 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 clinical stage of 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 clinical stage of development.
BriaCell Pipeline
BriaCell has developed a companion diagnostic test, BriaDX™,
that would allow a physician to prepare a personalized premade
treatment for each patient based on the presence of certain
biomarkers (HLA type). Testing is simple and performed on the
patient's saliva. This diagnostic test will be used in future
clinical trials to accelerate the clinical development success for
Bria-IMT and Bria-OTS™.
Based on BriaCell's 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. Bria-OTS includes a set of cell lines, each being
similar to Bria-IMT, which are being engineered to express various
premanufactured HLA types. With only 15 different HLA types,
Bria-OTS cell line combinations are expected to cover more than 90
percent of the United States' population. Bria-OTS is expected to
enter the clinics in 2019.
As noted above, BriaDX is used to determine the HLA types of
patients. Based on the results, one or two Bria-OTS premade 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 readily ordered because it is premade.
This appears to be great news for patients and therapists who
previously had few or no treatment options. The technology may be
applicable to other cancers as well.
Other Biotechs on the Move
Gilead Sciences (NASDAQ: GILD) is the
parent company of Kite Pharma, Inc., which develops
immunotherapies. Kite Pharma's therapies involve collecting and
using the patient's own immune cells to treat the cancer. The
company's focus is on developing engineered cell therapies that
express either a chimeric antigen receptor (CAR) or a T cell
receptor (TCR), depending on the type of cancer. With its dual
platform approach, Kite Pharma's technology is designed to address
both hematological and solid tumor cancers. However, with this
approach, each dose must be manufactured for each patient, which
can be time consuming and costly, and may include a complex
manufacturing system.
Cellectis S.A. (NASDAQ: CLLS) develops
off-the-shelf immunotherapies using next-generation CAR T cells.
Lead technology, TALEN®, is being developed to enable gene editing
to precisely edit or change the genetic code within a person's DNA.
As with Kite Pharma's approach, Cellectis' manufacturing of
treatment based on the patient's own T cells could also be a costly
and time consuming approach.
Neon Therapeutics' (NASDAQ: NTGN) work on
personalized immuno-oncology therapies lead the company to develop
treatments across both T cell therapies and vaccines using
neoantigen biology. Neon Therapeutics is developing multiple
clinical strategies to target neoantigens, which are foreign
substances encoded by tumor-specific mutated genes. This technology
requires extensive genetic analysis of the patient's tumor, another
often time-consuming method saddled with potentially high cost.
Loxo Oncology (NASDAQ: LOXO) is
focused on developing treatments for cancers caused by a single
inappropriate DNA change, or an "oncogenic driver." These drivers
are responsible for both the initiation and the maintenance of a
cancer. Loxo Oncology designs highly selective medicines that
target these drivers as the underlying cause of a cancer. These
therapies are targeted to the cancer of an individual patient, but
do not work through the immune system and may be unlikely to
eliminate all cancer cells from the body.
Personalized Cancer Immunotherapy: The Future of
Treatment for Advanced Breast Cancer
Personalized, off-the-shelf treatments have the potential to
revolutionize the way advanced breast cancer is treated. In a
recent interview, Williams voiced the company's commitment to
bringing its personalized immunotherapy treatments to the patients
with the disease.
"We remain confident in our technology's potential to deliver
clinical benefit to patients with advanced breast cancer, and are
working hard to make Bria-OTS, BriaCell's novel off-the-shelf
personalized immunotherapy, available to advanced breast cancer
patients as soon as possible," he stated.
For more information on BriaCell Therapeutics, visit BriaCell Therapeutics Corp.
(OTC: BCTXF) (TSX.V: BCT)
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