- BriaCell
is on its way to developing a personalized, off-the-shelf immunotherapy
for advanced breast cancer patients
- Because
of the market gap and the demand for such treatments, the development and
release of the product could be fast tracked
- BriaCell
has obtained excellent results in clinical trials so far as Bria-IMT
demonstrates the ability to shrink tumors at multiple sites in patients
with advanced breast cancer
BriaCell Therapeutics Corp. (OTCQB: BCTXF) (TSX.V: BCT) is
developing the first personalized, off-the-shelf advanced breast cancer
immunotherapy option using its proprietary targeted immunotherapy technology,
company president and CEO Dr. Bill Williams said in a recent interview with
Stock Day’s Everett Jolly (http://ibn.fm/EvrXz).
The biotechnology company focuses its efforts on
immuno-oncology and is known for its proprietary targeted immunotherapy
technology, which makes it possible to offer off-the-shelf personalized
treatments for advanced breast cancer patients. According to Williams, the
off-the-shelf personalized treatment that BriaCell is developing will be
similar to other forms of personalized immunotherapy that are time consuming
and costly to produce due to a complex manufacturing process.
Immunotherapy is on the forefront of the battle against
cancer. BriaCell is putting all of its effort and resources into the
development of treatment options that are highly effective and safe at the same
time, Williams explained.
Currently, BriaCell Therapeutics has two major programs –
Bria-IMT and Bria-OTS. Bria-IMT is currently in the clinic, while Bria-OTS is
in the process of development, Williams said. Previous clinical testing of
Bria-IMT has returned promising results. In a clinical trial for the treatment
of advanced breast cancer, Bria-IMT contributed to tumor shrinkage in multiple
sites (in patients with metastases). Through additional patient testing, the
original observations were confirmed.
The company is in Phase 2a clinical testing of its Bria-IMT
in combination with pembrolizumab [KEYTRUDA®; manufactured by Merck & Co.,
Inc. (NYSE: MRK)]. The combination study is listed on ClinicalTrials.gov as
NCT03328026.
Bria-OTS is being developed on the basis of results obtained
in the Bria-IMT clinical trials. Through its development, BriaCell Therapeutics
will be genetically engineering immunotherapy cell lines which will induce
specific immune responses against the cancer. The aim of such therapies is to
target breast cancer tumors and induce an immune response in a way that’s
personalized to the patient, Williams said. Such tailoring is possible through
the use of an HLA allele matching system.
According to Williams, BriaCell plans to communicate with
the Food and Drug Administration (FDA) about the design of a pivotal Bria-IMT
registration trial in 2019. Following the completion of this step, BriaCell
plans to start a registration study in 2020. The final Bria-IMT approval is
expected by 2023. The personalized, off-the-shelf version of this therapy
(Bria-OTS) is approximately two years behind in schedule in comparison to
Bria-IMT.
Patients with advanced breast cancer have an unmet need at
the moment, Williams noted. Because of the significant demand, the company’s
immunotherapies may qualify for accelerated FDA review.
While other immunotherapies are currently available on the
market, some patients have seen a poor response and others have experienced
serious side effects. Through the use of targeted therapies like the ones
developed by BriaCell, the immune response is generated in a specific way to
target solely cancerous cells. Healthy tissue is unaffected, which contributes
to the excellent tolerance demonstrated in the clinical trials.
According to Williams, numerous pharmaceutical companies are
interested in BriaCell’s developments, and they’re simply waiting for more
clinical data. “We have that data now and are just trying to put it into a
format that we can share with people who are very scientifically advanced. We
should be coming back to them within the next couple of months, hopefully
generating some additional excitement,” he said.
For more information, visit the company’s website at www.BriaCell.com
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