BriaCell Therapeutics Corp.
("BriaCell")
(TSX-V:BCT) (OTCQB:BCTXF), an immuno-oncology focused biotechnology
company with a proprietary targeted immunotherapy technology, is
providing a clinical update regarding its ongoing clinical trials
of Bria-IMT™ (formerly referred to as SV-BR-1-GM).
BriaCell currently is enrolling patients in two
separate but related clinical trials. Trial WRI-GEV-007 (listed in
ClinicalTrials.gov as NCT03066947) is a Phase I/IIa clinical study
designed to evaluate the safety and efficacy of Bria-IMT™ in
metastatic or locally recurrent breast cancer patients. In
this study, Bria-IMT™ is given in a regimen including low-dose
pre-dose cyclophosphamide (to reduce suppression of the immune
response) and post-dose interferon-alpha (to boost the immune
response). The second clinical trial, BRI-ROL-001 (listed in
ClinicalTrials.gov as NCT03328026), is a rollover study of
Bria-IMT™ in combination with Keytruda® [pembrolizumab] or Yervoy®
[ipilimumab].
Patient recruitment is on schedule despite
interruption due to temporary shutdown of some clinical sites,
affected by wildfires and hurricanes. Seven patients have enrolled
in the WRI-GEV-007 clinical trial with 6 treated to date (1 patient
dropped out after cyclophosphamide pre-treatment and did not
receive Bria-IMT™). Based on results to-date, Bria-IMT™ has been
very well tolerated and the majority of adverse events were limited
to expected minor local irritation at the injection sites. No
serious adverse events related to Bria-IMT™ have been reported and
no new or unexpected safety issues related to Bria-IMT™ have been
observed. The Phase I portion of the study has been
successfully completed, and the Phase IIa portion is currently
enrolling.
One patient is worth discussing in detail. This
73-year-old woman had breast cancer diagnosed in 1995. She
developed liver metastases in 2010, and then lung metastases in
2017. Prior treatments included surgery, radiation therapy,
hormonal therapy and seven rounds of chemotherapy with 8 different
chemotherapy agents. She received 5 cycles of Bria-IMT™ over the
first 3 months of treatment, then 3 additional cycles over the
following 3 months (6 months total). Evaluation was performed
after 3 months and 6 months. After 3 months, despite the extensive
prior therapy, her scans noted that, “there has been a clear
response in the multiple bilateral pulmonary nodules” indicating
that several lung tumors had disappeared or decreased in
size. This response was maintained after 6 months of
treatment with Bria-IMT™. The liver tumors were stable to
slightly increased at 3 months, and then progressed after 6
months.
Like the patient reported previously by Dr.
Wiseman, BriaCell’s Scientific Founder, in a proof-of-concept
clinical study, this patient is a double match with Bria-IMT™ at
two specific biomarkers (HLA-A and HLA-DRB3). This is highly
significant, as it supports our BriaDX™ hypothesis that these
biomarkers can be used to select the patients most likely to
respond to Bria-IMT™ therapy. We also noted in this patient
that, while circulating tumor-associated cells decreased following
the initial treatment, the expression of PD-L1, a molecule that
suppresses the immune response, increased during treatment. This
suggests that treating this patient (and other similar patients)
with Bria-IMT™ in combination with a potent PD-1 inhibitor such as
Keytruda® [pembrolizumab] may be a highly effective method to
improve the efficacy of the treatment and patient outcomes.
A third clinical site was recently added to the
study and several patients are being evaluated for the WRI-GEV-007
study. Discussions are ongoing with two additional clinical sites
which are expected to be added in the near future. The combination
rollover study, BRI-ROL-001, is available to enroll patients.
Other activities remain on track. The
companion diagnostic, BriaDX™, has been bolstered by the important
supporting data for the HLA biomarker matching hypothesis noted
above. BriaCell is also developing an off-the-shelf,
personalized immunotherapy (Bria-OTS™) to treat a much wider
patient population (with ~90% of the population being a
double-match with Bria-OTS™). In collaboration with
University of Zurich, Switzerland, BriaCell is testing other
drugs/product candidates that are expected to boost the
effectiveness of Bria-IMT™ and Bria-OTS™.
Ongoing work in the small molecule program to
select protein kinase C delta inhibitors for cancer and fibrotic
diseases is also progressing according to our timelines. The
medicinal chemistry work is being performed at Colorado State
University where the current library of compounds available is
being augmented.
Keytruda® is a registered trademark of Merck
Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Yervoy® is a registered trademark of Bristol-Myers Squibb
Company
About BriaCell
BriaCell is an immuno-oncology focused
biotechnology company developing a targeted and safe approach to
the management of cancer. Immunotherapy has come to the forefront
of the fight against cancer, harnessing the body's own immune
system in recognizing and selectively destroying cancer cells while
sparing normal ones. Immunotherapy, in addition to generally being
more targeted and less toxic than commonly used types of
chemotherapy, is also thought to be a potent approach with the
potential to prevent cancer recurrence.
Bria-IMT™ (SV-BR-1-GM), the Company's lead
product candidate, is derived from a breast cancer cell line
genetically engineered to release granulocyte-macrophage
colony-stimulating factor (GM-CSF), a substance that activates the
immune system by allowing the body to recognize and eliminate
cancerous cells by inducing tumor-directed T cell and potentially
antibody responses.
The results of two previous proof-of-concept
clinical trials (one with the precursor cell line not genetically
engineered to produce GM-CSF and one with Bria-IMT™) produced
encouraging results in patients with advanced breast cancer. Most
notably, one patient with metastatic breast cancer responded to
Bria-IMT™ with substantial reduction in tumor burden including
breast, lung, soft tissue and brain metastases. The company is
currently conducting a Phase I/IIa clinical trial for Bria-IMT™ in
patients with advanced breast cancer. This trial is listed in
ClinicalTrials.gov as NCT03066947. The trial is being
conducted along with the co-development of BriaDX™, the Company’s
companion diagnostic test. The interim data for the first 10
patients is expected by the first quarter of 2018. Additionally,
the FDA recently approved the roll-over combination study of
Bria-IMT™ with pembrolizumab [Keytruda; manufactured by Merck &
Co., Inc.] or ipilimumab [Yervoy; manufactured by Bristol-Myers
Squibb Company] for patients previously treated with Bria-IMT™ in
the Company’s ongoing Phase I/IIa clinical trial in advanced breast
cancer. The roll-over trial is listed in ClinicalTrials.gov as
NCT03328026.
BriaCell is also developing Bria-OTS™, an
off-the-shelf personalized Immunotherapy. Bria-OTS™ consists
of 14 individually pre-manufactured genetic alleles. BriaCell’s
BriaDX™ companion diagnostic reveals a patient’s specific HLA-types
and the 2 best matching alleles are administered to the patient.
BriaCell’s 14 alleles (8 Class I and 6 Class II) cover
approximately 90% of the Breast Cancer population while eliminating
the complex manufacturing logistics required for other personalized
immunotherapies. Bria-OTS™ is a personalized therapy without the
need for personalized manufacturing.
BriaCell is also developing novel, selective
protein kinase C delta (PKCδ) inhibitors. PKCδ inhibitors have
shown activity in a number of pre-clinical models of RAS genes’
transformed cancers including breast, pancreatic, non-small cell
lung cancer and neuroendocrine tumors (such as carcinoid
tumors).
For additional information on BriaCell, please
visit our website: http://briacell.com.
Cautionary Note Regarding Forward-Looking
Information
Except for the statements of historical fact,
this news release contains "forward-looking information" within the
meaning of the applicable Canadian securities legislation which
involves known and unknown risks relevant to the Company in
particular and to the biotechnology and pharmaceutical industries
in general, uncertainties and other factors that may cause actual
events to differ materially from current expectation. These risks
are more fully described in the Company's public filings available
at www.sedar.com.
Readers are cautioned not to place undue
reliance on these forward-looking statements, which speak only as
of the date of this press release. The Company disclaims any
intention or obligation, except to the extent required by law, to
update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise.
Contact Information
For further information, please contact:
BriaCell Therapeutics
Corp.:Farrah DeanManager, Corporate DevelopmentEmail:
farrah@BriaCell.com Phone: 1-888-485-6340
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