BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX:
BCT) (“BriaCell” or the “Company”), a clinical-stage
biotechnology company specializing in targeted immunotherapies for
cancer, announces that the U.S. Food and Drug Administration (FDA)
has granted Fast Track status to BriaCell’s lead candidate,
Bria-IMT™, for the treatment of metastatic breast cancer (breast
cancer that has spread beyond the breast).
The Fast Track designation will apply to
patients with metastatic breast cancer. BriaCell is developing
Bria-IMT™ in combination with immune checkpoint inhibitors in a
clinical trial listed in ClinicalTrials.gov as NCT03328026.
BriaCell is currently enrolling and dosing advanced breast cancer
patients in its Phase I/IIa combination study of Bria-IMT™ with
Incyte’s checkpoint inhibitor, retifanlimab, and its
immunomodulator, epacadostat under corporate collaboration with
Incyte.
Initial data on patient survival in this study
was first presented at the San Antonio Breast Cancer Symposium in
December 2021 and was over 12 months (average of 9 prior regimens)
compared with 7-10 months in a study in 3rd line breast cancer
patients (those who failed 2 prior regimens for metastatic breast
cancer)1. Other patient subsets with possible survival benefit
included those who match Bria-IMT™ at 1 or more HLA type and those
with grade I (well differentiated) or grade II (moderately
differentiated) breast cancer.
“We are grateful for the opportunity to
accelerate the development of our novel immunotherapy in advanced
breast cancer. We continue to move forward with the clinical
evaluation of Bria-IMT™ towards a potential registration study to
bring hope to patients living with this deadly disease,” said Dr.
Del Priore, BriaCell’s Chief Medical Officer.
____________________________1 Kazmi S et
al, 2020 Breast Cancer Res Treat. 2020 Aug 17
FDA Fast Track
According to the FDA website, the FDA Fast Track
is a process designed to facilitate the development and expedite
the review of drugs to treat serious conditions and fill an unmet
medical need. The purpose is to get important new drugs to the
patient earlier. Determining whether a condition is serious is a
matter of judgment, but generally is based on whether the drug will
have an impact on such factors as survival, day-to-day functioning,
or the likelihood that the condition, if left untreated, will
progress from a less severe condition to a more serious one.
Any drug being developed to treat or prevent a
condition with no current therapy obviously is directed at an unmet
need. If there are available therapies, a Fast Track drug must show
some advantage over available therapy, such as:
- Showing superior effectiveness,
effect on serious outcomes or improved effect on serious
outcomes
- Avoiding serious side effects of an
available therapy
- Improving the diagnosis of a
serious condition where early diagnosis results in an improved
outcome
- Decreasing a clinical significant
toxicity of an available therapy that is common and causes
discontinuation of treatment
- Ability to address emerging or
anticipated public health need
A drug that receives Fast Track designation is
eligible for some or all of the following:
- More frequent meetings with FDA to
discuss the drug's development plan and ensure collection of
appropriate data needed to support drug approval
- More frequent written communication
from FDA about such things as the design of the proposed clinical
trials and use of biomarkers
- Eligibility for Accelerated
Approval and Priority Review, if relevant criteria are met
- Rolling Review, which means that a
drug company can submit completed sections of its Biologic License
Application (BLA) or New Drug Application (NDA) for review by FDA,
rather than waiting until every section of the NDA is completed
before the entire application can be reviewed.
With Fast Track designation, early and frequent
communication between the FDA and a drug company is encouraged
throughout the entire drug development and review process. The
frequency of communication assists with resolving issues quickly,
potentially leading to earlier drug approval and access by
patients.
For additional information on FDA’s Fast Track
designation, see:
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track.
About Bria-IMT™
Bria-IMT™ is a cell-based immunotherapy designed
to selectively destroy tumor cells without harming the normal
cells.
To view the schematic video showing the
mechanism by which Bria-IMT™ destroys tumor cells in patients with
advanced breast cancer, please visit:
https://briacell.com/moa/.
About Phase I/IIa Clinical Trial of
Bria-IMT Combination
The clinical trial evaluates safety and efficacy
of Bria-IMT™, in combination with Incyte’s checkpoint inhibitor,
retifanlimab, and its immunomodulator, epacadostat, in patients
with advanced breast cancer. The combination study is listed in
ClinicalTrials.gov as NCT03328026.
About BriaCell Therapeutics
Corp.
BriaCell is an immuno-oncology focused
biotechnology company developing targeted and effective approaches
for the management of cancer. More information is available at
https://briacell.com/.
Safe Harbor
This press release contains “forward-looking
statements” that are subject to substantial risks and
uncertainties. All statements, other than statements of historical
fact, contained in this press release are forward-looking
statements. Forward-looking statements contained in this press
release may be identified by the use of words such as “anticipate,”
“believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,”
“seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,”
“target,” “aim,” “should,” “will,” “would,” or the negative of
these words or other similar expressions, although not all
forward-looking statements contain these words. Examples of
forward-looking statements in this news release include, among
others, statements the Company makes regarding: (i) the potential
impact of obtaining Fast Track status with the FDA; (ii) which
patients the Fast Track designation may apply to; (iii) the nature
and frequency of communications with the FDA; and (iv) any
acceleration in the drug approval and access process for Bria-IMT™.
Forward-looking statements are based on BriaCell’s current
expectations and are subject to inherent uncertainties, risks and
assumptions that are difficult to predict. Further, certain
forward-looking statements are based on assumptions as to future
events that may not prove to be accurate. These and other risks and
uncertainties are described more fully under the heading “Risks and
Uncertainties” in the Company's most recent Management’s Discussion
and Analysis, under the heading "Risk Factors" in the Company's
most recent Annual Information Form, and under “Risks and
Uncertainties” in the Company's other filings with the Canadian
securities regulatory authorities and the U.S. Securities and
Exchange Commission, all of which are available under our profiles
on SEDAR at www.sedar.com and on EDGAR at
www.sec.gov. Forward-looking statements contained
in this announcement are made as of this date, and BriaCell
Therapeutics Corp. undertakes no duty to update such information
except as required under applicable law.
Neither Toronto Stock Exchange nor its
Regulation Services Provider (as that term is defined in the
policies of the Toronto Stock Exchange) accepts responsibility for
the adequacy or accuracy of this release.
Contact Information
Company Contact:William V.
Williams, MDPresident &
CEO1-888-485-6340info@briacell.com
Media Relations:Jules
AbrahamDirector of Public RelationsCORE
IR917-885-7378julesa@coreir.com
Investor Relations Contact:CORE
IRinvestors@briacell.com
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