BriaCell Summarizes Clinical Data Poster Presented at the 2021 San Antonio Breast Cancer Symposium®
December 09 2021 - 9:00AM
BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW)
(TSX-V:BCT) (“BriaCell” or the “Company”), a
clinical-stage biotechnology company specializing in targeted
immunotherapies for advanced breast cancer and other cancers,
presented clinical results from its lead clinical candidate
Bria-IMT™ in a poster session held on December 8, 2021 during the
2021 San Antonio Breast Cancer Symposium® (SABCS) (the “Poster”).
The Poster submission was accepted by SABCS on
September 15, 2021 and summarized the previously-disclosed Phase
I/IIa clinical and pathological data from the clinical studies of
the Bria-IMT™ regimen alone (the monotherapy studies) and the
ongoing Phase I/IIa clinical study of Bria-IMT™ in combination with
immune checkpoint inhibitors, including pembrolizumab (KEYTRUDA®;
manufactured by Merck & Co., Inc.) and, more recently, Incyte’s
checkpoint inhibitor, retifanlimab.
Presentation Title: Overall
Survival following treatment with a modified whole tumor cell
targeted immunotherapy in patients with advanced breast
cancerSession Date: 5:00 - 6:30 p.m. CT on
Wednesday, December 8, 2021Session Title: Poster
Session 2Poster Number: P2-14-02
Summarized Data: Thirty-four
advanced breast cancer patients were treated with the Bria-IMT™
regimen: 26 in two monotherapy studies (the Bria-IMT™ regimen
alone) and 12 in the combination study, with four patients
transitioning from monotherapy to the combination study.
Patients had been heavily pre-treated and had a
median of five or greater prior regimens.
Safety: The treatment was
generally safe and well tolerated in both the monotherapy and the
combination studies.
Disease Control: The disease
control rate was 25% (n=4) and 30% (n=23) for the monotherapy
studies and 33% (n=12) for the combination study. Complete tumor
reduction of selected tumors was observed in several patients,
including those with 2+ HLA loci matches with Bria-IMT™ and Grade
I/II (i.e. moderately-well differentiated) tumors. For the
evaluable Grade I/II patients, disease control was seen in 1/2 and
4/6 patients in the monotherapy studies and 3/4 patients in the
combination study. This included two patients with partial
responses (PR) according to RECIST criteria. Both patients with PR
responses matched Bria-IMT™ at 2 HLA loci and both had Grade II
disease, matching the tumor grade of the tumor Bria-IMT™ was
derived from.
HLA-Typing: Cells with
HLA (human leukocyte antigen) molecules on their surface determine
and trigger the body’s immune response. BriaCell’s immunotherapy
treatment appears most effective when the patient’s HLA-type
matches with Bria-IMT™, allowing BriaCell to potentially identify
patients most likely to respond. HLA-typing is a simple and widely
available test.
Tumor Grade: BriaCell has
noted clinical benefit in its patients with grade I and grade II
tumors, suggesting another subgroup of patients for whom BriaCell’s
treatment would be most effective.
BriaCell Treatment 1 |
|
Leading Treatment Comparison 2 |
N = |
Filter |
Number of Prior
Regimens |
Overall Survival (Months) |
vs. |
Number of Prior Regimens |
Overall
Survival (Months) |
7 |
Combination Therapy only |
9 |
12.0 |
|
2 |
7.2 - 9.8 |
9 |
1+ HLA |
8 |
12.1 |
|
|
|
5 |
2+ HLA |
5 |
13.4 |
|
|
|
6 |
Tumor Grade I/II |
12 |
12.5 |
|
|
|
Patient 06-005 3 |
2 HLATumor Grade II |
13 |
21.4 |
|
|
|
1) BriaCell treats severely sick patients,
as indicated by the “Prior Regimens” column. Patients from
both the monotherapy and combination therapy are included unless
otherwise indicated.2) Overall survival of 7.2-9.8 months in
similar patients with metastatic breast cancer who have failed two
prior therapy attempts (i.e., third line setting); Kazmi S, et al.
Breast Cancer Res Treat. 2020 Aug 17.3) Remarkable Responder
highlighted; included within subsets “Tumor Grade I/II” and “2+
HLA”.
In summary, the overall survival was much higher
in the patients in the combination study, suggesting an additive or
synergistic effect and supporting our strategy of continuation with
the combination study. The data supports both clinical and survival
benefits in the patients who match Bria-IMT™ at one or more HLA
loci and those with Grade I/II tumors in the combined studies,
supporting the importance of these factors in the treatment
efficacy and focusing on these subgroups of patients in the ongoing
combination study.
A copy of the Poster will be posted on the
Company’s website here:
https://briacell.com/novel-technology/scientific-publications/.
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. 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
“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 TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in the policies of the TSX
Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release.
Contact Information
Company Contact: William V. Williams,
MDPresident & CEO 1-888-485-6340 info@briacell.com
Media Relations: Jules Abraham Director of
Public Relations CORE IR 917-885-7378 julesa@coreir.com
Investor Relations Contact: CORE IR
investors@briacell.com
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