BriaCell Showcases Data Demonstrating Unmatched Progression-Free Survival (PFS) and Clinical Efficacy in Antibody-Drug Conjugate (ADC) Resistant and Central Nervous System (CNS) Metastatic Breast Cancer at the 2024 AACR
April 09 2024 - 8:00AM
BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT)
(“BriaCell” or the “Company”), a clinical-stage biotechnology
company that develops novel immunotherapies to transform cancer
care, is presenting positive clinical data from its lead product
candidate, Bria-IMT™, in two posters of its three poster sessions
during the 2024 American Association for Cancer Research (AACR)
Annual Meeting held from April 5-10 at San Diego Convention
Center, San Diego, CA.
“We are extremely impressed by
the unprecedented survival and clinical benefit data for
Bria-IMT™ in patients who have failed ADCs,” stated lead author
Chaitali S. Nangia, MD, Partner at Hoag Medical Group. “ADCs are
the latest treatments for very difficult-to-treat advanced
metastatic breast cancer. However, some patients experience
resistance with rapid disease progression. To our knowledge, there
are no effective treatment options in this patient population for
whom the progression-free survival prognosis is only a few weeks.
Finding an alternative well-tolerated treatment option that is
effective is a matter of life and death for these patients.”
“Our clinical data further validates Bria-IMT™’s
novel mechanism of action to generate potent immune responses in
breast cancer patients who failed ADCs leading to clinically
relevant survival and treatment benefit in these patients,”
commented Dr. Giuseppe Del Priore, BriaCell’s CMO. “We look forward
to building upon the body of evidence with additional clinical data
in the coming months from the ongoing pivotal registration
trial.”
“We are excited about the safety and efficacy
data to date with Bria-IMT™ and expect that Bria-IMT™ will generate
positive effects on survival and clinical benefit in the Phase 3
study in advanced breast cancer patients whose medical needs remain
unmet,” commented Dr. William V. Williams, BriaCell’s President and
CEO.
The posters are summarized below and linked
here: https://briacell.com/scientific-publications/.
Poster 1 – Title: Efficacy
of Bria-IMT™ regimen in inducing CNS metastasis
regressionAbstract Presentation Number:
CT204
Superior clinical benefit
of Bria-IMT™ regimen - alone or combined with an immune
check point inhibitor (CPI) in advanced breast cancer patients with
CNS metastatic disease
- Clinical efficacy:
71% (5/7) intracranial objective response rate (iORR), defined as
the percentage of patients who achieve a complete response
(complete disappearance) or partial response (volume reduction of
30% or more) in intracranial tumors, achieved in patients with
central nervous system (CNS) metastases treated with the Bria-IMT™
regimen, either alone or in combination with an immune checkpoint
inhibitor (i.e. PD-1 inhibitor pembrolizumab or retifanlimab).
These patients failed multiple prior treatments including 2
antibody-drug conjugates in one case. Clinical benefit is observed
across all subsets of breast cancer.
- Safety profile:
Absence of both interstitial lung disease (ILD), a common serious
adverse event with ADCs, and no Bria-IMT™-related treatment
discontinuations underscore Bria-IMT™'s excellent tolerability and
favorable safety profile.
In summary, Bria-IMT™’s tumor reductions
observed in all breast cancer subtypes in patients with
intracranial disease underlines its potential clinical
effectiveness in managing CNS metastatic disease in advanced breast
cancer. BriaCell will continue to monitor the data in this subgroup
of patients including a pre-planned subgroup analysis in the
current pivotal Phase 3 study in advanced metastatic breast cancer.
Treatment of patients with CNS metastatic disease represents a
potential additional indication for market approval of
Bria-IMT™.
Poster 2 – Title:
Efficacy and safety of SV-BR-1-GM after progression on ADC in
metastatic breast cancer patientsAbstract
Presentation Number: CT206
Notable progression-free survival
benefit of Bria-IMT™ in ADC resistant advanced metastatic breast
cancer
Phase 2 clinical data of the Bria-IMT™ regimen
in 23 advanced metastatic breast cancer patients who failed
multiple prior treatments including ADCs and CPIs (median of 6
prior treatments) are presented.
- Progression-free Survival
Benefit: Median progression free survival (PFS), defined
as the length of time during which a patient’s cancer does not get
worse, in heavily pre-treated patients of 3.5 months is comparable
to that seen in similar studies in patients with a history of fewer
prior treatments (median of 4)1,2. Similarly, median PFS of 4.2
months in patients receiving the Bria-IMT™ pivotal phase 3
formulation is approximately twice the PFS figures reported for
treatment of physician’s choice (TPC) in other similar studies.
These PFS results suggest superior clinical efficacy considering
the larger number of prior treatments in Bria-IMT™ patients vs
those of the other studies.
- Clinical efficacy:
PFS is similar or better than that of the last regimen in 48%
(11/23) of the patients suggesting Bria-IMT™ effectiveness in
delivering clinical and survival benefits in these patients.
Additionally, a clinical benefit rate (CBR), defined as percentage
of patients whose disease shrinks or remains stable over a certain
time, of 56% is observed in evaluable patients further highlighting
clinical benefit.
- Subset specific clinical
benefits: Study data to date suggests clinical benefit for
multiple breast cancer subtypes including HR+/HER2- (the most
common breast cancer subtype, testing positive for estrogen and/or
progesterone receptors and negative for human epidermal growth
factor receptor 2 or HER2) with a CBR following treatment, of 63%
(5 of 8 patients); HER2+ subtype (a positive test for HER2) with a
100% CBR (2 of 2 patients) and HR-/HER2 low subtype (a negative
test for estrogen and/or progesterone receptor and a negative test
for HER2) showing a CBR of 66% (2 of 3 patients).
- Safety profile:
There are no incidents of interstitial lung disease - a
well-documented serious adverse event associated with ADCs, - in
either ADC naïve or ADC treated patients, and no treatment-related
discontinuations of Bria-IMT™.
In summary, the data to date shows that
Bria-IMT™ provides prolonged progression-free survival and clinical
benefits in heavily pre-treated, ADC resistant breast cancer
patients compared with those in other similar studies. BriaCell
will be monitoring ADC resistant patients in its ongoing pivotal
Phase 3 study of Bria-IMT™ and CPI in advanced metastatic breast
cancer.
________________________1 Cortes J et al.
Eribulin monotherapy versus treatment of physician’s choice in
patients with metastatic breast cancer (EMBRACE): a phase 3
open-label randomized study. Lancet (2011) 377: 914–232 Bardia
A et al. Final results from the randomized phase III ASCENT
clinical trial in metastatic triple-negative breast cancer and
association of outcomes by human epidermal growth factor receptor 2
and trophoblast cell surface antigen 2 expression. J Clin Oncol
(2024) 00:1-7
About BriaCell Therapeutics
Corp.
BriaCell is a clinical-stage biotechnology
company that develops novel immunotherapies to transform cancer
care. 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, including those about presenting three posters at the
2024 AACR, and the contents of such posters; the positive clinical
data from BriaCell’s Bria-IMT™ being presented in two posters
during the 2024 AACR; the clinical efficacy of Bria-IMT™ and its
potential clinical effectiveness in managing CNS metastatic disease
in advanced breast cancer; the unprecedented survival and clinical
benefit data for Bria-IMT™; Bria-IMT™’s ability to generate potent
immune responses in breast cancer patients who failed ADCs, leading
to clinically relevant survival and treatment benefit; BriaCell’s
ability to build upon their current body of evidence with
additional clinical data in the coming months from the ongoing
registration trial; Bria-IMT™’s ability to generate positive
effects on survival and clinical benefit in the Phase 3 study in
advanced breast cancer patients; Bria-IMT™'s tolerability and
favorable safety profile; Bria-IMT™'s significant potential in
managing CNS metastatic disease in advanced breast cancer; BriaCell
monitoring the data in a subgroup of patients including a
pre-planned subgroup analysis in the current pivotal Phase 3 study
in advanced metastatic breast cancer; the treatment of patients
with CNS metastatic disease representing a potential additional
indication for market approval of Bria-IMT™; Bria-IMT™’s
effectiveness in delivering clinical and survival benefits in
patients; the Bria-IMT™ data representing a clinical benefit for
multiple breast cancer subtypes including HR+/HER2; and BriaCell’s
monitoring of ADC resistant patients in their ongoing pivotal Phase
3 study of Bria-IMT™ and CPI in advanced metastatic breast cancer,
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 the Company's profiles on SEDAR+ at
www.sedarplus.ca 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 the 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 AbrahamCORE
IRjulesa@coreir.com
Investor Relations Contact:CORE
IRinvestors@briacell.com
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