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BriaCell Presents Positive Data Demonstrating Survival and Clinical Benefits in Advanced Metastatic Breast Cancer at the 2023 AACR 15 of 18 patients remain alive of those recruited since the study reopened in 2021. Longe

Key Takeaway: BriaCell Therapeutics Corp. presented promising clinical data at the 2023 AACR Annual Meeting, demonstrating the survival benefits of its Bria-IMT combination treatment in advanced metastatic breast cancer. Out of the 18 patients recruited since the study's reopening in 2021, 15 remain alive, reflecting a noteworthy survival rate. The treatment has not only activated immune responses in patients with weak immune systems but has also shown longer-than-expected survival times compared to previous therapies. This regimen is particularly vital for patients who have limited options due to prior treatment failures.

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POSITIVE FACTORS

  • 15 of 18 patients from the study remain alive, indicating strong survival rates.
  • Bria-IMT treatment shows longer-than-expected survival, showcasing its clinical effectiveness.
  • The regimen activated immune responses even in patients with very weak immune systems.
  • Positive data suggest that Bria-IMT could be effective in patients with advanced metastatic breast cancer who failed prior therapies.

Full Press Release Details

Presents Positive Data Demonstrating Survival and Clinical Benefits in Advanced Metastatic Breast Cancer at the 2023 AACR
15 of 18 patients remain alive of those recruited since the study reopened in 2021.
Longer than expected patient survival data highlights tolerability and clinical effectiveness of BriaCell's combination treatment.
The Bria-IMT combination regimen activated the immune system even in anergic patients with very weak immune systems.
Continued positive clinical data suggests more meaningful survival and clinical benefits in advanced metastatic breast cancer.
and VANCOUVER, British Columbia, April 17, 2023- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell"
or the "Company"), a clinical-stage biotechnology company specializing in targeted immunotherapies for cancer, is presenting
positive clinical data from its lead product candidate, Bria-IMT , summarized in four poster sessions during the 2023 American
Association for Cancer Research (AACR) Annual Meeting held from April 14 - 19, 2023 at Orange County Convention Center, Orlando,
data highlights the potential clinical value of the Bria-MT regimen in patients with advanced metastatic breast cancer after receiving
multiple prior therapies," said Carmen Calfa, M.D., of the Sylvester Comprehensive Cancer Center at the University of Miami, Associate
Professor of Clinical Medicine, Principal Clinical Investigator, and co-author of the study of Bria-IMT in combination with PD-1
inhibitors pembrolizumab and retifanlimab. "These results are promising and the fact that patients have had a great quality of
life thus far is remarkable. We are hopeful that this novel immunotherapy proves to be an effective therapy for our patients."
clinical findings continue to confirm our approach for our upcoming pivotal trial of Bria-IMT combination regimen," commented
Dr. William V. Williams, BriaCell's President and CEO. "With over 40,000 annual deaths in the U.S. alone, advanced metastatic
breast cancer remains an unmet medical need. Patients who have only months to live tend to avoid current therapies that are proven ineffective
and are associated with excessive toxicities. BriaCell's regimen has shown robust clinical efficacy, better than expected survival
outcomes, and an excellent safety profile in this very difficult to treat patient cohort. We are seeing benefits in patients who failed
other treatments and/or cannot tolerate the harsh side effects of other therapies."
posters are summarized below and linked here: https://briacell.com/scientific-publications/.
1 - Title: Whole cell antigen presenting immune stimulating cells (Bria-IMT ) for the treatment of metastatic breast cancer
Abstract Presentation Number: CT143
Progression Free Survival and Clinical Benefit
Free Survival (PFS) is the length of time during which a patient's cancer does not get worse and is used as a key survival and
efficacy measurement. PFS benefit was observed in BriaCell's combination regimen (with PD-1 inhibitor pembrolizumab (n=11) or retifanlimab
(n=20)), as measured by PFS difference from a patient's previous therapy (prior to enrolment in BriaCell's study). Most patients'
PFS values were similar or higher than those of their prior regimen, a positive finding that suggests better tolerability, clinical effectiveness,
and survival time. Patients treated with Bria-IMT remained on treatment for a longer period of time than expected. BriaCell's
patient cohort would have typically experienced shorter time on therapy with each subsequent line of treatment, given their advanced
18 patients recruited since the study reopened in 2021, 15 remain alive. This compares extremely well with overall survival of 6.7-9.8
months in other similar studies.1
data suggest a survival benefit in this group of difficult to treat patients who had failed multiple prior treatments and who had a typical
life expectancy of 6 months or less.
vs. Non-Anergic Patients:
cells, which can actively weaken the immune system, thus avoid being detected by the patient's immune system, allowing them to
grow and spread. This is a particularly pronounced problem in anergic patients (those unable to develop an immune response) who have
very weak immune systems. Delayed-type hypersensitivity (DTH) test was used to determine immune responses to Bria-IMT as a measure
of immune system activation/boost in patients treated with BriaCell's combination regimen.
out of 27 (56%) evaluable patients from BriaCell's combination study were anergic (i.e. weak immune systems). Following the treatment
with the Bria-IMT combination regimen, 70% of anergic patients and 89% of non-anergic patients showed immune system activation/boost.
Bria-IMT regimen activated/boosted the immune system and produced clinical benefit in both non-anergic and anergic patients with
more (i.e. double) clinical benefit in patients who developed an immune response to Bria-IMT .
observations are particularly meaningful for anergic patients with weakened immune systems who have failed to respond to multiple prior
Receptor Positive (HR+) Patients: Survival and clinical benefits were observed across multiple subtypes of advanced metastatic breast
cancer patients, especially in patients with hormone receptor positive (HR+) cancer, a very large segment of the patient population.
No immunotherapies have been shown to work in this group of patients. 8 out of 17 HR+ patients experienced progression-free
survival benefits in the BriaCell combination study.
Kazmi 2020; Adams 2022, O'Shaughnessy 2022.
positive data is expected as current patients continue to remain in our study, and new patients are being enrolled.
2 - Title: Engineering semi-allogeneic whole cancer vaccines with enhanced immunogenicity for the treatment of advanced solid tumors
Abstract Number: 685
has developed Bria-OTS2.0 or Bria-APTC, the next generation (enhanced version) of Bria-OTS , BriaCell's off-the-shelf personalized
immunotherapy for advanced metastatic breast cancer. It expresses other immune activating cytokine molecules in addition to its immune
boosting granulocyte-macrophage colony-stimulating factor (GM-CSF). As expected, Bria-OTS2.0 was significantly more effective than Bria-OTS
in activating na ve T-cells, potentially suggesting faster acting mechanisms of action and better potency. Bria-OTS2.0 may deliver
significant clinical efficacy and survival benefits in advanced metastatic breast cancer for the following reasons:
mechanisms of action to achieve strong immune response and clinical activity: The unique mechanism of action allows both direct activation
of T-cells, and indirect activation (i.e., by producing immune activating factors) of the immune cells for a more potent and faster acting
anti-tumor activity.
continues to develop Bria-OTS2.0 to enhance the potency of the initial version of Bria-OTS which is planned to be used in its
upcoming phase I/IIa clinical study. The pre-made design should allow fast and cost-effective treatment of patients within days following
a simple, rapid, and inexpensive HLA typing saliva test.
following two posters were presented in a collaboration led by a team from Creatv MicroTech, Inc., an oncology diagnostic company. Both
posters show potential easy to conduct diagnostic tests to predict clinical benefit in patients with advanced metastatic breast cancer.
3 - Title: Tumor macrophage fusion cells detected in the circulation of metastatic breast cancer patients is prognostic for rapid
progression and death
Abstract Number: 2310
4 - Title: Micronuclei in circulating stromal cells correlates with PD-L1 expression and predicts progression in metastatic breast
Abstract Number: 304
BriaCell Therapeutics Corp.
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/.
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 statements about: (i) BriaCell's
participation at the American Association for Cancer Research (AACR) 2023 Annual Meeting; (ii) the potential clinical value of Bria-IMT
(iii) the clinical efficacy, survival rates and safety profile associated with BriaCell's regimen; (iv) the potential content of
posters presented at AACR with respect to refreshed survival outcome updates, new patient data related to tolerability, clinical effectiveness
and survival time, among other things, and potential late-breaking discoveries; (v) the ability of Bria-OTS2.0 to be faster acting and
have better potency than Bria-OTS (vi) the ability of Bria-OTS2.0 to deliver significant clinical efficacy and survival benefits;
and (vii) the continued development of Bria-OTS2.0. 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 the Company's 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.
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.
Director of Public Relations

Frequently Asked Questions

What were the survival results of the study presented at AACR 2023?

15 out of 18 patients remained alive since the study resumed in 2021.

How effective is the Bria-IMT treatment in advanced breast cancer?

The Bria-IMT regimen showed significant clinical benefits and tolerability.

Did the treatment activate the immune systems of anergic patients?

Yes, it activated the immune system in 70% of anergic patients.

What is the relevance of hormone receptor positive (HR+) patients?

Survival benefits were noted, particularly in HR+ patients, a major patient group.

What are BriaCell's future plans for their immunotherapy?

BriaCell is developing Bria-OTS2.0 to enhance immunotherapy efficacy in patients.

Last updated: Apr 17, 2023