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BriaCell Quadruples Progression Free Survival (PFS) in Patient with "Eye-Bulging" Metastatic Breast Cancer Progression free survival (PFS) extended to 9.1 months in ADC resistant patient - quadruple the PFS of patients i

Key Takeaway: BriaCell Therapeutics Corp. announced significant results from its Phase 2 study of the Bria-IMT regimen for treating metastatic breast cancer. A heavily pre-treated patient achieved a progression-free survival (PFS) of 9.1 months, which is four times longer than reported in similar cases. The patient's tumors have markedly shrunk, and she continues to benefit from the treatment. BriaCell's leadership expressed optimism about replicating these results in an ongoing Phase 3 study aimed at addressing unmet medical needs for cancer patients.

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POSITIVE FACTORS

  • Quadrupled progression-free survival (PFS) to 9.1 months in a heavily pre-treated patient.
  • Significant reduction in tumor size for the patient with eye-bulging metastatic breast cancer.
  • BriaCell's treatment regimen demonstrates favorable safety and tolerability.
  • Company anticipates replicating positive results in ongoing Phase 3 study.

Full Press Release Details

Quadruples Progression Free Survival (PFS) in Patient with "Eye-Bulging" Metastatic Breast Cancer
Progression free survival (PFS) extended to 9.1 months in ADC resistant patient - quadruple the PFS of patients in similar studies 1,2, 3
Significant reduction of "Eye-Bulging" metastatic breast cancer tumor was previously reported
Heavily pre-treated patient had failed 8 prior regimens including antibody-drug conjugate (ADC) therapy and continues to receive BriaCell treatment
PA and VANCOUVER, British Columbia, July 18, 2024- 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
pleased to report significantly higher PFS for its top responder patient in the Phase 2 study of BriaCell's Bria-IMT regimen
in combination with an immune checkpoint inhibitor in metastatic breast cancer. The patient remains alive and she continues to receive
BriaCell's treatment regimen.
are extremely pleased with the unprecedented survival benefit in this very-difficult-to-treat patient," stated Dr. William V. Williams,
BriaCell's President and CEO. "This data represents a step forward in our efforts to build on our knowledge and successes
to transform cancer care for patients. We expect to replicate this positive data in our ongoing Phase 3 study and bring relief to cancer
patients whose medical needs remain unmet."
recent advances in cancer therapy, metastatic breast cancer remains an unmet medical need, as current treatments are limited by poor
survival and harsh side effects," commented Dr. Giuseppe Del Priore, BriaCell's Chief Medical Officer. "The Bria-IMT
regimen produced a much longer than expected survival benefit in addition to its favorable safety and tolerability in this patient suggesting
its potential as a therapeutic option for these cancer patients."
patient had a large right orbital lesion (behind the right eye) and a right temporal lobe lesion (in the right side of the brain). The
temporal lobe lesion is no longer detectable, while the orbital lesion has continued to shrink markedly (see figure showing resolution
of proptosis post treatment (small arrows) with reduction in tumor indicated by the large arrows). In addition, her tumor markers (blood
tests that correlate with the amount of tumor in the body) have markedly decreased from her pre-treatment levels.
1: Responder Images - Bria-IMT Regimen
1: Bria-IMT and historical clinical data in MBC patients who failed multiple prior treatments
Study PFS (months)
Top Responder Patient 9.1 +
Bardia, A. et. al. 1 1.7
Tripathy D. et. al. 2 1.9
O'Shaughnessy J. et. al. non-TNBC 3 2.3
O'Shaughnessy J. et. al. TNBC 3 1.6
Data is shown for the intent to treat population for the control group treated with treatment of physician's choice, which
is the comparator in the BriaCell's ongoing pivotal Phase 3 study.
This paper describes patients with brain metastases, which were also present in the patient described.
Indicates the patient is ongoing in the study.
1. 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 May 20;42(15):1738-1744. doi: 10.1200/JCO.23.01409. Epub 2024 Feb 29. PMID: 38422473.
2. Tripathy D, et al. Treatment with etirinotecan pegol for patients with metastatic breast cancer and brain metastases: final results from the phase 3 ATTAIN randomized clinical trial. JAMA Oncol. 2022;8(7):1047-1052. doi:10.1001/jamaoncol.2022.0514.
3. O'Shaughnessy J et al. Analysis of patients without and with an initial triple-negative breast cancer diagnosis in the phase 3 randomized ASCENT study of sacituzumab govitecan in metastatic triple-negative breast cancer. Breast Cancer Res Treat. 2022 Sep;195(2):127-139. doi: 10.1007/s10549-022-06602-7. Epub 2022 May 11. PMID: 35545724; PMCID: PMC9374646.
BriaCell Therapeutics Corp.
is a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care. More information is available
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 BriaCell replicating positive data in its ongoing Phase
3 study; BriaCell's Bria-IMT regimen bringing relief to cancer patients whose medical needs remain unmet; and the Bria-IMT
regimen becoming a therapeutic option for metastatic breast cancer patients, 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.
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.

Frequently Asked Questions

What is the significance of the 9.1 months PFS?

The 9.1 months PFS is four times longer than other studies for similar patients.

How many treatment regimens had the patient failed?

The patient had previously failed eight treatment regimens, including ADC therapy.

What treatment is the patient receiving now?

The patient continues to receive the Bria-IMT treatment regimen from BriaCell.

What tumors were present in the patient?

The patient had an orbital lesion and a temporal lobe lesion affecting her brain.

What outcomes were observed post-treatment?

The temporal lobe lesion is undetectable, and the orbital lesion has significantly shrunk.

Last updated: Jul 18, 2024