• Median overall survival of 13.5 months in BriaCell’s advanced metastatic breast cancer patients (vs. 6.7-9.8 months for similar patients reported in the literature)
  • 21 out of 29 patients treated since 2022 are still alive suggesting a strong survival benefit for BriaCell’s combination regimen
  • No dose limiting toxicities to date

PHILADELPHIA, PA, USA and VANCOUVER, Canada I September 08, 2023 I 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, today announces the completion of patient enrollment in its Phase 2 clinical study and reports clinical data showing strong patient survival benefit and clinical benefit in advanced metastatic breast cancer patients.

“The promising survival data of BriaCell’s combination regimen suggests the potential for an industry-shaping leap in advanced metastatic breast cancer treatment,” stated Carmen Calfa, M.D., of the Sylvester Comprehensive Cancer Center at the University of Miami, Associate Professor of Clinical Medicine, and Principal Clinical Investigator of the Phase 2 Bria-IMT™ plus check point inhibitors study. “The overall safety profile and survival data in advanced metastatic breast cancer is extremely encouraging in this heavily pre-treated patient population.”

“We are forging a new path for advanced metastatic breast cancer, a terminal disease with a very limited life expectancy of 6.7 to 9.8 months,” stated Dr. William V. Williams, BriaCell’s President and CEO. “The impressive survival benefit and tolerability of the Bria-IMT™ regimen highlights the importance of this treatment option for patients in which all other therapies have failed.”

Phase 2 Combination Study of Bria-IMT™ with Immune Check Point Inhibitor

  • The Phase 2 study is fully enrolled.
  • To date, 46 heavily pre-treated (average number of prior treatments = 5) advanced metastatic breast cancer patients have been enrolled in the study evaluating BriaCell’s lead clinical candidate, Bria-IMT™, and immune check point inhibitor combination regimen {11 patients with Merck & Co., Inc.’s KEYTRUDA® (pembrolizumab), and 36 patients with Incyte’s ZYNYZ™ (retifanlimab-dlwr) with one patient cross over from the KEYTRUDA® study to the ZYNYZ™ study}. 29 patients have received treatment since 2022. Our findings are summarized below.

Tolerability: The tolerability of the treatment regimen remains excellent with no dose limiting toxicities.

Survival Update:

  • 21 out of 29 patients that have received treatment since 2022 remain alive suggesting tolerability and survival efficacy. The data is not yet mature as patients continue to remain on the study.
  • Median overall survival rate in all patients has been recorded at 13.5 months using Kaplan-Meier curve method which measures the probability of patients’ survival in time.
  • The overall survival in advanced breast cancer patients (third line or later) is very limited, 6.7-9.8 months in publications that evaluated similar patients (Cortes J, et al. Annals of Oncology 2018; Kazmi S, et al. Breast Cancer Res Treat. 2020 Aug 17; O’Shaughnessy J et al. Breast Cancer Res Treat. 2022; Tripathy D, et al. JAMA Oncol. 2022).

The survival findings support BriaCell’s hypothesis of additive and/or synergistic effects of immune check point inhibitors with Bria-IMT™ and support using this combination regimen for our upcoming pivotal study in advanced breast cancer.

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/.

SOURCE: BriaCell Therapeutics