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Briacell Therapeutics Corp (2)
Symbol BCT
Shares Issued 15,981,726
Close 2023-09-08 C$ 8.88
Market Cap C$ 141,917,727
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Briacell completes enrolment in phase 2 Bria-IMT study

2023-09-08 09:10 ET - News Release

Dr. William Williams reports

BRIACELL REPORTS BENCHMARK-BEATING PATIENT SURVIVAL AND CLINICAL BENEFIT IN ADVANCED METASTATIC BREAST CANCER

Briacell Therapeutics Corp. has completed patient enrolment in its phase 2 clinical study, and released 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, MD, 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 pretreated 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 chief executive officer. "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 pretreated (average number of prior treatments equals five) 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 crossover from the Keytruda study to the Zynyz study). Twenty-nine patients have received treatment since 2022. The company's 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 are not yet mature, as patients continue to remain in 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 to 9.8 months in publications that evaluated similar patients (J. Cortes et al., Annals of Oncology, 2018; S. Kazmi et al., Breast Cancer Res Treat., Aug. 17, 2020; J. O'Shaughnessy et al., Breast Cancer Res Treat., 2022; D. Tripathy 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 the company's 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.

We seek Safe Harbor.

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