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BriaCell Therapeutics advances Phase 3 MBC clinical study

Health Care, Market News
TSX:BCT
15 October 2024 13:15 (EDT)
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BriaCell Therapeutics (TSX:BCT) has provided an update on its Phase 3 study of Bria-IMT in combination with immune check point inhibitor on metastatic breast cancer (MBC).

In a press release, the company said the study will enroll up to 354 patient, with enrollment expected to be completed by mid-2025.

The primary endpoint of the study is overall survival with Bria-IMT regimen plus check point inhibitor versus treatment of a physician’s choice.

“We are very pleased to report that patient enrollment is on track for expected completion by mid-2025,” Dr William V. Williams, CEO of BriaCell Therapeutics, said in a statement. We anticipate the interim data analysis of the ongoing pivotal Phase 3 study will confirm the effectiveness of the Bria-IMT™ combination regimen in patients with metastatic breast cancer who failed approved therapies.”

Interim data will be analyzed when 144 deaths have occured in order to compare the overall survival (OS) in patients who have been treated with the Bria-IMT™ combination regimen versus those treated with physician’s choice as the primary endpoint.

Results from the study are vital in receving full approval and marketing of Bria-IMT™ in MBC patients.

As it currently stands, 35 clinical sites —— 18 main and 17 satellite —— are currently enrolling patients in the study, with additional sites in various stages of start-up.

Bria-IMT is the company’s Phase 3 lead candidate and is a patented, off-the-shelf, cell-based, targeted immunotherapy that activates the patient’s immune system to target and kill cancer cells without harming other cells. 

Headquartered out of Vancouver, B.C., BriaCell Therapeutics is a clinical-stage biotechnology company focused on developing novel immunotherapies to treat cancer.

Shares of BriaCell Therapeutics are up 4.13 per cent to C$0.93 as of 12:15 p.m. ET.

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