BriaCell Patients' Images Show Regression and Resolution of Metastasized Tumors and Immune Activation
Executive Summary
- BriaCell released imaging data showing tumor regression and immune activation in heavily pre‑treated metastatic breast cancer patients treated with its Bria‑IMT regimen.
- Select patients demonstrated long‑term survival (25–27 months) with complete or substantial resolution of lesions in the brain, orbit, spine, and liver.
- No Bria‑IMT‑related discontinuations have been reported among the 54‑patient Phase 2 cohort; 37 patients received the formulation now advancing to a pivotal Phase 3 trial (NCT06072612).
Key Details
- Patient 11‑018 (ER+/PR+/HER2+):
- Age 66, 8 prior regimens (incl. Enhertu).
- Alive at 27 months post‑enrollment; received 35 cycles of Bria‑IMT.
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Complete resolution of right temporal lobe metastasis, substantial orbital tumor regression, stable bone disease.
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Patient 15‑005 (ER+/PR+/HER2‑):
- Age 44, 5 prior regimens.
- Alive at 27 months; completed 6 cycles of Bria‑IMT with best response of stable disease.
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CD8 ImmunoPET shows increased CD8⁺ T‑cell infiltration in cervical lymph nodes post‑treatment.
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Patient 15‑006 (ER+/PR‑/HER2‑):
- Age 64, 8 prior regimens (incl. Trodelvy).
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Alive at 25 months; baseline hepatic metastasis became “hot” with marked CD8⁺ T‑cell infiltration after therapy.
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Phase 2 Cohort:
- Total enrolled: 54 metastatic breast cancer patients (median 6 prior therapies).
- All received Bria‑IMT plus a checkpoint inhibitor.
- No treatment‑related discontinuations reported to date.
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37 patients treated with the same formulation now being evaluated in pivotal Phase 3 study (NCT06072612).
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Regulatory Status: Bria‑IMT regimen continues under Fast Track Designation from the U.S. FDA.
Notable Quotes
“The CD8 ImmunoPET images are remarkable, verifying the ability of the BriaCell treatment to activate CD8+ cytotoxic (‘killer’) T cells and induce their infiltration into the cancerous tumors… likely play a role in enhancing the long‑term survival of patients even after they come off study,” – Dr. William V. Williams, President & CEO, BriaCell Therapeutics Corp.