Nano-Cap BriaCell Confirms Full Resolution Of Lung Metastasis In Breast Cancer Trial, Stock Shoots Higher

BriaCell Therapeutics Corp. BCTX confirmed on Thursday that it has sustained a complete resolution of the lung metastasis, first reported in February 2025, two months after the initial treatment in the ongoing Phase 1/2 Bria-OTS study.

The latest data, at four months, also demonstrate stable disease elsewhere.

Treatment with Bria-OTS monotherapy resulted in 100% resolution of tumor in the lung of the metastatic breast cancer (MBC) patient following 2 months of therapy. It was confirmed at 4 months of therapy (axial and coronal views).

The company said the lesion in the patient’s right lung is undetectable after two months and confirmed resolved at 4 months.

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The updated images supersede those previously reported.

The patient, a 78-year-old woman with metastatic breast cancer (hormone receptor-positive, HER2 negative), had failed several prior lines of therapy and received the lowest dose level in the Phase 1/2a Bria-OTS study.

At enrollment on November 21, 2024, she had extensive metastases, including bone, lymph node and lung involvement.

Following Bria-OTS intradermal injections every 2 weeks for six weeks (4 total doses) and subsequent dosing every 3 weeks, the lung metastasis completely resolved with stable disease elsewhere.

Bria-OTS is a personalized off-the-shelf immunotherapy currently under investigation in a Phase 1/2a dose escalation study in metastatic recurrent breast cancer.

The Phase 1/2a trial in metastatic breast cancer is a dose escalation study initially evaluating the safety and efficacy of Bria-OTS as monotherapy. Bria-OTS will follow it in combination with an immune checkpoint inhibitor.

In April, BriaCell Therapeutics released new survival data from its Phase 2 study of Bria-IMT plus checkpoint inhibitors (CPI), which outperformed ADC drugs in hormone receptor-positive (HR+) metastatic breast cancer (MBC) patients.

The survival data of 25 patients (17.3 months) exceeded those of the current ADC standard of care Gilead Sciences Inc’s GILD Trodelvy (sacituzumab govitecan) (14.4 months).

The survival data for the Bria-IMT regimen + immune checkpoint inhibitor in triple-negative breast cancer (TNBC) was similar to Trodelvy but still markedly higher (70%) than those of chemotherapy.

On Tuesday, BriaCell Therapeutics announced that its ongoing pivotal Phase 3 clinical study for Bria-IMT plus an immune checkpoint inhibitor versus a physician’s choice in advanced metastatic breast cancer has obtained consent from over 100 patients and has enrolled more than 75.

BriaCell anticipates completing patient enrollment in late 2025 or early 2026 and may report topline data as early as H1-2026.

In February, the company closed a public offering of 762,500 shares at $4.00 per share, raising $3.05 million in gross proceeds.

Price Action: BCTX stock is up 65% at $8.96 during the premarket session at the last check Thursday.

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