BriaCell Patient Achieves Sustained Complete Resolution of Lung Metastasis in Bria-OTS™ Metastatic Breast Cancer Study

Rhea-AI Summary

BriaCell Therapeutics (NASDAQ: BCTX) reported sustained complete resolution of lung metastasis in the first patient treated with Bria-OTS, their personalized off-the-shelf immunotherapy for metastatic breast cancer. The 78-year-old patient with hormone receptor-positive, HER2-negative metastatic breast cancer showed 100% resolution of lung metastasis, maintained at 2, 4, and 6 months after treatment.

The patient, who had multiple prior treatment failures, has received 12 cycles of Bria-OTS monotherapy with no treatment-limiting toxicities. This milestone was achieved at the lowest dose level, demonstrating strong single-agent activity in a challenging patient population.

Positive

• Complete (100%) resolution of lung metastasis maintained for 6 months
• No treatment-limiting toxicities observed in the patient
• Strong single agent activity achieved at lowest dose level
• Patient remains on study with stable disease

Negative

• Results limited to only one patient so far
• Study still in early Phase 1/2a stage

• [IMAGES BELOW] Complete resolution maintained at 6 months in first patient treated with BriaCell’s Bria-OTS in Phase 1/2a study
• No treatment limited toxicities observed
• Patient remains on study with stable disease elsewhere
  

PHILADELPHIA and VANCOUVER, British Columbia, July 09, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, today announced the sustained complete resolution of lung metastasis in a patient with hormone receptor-positive (HR+), HER2-negative, metastatic breast cancer (MBC) treated with Bria-OTS, the Company’s personalized off the shelf immunotherapy.

BriaCell’s first Bria-OTS study patient, a 78-year-old woman with advanced disease and multiple prior treatment failures, achieved 100% resolution of a lung metastasis following four doses of BriaCell’s Bria-OTS monotherapy. The complete response was first observed at two months (previously reported) and confirmed at four (previously reported) and now six months. The patient has been dosed with 12 cycles of Bria-OTS to date.

Figure 1: Treatment with Bria-OTS monotherapy resulted in 100% resolution of tumor in the right lung of the metastatic breast cancer (MBC) patient following 2 months of therapy and confirmed at 4, and 6 months of therapy¹ (axial and coronal views)

“These results represent an exciting clinical milestone in the Bria-OTS program,” stated Neal S. Chawla MD, Director at the Sarcoma Oncology Center, Santa Monica, CA, and Principal Investigator for the Bria-OTS study. “We are seeing strong single agent activity in a very challenging population and are eager to explore this approach across more patient subtypes and tumors.”

“We are highly encouraged by this remarkable and durable clinical response, especially at the lowest dose level,” added Dr. William V. Williams, BriaCell’s President and CEO. “This data underscores the therapeutic potential of our Bria-OTS platform, and we look forward to further evaluating it in combination with a checkpoint inhibitor to improve outcomes in patients with advanced breast cancer.”

About Bria-OTS

Bria-OTS is a next generation, off-the-shelf personalized immunotherapy based on BriaCell’s lead candidate Bria-IMT currently being evaluated in a Phase 1/2a study (ClinicalTrials.gov identifier: NCT06471673) in patients with metastatic recurrent breast cancer. The trial includes both monotherapy dose escalation and check point inhibition combination dose expansion cohorts. The Company recently progressed into the dose expansion phase.

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/.

Safe Harbor

This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release include statements regarding: BriaCell continuing the Phase 1/2a Bria-OTS study and reproducing similar results in patients with MBC and other cancers; the use of the Bria-OTS platform as monotherapy; and Bria-OTS’s validation as a personalized immunotherapy approach. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully under the heading “Risks and Uncertainties” in the Company’s most recent Management’s Discussion and Analysis, under the heading “Risk Factors” in the Company’s most recent Annual Information Form, and under “Risks and Uncertainties” in the Company’s other filings with the Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, all of which are available under the Company’s profiles on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Forward-looking statements contained in this announcement are made as of this date, and BriaCell Therapeutics Corp. undertakes no duty to update such information except as required under applicable law.

Neither the Toronto Stock Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Toronto Stock Exchange) accepts responsibility for the adequacy or accuracy of this release.

Contact Information

Company Contact:
William V. Williams, MD
President & CEO
1-888-485-6340
info@briacell.com 

Investor Relations Contact:
investors@briacell.com

¹ Note that the other white dots in the lungs are blood vessels.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/086d3bd1-2e71-468f-9d93-f7ebafff2797.

FAQ

What are the latest clinical results for BriaCell's (BCTX) Bria-OTS cancer treatment?

BriaCell reported complete (100%) resolution of lung metastasis in their first Bria-OTS patient, maintained at 2, 4, and 6 months, with no treatment-limiting toxicities observed.

How effective is BCTX's Bria-OTS treatment for metastatic breast cancer?

The first patient treated showed 100% resolution of lung metastasis after 4 doses, maintained through 12 treatment cycles, though broader efficacy data across more patients is still pending.

What type of cancer patients are being treated in the BCTX Bria-OTS trial?

The trial is treating patients with hormone receptor-positive (HR+), HER2-negative metastatic breast cancer (MBC). The first patient was a 78-year-old woman with advanced disease and multiple prior treatment failures.

What is the current development stage of BriaCell's Bria-OTS therapy?

Bria-OTS is currently in a Phase 1/2a clinical trial, with plans to evaluate it in combination with checkpoint inhibitors for advanced breast cancer treatment.

What makes BriaCell's (BCTX) Bria-OTS treatment unique?

Bria-OTS is a personalized off-the-shelf immunotherapy, designed to transform cancer care through novel immunotherapy approaches for metastatic breast cancer patients.