SV BR 1 GM cancer vaccine ( BriaCell Therapeutics)

Lung metastasis (from metastatic breast cancer) resolved – after only 2 months (4 doses) of treatment with Bria-OTS™ monotherapy No toxicity related to the treatment; Patient remains on study Unprecedented result in first patient dosed supports Bria-OTS™ personalized immunotherapy approach Ongoing Phase 1/2a dose escalation study to evaluate Bria-OTS™, BriaCell’s personalized off-the-shelf immunotherapy in metastatic breast cancer PHILADELPHIA and VANCOUVER, British Columbia, Feb. 03, 2025 (GLOBE NEWSWIRE) — BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, is pleased to announce an unprecedented clinical response including resolution of a lung metastasis (breast cancer tumor that spread to the lung) with stable disease elsewhere. This patient is the first metastatic breast cancer (MBC) patient treated with Bria-OTS™. Bria-OTS™ is a personalized off-the-shelf immunotherapy, currently under investigation in a Phase 1/2a dose escalation study (ClinicalTrials.gov identifier: NCT06471673 ) in metastatic recurrent breast cancer. Bria-OTS™ represents a personalized, next generation, advancement of BriaCell’s lead candidate Bria-IMT™ which is currently in a pivotal Phase 3 study for metastatic breast cancer. Figure 1: Treatment with Bria-OTS™ monotherapy resulted in 100% resolution of tumor in the lung of the MBC patient following 4 injection cycles[1] As shown in Figure 1, the lesion in the patient’s right lung (left side of the image) is no longer detectable on the images taken 2 months after treatment with Bria-OTS™ monotherapy. This 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 Nov 21, 2024, she had extensive metastases including multiple bone, lymph node and lung metastases. Following 4 injections with Bria-OTS™ every 2 weeks, the lung metastasis completely resolved, and she had stable disease elsewhere. “Despite recent advancements in cancer treatment with antibody-drug-conjugates (ADCs) and immune check point inhibitors (CPIs), metastatic breast cancer remains an unmet medical need as many patients do not respond to these treatments,” stated Dr. Neal Chawla, Associate Director of Clinical Research at the Sarcoma Oncology Center, and Principal Investigator for the Bria-OTS™ study. “We are very impressed by the clinical response observed showing rapid and robust clinical activity in addition to excellent tolerability in the first patient treated with Bria-OTS™ and look forward to reproducing these results in other cancer patients in the study.” “This data supports our hypothesis of personalized immunotherapy with Bria-OTS™, potentially leading to new and effective treatment of metastatic breast cancer,” stated Dr. William V. Williams, BriaCell’s President and CEO. “We hope to transform the way we treat cancer patients with our novel personalized off-the-shelf immunotherapy approach.” “Resolution of metastatic lung disease in this breast cancer patient highlights the clinical effectiveness of Bria-OTS™, and its therapeutic potential in MBC,” commented Dr. Giuseppe Del Priore, BriaCell’s Chief Medical Officer. “This result represents a major step towards advancing our innovative technology platform and our goal of offering safe and effective treatment to MBC patients and our plans to extend into prostate cancer, melanoma, and lung cancer.” The Phase 1/2a clinical trial is initially evaluating the safety and efficacy of Bria-OTS™ as monotherapy and, later, in combination with an immune checkpoint inhibitor in metastatic breast cancer. Key inclusion criteria include recurrent metastatic breast cancer and at least two failed prior attempts of systemic therapy (e.g., chemotherapy). The study design includes a dose escalation monotherapy phase followed by an expansion phase that will include combination therapy with an immune check point inhibitor. 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 reproducing similar results in other cancer patients in BriaCell’s Phase 1/2a Bria-OTS™ study; Bria-OTS™ potentially leading to new and effective treatment of metastatic breast cancer; BriaCell transforming the way we treat cancer patients with its novel personalized off-the-shelf immunotherapy approach; the clinical effectiveness of Bria-OTS™ and its therapeutic potential in MBC; BriaCell’s technology offering a safe and effective treatment to MBC patients; BriaCell’s plans to extend into prostate cancer, melanoma, and lung cancer; and BriaCell’s Phase 1/2a clinical trial initially evaluating the safety and efficacy of Bria-OTS™ as monotherapy and later in combination with an immune checkpoint inhibitor in metastatic breast cancer. 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 Media Relations: Jules Abraham CORE IR julesa@coreir.com Investor Relations Contact: CORE IR investors@briacell.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/90d9b907-91ef-40c5-ac9f-87ff883327f6 [1]Note that the other white dots in the lungs are blood vessels.

BriaCell reports influx of cancer fighting CD8+ “killer” T cell into metastatic breast cancer tumors and lymph organs turning “Cold” tumors and lymph nodes “Hot” on ImmunoPET imaging in cancer patients treated with Bria-IMT™ plus an immune checkpoint inhibitor (CPI)Imaging confirms clinical responses seen in metastatic breast cancer correlate with increase in CD8+ “killer” T Cells in lesions and lymph nodes PHILADELPHIA and VANCOUVER, British Columbia, Dec. 13, 2024 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, highlights the infiltration of cancer fighting immune cells into tumors, using leading CD8 ImmunoPET imaging technology, in its poster presentation at the 2024 San Antonio Breast Cancer Symposium ® at Henry B. Gonzalez Convention Center, San Antonio, TX. Today’s poster shows influx of cancer fighting immune cells into tumors and lymphatic tissue leading to cancer cell destruction following treatment with the Bria-IMT™ plus CPI regimen. BriaCell employed this advanced imaging technology as a precision diagnostic tool to monitor patients’ immune system responses in its phase 2 study, establishing the ability of the Bria-IMT™ regimen to induce tumor infiltration with CD8+ “killer” T cells. These results suggest a potential value of CD8 ImmunoPET in identifying pseudo progression in patients with clinical benefit vs tumor progression. CD8+ T cell infiltration also correlated with a marked reduction in tumor markers, indicating clinical benefit, in some patients. “We are excited to successfully utilize innovative technology such as CD8 ImmunoPET imaging to gain insight into the mechanism of action and potential strength of the BriaCell immunotherapy program,” stated Russ Kuker, MD, Associate Professor of Clinical Radiology at the University of Miami Miller School of Medicine and author of the P5-10-12 poster. “By employing more accurate precision imaging techniques, we have been able to document the mechanism of action of the Bria-IMT™ regimen as we progress this therapy to revolutionize the way we treat cancer patients and improve patient outcomes,” noted Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. The details about the poster presentation are as follows:Abstract Number: SESS-1069Title: Bria-IMT CD8+ tumor infiltrating lymphocytes turn “Cold” tumor “Hot” in metastatic breast cancerTime: Friday, December 13, 2024 12:00 PM – 2:00 PM CSTPresentation ID: P5-10-12CD8 ImmunoPET imaging, an imaging analysis technology, is used to mark CD8+ T-cells (also known as cytotoxic “killer” T cells) that are important components of the immune system and key to cancer cell detection and destruction. Bria-IMT™ plus CPI produced cancer-fighting CD8+ T cells infiltration into metastatic tumors and lymphoid tissue, leading to cancer destruction - turning “Cold” tumors and lymph nodes “Hot” on ImmunoPET imaging Using metastatic site-specific CD8+ PET imaging technology, BriaCell reports the following in 6 patients treated {median # of prior treatments = 7; prior lines of treatment included antibody-drug conjugates (ADCs) and CPIs} with Bria-IMT™ plus CPI after 9 cycles (27weeks) of treatment: Treatment generally well toleratedReduction in tumor markers in 2 patients who had cold tumors turn hot3 out of the 6 patients (50%) showed a decrease in neutrophil/lymphocyte ratio (NLR) at cycle 2 when compared to baseline values suggesting immune system activation of the patientsEvidence of “cold” tumors and lymph nodes becoming “hot” suggesting immune system activation in the patientsImmune system activation results in increased migration of cancer-fighting CD8+ T-cells into MBC tumors and lymphatic tissue, leading to destruction of cancer cellsImmune response following peripheral non-lesional Bria-IMT™ therapy suggests systemic activation of the immune systemClinical and CD8+ T cell response support the clinical benefit of the Bria-IMT™ plus CPI regimen in cancer patients In summary, advanced ImmunoPET imaging technology correlates with clinical benefit with the Bria-IMT™ combination regimen in metastatic breast cancer and suggests possible use in identifying immunotherapy responsive tumors. These findings support the continued use of the Bria-IMT™ combination regimen in BriaCell’s ongoing pivotal Phase 3 study (listed on ClinicalTrials.gov as NCT06072612) in MBC. To view the posters, please visit https://briacell.com/scientific-publications/. 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 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. Forward-looking statements, including those about BriaCell’s phase 2 study results suggesting a potential value of CD8 ImmunoPET in identifying pseudo progression in patients with clinical benefit vs tumor progression; the Bria-IMT™ regimen having the ability to revolutionize the treatment of cancer patients and improve patient outcomes; and the potential use of the Bria-IMT™ combination regimen in identifying immunotherapy responsive tumors are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements, such as those 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, MDPresident & CEO1-888-485-6340info@briacell.com Media Relations:Jules AbrahamCORE IRjulesa@coreir.com Investor Relations Contact:CORE IRinvestors@briacell.com