This is a multicenter randomized, open label study to evaluate overall survival with the Bria-IMT regimen in combination with Checkpoint Inhibitor [Retifanlimab], versus Treatment of Patients'/Physicians' Choice (TPC) in advanced metastatic or locally recurrent breast cancer (aMBC) patients with no approved alternative therapies available.

Start Date05 Dec 2023

Sponsor / Collaborator

BriaCell Therapeutics Corp.

NCT03328026

/ Enrolling by invitationPhase 1/2

A Phase I/II Study of the SV-BR-1-GM Regimen in Metastatic or Locally Recurrent Breast Cancer Patients in Combination With Retifanlimab

This is an open-label, phase I/II double arm study of the SV-BR-1-GM regimen in combination with retifanlimab in patients with metastatic or locally recurrent breast cancer who have failed standard therapy.
Patients will receive the SV-BR-1-GM regimen with combination immunotherapy. There will be an initial evaluation of the combination of the SV-BR-1-GM regimen with retifanlimab every 3 weeks. If this is found to be safe and well tolerated in a cohort of at least 12 patients (dose-limiting toxicities (DLTs) in less than 30% of the patients evaluated), then an expansion cohort of up to 24 patients will be treated with that combination. These will be randomized to two regimens differing in the timing of checkpoint inhibitor administration.

Start Date16 Mar 2018

Sponsor / Collaborator

BriaCell Therapeutics Corp.

[+1]

NCT03066947

/ CompletedPhase 1/2

A Phase I/IIa Study of SV-BR-1-GM in Metastatic or Locally Recurrent Breast Cancer Patients

This is a single arm, open label study of SV-BR-1-GM, a targeted immunotherapy for breast cancer. Eligible patients will have histological confirmation of breast cancer with recurrent and/or metastatic lesions. The treatment regimen includes a pre-treatment with low-dose cyclophosphamide 2-3 days before the inoculation; inoculation in 4 sites on the thighs and upper back; and post-treatment inoculation of Interferon-alpha-2b into the sites of inoculation
2 and
4 days after the inoculation. These is repeated every 2 weeks for one month (3 treatments), then monthly for up to one year. Standard tumor assessments are performed at baseline and then every 2-3 months.

Start Date05 May 2017

Sponsor / Collaborator

BriaCell Therapeutics Corp.

[+1]

100 Clinical Results associated with SV BR 1 GM cancer vaccine ( BriaCell Therapeutics)

100 Translational Medicine associated with SV BR 1 GM cancer vaccine ( BriaCell Therapeutics)

100 Patents (Medical) associated with SV BR 1 GM cancer vaccine ( BriaCell Therapeutics)

Literatures (Medical) associated with SV BR 1 GM cancer vaccine ( BriaCell Therapeutics)

31 Dec 2024·Human Vaccines & Immunotherapeutics

Results of a phase I/IIa trial of SV-BR-1-GM inoculation with low-dose cyclophosphamide and interferon alpha (Bria-IMT) in metastatic breast cancer

Article

Author: Adams, Daniel L. ; Calfa, Carmen ; Williams, William V. ; Del Priore, Giuseppe ; Bhattacharya, Saveri ; Peoples, George E. ; Chang, Mingjin ; Wiseman, Charles L. ; Holmes, Jarrod P. ; Dakhil, Shaker R. ; Kharazi, Alex ; Lopez-Lago, Miguel ; Lacher, Markus D.

This Phase I/IIa open-label, single-arm clinical trial addressing advanced, refractory, metastatic breast cancer was conducted at six medical centers in the United States. We repeated inoculations with irradiated SV-BR-1-GM, a breast cancer cell line with antigen-presenting activity engineered to release granulocyte-macrophage colony-stimulating factor (GM-CSF), with pre-dose low-dose cyclophosphamide and post-dose local interferon alpha. Twenty-six patients were enrolled; 23 (88.5%) were inoculated, receiving a total of 79 inoculations. There were six Grade 4 and one Grade 5 adverse events noted (judged unrelated to SV-BR-1-GM). Disease control (stable disease [SD]) occurred in 8 of 16 evaluable patients; 4 showed objective regression of metastases, including 1 patient with near-complete regressions in 20 of 20 pulmonary lesions. All patients with regressions had human leukocyte antigen (HLA) matches with SV-BR-1-GM; non-responders were equally divided between matching and nonmatching (p = .01, Chi-squared), and having ≥2 HLA matches with SV-BR-1-GM (n = 6) correlated with clinical benefit. Delayed-type hypersensitivity (DTH) testing to candida antigen and SV-BR-1-GM generated positive responses (≥5 mm) in 11 (42.3%) and 13 (50%) patients, respectively. Quantifying peripheral circulating tumor cells (CTCs) and cancer-associated macrophage-like cells (CAMLs) showed that a drop in CAMLs was significantly correlated with an improvement in progression-free survival (PFS; 4.1 months vs. 1.8 months, p = .0058). Eight of 10 patients significantly upregulated programmed cell death ligand 1 (PD-L1) on CTCs/CAMLs with treatment (p = .0012). These observations support the safety of the Bria-IMT regimen, demonstrate clinical regressions, imply a role for HLA matching, and identify a possible value for monitoring CAMLs in peripheral blood.

01 May 2023·Recent Patents on Anti-Cancer Drug Discovery

Regression of Breast Cancer Metastases Following Treatment with Irradiated SV-BR-1-GM, a GM-CSF Overexpressing Breast Cancer Cell Line: Intellectual Property and Immune Markers of Response

Author: Lacher, Markus D. ; Macúchová, Eva ; Sunkari, Vivekananda G. ; Dozio, Vito ; Kharazi, Alexander ; Galeas, Jacqueline L. ; Wiseman, Charles L. ; Williams, William V. ; Hashwah, Hind

Background:SV-BR-1-GM, derived from a patient with grade 2 (moderately differentiated) breast cancer, is a GM-CSF-secreting breast cancer cell line with properties of antigen-presenting cells. SV-BR-1-GM and next-generation versions are covered by several pending and granted patents.Methods:We report findings from an open-label phase I, single-arm pilot study with irradiated SV-BR-1-GM cells in 3 breast and 1 ovarian cancer subjects. Inoculations were preceded by low-dose intravenous cyclophosphamide and followed by interferon-alpha2b injections into the SV-BR-1-GM inoculation sites. We assessed both cellular and humoral immune responses, and measured expression levels of SV-BR-1-GM HLA alleles.Results:Treatment was generally safe and well tolerated. Immune responses were elicited universally. Overall survival was more than 33 months for three of the four patients. As previously reported, one patient had prompt regression of metastases in lung, breast, and soft tissue. Following cessation of treatment, the patient relapsed widely, including in the brain. Upon retreatment, rapid tumor response was again seen, including complete regression of brain metastases. Consistent with a role of Class II HLA in contributing to SV-BR-1-GM’s mechanism of action, this patient allele-matched SV-BR-1-GM at the HLA-DRB1 and HLA-DRB3 loci. We are in the process of developing next-generation SV-BR-1-GM, expressing patient-specific HLAs. Patent applications were filed in various jurisdictions. Thus far, one is granted, in Japan.Conclusion:A whole-cell immunotherapy regimen with SV-BR-1-GM cells induced regression of met-astatic breast cancer. We develop intellectual property based on SV-BR-1-GM’s predicted mechanism of action to develop additional whole-cell immunotherapies for cancer patients.Clinical Trail Registration:This clinical trial was registered under ClinicalTrials.gov Identifier NCT00095862.

Frontiers in ImmunologyQ2 · MEDICINE

SV-BR-1-GM, a Clinically Effective GM-CSF-Secreting Breast Cancer Cell Line, Expresses an Immune Signature and Directly Activates CD4+ T Lymphocytes

Q2 · MEDICINE

ArticleOA

Author: Wagner, Joseph P ; Williams, William V ; Graeve, Sanne ; Hackett, Tia ; Coleal-Bergum, Dane P ; Fury, Brian ; Wiseman, Charles L ; Lacher, Markus D ; Perotti, Nicholas H ; Kwok, William W ; Kong, Ying Y ; Petrie, Tye D ; Fledderman, Emily L ; Bauer, Gerhard

Targeted cancer immunotherapy with irradiated, granulocyte-macrophage colony-stimulating factor (GM-CSF)-secreting, allogeneic cancer cell lines has been an effective approach to reduce tumor burden in several patients. It is generally assumed that to be effective, these cell lines need to express immunogenic antigens coexpressed in patient tumor cells, and antigen-presenting cells need to take up such antigens then present them to patient T cells. We have previously reported that, in a phase I pilot study (ClinicalTrials.gov NCT00095862), a subject with stage IV breast cancer experienced substantial regression of breast, lung, and brain lesions following inoculation with clinical formulations of SV-BR-1-GM, a GM-CSF-secreting breast tumor cell line. To identify diagnostic features permitting the prospective identification of patients likely to benefit from SV-BR-1-GM, we conducted a molecular analysis of the SV-BR-1-GM cell line and of patient-derived blood, as well as a tumor specimen. Compared to normal human breast cells, SV-BR-1-GM cells overexpress genes encoding tumor-associated antigens (TAAs) such as PRAME, a cancer/testis antigen. Curiously, despite its presumptive breast epithelial origin, the cell line expresses major histocompatibility complex (MHC) class II genes (HLA-DRA, HLA-DRB3, HLA-DMA, HLA-DMB), in addition to several other factors known to play immunostimulatory roles. These factors include MHC class I components (B2M, HLA-A, HLA-B), ADA (encoding adenosine deaminase), ADGRE5 (CD97), CD58 (LFA3), CD74 (encoding invariant chain and CLIP), CD83, CXCL8 (IL8), CXCL16, HLA-F, IL6, IL18, and KITLG. Moreover, both SV-BR-1-GM cells and the responding study subject carried an HLA-DRB3*02:02 allele, raising the question of whether SV-BR-1-GM cells can directly present endogenous antigens to T cells, thereby inducing a tumor-directed immune response. In support of this, SV-BR-1-GM cells (which also carry the HLA-DRB3*01:01 allele) treated with yellow fever virus (YFV) envelope (Env) 43-59 peptides reactivated YFV-DRB3*01:01-specific CD4⁺ T cells. Thus, the partial HLA allele match between SV-BR-1-GM and the clinical responder might have enabled patient T lymphocytes to directly recognize SV-BR-1-GM TAAs as presented on SV-BR-1-GM MHCs. Taken together, our findings are consistent with a potentially unique mechanism of action by which SV-BR-1-GM cells can act as APCs for previously primed CD4⁺ T cells.

News (Medical) associated with SV BR 1 GM cancer vaccine ( BriaCell Therapeutics)

30 Apr 2025

·www.globenewswire.com

BriaCell Reports “Late-Breaker” Phase 3 Data at AACR 2025: Positive Tolerability Profile and Potential Response Biomarkers Identified

Phase 3 clinical data shows potential predictive biomarkers for treatment response, first identified in Phase 2 studyBiomarkers could be utilized to predict and provide better patient outcomes, including response rates and survival benefitsPositive delayed-type hypersensitivity (DTH) (p = 0.001) and a favorable Neutrophil-to-Lymphocyte Ratio (NLR) (p = 0.02) linked to longer progression-free survival (PFS) in Phase 3 patientsPresence of Circulating Tumor Cells (CTC) after patients’ initial Phase 3 treatment supports role as negative prognostic marker (p = 0.04)Bria-IMT Phase 3 regimen was well-tolerated with a preferred tolerability profile PHILADELPHIA and VANCOUVER, British Columbia, April 30, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, is presenting clinical data from the pivotal Phase 3 study of its lead product candidate, Bria-IMT™, in metastatic breast cancer (BRIA-ABC; NCT06072612) supporting the use of specific biomarkers to predict patients’ clinical response to Bria-IMT treatments. Biomarkers could be utilized to predict and provide better patient outcomes, including response rates and survival benefits with BriaCell’s novel Bria-IMT regimen. “Using biomarkers as powerful instruments to predict patient responsiveness to the Bria-IMT treatment would allow physicians and oncologists to identify potential responders sooner, providing better clinical outcomes and ultimately extending patients’ lives,” stated Carmen Calfa, MD, Clinical Research Lead for the breast site disease group at the University of Miami Miller School of Medicine, Co-Director of the Cancer Survivorship Program at Sylvester Comprehensive Cancer Center, and Principal Clinical Investigator of the Phase 2 Bria-IMT study. “We are very pleased with our early Phase 3 biomarker data highlighting their importance as important tools in BriaCell’s fight against metastatic breast cancer, a difficult to treat and deadly disease,” stated Dr. William V. Williams, BriaCell’s President & CEO. “The clinical data reported today demonstrates the potential use of certain key biomarkers to predict MBC patients’ clinical response to the Bria-IMT regimen,” noted Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. “We will continue to evaluate these findings as we advance our goal of treating this serious disease.” The poster is summarized below and linked here: https://briacell.com/scientific-publications/. Title: Bria-ABC1 vs physician choice in late-stage MBC; early biomarker correlates of the randomized registration trialSession Title: Late-Breaking Research: Clinical Research 4Session Date and Time: 4/30/2025 9:00 AM – 12:00 PM CSTLocation: Poster Section 49Poster Board Number: 14Abstract Presentation Number: LB408 Kaplan Meier analysis of early clinical data (n=62) in this multicenter study showed median progression free survival across all arms of 3.67 months. Prespecified subset analyses of PFS based on biomarker status were reported as follows: Positive DTH was significantly related to better PFS (4.5 vs 2.5 months, p = 0.001)Neutrophil-to-lymphocyte ratio (NLR) < 0.7 and ≥ 2.3 following the 1st treatment administration had significantly lower (p = 0.02) median progression-free survival (PFS)Circulating tumor cells (CTCs) < 1 were significantly related to better PFS values (3.8 months vs 2.4 vs, p = 0.04)Baseline Cancer-Associated Macrophage-Like Cells (CAML) count ≥ 5 trended toward a higher PFS value (3.7 vs 2.2 months, p = 0.10) The Bria-IMT regimen remains well-tolerated, with generally manageable treatment-emergent adverse events (TEAEs). There have been no Bria-IMT related treatment discontinuations, underscoring Bria-IMT's excellent tolerability and favorable safety profile. About the Bria-ABC Study The multicenter randomized open label study is evaluating overall survival with the Bria-IMT regimen in combination with checkpoint inhibitor, versus Treatment of Patients’/Physicians’ Choice (TPC) in advanced metastatic or locally recurrent breast cancer (aMBC) patients with no approved alternative therapies available. Fifty-seven clinical sites in the US are actively enrolling patients and additional sites are in various stages of start-up. Interim data will be analyzed once 144 patient events (deaths) occur, comparing the overall survival (OS) in patients treated with the Bria-IMT combination regimen versus those treated with physician’s choice as the primary endpoint. Positive results of the pivotal Phase 3 study could result in full approval and marketing authorization for Bria-IMT in MBC patients. BriaCell recently announced positive Phase 2 survival data in a similar MBC patient population treated with the same Bria-IMT combination regimen. The Bria-IMT combination regimen has received FDA Fast Track designation. For additional information on BriaCell’s pivotal Phase 3 study of Bria-IMT and an immune check point inhibitor in metastatic breast cancer, please visit ClinicalTrials.gov NCT06072612. 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 use of biomarkers in its ongoing Phase 3 study to predict patient responsiveness to the Bria-IMT treatment, providing better clinical outcomes and extending patients’ lives; the use of biomarkers to predict clinical responses to the Bria-IMT regimen with respect to MBC patients specifically; BriaCell continuing to evaluate findings as they advance their goal of treating MBC patients; Bria-IMT’s tolerability and safety profile; timelines regarding BriaCell’s analysis of interim data; and positive results of BriaCell’s Phase 3 study resulting in full approval and marketing authorization for Bria-IMT in MBC patients, , are based on BriaCell’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. 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, MDPresident & CEO1-888-485-6340info@briacell.com Investor Relations Contact:investors@briacell.com 1 Bria-ABC refers to the pivotal Phase 3 Study entitled, Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer (BRIA-ABC) NCT06072612

Phase 3Clinical ResultImmunotherapyFast Track

28 Apr 2025

·www.globenewswire.com

BriaCell Presents Benchmark Beating Survival and Clinical Benefit at AACR 2025; Advancements in Next Generation Bria-OTS+™ Development

Overall survival and clinical benefit in Phase 2 continue to outperform historical benchmarks, including very heavily pretreated patientsClinical benefit observed in 83% of evaluable patient sub-group treated with the phase 3 formulationImproved new Bria-OTS+ platform provides powerful innate and adaptive immune system activationPhase 3 biomarker data to be presented on Wed April 30 from 9:00 AM - 12:00 PM CST; Abstract # LB408 PHILADELPHIA and VANCOUVER, British Columbia, April 28, 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 presenting positive data from its Phase 2 study of lead product candidate, Bria-IMT™, in metastatic breast cancer, and from its preclinical Bria-OTS+ platform at the 2025 American Association for Cancer Research (AACR) Annual Meeting taking place from April 25th – 30th at McCormick Place Convention Center, Chicago, IL. In addition, Phase 3 early biomarker data will be presented as a late breaking abstract. The posters are summarized below and linked here: https://briacell.com/scientific-publications/. Title: Survival outcomes in a randomized phase 2 of Bria-IMT: An allogeneic whole cell cancer vaccineSession Title: Phase II and Phase III Clinical TrialsSession Start: 4/28/2025 2:00 PM – 5:00 PM CSTLocation: Poster Section 50Poster Board Number: 18Abstract Presentation Number: CT100 “We are thrilled to share impressive survival and clinical efficacy data at AACR on the advantages of using Bria-IMT plus checkpoint inhibitor in heavily treated patients who have failed multiple prior treatments, including ADCs and CPIs,” stated lead author, Saranya Chumsri, MD, Principal Investigator and Professor of Oncology, Mayo Clinic. “Treatment options have been limited for patients who progress after ADC therapy, making this a particularly challenging clinical setting. Our clinical findings support the use of Bria-IMT as a well-tolerated, alternative treatment option for these very difficult-to-treat patients with unmet medical needs.” “The excellent survival responses reported in patients with different tumor types in the Phase 2 study is very exciting, and we look forward to seeing these promising data replicate in the pivotal Phase 3 study,” stated Dr. William V. Williams, BriaCell’s President & CEO. Of 54 metastatic breast cancer patients in the Phase 2 study, 37 patients received Bria-IMT formulation that is currently being used in BriaCell’s ongoing pivotal Phase 3 study (ClinicalTrials.gov as NCT06072612). Patients have been heavily pre-treated a median of 6 prior treatments -- including Antibody-Drug Conjugates (ADCs) and check point inhibitors (CPIs). Clinical benefit rates [CR, PR, SD] ranged from 45% to 100% based on subtypeDecrease in size or no change in all tumors noted in 83% of patients receiving Phase 3 formulationOverall survival (OS) with the Phase 3 formulation was 17.3 months for HR+ patients and 11.44 months for patients with triple negative breast cancer (TNBC)Overall response rate (ORR) for patients with intracranial metastases was 50% with a 75% clinical benefit rateSafety profile: No unexpected adverse events, no treatment related discontinuation of therapy Title: Bria-OTS+: A versatile therapeutic platform for inducing anti-cancer immunitySession Category: ImmunologySession Title: Vaccines, In Situ Vaccines, and Vaccine CombinationsSession Date and Time: 4/28/2025 2:00 – 5:00 PM CSTLocation: Poster Section 39Poster Board Number: 29Published Abstract Number: 3553 Miguel A. Lopez-Lago, PhD, BriaCell’s Chief Scientific Officer, commented, “We are very excited with the anti-cancer activity of Bria-OTS+ and expect the platform will enable the delivery of powerful and long-lasting immune activity against cancer.” “This data further validates the mechanism of action of our next-generation Bria-OTS+ platform. Additional immune activating factors are expected to enhance efficacy, and we look forward to replicating these results clinically as we advance our next generation Bria-BRES+ breast cancer and Bria-PROS+ prostate cancer programs,” stated Dr. William V. Williams, BriaCell’s President and CEO. Bria-OTS+ is an immunotherapy platform and enhanced version of Bria-OTS™, BriaCell’s personalized pre-manufactured immunotherapy already demonstrating tremendous results as announced on April 24 2025. Bria-OTS+ immunotherapy expresses multiple immune-activating cytokines and co-stimulatory molecules in addition to immune-boosting granulocyte-macrophage colony-stimulating factor (GM-CSF). Bria-BRES+™ for breast cancer and Bria-PROS+™ for prostate cancer are expected to be investigated in BriaCell’s upcoming Phase 1/2a clinical studies. 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 presenting positive data from its Phase 2 study of lead product candidate, Bria-IMT, in metastatic breast cancer, and from its preclinical Bria-OTS+ platform at the AACR as well as Phase 3 early biomarker data being presented at the AACR as a late breaking abstract; whether BriaCell will be able to see prior results replicated in the pivotal Phase 3 study; BriaCell's expectations that the Bria-OTS+ platform will enable the delivery of powerful and long-lasting immune activity against cancer; whether additional immune activating factors will enhance efficacy of the Bria-OTS+ platform; whether prior results will be replicated in clinical studies of the next generation Bria-BRES+ breast cancer and Bria-PROS+ prostate cancer programs; and expectations for what will be investigated in BriaCell’s planned Phase 1/2a clinical studies; are based on BriaCell’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. 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, MDPresident & CEO1-888-485-6340info@briacell.com Investor Relations Contact:investors@briacell.com

Phase 2ImmunotherapyClinical ResultPhase 3Vaccine

28 Apr 2025

·briacell.com

BriaCell Presents Benchmark Beating Survival and Clinical Benefit at AACR 2025; Advancements in Next Generation Bria-OTS+(TM) Development

Overall survival and clinical benefit in Phase 2 continue to outperform historical benchmarks, including very heavily pretreated patients Clinical benefit observed in 83% of evaluable patient sub-group treated with the phase 3 formulation Improved new Bria-OTS+ platform provides powerful innate and adaptive immune system activation Phase 3 biomarker data to be presented on Wed April 30 from 9:00 AM – 12:00 PM CST; Abstract # LB408 PHILADELPHIA and VANCOUVER, British Columbia, April 28, 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 presenting positive data from its Phase 2 study of lead product candidate, Bria-IMT™, in metastatic breast cancer, and from its preclinical Bria-OTS+ platform at the 2025 American Association for Cancer Research (AACR) Annual Meeting taking place from April 25th – 30th at McCormick Place Convention Center, Chicago, IL. In addition, Phase 3 early biomarker data will be presented as a late breaking abstract. The posters are summarized below and linked here: https://briacell.com/scientific-publications/. Title: Survival outcomes in a randomized phase 2 of Bria-IMT : An allogeneic whole cell cancer vaccine Session Title: Phase II and Phase III Clinical Trials Session Start: 4/28/2025 2:00 PM – 5:00 PM CST Location: Poster Section 50 Poster Board Number: 18 Abstract Presentation Number: CT100 “The excellent survival responses reported in patients with different tumor types in the Phase 2 study is very exciting, and we look forward to seeing these promising data replicate in the pivotal Phase 3 study,” stated Dr. William V. Williams, BriaCell’s President & CEO. Of 54 metastatic breast cancer patients in the Phase 2 study, 37 patients received Bria-IMT formulation that is currently being used in BriaCell’s ongoing pivotal Phase 3 study (ClinicalTrials.gov as NCT06072612 ). Patients have been heavily pre-treated a median of 6 prior treatments — including Antibody-Drug Conjugates (ADCs) and check point inhibitors (CPIs). Clinical benefit rates [CR, PR, SD] ranged from 45% to 100% based on subtype Decrease in size or no change in all tumors noted in 83% of patients receiving Phase 3 formulation Overall survival (OS) with the Phase 3 formulation was 17.3 months for HR+ patients and 11.44 months for patients with triple negative breast cancer (TNBC) Overall response rate (ORR) for patients with intracranial metastases was 50% with a 75% clinical benefit rate Safety profile: No unexpected adverse events, no treatment related discontinuation of therapy Title: Bria-OTS+: A versatile therapeutic platform for inducing anti-cancer immunity Session Category: Immunology Session Title: Vaccines, In Situ Vaccines, and Vaccine Combinations Session Date and Time: 4/28/2025 2:00 – 5:00 PM CST Location: Poster Section 39 Poster Board Number: 29 Published Abstract Number: 3553 Miguel A. Lopez-Lago, PhD, BriaCell’s Chief Scientific Officer, commented, “We are very excited with the anti-cancer activity of Bria-OTS+ and expect the platform will enable the delivery of powerful and long-lasting immune activity against cancer.” “This data further validates the mechanism of action of our next-generation Bria-OTS+ platform. Additional immune activating factors are expected to enhance efficacy, and we look forward to replicating these results clinically as we advance our next generation Bria-BRES+ breast cancer and Bria-PROS+ prostate cancer programs,” stated Dr. William V. Williams, BriaCell’s President and CEO. Bria-OTS+ is an immunotherapy platform and enhanced version of Bria-OTS™, BriaCell’s personalized pre-manufactured immunotherapy already demonstrating tremendous results as announced on April 24 2025 . Bria-OTS+ immunotherapy expresses multiple immune-activating cytokines and co-stimulatory molecules in addition to immune-boosting granulocyte-macrophage colony-stimulating factor (GM-CSF). Bria-BRES+™ for breast cancer and Bria-PROS+™ for prostate cancer are expected to be investigated in BriaCell’s upcoming Phase 1/2a clinical studies. 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 presenting positive data from its Phase 2 study of lead product candidate, Bria-IMT, in metastatic breast cancer, and from its preclinical Bria-OTS+ platform at the AACR as well as Phase 3 early biomarker data being presented at the AACR as a late breaking abstract; whether BriaCell will be able to see prior results replicated in the pivotal Phase 3 study; BriaCell’s expectations that the Bria-OTS+ platform will enable the delivery of powerful and long-lasting immune activity against cancer; whether additional immune activating factors will enhance efficacy of the Bria-OTS+ platform; whether prior results will be replicated in clinical studies of the next generation Bria-BRES+ breast cancer and Bria-PROS+ prostate cancer programs; and expectations for what will be investigated in BriaCell’s planned Phase 1/2a clinical studies; are based on BriaCell’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. 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

Phase 2ImmunotherapyClinical ResultPhase 3Vaccine

100 Deals associated with SV BR 1 GM cancer vaccine ( BriaCell Therapeutics)

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HER2-negative breast cancer	Phase 3	United States	BriaCell Therapeutics Corp.	05 Dec 2023
Triple Negative Breast Cancer	Phase 3	United States	BriaCell Therapeutics Corp.	05 Dec 2023
Metastatic breast cancer	Phase 2	United States	BriaCell Therapeutics Corp.	05 May 2017
Metastatic breast cancer	Discovery	United States	LumaBridge LLC	05 May 2017
Breast Cancer	Discovery	United States	Wiseman Research Initiatives LLC	19 Oct 2004
Ovarian Epithelial Carcinoma	Discovery	United States	BriaCell Therapeutics Corp.	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03328026 (GlobeNewswire \| Company_Website) Manual	Phase 2	Hormone receptor positive breast cancer	54	Bria-IMT™ + Check Point Inhibitors (CPI) (HR+)	(nrlpylcmws) = xwrtlhhgpf vtxhnoehck (gvdyetoyfw )	Positive	16 Apr 2025
				TRODELVY® (sacituzumab govitecan-hziy) (HR+)	(nrlpylcmws) = alsggwgobp vtxhnoehck (gvdyetoyfw )
NCT06072612 (GlobeNewswire) Manual	Phase 2	Metastatic breast cancer	54	Bria-IMT™ regimen + immune checkpoint inhibitor (since 2022)	(eazyhsfvoy) = quhvwfmqnk psnfjaofxl (wpckznxcdv ) View more	Positive	11 Sep 2024
				Bria-IMT™ regimen + immune checkpoint inhibitor (total)	(eazyhsfvoy) = uvsgnvmfni psnfjaofxl (wpckznxcdv ) View more
NCT03328026 (ASCO2024) Manual	Phase 1/2	Metastatic breast cancer \| Advanced breast cancer CAMLs \| CTCs	54	SV-BR-1-GMegimen with oriretifanlimabce	(pxfoacbjlx) = xgcnzcppoe pyolfjpyjn (hxlvkwptob ) View more	Positive	24 May 2024
NCT03328026 (SV-BR-1-GM, ASCO2024)	Phase 2	Metastatic breast cancer	54	Bria-IMT + CPI	wnfmgffmbb(fxjbvvnkzq) = 43% (10/23) reported grade 3 or 4 AEs, independent of study drug causality. AEs included injection site reaction (39%), fatigue (26%), and nausea/vomiting (43%), mostly mild to moderate. One case of elevated lipase was the most clinically significant grade 4 AE. No interstitial lung disease (ILD) was reported. snhjzaenwr (nbavnfnzqd ) View more	Positive	24 May 2024
AACR2024	Not Applicable	Neoplasm Metastasis ER+/PR+ \| HER2- \| ER-/PR- ... View more	-	Bria-IMT monotherapy	xxgmpukqvg(khjiwpuvql) = utltoophvg ikdonzctlo (yfejjiedbe )	-	05 Apr 2024
				Bria-IMT + immune checkpoint inhibitor	xxgmpukqvg(khjiwpuvql) = szjquynaxb ikdonzctlo (yfejjiedbe )
GlobeNewswire Manual	Not Applicable	Advanced breast cancer	-	Bria-IMT±Checkpoint Inhibitor	(ftvpuqzhaq) = jeekvusygx nubbzicklb (kyilwuwanu )	Positive	28 Dec 2023
NCT03066947 \| NCT03328026 (AACR2023) Manual	Phase 1/2	Metastatic breast cancer	51	SV-BR-1-GM	(jelgkkkloa) = ivzracnsfc byarsmlfnk (fpkgazwacg ) View more	Positive	14 Apr 2023
				SV-BR-1-GM+Pembrolizumab or Retifanlimab	(jelgkkkloa) = ypwihqpexj byarsmlfnk (fpkgazwacg ) View more
NCT03066947 \| NCT03328026 (P1-05-28, SABCS2023)	Phase 1	Metastatic breast cancer CTCs \| CAMLs \| CAML PD-L1	33	SV-BR-1-GM monotherapy	lyezaiwdcz(cxazqbbzcg) = gvurmvmhaa tovvhvfqbv (gkxbweniar ) View more	Positive	01 Mar 2023
				SV-BR-1-GM + anti-PD-1 combination therapy	lyezaiwdcz(cxazqbbzcg) = gfdkobclfw tovvhvfqbv (gkxbweniar ) View more
NCT03066947 \| NCT03328026 (AACR 12021 \| AACR 22021) Manual	Phase 1/2	Advanced breast cancer	23	SV-BR-1-GM	(uolrdekigx) = ursvjuaocq ypmwahsvtz (houmpuelxo ) View more	Positive	01 Jul 2021
				SV-BR-1-GM +pembrolizumab or INCMGA00012	(uolrdekigx) = uwqvnebbga ypmwahsvtz (houmpuelxo ) View more
ASCO2009	Not Applicable	Gastrointestinal Stromal Tumors First line	85	IMT 400 mg daily	(gonnyaoyeu) = fcyxszmief gsyeqziozq (atpqbhzusg ) View more	-	20 May 2009

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SV BR 1 GM cancer vaccine ( BriaCell Therapeutics)

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