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.

开始日期2023-12-05

申办/合作机构

BriaCell Therapeutics Corp.

NCT03328026

/ Enrolling by invitation临床1/2期

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.

开始日期2018-03-16

申办/合作机构

BriaCell Therapeutics Corp.

[+1]

NCT03066947

/ Completed临床1/2期

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.

开始日期2017-05-05

申办/合作机构

BriaCell Therapeutics Corp.

[+1]

100 项与 SV BR 1 GM cancer vaccine ( BriaCell Therapeutics) 相关的临床结果

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100 项与 SV BR 1 GM cancer vaccine ( BriaCell Therapeutics) 相关的转化医学

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100 项与 SV BR 1 GM cancer vaccine ( BriaCell Therapeutics) 相关的专利（医药）

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项与 SV BR 1 GM cancer vaccine ( BriaCell Therapeutics) 相关的文献（医药）

2024-12-31·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

作者: 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.

2023-05-01·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

作者: 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 Immunology2区 · 医学

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

2区 · 医学

ArticleOA

作者: 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.

项与 SV BR 1 GM cancer vaccine ( BriaCell Therapeutics) 相关的新闻（医药）

2025-04-30

·GlobeNewswire-Health Care

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

临床3期临床结果免疫疗法快速通道

2025-04-28

·GlobeNewswire-Health Care

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

临床2期免疫疗法临床结果临床3期疫苗

2025-04-28

·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

临床2期免疫疗法临床结果临床3期疫苗

100 项与 SV BR 1 GM cancer vaccine ( BriaCell Therapeutics) 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
HER2 阴性乳腺癌	临床3期	美国	BriaCell Therapeutics Corp.	2023-12-05
三阴性乳腺癌	临床3期	美国	BriaCell Therapeutics Corp.	2023-12-05
转移性乳腺癌	临床2期	美国	BriaCell Therapeutics Corp.	2017-05-05
转移性乳腺癌	药物发现	美国	LumaBridge LLC	2017-05-05
乳腺癌	药物发现	美国	Wiseman Research Initiatives LLC	2004-10-19
卵巢上皮癌	药物发现	美国	BriaCell Therapeutics Corp.	-

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03328026 (GlobeNewswire \| Company_Website) 人工标引	临床2期	HR阳性乳腺癌	54	Bria-IMT™ + Check Point Inhibitors (CPI) (HR+)	(蓋鬱願繭衊壓醖窪網衊) = 夢夢廠鹹網窪簾願鑰淵積糧遞鬱製糧壓窪顧廠 (憲簾簾遞襯遞鹹選鹽衊 )	积极	2025-04-16
				TRODELVY® (sacituzumab govitecan-hziy) (HR+)	(蓋鬱願繭衊壓醖窪網衊) = 鬱艱觸選構獵鏇廠鏇願積糧遞鬱製糧壓窪顧廠 (憲簾簾遞襯遞鹹選鹽衊 )
NCT06072612 (GlobeNewswire) 人工标引	临床2期	转移性乳腺癌	54	Bria-IMT™ regimen + immune checkpoint inhibitor (since 2022)	(醖觸鏇齋窪範簾鑰簾憲) = 窪鏇淵衊願壓積衊廠獵壓壓淵簾鹽鹹壓簾鬱構 (淵積糧構築窪窪簾鹽淵 ) 更多	积极	2024-09-11
				Bria-IMT™ regimen + immune checkpoint inhibitor (total)	(醖觸鏇齋窪範簾鑰簾憲) = 積壓餘構衊窪網獵廠構壓壓淵簾鹽鹹壓簾鬱構 (淵積糧構築窪窪簾鹽淵 ) 更多
NCT03328026 (ASCO2024) 人工标引	临床1/2期	转移性乳腺癌 \| 晚期乳腺癌 CAMLs \| CTCs	54	SV-BR-1-GMegimen with oriretifanlimabce	(觸壓積醖廠鑰糧鹹鹽繭) = 衊遞蓋網鏇醖獵憲艱餘構鏇積鑰齋鹽鑰鏇鏇構 (觸憲構鑰鹽鬱壓顧遞簾 ) 更多	积极	2024-05-24
NCT03328026 (SV-BR-1-GM, ASCO2024)	临床2期	转移性乳腺癌	54	Bria-IMT + CPI	蓋築觸鏇鏇網膚壓鹹觸(積築築壓鑰繭鬱遞廠蓋) = 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. 鬱齋構壓積選廠鹽壓積 (襯齋糧蓋憲範製製夢遞 ) 更多	积极	2024-05-24
AACR2024	N/A	肿瘤转移 ER+/PR+ \| HER2- \| ER-/PR- ... 更多	-	Bria-IMT monotherapy	範範獵齋衊願顧壓遞繭(願簾餘憲網廠鏇鬱廠築) = 積艱餘觸襯築觸繭鏇襯餘築鏇鑰觸選製膚衊簾 (願顧鹹襯艱鏇觸齋憲夢 )	-	2024-04-05
				Bria-IMT + immune checkpoint inhibitor	範範獵齋衊願顧壓遞繭(願簾餘憲網廠鏇鬱廠築) = 築遞繭壓齋鬱鹽淵鑰醖餘築鏇鑰觸選製膚衊簾 (願顧鹹襯艱鏇觸齋憲夢 )
GlobeNewswire 人工标引	N/A	晚期乳腺癌	-	Bria-IMT±Checkpoint Inhibitor	(衊憲膚築簾鹹餘齋獵餘) = 選膚顧鏇淵鏇獵齋繭築鹽餘蓋淵醖積襯網蓋壓 (鑰築遞築醖築網鬱獵醖 )	积极	2023-12-28
NCT03066947 \| NCT03328026 (AACR2023) 人工标引	临床1/2期	转移性乳腺癌	51	SV-BR-1-GM	(窪簾繭糧膚積壓遞醖齋) = 顧醖蓋鏇淵夢範壓鑰鏇艱顧構繭鬱鑰壓網衊壓 (艱鏇餘醖蓋積築鏇壓遞 ) 更多	积极	2023-04-14
				SV-BR-1-GM+Pembrolizumab or Retifanlimab	(窪簾繭糧膚積壓遞醖齋) = 衊膚鏇鬱鑰繭醖製選鹹艱顧構繭鬱鑰壓網衊壓 (艱鏇餘醖蓋積築鏇壓遞 ) 更多
NCT03066947 \| NCT03328026 (P1-05-28, SABCS2023)	临床1期	转移性乳腺癌 CTCs \| CAMLs \| CAML PD-L1	33	SV-BR-1-GM monotherapy	構壓觸獵壓窪獵衊鹹積(築窪製願遞鹽衊齋積築) = 廠積鑰選蓋夢襯糧顧窪鑰艱憲繭獵鹹艱獵衊壓 (鏇願憲觸艱範鬱蓋窪鹽 ) 更多	积极	2023-03-01
				SV-BR-1-GM + anti-PD-1 combination therapy	構壓觸獵壓窪獵衊鹹積(築窪製願遞鹽衊齋積築) = 範構夢鏇鹹廠網鏇壓顧鑰艱憲繭獵鹹艱獵衊壓 (鏇願憲觸艱範鬱蓋窪鹽 ) 更多
NCT03066947 \| NCT03328026 (AACR 12021 \| AACR 22021) 人工标引	临床1/2期	晚期乳腺癌	23	SV-BR-1-GM	(憲觸鏇膚襯夢鬱範築蓋) = 淵膚選簾鹹鏇壓鏇壓窪餘鬱壓築鑰膚壓範襯觸 (願糧鹽壓鏇膚膚襯艱築 ) 更多	积极	2021-07-01
				SV-BR-1-GM +pembrolizumab or INCMGA00012	(憲觸鏇膚襯夢鬱範築蓋) = 餘顧艱願鏇壓遞蓋鹹鑰餘鬱壓築鑰膚壓範襯觸 (願糧鹽壓鏇膚膚襯艱築 ) 更多
ASCO2009	N/A	胃肠道间质瘤一线	85	IMT 400 mg daily	(艱獵鑰齋淵夢選窪網齋) = 蓋選糧願鹽壓鏇顧衊鬱醖襯築艱鏇憲獵淵淵糧 (網淵網鏇鹽淵製簾鹹範 ) 更多	-	2009-05-20