Latest news with #GiuseppeDelPriore
Yahoo
15-07-2025
- Business
- Yahoo
BriaCell Adds Mayo Clinic to Phase 3 Study in Metastatic Breast Cancer
PHILADELPHIA and VANCOUVER, British Columbia, July 15, 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, is pleased to announce the addition of a key clinical site, Mayo Clinic, to its ongoing pivotal Phase 3 clinical study ( as NCT06072612) in metastatic breast cancer. BriaCell's Phase 3 study now has 69 active clinical sites across 15 states, including Mayo Clinic, DHR Health Oncology Institute, Hematology Oncology Associates of Fredericksburg, Los Angeles Cancer Network, Manhattan Hematology/Oncology Associates, New York Cancer & Blood Specialists, Northwestern University, Smilow Cancer Hospital at Yale New Haven, Sylvester Comprehensive Cancer Center, Texas Oncology-Baylor Charles A. Sammons Cancer Center, and University of Arizona. 'We are very excited to be working with renowned clinical experts at a leading cancer center like Mayo Clinic, who also participated in BriaCell's Phase 2 study,' stated Dr. Giuseppe Del Priore, BriaCell's Chief Medical Officer. 'We strongly believe that our novel immunotherapy has the potential to transform cancer care for patients and their families.' BriaCell's pivotal Phase 3 clinical study is evaluating BriaCell's lead clinical candidate, Bria-IMT™, plus immune check point inhibitor (CPI) versus physician's choice in advanced metastatic breast cancer (Bria-ABC). 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. BriaCell recently (ASCO 2025) 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 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 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 the Company's beliefs regarding the potential of the Bria-IMT therapy to transform cancer care; the Company's anticipated timeline for analyzing interim data; the Company's analysis of interim data 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 and on EDGAR at 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@ Investor Relations Contact:investors@
Yahoo
23-05-2025
- Business
- Yahoo
BriaCell Abstracts Showcase Positive Survival and Clinical Benefit Data at ASCO 2025
PHILADELPHIA and VANCOUVER, British Columbia, May 23, 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 announces the presentation of positive survival and clinical benefit data in three clinical poster presentations and one publish-only abstract at the upcoming 2025 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 30 – June 3 at McCormick Place, Chicago, IL. 'We are highly encouraged by the survival and clinical benefit data from our Phase 2 Bria-IMT™ study which meets and outperforms outcomes seen with FDA approved therapies - despite our patients being more heavily pre-treated,' stated Dr. William V. Williams, BriaCell's President & CEO. 'These results reinforce our belief in Bria-IMT's potential to address the urgent, unmet needs of patients with metastatic breast cancer and we look forward to confirming results in our ongoing pivotal Phase 3 study.' 'These data provide additional validation of the mechanism of action and support the clinical efficacy of Bria-IMT,' noted Giuseppe Del Priore, MD, MPH, BriaCell's Chief Medical Officer. 'Importantly, the regimen has been well-tolerated and its favorable safety and efficacy profile positions it as a promising, less toxic therapeutic option for patients battling metastatic breast cancer.' The details of the poster presentation sessions and publish-only abstract are listed below. Abstract Title: Update on phase III pivotal trial of Bria-IMT + CPI vs physician's choice in advanced metastatic breast cancer (BRIA-ABC) Session Date and Time: June 2, 2025 9:00 AM-12:00 PM CDTAbstract Number for Publication: TPS1138 Poster Board Number: 108aSession Type and Title: Poster Session – Breast Cancer—Metastatic Preliminary selected clinical and biomarker data from BriaCell's ongoing pivotal Phase 3 study of Bria-IMT plus an immune checkpoint inhibitor (CPI) in metastatic breast cancer (NCT06072612). Abstract Title: Bria-IMT + checkpoint inhibitor: Phase I/II survival results compared to benchmark trials in metastatic breast cancerSession Date and Time: June 2, 2025 9:00 AM-12:00 PM CDTAbstract Number for Publication: 1096Poster Board Number: 75Session Type and Title: Poster Session – Breast Cancer—Metastatic Phase 2 study of Bria-IMT in combination immunotherapy with an immune checkpoint inhibitor (CPI) consisted of 54 patients; 11 received pembrolizumab, 44 retifanlimab (1crossover). Table 1: Median overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and clinical benefit rate (CBR) were evaluated against two pivotal Phase 3 studies of FDA approved drugs, ASCENT (Trodelvy® (SG) or Treatment of Physicians Choice (TPC) in triple-negative breast cancer (TNBC)) and TROPiCS-02 (SG or TPC in Hormone Receptor +/HER2- MBC) Trial (Cohort) Age (median, range) Prior Therapies (median, range) OS (months) PFS (months) ORR(%) CBR(%) Bria-IMT (Overall Cohort) 61 (38-81) 6 (2-13) 9.9 (1.8-30.3) 3.6 10% 55% Bria-IMT (Phase 3 regimen) 62 (44-80) 6 (2-13) 13.43 (1.8-30.3) 3.6 (1.8-16.5) 14% 61% ASCENT (SG) 54 (27-82) 4 (2-17) 11.8 4.8 31% 40% ASCENT (TPC) 53 (27-81) 4 (2-14) 6.9 1.7 4% 8% TROPiCS-02 (SG) 57 (49-65) 3 14.4 5.5 21% 34% TROPiCS-02 (TPC) 55 (48-63) 3 11.2 4 14% 22% Bria-IMT was well-tolerated with no treatment-related discontinuations. 22% of patients are still in active survival follow up. This analysis does not stratify Bria-IMT patients by hormone receptor or HER2 status, and the dataset reflects the information available at the time of abstract submission. Updated data will be shared during the company's presentation at ASCO 2025. PFS (median) and OS (median): Patients treated with Bria-IMT's selected Phase 3 formulation (without IFNγ; N = 37) demonstrated significantly improved progression-free survival (3.6 vs. 2.6 months; P = 0.01) and overall survival (13.4 vs. 6.9 months; P = 0.01) compared to those who received the alternate formulation not advanced to Phase 3. The overall survival observed in the Phase 3 formulation cohort (13.4 months) was comparable to that reported in the ASCENT (11.8 months) and TROPiCS-02 (14.4 months) studies and exceeded survival outcomes in their respective treatment of physician's choice (TPC) arms (6.9 and 11.2 months). BriaCell's Phase 2 study also achieved a Clinical Benefit Rate (CBR) of 61%, outperforming ASCENT (40%) and TROPiCS-02 (34%), and an Objective Response Rate (ORR) of 14%, which matched or exceeded the TPC arms in both studies (4% and 14%). Importantly, these outcomes were achieved in a more heavily pretreated patient population than those in the comparator trials—highlighting Bria-IMT's strong anti-cancer activity. The favorable efficacy profile of the Phase 3 formulation supports its continued evaluation in BriaCell's ongoing pivotal Phase 3 trial comparing Bria-IMT to treatment of physician's choice (NCT06072612). Abstract Title: Trial in progress: A study of Bria-OTS™ cellular immunotherapy in metastatic recurrent breast cancerSession Date and Time: June 2, 2025 9:00 AM-12:00 PM CDTAbstract Number for Publication: TPS1136Poster Board Number: 107aSession Type and Title: Poster Session – Breast Cancer—Metastatic Heavily pre-treated MBC patients were treated in a dose escalation Phase 1/2 study of Bria-OTS monotherapy (single agent). The Phase 1 part of the study has enrolled and treated 3 patients. The first patient treated with single agent therapy has confirmed resolution of a breast cancer metastasis in the lung and remains on study. Publish-Only Abstract Title: Impact of HLA Matching on Clinical Outcomes in a Phase 2 Trial of Bria-IMT Plus Anti PD1 in Advanced Breast Cancer Following the presentations, copies of the presentations will be posted on About BriaCell Therapeutics Corp. BriaCell is a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care. More information is available at 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 successful completion of the pivotal Phase 3 study supporting biologics license application, priority review, full approval, and commercialization; Bria-IMT's potential to address the urgent, unmet needs of patients with metastatic breast cancer; BriaCell confirming results in their ongoing pivotal Phase 3 study; Bria-IMT being positioned as a promising, less toxic therapeutic option for patients battling metastatic breast cancer; BriaCell presenting at the 2025 American Society of Clinical Oncology and the contents of such presentations 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 and on EDGAR at 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@ Investor Relations Contact:investors@
Yahoo
20-03-2025
- Business
- Yahoo
Second Data Safety Monitoring Board Issues Positive Recommendation to Continue BriaCell's Phase 3 Study in Metastatic Breast Cancer
PHILADELPHIA and VANCOUVER, British Columbia, March 20, 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, announces that the external Data Safety Monitoring Board (DSMB), an independent group of experts who review and monitor the safety data of the BriaCell clinical study to determine if the study should continue, be modified, or be halted, has completed its second safety data review of BriaCell's pivotal Phase 3 study of Bria-IMT plus immune checkpoint inhibitor (CPI) in metastatic breast cancer (NCT06072612) and recommended continuation of the ongoing study without any modifications. BriaCell's pivotal Phase 3 study is currently being conducted under Fast Track Designation with the Food and Drug Administration (FDA). 'We are very pleased with the safety and tolerability profile of Bria-IMT plus immune checkpoint inhibitor (CPI) combination in metastatic breast cancer to date,' stated Dr. William V. Williams, BriaCell's President & CEO. 'The DSMB's second positive data review and recommendation to continue with patient enrollment in BriaCell's pivotal Phase 3 study clinical trial is highly encouraging and further highlights the potential of our groundbreaking novel immunotherapy to treat this urgent medical need.' 'Metastatic breast cancer is a devastating disease for patients and their families, and the DSMB's positive review represents an important step forward towards our goal of transforming cancer care, and improving patients' survival and quality of life outcomes,' noted Giuseppe Del Priore, MD, MPH, BriaCell's Chief Medical Officer. 'We look forward to sharing additional updates from BriaCell's pivotal Phase 3 trial in the coming months.' About BriaCell Therapeutics Corp. BriaCell is a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care. More information is available at 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 clinical advancement of Bria-IMT as a safe and effective treatment option for metastatic cancer patients; the ability of Bria-IMT to transform cancer care in metastatic breast cancer patients; the potential use of the combination regimen for metastatic breast cancer patients; the potential of BriaCell's novel immunotherapy to be a groundbreaking treatment for metastatic breast cancer; and BriaCell sharing additional updates about its pivotal Phase 3 trial in the coming months, 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, 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 and on EDGAR at 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@ Investor Relations Contact:investors@ in to access your portfolio
