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)

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.

01 Jul 2015·AnesthesiologyQ1 · MEDICINE

Effects of an Innovative Psychotherapy Program for Surgical Patients

Q1 · MEDICINE

Article

Author: Krampe, Henning ; Wernecke, Klaus-Dieter ; Romanczuk-Seiferth, Nina ; Lau, Alexandra ; Glaesmer, Heide ; Balzer, Felix ; Spies, Claudia D. ; Kerper, Léonie F. ; Neumann, Tim ; Weiß-Gerlach, Edith ; Salz, Anna-Lena ; Tafelski, Sascha ; Brähler, Elmar ; Neuner, Bruno

AbstractBackground:The stepped care program Bridging Intervention in Anesthesiology (BRIA) aims at motivating and supporting surgical patients with comorbid mental disorders to engage in psychosocial mental healthcare options. This study examined the efficacy of BRIA.Methods:This randomized, parallel-group, open-label, controlled trial was conducted in the preoperative anesthesiological assessment clinics and surgical wards of a large university hospital in Germany. A total of 220 surgical patients with comorbid mental disorders were randomized by using the computer-generated lists to one of two intervention groups: BRIA psychotherapy sessions up to 3 months postoperatively (BRIA) versus no psychotherapy/computerized brief written advice (BWA) only. Primary outcome was participation in psychosocial mental healthcare options at month 6. Secondary outcome was change of self-reported general psychological distress (Global Severity Index of the Brief Symptom Inventory) between baseline and month 6.Results:At 6-month follow-up, the rate of patients who engaged in psychosocial mental healthcare options was 30% (33 of 110) in BRIA compared with 11.8% (13 of 110) in BWA (P = 0.001). Number needed to treat and relative risk reduction were 6 (95% CI, 4 to 13) and 0.21 (0.09 to 0.31), respectively. In BRIA, Global Severity Index decreased between baseline and month 6 (P < 0.001), whereas it did not change significantly in BWA (P = 0.197).Conclusions:Among surgical patients with comorbid mental disorders, BRIA results in an increased engagement in subsequent therapy options and a decrease of general psychological distress. These data suggest that it is reasonable to integrate innovative psychotherapy programs into the context of interdisciplinary surgical care.

01 Sep 2004·Journal of nuclear medicine : official publication, Society of Nuclear Medicine

Molecular transport mechanisms of radiolabeled amino acids for PET and SPECT.

Article

Author: Langen, Karl-Josef ; Bröer, Stefan

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

08 Nov 2024

·www.globenewswire.com

BriaCell Showcases Robust Anti-Cancer Activity of Personalized Off-the-Shelf Immunotherapy Pipeline at the 2024 SITC Conference

BriaCell’s clinical candidates for next generation breast cancer (Bria-BRES+™) and prostate cancer (Bria-PROS+™) generate robust anti-cancer activity in preclinical modelsNovel therapy activates both innate and adaptive immune systemsProof of concept Phase 1/2 Study of Bria-BRES™ in metastatic breast cancer currently underway PHILADELPHIA and VANCOUVER, British Columbia, Nov. 08, 2024 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, today is pleased to report preclinical data showing strong anti-cancer activity of its next generation, personalized, off-the-shelf, cell-based breast and prostate cancer immunotherapies, Bria-BRES+™ and Bria-PROS+™, respectively, during a poster session at the 2024 Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting, held November 6-10, 2024, in Houston, TX. Bria-OTS+™ is an Off-The-Shelf (i.e. pre-manufactured and ready for use) cell-based personalized immunotherapy platform for cancer. First generation Bria-OTS™ immunotherapy is HLA matched to individual patients and expresses a variety of cancer-related antigens, including Tumor-Associated Antigens (TAAs) and Post-Translational Modifications (PTMs). Bria-OTS+™ further expresses multiple immune activating cytokines and co-stimulatory molecules in addition to immune boosting granulocyte-macrophage colony-stimulating factor (GM-CSF). The Bria-OTS+™ platform technology includes both Bria-BRES+™ and Bria-PROS+™, expansions of the Bria-OTS™ program. “Bria-OTS+™ represents a significant advancement in the fight against cancer, leveraging gene-modified allogeneic tumor cells as a comprehensive immunotherapeutic platform. This innovative approach is set to address major challenges in cancer therapy, including effective antigen selection, T-cell immune escape, and manufacturing complexities. The development of Bria-OTS+™ builds on the success of BriaCell's initial platform, Bria-IMT™, which has shown promising clinical results in metastatic breast cancer,” commented Miguel A. Lopez-Lago, PhD, BriaCell’s Chief Scientific Officer. “We are thrilled with our pre-clinical data confirming the expected high potency and potential for long-lasting anti-tumor activity of our novel next-generation immunotherapy in multiple cancer models,” commented Dr. William V. Williams, BriaCell’s President and CEO. “We believe that activating both adaptive and innate immune systems is a novel and highly effective approach for cancer treatment and look forward to generating proof of concept data in our ongoing Phase 1/2 study of Bria-OTS™ in metastatic breast cancer, and other cancers.” The poster is summarized below and linked here: https://briacell.com/scientific-publications/. Title: Bria-OTS+™: A Cellular Cancer Vaccine Platform Targeting Innate and Adaptive ImmunityLocation: Exhibit Halls A B George R. Brown Convention Center, Houston, TX Date and Time: Friday, Nov. 8, 2024, 9:00 am -7:00 pm CST Results: Both Bria-BRES+™ (clinical candidate for breast cancer) and Bria-PROS+™ (clinical candidate for prostate cancer) activated key components of the innate immune system, the body’s first line of defense against cancer, including Natural Killer (NK) cells and NKT cells in preclinical cancer models.Activation of the innate immune system by Bria-BRES+™ and Bria-PROS+™ was mediated by CD86, IL-12, NKG2D and inhibited by HLA class I moleculesBria-BRES+™ and Bria-PROS+™ both effectively activated immune cells to destroy breast cancer and prostate cancer cells in a pre-clinical cancer modelBoth Bria-BRES+™ and Bria-PROS+™ activated key adaptive immune responses demonstrating immunological memory and suggesting potent and durable anti-cancer effects in cancer patients Conclusion:The characteristics of the next generation Bria-OTS+™ immunotherapy platform include the following: Engages multiple facets of the adaptive immune responseActivates components of the innate immune systemSpecifically activates Natural Killer (NK) cells to offset cancer immune escape caused by the loss of human leukocyte antigens (HLA)Designed for both personalized and ready-to-use therapy with long-term stabilitySimplified intradermal administration (injection into the skin)Targeted mechanism of action expected drive high efficacy with a favorable side effect profile “The preclinical data demonstrating targeted activation of both the innate and adaptive immune systems suggest potential efficacy and safety across multiple cancer indications,” stated Adam M. Brufsky, MD, PhD, FACP, Professor of Medicine at the University of Pittsburgh School of Medicine and Medical Director of the Magee-Women's Cancer Program. “Personalized off-the-shelf cancer immunotherapy is an especially exciting treatment modality that would benefit many cancer patients.” BriaCell is currently conducting its Phase 1/2 Study of Bria-OTS™ (first generation product), also known as Bria-BRES™, in metastatic breast cancer (listed on ClinicalTrials.gov as NCT06471673). This is a bucket trial with other cancer indications expected to be added soon. The next generation (Bria-OTS+™) is expected to enter the clinic in 1H2025 starting with Bria-PROS+™ for prostate cancer. Bria-OTS+™ leverages advanced biomanufacturing techniques, ensuring scalability and cost-effectiveness, crucial for rapid global deployment. It is designed to target a range of cancer types and strong intellectual property strategy protects Bria-OTS+™ innovations and strengthens BriaCell’s competitive position. Bria-OTS+™ is designed as an open-ended, modular platform, allowing for continuous refinement and the addition of new components. This flexibility enables BriaCell to rapidly adapt to emerging scientific insights and therapeutic needs, ensuring long-term relevance and effectiveness. 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 Bria-OTS+™ addressing certain challenges in cancer therapy, such as effective antigen selection, T-cell immune escape, and manufacturing complexities; BriaCell generating proof of concept data in the ongoing Phase 1/2 study of Bria-OTS+™ in various cancers, such as metastatic breast cancer; the preclinical data of Bria-OTS+™ demonstrating potential efficacy and safety across multiple cancer indications; BriaCell’s personalized off-the-shelf immunotherapy benefiting many cancer patients; BriaCell continuing its clinical study investigations of its novel targeted immunotherapy candidates, including the addition of new cancer indications; and BriaCell’s anticipated timeline of clinical studies on Bria-OTS+™ and Bria-PROS+™, 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 www.sedarplus.ca and on EDGAR at www.sec.gov. Forward-looking statements contained in this announcement are made as of this date, and BriaCell Therapeutics Corp. undertakes no duty to update such information except as required under applicable law. Neither the Toronto Stock Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Toronto Stock Exchange) accepts responsibility for the adequacy or accuracy of this release. Contact Information Company Contact:William V. Williams, MDPresident & CEO1-888-485-6340info@briacell.com Media Relations:Jules AbrahamCORE IRjulesa@coreir.com Investor Relations Contact:CORE IRinvestors@briacell.com

ImmunotherapyVaccine

22 Oct 2024

·www.globenewswire.com

BriaCell Reports Outperforming Metastatic Breast Cancer Patients and Standard-Beating Survival Data

55% of BriaCell patients1 remained alive one year since enrollment in BriaCell’s Phase 2 study, markedly exceeding the survival rate of current standard of care for similar patientsMultiple outperforming patients with overall survival of over 2 yearsSurvival benefit observed even in heavily pre-treated patients who failed treatment with checkpoint inhibitors (CPIs) and/or antibody-drug conjugates (ADCs) Final median overall survival calculation for the Phase 2 study is pending, as many patients remain alive No Bria-IMT™ related discontinuations reported to date PHILADELPHIA and VANCOUVER, British Columbia, Oct. 22, 2024 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, announces new positive survival data, outperforming patients, and survival rates in its Phase 2 metastatic breast cancer (MBC) study. In BriaCell’s Phase 2 clinical study, patients treated with the same Bria-IMT™ regimen formulation being used in the ongoing Phase 3 pivotal trial experienced a one-year survival rate of 55% (i.e. 55% of patients remain alive at least one year after starting on the study). This rate exceeds the survival data of the current standard of care for similar patients (see Table 1). Notably, 4 of 13 patients recruited in 2022 remain in survival follow-up as well, including: Patient 01-009: Overall survival (OS) of 25 months has been reported in a patient who had failed 6 prior treatments prior to the BriaCell regimen. Stable disease and lymph node shrinkage has been recorded during 13 cycles of therapy.Patient 07-001: OS of 24 months. She had stable disease and received 8 cycles of BriaCell’s therapy.Patient 16-003: OS of 15 months and received 8 cycles of therapy with stable disease. Prior to the BriaCell regimen, she had 7 lines of therapy, which included the progression of disease while on the antibody-drug conjugate (ADC) Enhertu.Patient 11-018: OS of 14 months. This previously-reported responder with 100% resolution of her brain metastasis has recently completed her 19th cycle of therapy. “With over 40,000 deaths each year in the US alone, late-stage MBC remains an important unmet medical need for many patients and their families. Approved treatments are restricted by poor survival and harsh side effects,” stated Adam M. Brufsky, MD, PhD, FACP, Professor of Medicine at the University of Pittsburgh School of Medicine and Medical Director of the Magee-Women's Cancer Program. “We are impressed with BriaCell’s promising randomized Phase 2 survival data indicating robust survival and a preferred tolerability profile for Bria-IMT™ and look forward to seeing the data being replicated in BriaCell’s pivotal Phase 3 study.” “A number of patients with metastatic breast cancer have disease progression on currently approved drugs, including CPIs and ADCs, with limited overall survival,” remarked Dr. Aditya Bardia, Program Director of Breast Medical Oncology at UCLA, who was not involved with the BriaCell Phase 2 clinical trial. “BriaCell’s clinical data is interesting and highlights the role of the combination of Bria-IMT™ with CPIs in MBC.” “Significant numbers of patients with metastatic breast cancer do not respond to currently approved drugs, including CPIs and ADCs, and have a very limited lifespan of weeks to a few months,” said Dr. William V. Williams, BriaCell’s President and CEO. “BriaCell’s clinical data supports our hypothesis that our regimen has prolonged survival in patients with metastatic breast cancer who otherwise have not responded to currently available treatments. We look forward to further confirming these impressive data in our ongoing pivotal Phase 3 study, with interim results expected in the second half of 2025. Overall survival is the primary endpoint in our pivotal Phase 3 study.” Table 1: Comparable Analysis of 1 year survival for the BriaCell Phase 2 studyReferenceBreast Cancer TypeMedian prior lines of therapyMedian OS (months)Percent Survival at 1 yearBria-IMT™ plus CPIAll types61% HR+33% TNBC6% HER2+613.4* 15.6**55%Cortes et al.1All types 57% HR+ 18-19% TNBC18-20% HER2+49.1-9.3~38-40%Kazmi et al.2 All types 51-52% HR+ 25-29% TNBC9-24% HER2+27.2-9.830-38%Bardia et al. (TPC arm)3TNBC2-36.9~23% Rugo et al (TPC arm)4HR+ HER2-211.247%* Patients treated with the Phase 3 formulation** Patients treated with the Phase 3 formulation since 2022 1. Cortes J, et al. Annals of Oncology 20182. Kazmi S, et al. Breast Cancer Res Treat. 20203. Bardia A, et al. J Clin Oncol. 20244. Rugo HS, et al. The Lancet. 2023 Abbreviations: HR+: hormone receptor-positiveTNBC: Triple-negative breast cancer (lacks or has low levels of the estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 (HER2))HER2+: Human epidermal growth factor receptor 2 positiveHR+ HER2-: hormone receptor-positive and human epidermal growth factor receptor 2 negativeTPC: Treatment of Physicians Choice The Phase 2 study enrolled 54 heavily pre-treated metastatic breast cancer patients (median number of prior treatments = 6) who received the Bria-IMT™ regimen plus checkpoint inhibitor. Of these 54 patients, 37 were treated with the formulation currently being used in BriaCell’s ongoing pivotal Phase 3 study in metastatic breast cancer (listed on ClinicalTrials.gov as NCT06072612). Final median overall survival calculation for the Phase 2 study is pending, as many patients remain alive. No Bria-IMT™ related discontinuations have been reported to date. 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 statements about: the impact of Bria-IMT™ on patients with metastatic breast cancer; BriaCell’s further clinical development of Bria-IMT™; the Company’s beliefs regarding the results of BriaCell’s pivotal Phase 3 study; and the efficacy of immune check point inhibitors, 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 & CEO 1-888-485-6340 info@briacell.com Media Relations: Jules Abraham CORE IR julesa@coreir.com Investor Relations Contact: CORE IR investors@briacell.com 1 Patients treated with the Bria-IMT™ formulation being used in the phase 3 study.

Phase 2Phase 3ImmunotherapyClinical ResultADC

15 Oct 2024

·www.globenewswire.com

BriaCell Provides Phase 3 Clinical Engagement Update in Metastatic Breast Cancer Pivotal Study

35 sites active and enrolling in pivotal Phase 3 study of Bria-IMT™ combination with immune check point inhibitor in metastatic breast cancer (MBC)Primary endpoint is overall survival (OS) with Bria-IMT™ regimen plus Check Point Inhibitor (CPI) vs treatment of physician’s choiceInterim data analysis planned at 144 events (deaths) could provide full approval and marketing authorizationPivotal Phase 3 study patient enrollment completion is expected in mid-2025 No serious adverse events related to Bria-IMT™ have been reported to date PHILADELPHIA and VANCOUVER, British Columbia, Oct. 15, 2024 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (NASDAQ: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, today provides a clinical engagement update of its pivotal Phase 3 study of Bria-IMT™ in combination with immune check point inhibitor in metastatic breast cancer (MBC). The study will enroll up to 354 patients randomized 1:1 to the BriaCell combination regimen or physician’s choice and will include a small number (n=50) of patients randomized to Bria-IMT™ monotherapy. “We are very pleased to report that patient enrollment is on track for expected completion by mid-2025. We anticipate the interim data analysis of the ongoing pivotal Phase 3 study will confirm the effectiveness of the Bria-IMT™ combination regimen in patients with metastatic breast cancer who failed approved therapies,” stated Dr. William V. Williams, BriaCell’s President and CEO. “Despite multiple approved drugs, breast cancer remains the second-leading cause of cancer death in American women,” stated Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. “We are determined to make our novel immunotherapy available to breast cancer patients whose medical needs remain unmet.” 35 clinical sites (18 main and 17 satellite) are active and enrolling patients in BriaCell’s pivotal Phase 3 study in metastatic breast cancer. Additional sites are in various stages of start-up. Interim data will be analyzed once 144 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. Secondary analyses include comparison of the Bria-IMT™ combination regimen vs Bria-IMT™ monotherapy. BriaCell recently announced impressive Phase 2 survival data in a similar MBC patient population. 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 statements about: the Company’s beliefs about expected timing and completion of patient enrollment in BriaCell’s pivotal Phase 3 clinical study in metastatic breast cancer and the Company’s future reporting of specific patient enrolment numbers; the Company’s proposed analysis of interim data, and the Company’s belief that such interim data will confirm the effectiveness of the Bria-IMT™ combination regimen in certain patients; the Company’s beliefs regarding the availability of the Bria-IMT™ immunotherapy to patients whose medical needs remain unmet; and the Company’s belief that the results of the Phase 3 study could result in full approval and marketing authorization for Bria-IMT™, 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 Media Relations:Jules AbrahamCORE IRjulesa@coreir.com Investor Relations Contact:CORE IRinvestors@briacell.com

ImmunotherapyPhase 3Phase 2Fast Track

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

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Breast Cancer	Phase 3	US	BriaCell Therapeutics Corp.	05 Dec 2023
Metastatic breast cancer	Phase 2	US	BriaCell Therapeutics Corp.	05 May 2017
Metastatic breast cancer	Discovery	US	LumaBridge LLCStartup	05 May 2017
Ovarian Epithelial Carcinoma	Discovery	US	BriaCell Therapeutics Corp.	-

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06072612 (GlobeNewswire) Manual	Phase 2	Metastatic breast cancer	54	Bria-IMT™ regimen + immune checkpoint inhibitor (since 2022)	(eoupzsnjoi) = pmsbalazjn mlobuelvwi (bcadtqsadz ) View more	Positive	11 Sep 2024
				Bria-IMT™ regimen + immune checkpoint inhibitor (total)	(eoupzsnjoi) = tywoksyeks mlobuelvwi (bcadtqsadz ) View more
NCT03328026 (ASCO2024) Manual	Phase 1/2	Metastatic breast cancer \| Advanced breast cancer CAMLs \| CTCs	54	SV-BR-1-GM±pembrolizumab±retifanlimab	(qcoezfqrtn) = fwvcjxxvyw lrgspzhcum (vmcxofgwpf ) View more	Positive	24 May 2024
NCT03328026 (SV-BR-1-GM, ASCO2024)	Phase 2	Metastatic breast cancer	54	Bria-IMT + CPI	lfrypvsxab(shpjrrtdsu) = 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. rdbwixjhcv (wnezntuufk ) View more	Positive	24 May 2024
AACR2024	Not Applicable	Neoplasm Metastasis ER+/PR+ \| HER2- \| ER-/PR- ... View more	-	Bria-IMT monotherapy	xmqeofjopl(pmogkmjqmm) = uhzrtnrtml iocamrnzfd (acyxrlkhze )	-	05 Apr 2024
				Bria-IMT + immune checkpoint inhibitor	xmqeofjopl(pmogkmjqmm) = ojbtgtdthh iocamrnzfd (acyxrlkhze )
GlobeNewswire Manual	Not Applicable	Advanced breast cancer	-	Bria-IMT±Checkpoint Inhibitor	(syvuucqqow) = tvhqbuszmy zxpkpoayva (dlwdgbywpq )	Positive	28 Dec 2023
NCT03066947 \| NCT03328026 (AACR2023) Manual	Phase 1/2	Metastatic breast cancer	51	SV-BR-1-GM	(tfjbxuvpvc) = odrpycpcrv heahhuhafu (odjimnqbsa ) View more	Positive	14 Apr 2023
				SV-BR-1-GM+Pembrolizumab or Retifanlimab	(tfjbxuvpvc) = vjwarongwl heahhuhafu (odjimnqbsa ) View more
NCT03066947 \| NCT03328026 (AACR2021) Manual	Phase 1/2	Advanced breast cancer	23	SV-BR-1-GM	(dbiqrdsxmm) = gwrwikmkix covazowfvg (zlaalpgbxx ) View more	Positive	01 Jul 2021
				SV-BR-1-GM +pembrolizumab or INCMGA00012	(dbiqrdsxmm) = nipzkjidry covazowfvg (zlaalpgbxx ) View more
ASCO2009	Not Applicable	Gastrointestinal Stromal Tumors First line	85	IMT 400 mg daily	(tjcotrhwwt) = kuzywarghc bqomvkcfoi (gmgysdedup ) View more	-	20 May 2009

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