Bria-IMT (SV-BR-1-GM) / BriaCell - LARVOL DELTA

Bria-ABC vs physician choice in late stage MBC: Early biomarker correlates of the randomized registration trial (AACR 2025) - P3 | "The Bria-IMT™ regimen includes preconditioning w/ cyclophosphamide (300 mg/m²) on day -2/-3, intradermal SV-BR-1-GM inoculations (x4) on day 0, and interferon at inoculation sites (Days 1-3). CPI (retifanlimab 375 mg) may be given between days -2 to 2...Future analyses will assess OS, PFS, ORR, CBR, QoL, and CNS event-free survival as data becomes available. Expected to close to enrollment by 2025, with final analyses planned for 2026."

Biomarker • Clinical • Late-breaking abstract • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • CTCs • HER-2

Survival outcomes in a randomized phase 2 ofBria-IMT: An allogeneic whole cell cancer vaccine (AACR 2025) - P1/2, P3 | "11 pts received pembrolizumab, 44 retifanlimab, w/ 1 pt transitioning from pembrolizumab to retifanlimab. Randomized phase 2 Bria-IMT demonstrated efficacy and safety in heavily pretreated MBC. Post-progression survival exceeding median OS in pts still undergoing survival follow-up suggests long-term benefit extending beyond treatment period. C1 vs C2 CPI initiation showed no statistical or clinically significant difference in OS."

Clinical • IO biomarker • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CSF2 • CTCs • HER-2 • IFNG • PD-L1 • PGR

Bria-OTS+: A versatile therapeutic platform for inducing anti-cancer immunity (AACR 2025) - "Initial results with the SV-BR-1-GM (Bria-IMT) breast cancer cell line, expressing GM-CSF, have shown promise. Bria-OTS+ is an adaptable cancer immunotherapy platform with strong clinical potential. It expresses a broad range of cancer antigens, including Tumor-Associated Antigens and Post-Translational Modifications, to stimulate robust immune responses. The platform activates both adaptive and innate immunity, overcoming immune escape by engaging NK cells in cases of HLA deletion."

IO biomarker • Breast Cancer • Melanoma • Oncology • Solid Tumor • CSF2

Impact of HLA matching on clinical outcomes in a phase 2 trial of Bria-IMT plus anti PD1 in advanced breast cancer. (ASCO 2025) - P1/2 | "Clinical Trial Registration Number: NCT03328026? The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Clinical data • Metastases • P2 data • Breast Cancer • Oncology • Solid Tumor

Bria-IMT + checkpoint inhibitor: Phase I/II survival results compared to benchmark trials in metastatic breast cancer. (ASCO 2025) - P1/2 | "Clinical Trial Registration Number: NCT03328026? The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Checkpoint inhibition • Metastases • P1/2 data • Breast Cancer • Oncology • Solid Tumor

Update on phase III pivotal trial of Bria-IMT + CPI vs physician's choice in advanced metastatic breast cancer (BRIA-ABC). (ASCO 2025) - P1/2 | "Clinical Trial Registration Number: NCT03328026? The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Metastases • P3 data • Breast Cancer • Oncology • Solid Tumor

BriaCell Announces Four Clinical Data Presentations at ASCO 2025 (GlobeNewswire) - "BriaCell Therapeutics Corp...is pleased to announce three clinical data poster presentations and one publish-only abstract at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 30 – June 3 at McCormick Place, Chicago, IL."

Clinical data • Breast Cancer

BriaCell Enrollment Pace Accelerating in Phase 3 Clinical Study in Advanced Metastatic Breast Cancer (Bria-ABC) (GlobeNewswire) - "BriaCell Therapeutics Corp....is pleased to announce that its ongoing pivotal Phase 3 clinical study...has consented over 100 and has enrolled over 75 patients. BriaCell anticipates completing patient enrollment in late 2025 or early 2026, and may report top line data as early as H1-2026....54 clinical sites across 15 states currently enrolling patients including Sylvester Comprehensive Cancer Center, Cancer Care Northwest, Hematology Oncology Associates of Fredericksburg, Northwestern University, Manhattan Hematology/Oncology Associates, New York Cancer and Bood Specialists, and Texas Oncology-Baylor Charles A. Sammons Cancer Center."

P3 data: top line • Trial status • Breast Cancer

BriaCell Phase 2 Survival Data Beats Leading Standard in HR+ Breast Cancer (GlobeNewswire) - P1/2 | N=36 | NCT03328026 | Sponsor: BriaCell Therapeutics Corporation | "BriaCell Therapeutics Corp...announces new positive survival data in its Phase 2 study of Bria-IMT plus check point inhibitors (CPI), outperforming ADC drugs in hormone receptor positive (HR+) metastatic breast cancer (MBC) patients....the survival data of these 25 patients (17.3 months) exceeds those of the current ADC standard of care TRODELVY (14.4 months). The survival data for the Bria-IMT regimen + immune check point inhibitor in the triple negative breast cancer (TNBC), characterized by the absence of estrogen (ER), progesterone (PR) and human epidermal growth factor (HER2) receptors, was similar to TRODELVY but still markedly higher (70%) than those of chemotherapy."

P2 data • Hormone Receptor Positive Breast Cancer • Triple Negative Breast Cancer

BriaCell to Present Clinical and Preclinical Data at the 2025 AACR Conference (GlobeNewswire) - "BriaCell Therapeutics Corp...is pleased to announce that the Company will be presenting three posters at the 2025 American Association for Cancer Research (AACR) Annual Meeting taking place from April 25th – 30th at McCormick Place Convention Center, Chicago, IL."

Clinical data • Preclinical • Breast Cancer • Oncology

BRIA-ABC: Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer. (clinicaltrials.gov) - P3 | N=404 | Recruiting | Sponsor: BriaCell Therapeutics Corporation | Trial completion date: Dec 2025 ➔ Jun 2026 | Trial primary completion date: Jun 2025 ➔ Jan 2026

Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • PGR

Second Data Safety Monitoring Board Issues Positive Recommendation to Continue BriaCell’s Phase 3 Study in Metastatic Breast Cancer (GlobeNewswire) - "BriaCell Therapeutics Corp...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...and recommended continuation of the ongoing study without any modifications....We look forward to sharing additional updates from BriaCell’s pivotal Phase 3 trial in the coming months."

DSMB • Trial status • Breast Cancer

PD-L1 Measured by Blood Test Reveals Important Clinical Information (PRNewswire) - P1/2 | N=36 | NCT03328026 | Sponsor: BriaCell Therapeutics Corporation | "Researchers from Creatv Bio...and The Mayo Clinic (Jacksonville, FL), in collaboration with BriaCell Therapeutics Corporation (Philadelphia, PA), have shown in a study of Metastatic Breast Cancer (mBC) patients treated with SV-BR-1-GM vaccine in combination with an immunotherapy drug, that the vaccine can change the PD-L1 expression of the tumor. The PD-L1 expression is determined by the LifeTracDx blood test, which captures Circulating Tumor Cells (CTCs) and Cancer Associated Macrophage-Like cells (CAMLs) by staining the cells for PD-L1 marker.

P1/2 data • Breast Cancer

BRI-ROL-001: Combination Study of SV-BR-1-GM With Retifanlimab (clinicaltrials.gov) - P1/2 | N=36 | Enrolling by invitation | Sponsor: BriaCell Therapeutics Corporation | Trial completion date: Jun 2024 ➔ Nov 2028 | Trial primary completion date: Jun 2024 ➔ Nov 2025

Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • PGR • PIK3CA

BriaCell Presents Unprecedented Overall Survival Data in Metastatic Breast Cancer in Spotlight Poster at 2024 SABCS (GlobeNewswire) - P1/2 | N=36 | NCT03328026 | Sponsor: BriaCell Therapeutics Corporation | "Interim analysis after at least one year of Bria-IMT plus CPI regimen shows the following: Significantly lowered levels of circulating tumor cells (CTCs) and cancer associated macrophage-like cells (CAMLs) in 40% of heavily pre-treated MBC patients; Lower CTCs/CAMLs levels were significantly correlated with better survival outcomes (i.e. better PFS and trended for better OS); Bria-IMT appeared to increase PD-L1 levels in 15 patients which correlated with better clinical responses to combination treatment with the anti-PD-1 check point inhibitor retifanlimab."

P1/2 data • Breast Cancer

BriaCell Presents Unprecedented Overall Survival Data in Metastatic Breast Cancer in Spotlight Poster at 2024 SABCS (GlobeNewswire) - "BriaCell successfully identified immunogenic (i.e. immune system activating) peptides in patients treated with Bria-IMT, a cell-based cancer vaccine, and showed Bria-IMT’s ability to produce a targeted immune response against tumor antigens...Key immunogenic peptides detected included those with post-translational modifications (PTMs), such as citrullination and cysteinylation, an important type of neoantigen that may be shared across many patients with cancer; Highlighted the advantage of cell-based cancer vaccines over RNA and peptide-based vaccines including their ability to present a broad and diverse repertoire of antigens (i.e. both conventional and unconventional types)....In conclusion, scientific data presented suggests that the unique mechanism of cell-based cancer vaccines may reduce cancer cells’ immune escape and may potentially lead to strong and long-lasting clinical outcomes in cancer patients."

Clinical • Breast Cancer

BriaCell 2024 SABCS Poster Highlights Ability of Bria-IMT Regimen to Increase Cancer-Fighting Immune Cells in Metastatic Breast Cancer (GlobeNewswire) - P1/2 | N=36 | NCT03328026 | Sponsor: BriaCell Therapeutics Corporation | "BriaCell employed this advanced imaging technology as a precision diagnostic tool to monitor patients’ immune system responses in its phase 2 study, establishing the ability of the Bria-IMT regimen to induce tumor infiltration with CD8+ 'killer' T cells...Using metastatic site-specific CD8+ PET imaging technology, BriaCell reports the following in 6 patients treated {median # of prior treatments = 7; prior lines of treatment included antibody-drug conjugates (ADCs) and CPIs} with Bria-IMT plus CPI after 9 cycles (27weeks) of treatment: Treatment generally well tolerated; Reduction in tumor markers in 2 patients who had cold tumors turn hot; 3 out of the 6 patients (50%) showed a decrease in neutrophil/lymphocyte ratio (NLR) at cycle 2 when compared to baseline values suggesting immune system activation of the patients."

P2 data • Breast Cancer

BriaCell Presents Unprecedented Overall Survival Data in Metastatic Breast Cancer in Spotlight Poster at 2024 SABCS (GlobeNewswire) - "The poster provides the details of a planned Phase 2 study design expanding the use of Bria-IMT + CPI to tumor agnostic cancer patients (i.e. kidney cancer, brain cancer, etc.) with central nervous system (CNS) metastasis."

Clinical protocol • New P2 trial • Brain Cancer • Kidney Cancer

ASTRO-VAC CNS : Bria-IMT in the Management of Tumor Agnostic Metastatic CNS Lesions (SABCS 2024) - P1/2, P3 | " This is a single site, open label, single-arm, phase 1, multi disease basket trial to evaluate the feasibility and efficacy of the Bria-IMT regimen in combination with pembrolizumab (CPI) in patients with CNS metastases who progress on SOC therapy...The Bria-IMT regimen includes: Day -2/-3 Cyclophosphamide 300mg/m2, Day 0; 20 million irradiated SV-BR-1-GM cells intradermally in 4 sites, and 0.6 mcg peg α interferon subcutaneously in the inoculation sites...Follow-up will be continued for 3 months after treatment termination. Each subject is anticipated to participate in the trial for approximately 6 months unless withdrawn from study or is lost to follow-up before the end of the study."

Metastases • Pan tumor • Breast Cancer • Oncology • CD8 • CSF2

PD-L1 Upregulation in Circulating Tumor Associated Cells Predicts for clinical outcomes in a phase I/II clinical trial using SV-BR-1-GM vaccine with the check point inhibitor retifanlimab in Metastatic Breast Cancer Patients, an Interim Analysis (SABCS 2024) - P1/2 | " SV-BR-1-GM treatment includes low pre-dose cyclophosphamide, intradermal inoculation of ~20 million irradiated SV-BR-1-GM cells, post-dose local interferon-α with cycles and an anti-PD-1 inhibitor (retifanlimib), with cycles every 3 weeks. In an interim analysis of heavily treated mBC patient population, we observed that treatment with the SV-BR-1-GM regimen was associated with decreases in the presence of CTCs and CAMLs in 38% of patients, which significantly correlated with better PFS and trended for better OS within 2 years. Further, SV-BR-1-GM therapy appeared to upregulate PD-L1 in n=13 patients which appeared to have better responses to combination treatment with the anti-PD-1 check point inhibitor retifanlimab."

Clinical • Clinical data • IO biomarker • Metastases • P1/2 data • Breast Cancer • Oncology • Solid Tumor • CTCs

Overall Survival Results of Bria-IMT Allogenic Whole Cell-Based Cancer Vaccine. (SABCS 2024) - P1/2, P3 | "Methods This phase I/II study evaluated the Bria-IMT regimen consisting of low-dose cyclophosphamide (Day –2) followed by SV-BR-1-GM and CPI (pembrolizumab or retifanlimab), then low-dose local peg- interferon α, all given every 3 wks. In heavily pretreated MBC patients, the Bria-IMT regimen demonstrated promising results across all subtypes of breast cancer with favorable safety profiles. There was no significant difference in OS among patients treated with immediate vs. delayed CPI."

Clinical • IO biomarker • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Triple Negative Breast Cancer • CSF2 • CTCs • HER-2 • IFNG • PD-L1 • PGR

Bria-IMT CD8+ Tumor Infiltrating Lymphocytes Turn "Cold" Tumor "Hot" in Metastatic Breast Cancer (SABCS 2024) - P1/2 | "It also provides support that the Bria-IMT combination immune-based therapy can result in an increase of CD8+ tumor infiltrating lymphocytes in breast cancer metastatic sites as well as in lymphoid organs. This advance may aid in triaging patients, adjudicating pseudo-progression and predicting clinical benefit of immune based therapies."

Metastases • Tumor-infiltrating lymphocyte • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • CD8 • HER-2 • PGR

Identification of Antigenic Determinants in SV-BR-1 derived Cellular Breast Cancer Vaccines (SABCS 2024) - "This study identified a wide array of antigenic determinants in SV-BR-1 derived cellular breast cancer vaccines using MHC-associated peptide profiling and antigen/epitope mapping. The analysis revealed diverse peptides, including PTM and mutated variants, in MHC class I and II molecules. These findings highlight the potential of vaccines like Bria-IMT and Bria-OTS+ to elicit strong immune responses by presenting a broad range of tumor-specific antigens, paving the way for improved personalized cancer immunotherapy strategies."

IO biomarker • Breast Cancer • Oncology • Solid Tumor • CD4 • CD40LG • CD8 • CSF2 • IL2 • TNFRSF9

BriaCell Receives Green-Light from Data Safety Monitoring Board for its Phase 3 Study in Metastatic Breast Cancer (GlobeNewswire) - "BriaCell Therapeutics Corp...announces that the Data Safety Monitoring Board (DSMB), an independent group of experts who review and monitor safety data of a clinical study to determine if a study should continue, be modified, or be halted early, has completed its first review of safety events in patients enrolled in BriaCell’s pivotal randomized Phase 3 study of Bria-IMT plus an immune checkpoint inhibitor (CPI) combination regimen (NCT06072612). The DSMB issued a statement recommending continuation of the study in metastatic breast cancer patients. BriaCell’s pivotal Phase 3 study is currently being conducted under Fast Track Designation with the Food and Drug Administration (FDA)."

DSMB • Breast Cancer • Oncology • Solid Tumor

BriaCell 2024 SABCS Spotlight Poster to Showcase Positive Overall Survival Data Across All Patient Subtypes in Metastatic Breast Cancer (GlobeNewswire) - "Five poster presentations to feature increased presence of cancer fighting CD8+ 'killer' T cell in metastatic breast cancer tumors, response in central nervous system (CNS) metastases and additional Bria-IMT clinical data from the Phase 2 trial of Bria-IMT + immune check point inhibitor in metastatic breast cancer....'We plan to confirm the potential use of key biomarkers to predict patient clinical outcomes in the Bria-IMT plus CPI ongoing pivotal Phase 3 study (NCT06072612) in metastatic breast cancer.'"

Clinical data • Breast Cancer • Solid Tumor