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

BriaCell Highlights Additional Phase 3 Clinical Sites Including Los Angeles Cancer Network and Smilow Cancer Hospital at Yale New Haven (The Manila Times) - "BriaCell Therapeutics Corp...is pleased to announce the addition of two key large cancer centers to its ongoing pivotal Phase 3 clinical study (ClinicalTrials.gov as NCT06072612): Los Angeles Cancer Network and Smilow Cancer Hospital at New Haven. Each has 15 satellite locations. BriaCell anticipates completing patient enrollment in late 2025 or early 2026 and may report top line data as early as H1-2026. 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)."

P3 data: top line • Trial status • Breast Cancer

BriaCell Announces Positive Recommendation from Data Safety Monitoring Board for Pivotal Phase 3 Study in Metastatic Breast Cancer (GlobeNewswire) - "BriaCell Therapeutics...is pleased to report that the independent Data Safety Monitoring Board (DSMB) has completed its third scheduled safety data review of BriaCell’s pivotal Phase 3 study of Bria-IMT plus immune checkpoint inhibitor (CPI) in metastatic breast cancer (NCT06072612). Following its review, the DSMB raised no safety concerns and recommended that the study continue without modifications. DSMB meetings occur quarterly as per the study protocol, and this marks the third consecutive positive recommendation from the DSMB affirming the favorable safety profile observed to date."

DSMB • Breast Cancer

Bria-IMT + checkpoint inhibitor: Phase I/II survival results compared to benchmark trials in metastatic breast cancer. (ASCO 2025) - P1/2, P3 | " 54 pts (22 Ph I, 32 Ph II) enrolled; 11 received pembrolizumab, 44 retifanlimab (1 crossover). The Bria-IMT Ph 3 formulation cohort OS was comparable to ASCENT and TROPiCS-02 (13.43 vs 11.8, 14.4 mos), exceeding TPC arms (6.9, 11.2 mos). CBR (61%) compared favorably to ASCENT (40%) and TROPiCS-02 (34%); ORR (14%) matched or exceeded TPC arms (4%, 14%). These outcomes were observed in a more heavily pretreated population, demonstrating Bria-IMT's clinical activity."

Checkpoint inhibition • IO biomarker • Metastases • P1/2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Immunology • Oncology • Solid Tumor • Triple Negative Breast Cancer • CSF2 • CTCs • HER-2 • IFNG • PD-L1 • PGR

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, P3 | "Matching at Class I seemed to decrease PFS & OS, but did not have a similar effect on ORR and CBR. Both matched and non matched pts demonstrated favorable OS and response rates. These findings support further investigation into specific mechanisms and the clinical significance of HLA matching in immunotherapy response."

Clinical • Clinical data • IO biomarker • Metastases • P2 data • Breast Cancer • Oncology • Solid Tumor • CSF2

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 | "The Bria-IMT regimen consists of: Day -2: Cyclophosphamide 300 mg/m², Day 0: 20M irradiated SV-BR-1-GM cells, Day 2/3: 0.1 mcg pegylated α interferon at each inoculation site. Secondary endpoints: PFS, overall response rate, CBR, CNS event free survival, and TWiST. Safety analyses ongoing; pt reported outcomes assess subjective treatment impact."

Metastases • P3 data • Breast Cancer • Oncology • Solid Tumor • CD4 • CD8 • CSF2

Robust survival and clinical benefit data from its Bria-IMT Phase 2 clinical study (GlobeNewswire) - P1/2 | N=36 | NCT03328026 | Sponsor: BriaCell Therapeutics Corporation | "Trial in Progress poster presents early enrollment data and the overall design of the Phase 3 pivotal trial along with updated clinical outcomes from the Phase 2 Bria-IMT study....In the Phase 2 study of Bria-IMT combined with an immune checkpoint inhibitor (CPI) in 54 heavily pre-treated metastatic breast cancer (MBC) patients (median of six prior systemic therapies; range 2–13), Bria-IMT demonstrated promising efficacy and safety. Notably, 44% of patients had failed a prior antibody-drug conjugate, and 20% had failed a prior CPI. Among these patients, the overall clinical benefit rate (CBR; defined as CR, PR, or SD) was 55%, with CBRs of 100% in HER2+, 55% in HR+/HER2-, and 45% in triple-negative breast cancer (TNBC) subgroups, indicating antitumor activity across MBC subtypes."

P2 data • Trial status • Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Triple Negative Breast Cancer

American Oncology Network Announces Research Studies Presented at ASCO 2025 Annual Meeting (GlobeNewswire) - "American Oncology Network (AON)...is pleased to announce that multiple research studies co-authored by AON physicians and leaders were selected for presentation at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting, held May 30-June 3 in Chicago."

Clinical data • Breast Cancer • Neuroendocrine Neoplasm

Bria-IMT + checkpoint inhibitor: Phase I/II survival results compared to benchmark trials in metastatic breast cancer (GlobeNewswire) - "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%)."

Retrospective data • Breast Cancer

BriaCell Abstracts Showcase Positive Survival and Clinical Benefit Data at ASCO 2025 (GlobeNewswire) - "BriaCell Therapeutics Corp...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."

Clinical data • Breast Cancer

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

BriaCell Reports “Late-Breaker” Phase 3 Data at AACR 2025: Positive Tolerability Profile and Potential Response Biomarkers Identified (GlobeNewswire) - P3 | N=404 | BRIA-ABC (NCT06072612) | Sponsor: BriaCell Therapeutics Corporation | "BriaCell Therapeutics Corp...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....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)."

P3 data • Breast Cancer

Survival outcomes in a randomized phase 2 of Bria-IMT: An allogeneic whole cell cancer vaccine (GlobeNewswire) - P1/2 | N=36 | NCT03328026 | Sponsor: BriaCell Therapeutics Corporation | "BriaCell Therapeutics Corp...is presenting positive data from its Phase 2 study of lead product candidate, Bria-IMT, in metastatic breast cancer...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."

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

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

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

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