Bria-OTS / BriaCell - LARVOL DELTA

BriaCell to Present Robust Anti-Cancer Activity of Bria-OTS+ in Breast and Prostate Cancer Models (GlobeNewswire)

Preclinical • Breast Cancer • Prostate Cancer

BriaCell Presents Robust Anti-Cancer Activity of Bria-OTS+ at SITC 2025 (GlobeNewswire) - "Both Bria-BRES+ and Bria-PROS+ produced sustained, and durable anti-cancer immune responses that may translate into prolonged clinical benefit for patients treated with the Bria-OTS+ platform of whole cell immunotherapies."

Preclinical • Breast Cancer • Prostate Cancer

Redefining Cancer Vaccines: Bria-OTS+ Integrates Trained Innate Immunity and Adaptive Memory to Overcome Immune Resistance (SITC 2025) - "Immune profiling demonstrated hallmarks of trained innate immunity and adaptive memory, supporting the potential for sustained, durable immune responses.Conclusions Bria-OTS+ drives coordinated activation of T cells and NK cells, enables HLA-matched precision therapy, and provides an off-the-shelf, cost-effective option through its allogeneic design. It also induces durable immune responses via trained innate immunity and adaptive memory."

IO biomarker • Genito-urinary Cancer • Melanoma • Oncology • Prostate Cancer • Solid Tumor • CD40 • CD8 • CD80 • CD86 • CSF2 • IFNA1 • IL12A • IL7

BriaCell Announces Collaboration with MSK Accelerator to Advance Bria-OTS+ for Breast Cancer (GlobeNewswire) - "The collaboration starts with manufacturing, IND development and clinical protocol support for a Phase 1 clinical trial with Bria-BRES+, BriaCell’s next generation personalized immunotherapy for patients with breast cancer under the Bria-OTS+ platform."

Licensing / partnership • Breast Cancer

BriaCell to Present Bria-OTS+ Preclinical Data at SITC 2025 Annual Meeting (GlobeNewswire)

Preclinical • Oncology

BriaCell’s Bria-OTS+ Mechanism of Action Validated in Highly Rated Peer Reviewed Cancer Journal (GlobeNewswire) - "Data from BriaCell and the US National Cancer Institute (NCI) support the cancer cell killing potential of BriaCell’s Bria-OTS+ platform."

Preclinical • Oncology

Trial in progress: A study of Bria-OTS cellular immunotherapy in metastatic recurrent breast cancer. (ASCO 2025) - P1/2 | "Key Exclusion Criteria: Concurrent anti-cancer treatment or concurrent cancer; Anti-cancer treatment within 3 weeks of first treatment; History of hypersensitivity to study therapies; New York Heart Association stage 3-4 cardiac disease; Moderate-severe pleural or pericardial effusion; Pregnant or nursing; HIV+; Known immunodeficiency or ongoing treatment with immunosuppressive therapy >10 mg/day prednisone equivalent; Severe psychiatric or other clinically progressive major medical problems...During the Phase 1 combination and Phase 2 expansion phases, all patients will be treated with BC1 cells as part of the Bria-OTS regimen, which includes cyclophosphamide 300 mg/m2 2-3 days prior to BC1 cell inoculation, and concurrent peg-interferon 0.6 mcg s.c. on the day of BC1 cell inoculation...for 2 years. The phase 1 monotherapy part of the study has enrolled and treated 3 patients."

Metastases • Alopecia • Breast Cancer • Heart Failure • Human Immunodeficiency Virus • Immunology • Infectious Disease • Oncology • Psychiatry • Solid Tumor

Clinical progress data from phase 1/2 study of Bria-OTS in metastatic breast cancer. (GlobeNewswire) - "In a dose-escalation Phase 1/2 study, heavily pre-treated MBC patients received Bria-OTS monotherapy (single agent Bria-OTS cells only). The Phase 1 segment enrolled and treated 3 patients with the first patient achieving a confirmed resolution of a breast cancer lung metastasis and remaining on study with single agent Bria-OTS. Following successful completion of safety evaluations, BriaCell has initiated the combination cohort dosing the first patient with Bria-OTS plus checkpoint inhibitor (CPI)."

Trial status • Breast Cancer

BriaCell Bria-OTS Phase 1/2 Study Clears Safety Evaluation; Doses First Patient in Combination with Checkpoint Inhibitor (GlobeNewswire) - "BriaCell Therapeutics...announced that Bria-OTS has cleared its safety evaluation in the Phase 1/2 monotherapy study and has now transitioned to dosing patients in combination with a checkpoint inhibitor (CPI). The first patient has been dosed in the checkpoint inhibitor combination cohort of the ongoing Phase 1/2 study of Bria-OTS (NCT06471673) in metastatic breast cancer....The CPI combination cohort follows the successful completion of a three-patient monotherapy safety run-in....The ongoing study will assess Bria-OTS in combination with a CPI in up to 12 patients with metastatic breast cancer, with safety and objective response rate (ORR) as primary endpoints."

Trial status • Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive 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

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 Confirms 100% Resolution of Lung Metastasis with Bria-OTS (GlobeNewswire) - P1/2 | N=18 | NCT06471673 | Sponsor: BriaCell Therapeutics Corporation | "Complete resolution of lung metastasis confirmed at 4 month follow-up in hormone receptor positive (HR+) breast cancer patient; Treatment well-tolerated and patient remains on study with stable disease elsewhere; Sustained clinical response supports Bria-OTS personalized, off-the-shelf immunotherapy approach in Phase 1/2a metastatic breast cancer study."

P1/2 data • 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

BriaCell Announces Resolution of Lung Metastasis in First Patient treated with Bria-OTS (GlobeNewswire) - P1/2a | N=18 | NCT06471673 | Sponsor: BriaCell Therapeutics Corporation | "BriaCell Therapeutics Corp...is pleased to announce an unprecedented clinical response including resolution of a lung metastasis (breast cancer tumor that spread to the lung) with stable disease elsewhere. This patient is the first metastatic breast cancer (MBC) patient treated with Bria-OTS....This 78-year-old woman with metastatic breast cancer (hormone receptor positive, HER2 negative) had failed several prior lines of therapy and received the lowest dose level in the Phase 1/2a Bria-OTS study. At enrollment on Nov 21, 2024, she had extensive metastases including multiple bone, lymph node and lung metastases. Following 4 injections with Bria-OTS every 2 weeks, the lung metastasis completely resolved, and she had stable disease elsewhere."

P1/2 data • HER2 Negative Breast Cancer

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 Announces First Patient Dosed with Bria-OTS in Metastatic Breast Cancer Study (GlobeNewswire) - "BriaCell Therapeutics...announces that the first patient was dosed in its Phase 1/2 study (ClinicalTrials.gov identifier: NCT06471673) to evaluate the safety and efficacy of Bria-OTS, BriaCell’s personalized next generation immunotherapy. The study will investigate Bria-OTS alone and in combination with immune check point inhibitor tislelizumab (manufactured and supplied by BeiGene, Ltd.) for the treatment of metastatic breast cancer....The Phase 1/2 clinical trial will initially evaluate the safety and efficacy of Bria-OTS as monotherapy and, later, in combination with tislelizumab in advanced breast cancer."

Trial status • Breast Cancer

Bria-OTS+: a cellular cancer vaccine targeting innate and adaptive immunity (SITC 2024) - "Our initial version, SV-BR-1-GM (Bria-IMT), a breast cancer cell line expressing GM-CSF, shows promising clinical data. 2) Precision Therapy: Bria-OTS will be precisely tailored to individual patients based on their unique HLA profiles. 3) Our ready-to-use cell lines offer a rapid, cost-effective treatment option by avoiding the need for personalized cell line production."

IO biomarker • Breast Cancer • Oncology • Solid Tumor • CD40 • CD8 • CD80 • CD86 • CSF2 • IFNA1 • IL12A • IL7

BriaCell Showcases Robust Anti-Cancer Activity of Personalized Off-the-Shelf Immunotherapy Pipeline at the 2024 SITC Conference (GlobeNewswire) - "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 molecules; Bria-BRES+ and Bria-PROS+ both effectively activated immune cells to destroy breast cancer and prostate cancer cells in a pre-clinical cancer model....The next generation (Bria-OTS+) is expected to enter the clinic in 1H2025 starting with Bria-PROS+ for prostate cancer."

New trial • Preclinical • Breast Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study of BRIA-OTS Cellular Immunotherapy in Metastatic Recurrent Breast Cancer (clinicaltrials.gov) - P1/2 | N=18 | Recruiting | Sponsor: BriaCell Therapeutics Corporation

IO biomarker • Metastases • New P1/2 trial • Breast Cancer • Oncology • Solid Tumor • PD-L1 • PD-L2 • PRAME

BriaCell Initiates Patient Enrollment in First-in-Human Study of Bria-OTS in Advanced Metastatic Breast Cancer (GlobeNewswire) - "BriaCell Therapeutics Corp...announces initiation of a first-in-human, Phase 1/2 study evaluating safety and efficacy of Bria-OTS, BriaCell’s personalized off-the-shelf next generation immunotherapy, as monotherapy and in combination with PD-1 inhibitor tislelizumab, in advanced metastatic breast cancer."

Enrollment open • Breast Cancer • Oncology • Solid Tumor

BriaCell Announces Clinical Supply Agreement with BeiGene for Bria-OTS First in Human Study (GlobeNewswire) - "BriaCell Therapeutics Corp...announces a clinical supply agreement with BeiGene, Ltd...to evaluate the safety and efficacy of Bria-OTS, BriaCell’s next generation immunotherapy, in combination with BeiGene's anti-PD-1 antibody, tislelizumab, for the treatment of advanced heavily pretreated metastatic breast cancer....The limited access Phase 1/2 clinical trial will initially evaluate the safety and efficacy of Bria-OTS alone in breast cancer and later in combination with tislelizumab. BriaCell also plans to evaluate Bria-OTS in prostate and other cancers."

Licensing / partnership • Breast Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Bria-OTS immunotherapy platform: Harnessing gene-modified tumor cells to reinvigorate the cancer immunity cycle for precision anti-tumor responses (AACR 2024) - "Our initial version, SV-BR-1-GM, a breast cancer cell line expressing GM-CSF, demonstrates promising clinical outcomes by directly activating CD4+ T-cells in an antigen-specific, HLA-restricted manner. The Bria-OTS cell lines will offer the following key features: 1) multimodal mechanisms of action including thwarting some mechanisms of cancer immune escape. 2) Precision Therapy; Bria-OTS will be precisely matched to individual patients based on their HLA alleles, encompassing over 99% of the U.S. population. 3) rapid, cost-effective treatment as our 'off-the-shelf' cell lines eliminate the need for personalized manufacturing."

IO biomarker • Tumor cell • Breast Cancer • Oncology • Solid Tumor • CD40 • CD80 • CD86 • CSF2 • IFNA1 • IL12A • IL7

BriaCell 2024 AACR Preclinical Poster Confirms Strong Anti-Cancer Activity of Bria-OTS and Bria-PROS Clinical Candidates for Breast and Prostate Cancer (GlobeNewswire) - "BriaCell Therapeutics Corp....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-OTS and Bria-PROS, in a poster session during the 2024 American Association for Cancer Research (AACR) Annual Meeting held from April 5-10 at San Diego Convention Center, San Diego, CA....BriaCell expects to use Bria-OTS and Bria-PROS in its upcoming phase 1/2a clinical studies for breast and prostate cancer, respectively....Bria-OTS and Bria-PROS engage multiple facets of the adaptive immune response. This may result in lasting anti-cancer effects in patients; Specifically activates Natural Killer (NK) cells to counter cancer immune escape caused by the loss of human leukocyte antigens (HLA)."

Preclinical • Breast Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

BriaCell Receives and Executes Letter of Intent to Advance Clinical Development of Breast and Prostate Cancer Immunotherapies (GlobeNewswire) - "BriaCell Therapeutics Corp...announces that it has received and executed a letter of intent with Paula Pohlmann, MD, MSc, PhD, Associate Professor, Department of Investigational Cancer Therapeutics and Breast Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX to advance the clinical development of Bria-OTS+ and Bria-PROS+, BriaCell’s personalized off-the-shelf cellular cancer vaccines in advanced breast cancer and prostate cancer, respectively....'We strongly believe in the therapeutic potential of our novel personalized next-generation vaccine platform and this agreement will be invaluable to us as we advance the clinical development of our off-the-shelf therapies to those cancer patients with persistent unmet medical needs.'"

Licensing / partnership • Breast Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

BriaCell to Present Clinical Data in Central Nervous System (CNS) Metastasis and Antibody-Drug Conjugate (ADC) Resistant Breast Cancer at the 2024 AACR Conference (GlobeNewswire) - "BriaCell Therapeutics Corp...is pleased to announce that the Company will be presenting three posters at the 2024 American Association for Cancer Research (AACR) Annual Meeting taking place April 5-10 at San Diego Convention Center, San Diego, CA."

Clinical data • Breast Cancer • Oncology • Solid Tumor