Bria-OTS / BriaCell - LARVOL DELTA

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

Trial in progress: A study of Bria-OTS cellular immunotherapy in metastatic recurrent breast cancer. (ASCO 2025) - P1/2 | "Clinical Trial Registration Number: NCT06471673 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Metastases • Breast Cancer • Oncology • Solid Tumor

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

BriaCell Reports Unprecedented Anti-Tumor Activity of its Next Generation Personalized Breast and Prostate Cancer Immunotherapies in Tumor Models at the 2023 SITC Annual Meeting; FDA Greenlights Bria-OTS IND (GlobeNewswire) - "Therapeutics Corp...is pleased to report unprecedented activity of its next generation, personalized, off-the-shelf, cell-based breast and prostate cancer immunotherapies at the 2023 Society for Immunotherapy of Cancer (SITC) annual meeting. These novel immunotherapies have been shown to activate the immune system through multiple mechanisms including adaptive responses of naïve (resting) T cells and innate responses of dendritic cells and natural killer (NK) cells leading to enhanced clinical efficacy and prevention of immune escape....In separate news, FDA has stated that BriaCell may proceed with the clinical study of Bria-OTS^™. This opens the path to the clinic for Bria-OTS^™, the first generation of BriaCell’s personalized off-the-shelf cellular immunotherapy for breast cancer."

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

BriaCell Awarded National Cancer Institute Grant to Advance its Bria-OTS Immunotherapy for Cancer (GlobeNewswire) - "BriaCell Therapeutics...is pleased to announce that the National Cancer Institute (NCI), the United States federal government's principal agency for cancer research and training, has awarded the Company a research grant to advance its platform of personalized off-the-shelf immunotherapies for cancer....The Company intends to use the funds for the development of Bria-OTS™, BriaCell’s novel personalized off-the-shelf immunotherapies for advanced metastatic breast cancer, prostate cancer, lung cancer, and melanoma."

Financing • Breast Cancer • Genito-urinary Cancer • Lung Cancer • Melanoma • Oncology • Prostate Cancer • Skin Cancer • Solid Tumor • Thoracic Cancer

Engineering semi-allogeneic whole cancer vaccines with enhanced immunogenicity for the treatment of advanced solid tumors (AACR 2023) - "We sought to harness gene-modified tumor cells as a vaccine platform and developed cancer vaccines composed of breast cancer cells expressing GM-CSF (SV-BR-1-GM). Different types of cancer vaccines have been developed with moderate success, often hampered by lack of strong immunogenicity and complex manufacturing. BriaCell’s Bria OTS provides a solution by increasing vaccine immunogenicity and decreasing manufacturing costs while personalizing the therapy based on matching the patient’s HLA type.1.Lacher MD et al, Front Immunol. 2018 May 15;9:776"

Metastases • Breast Cancer • Genito-urinary Cancer • Lung Cancer • Melanoma • Oncology • Prostate Cancer • Solid Tumor • CD4 • CD80 • CD86 • CSF2 • IFNA1 • IL12A • IL7

BriaCell Announces New Patent Issuance, Bria-OTS IND Timing Guidance, and Additional Clinical Sites to Boost Enrolment (GlobeNewswire) - "BriaCell Therapeutics Corp....announce that it has received an Issue Notification from the United States Patent and Trademark Office for the composition of matter and method of use of its personalized off-the-shelf cell-based immunotherapy for cancer. The patent will issue on January 24, 2023 as US Patent No. 11,559,574 with the term extending to May 25, 2040. Additionally, BriaCell was awarded an Australian patent (Patent No. 2017224232, extends to February 27, 2037) covering composition of matter and method of use for its whole-cell cancer immunotherapy technology in Australia....BriaCell expects to initiate the Bria-OTS study under an Investigational New Drug Application (IND) in the first half of 2023. BriaCell is pleased to announce that it has added...two additional clinical sites for the screening and enrollment of advanced breast cancer patients in the randomized Phase II study of BriaCell’s lead candidate, Bria-IMT™, with Incyte’s PD-1 inhibitor, retifanlimab."

Enrollment status • IND • Patent • Trial status • Breast Cancer • Oncology

BriaCell advances preparatory work for new Bria-OTS breast cancer clinical trial (GlobeNewswire) - "BriaCell Therapeutics Corp...announces that its novel off-the-shelf (OTS) personalized immunotherapy, Bria-OTS™, is currently being manufactured at a cGMP facility and undergoing quality control testing for the potential upcoming clinical trial for patients with advanced breast cancer...BriaCell expects Bria-OTS™ to enter an open-label Phase I/IIa clinical trial designed to evaluate its safety and efficacy in patients with advanced breast cancer. The clinical trial will be managed by Cancer Insight, LLC...BriaCell anticipates treating each patient with the appropriate pre-manufactured Bria-OTS™ formulation based on each patient’s human leukocyte antigens (HLA-type)."

Commercial • New P1/2 trial • Breast Cancer • Oncology • Solid Tumor

BriaCell Presents Development Details of Bria-OTS Platform Technology at the American Association for Cancer Research (AACR) Annual Meeting 2022 (GlobeNewswire) - "The AACR poster discloses the specific alleles selected and the strategy for performing the genetic engineering. BriaCell anticipates treating each patient with the appropriate pre-manufactured Bria-OTS formulation based on each patient’s HLA-type....Bria-OTS will be used to treat patients with advanced breast cancer, providing patients with readily available personalized treatment....Bria-OTS™ cell lines developed at BriaCell facilities have been transferred to a cGMP facility for testing and clinical production in preparation for the upcoming clinical trial in advance breast cancer....BriaCell expects Bria-OTS to enter an open-label Phase I/IIa clinical trial designed to evaluate its safety and efficacy in patients with advanced breast cancer."

Clinical • Commercial • New P1/2 trial • Breast Cancer • Oncology • Solid Tumor