This is an open-label Phase 1/2a study. Once the safety of the BC1 cell line alone has been demonstrated in Phase 1, in Phase 2, patients will be treated with the Bria-OTS regimen (see below) and a clinically available check point inhibitor (CPI).
During the monotherapy phase of Phase 1, one patient will be treated intradermally every 2 weeks for 6 weeks (4 doses) with an initial dose of the BC1 cell line. If this dose is tolerated, the next patient will receive an increased dose of BC1. If once again tolerated, the third patient will receive a further dose increase of the BC1. Once at least 3 patients have been safely treated with the BC1 cell line, with no dose-limiting toxicity (DLT), the combinational phase of the study will commence.
Following the monotherapy phase, patients will be treated with BC1 and the Bria-OTS regimen (see below) every 3 weeks, plus a CPI at the FDA approved labelled dose and schedule. There will be at least a 2-week spacing between enrollment of each of the first three subjects in the study in order to assess for any early unanticipated risk(s).
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 peginterferon alpha-2a administered on the same day, following BC1 cell inoculation.

开始日期2024-05-29

申办/合作机构

BriaCell Therapeutics Corp.

100 项与 Bria-OTS 相关的临床结果

登录后查看更多信息

100 项与 Bria-OTS 相关的转化医学

登录后查看更多信息

100 项与 Bria-OTS 相关的专利（医药）

登录后查看更多信息

项与 Bria-OTS 相关的文献（医药）

RSC advances3区 · 化学

Fabrication of mechanically resistant superhydrophobic synthetic suede materials

3区 · 化学

ArticleOA

作者: Li, Hui-Gui ; Huang, Meng-Chen ; Xue, Chao-Hua ; Wang, Wei-Hao ; Luo, Xiang-Dong ; Wei, Ren-Xuan ; Du, Mi-Mi

Functionalization of synthetic suede materials with excellent superhydrophobicity can expand their application ranges.

项与 Bria-OTS 相关的新闻（医药）

2024-11-08

·GlobeNewswire-Health Care

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

免疫疗法疫苗

2024-09-10

·GlobeNewswire-Health Care

BriaCell Announces Positive Pre-IND Meeting with FDA for Bria-PROS+™ for Prostate Cancer

BriaCell has received positive feedback from its Pre-Investigational New Drug Application (Pre-IND) meeting with FDA for Bria-PROS+™ in prostate cancerThe meeting provides a clear path towards filing an IND and conducting a Phase 1/2 study of Bria-PROS+™ PHILADELPHIA and VANCOUVER, British Columbia, Sept. 10, 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, is pleased to announce that it has received positive feedback from its Pre-IND meeting with the U.S. Food and Drug Administration (FDA), which is a step forward to opening an IND to conduct a Phase 1/2 study of its personalized off-the-shelf immunotherapy, Bria-PROS+™, in advanced prostate cancer. “We were truly impressed by the FDA team of experts’ keen interest in Bria-PROS+™ as a potential novel personalized approach for advanced prostate cancer,” stated Dr. William V. Williams, BriaCell’s President and CEO. “Despite numerous approved drugs, prostate cancer remains the second-leading cause of cancer death in American men. We view the FDA’s positive feedback as a major step forward in the clinical development of our Bria-PROS+™ and in our efforts to bring hope to patients and families suffering from this deadly disease.” As a result of the Pre-IND meeting, FDA waived the animal toxicology and animal pharmacokinetic (PK) studies requirement for opening the IND, greatly simplifying the development pathway for Bria-PROS+™. Other areas of discussion included BriaCell’s plan to initiate the Phase 1/2 study pending completion of standard manufacturing and testing requirements. These interactions also inform the further development of the proprietary Bria-OTS+™ platform as the company pursues the development of Bria-BRES+™, Bria-LUNG+™ and Bria-MEL+™, for breast cancer, lung cancer and melanoma, respectively. BriaCell is currently evaluating its personalized immunotherapy Bria-BRES™ in a phase 1/2a study in metastatic breast cancer (ClinicalTrials.gov NCT06471673). 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 belief of the therapeutic potential of Bria-PROS+™’s as a safe and effective treatment for prostate cancer patients, 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

免疫疗法

2024-05-30

·BioSpace

BriaCell Initiates Patient Enrollment in First-in-Human Study of Bria-OTS™ in Advanced Metastatic Breast Cancer

PHILADELPHIA and VANCOUVER, British Columbia, May 30, 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 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. “Advancing Bria-OTS™ as our second novel immunotherapy candidate into the clinic is a significant milestone for BriaCell. We believe personalization through our Bria-OTS™ immunotherapy platform will produce more potent and long-lasting responses than previously observed, with potential synergistic effects with the immune check point inhibitor,” stated Dr. William V. Williams, BriaCell’s President & CEO. “We are grateful to our scientific and clinical teams for the successful completion of the Institutional Review Board (IRB), Clinical Trial Site Agreement (CTA), and obtaining FDA authorization for the Investigational New Drug (IND) filings, as well as to our investors and collaborators for their support in bringing Bria-OTS™ one step closer to cancer patients.” Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer stated, “The off-the-shelf nature of our treatment will allow the patients to be treated rapidly – which can be life changing for advanced metastatic breast cancer patients. Additionally, we expect the preferred safety pro our personalized immunotherapy, Bria-OTS™, to improve the quality of life and add months and even years to the lives of these heavily pretreated patients, a distinctive combination of benefits in late-stage cancer care.” About Bria-OTS™ Platform Awarded numerous US and international patents and supported by clinical data of Bria-IMT™, BriaCell’s lead clinical candidate - currently in a pivotal Phase 3 study for advanced metastatic breast cancer (ClinicalTrials.gov NCT06072612), Bria-OTS™ is BriaCell’s personalized off-the-shelf immunotherapy platform, and the basis for BriaCell’s “OTS” strategy. Bria-OTS™ for advanced metastatic breast cancer is the first use of this platform. Similar cell lines are in development for prostate cancer (Bria-PROS+™), lung cancer (Bria-LUNG+™), and melanoma (Bria-MEL+™). An Investigational New Drug Application (IND) is currently open for the Bria-OTS™ breast cancer therapy also known as, Bria-BRES™ for advanced metastatic breast cancer. Bria-BRES™ will initiate a bucket trial (i.e. a study that investigates multiple product candidates in a single study) with other cancer indications. Bria-OTS™ received a Small Business Innovation Research (SBIR) award from the National Cancer Institute (NCI). More information is available at . About BriaCell Therapeutics Corp. BriaCell is a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care. More information is available at . 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 BriaCell's personalization through the Bria-OTS™ immunotherapy platform producing more potent and long-lasting responses than previously observed, with potential synergistic effects with the immune check point inhibitor; the preferred safety pro Bria-OTS™ improving the quality of life and increasing the lifespan of heavily pretreated patients; and Bria-BRES™ initiating a bucket trial with other cancer indications, 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 and on EDGAR at . 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, MD President & 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

免疫疗法临床3期

100 项与 Bria-OTS 相关的药物交易

登录后查看更多信息