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

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100 项与 Bria-OTS 相关的转化医学

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100 项与 Bria-OTS 相关的专利（医药）

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项与 Bria-OTS 相关的新闻（医药）

2026-05-06

·BioSpace

BriaCell Receives FDA Clearance to Initiate Bria-BRES+™ Clinical Study in Breast Cancer

FDA clearance of Investigational New Drug (IND) application opens path to commence Phase 1/2a clinical study for Bria-BRES+ in metastatic breast cancer Bria-BRES+ is BriaCell’s next generation personalized immunotherapy for breast cancer, and features additional immune activating components designed to enhance clinical efficacy BriaCell has prepared clinical supplies of Bria-BRES+ and plans to initiate a Phase 1/2a clinical study in metastatic breast cancer in the coming months PHILADELPHIA and VANCOUVER, British Columbia, May 06, 2026 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, is pleased to report it has received FDA clearance to initiate clinical evaluation of Bria-BRES+, its next generation, personalized, off-the-shelf, cell-based immunotherapy for metastatic breast cancer. “We are honored to announce FDA clearance of the first IND for our next generation personalized immunotherapy, Bria-BRES+,” stated Dr. William V. Williams, BriaCell’s President & CEO. “The unique design of Bria-BRES+ offers the potential for a favorable safety pro meaningful therapeutic benefit in metastatic breast cancer. We look forward to advancing Bria-BRES+ into the clinic as we seek to bring new hope to these patients who have few to no effective treatment options.” As reported in BriaCell’s recent AACR preclinical poster presentation , Bria-BRES+ demonstrated activation of both adaptive and innate immunity including activation of naïve (resting) T-cells, dendritic cells and natural killer (NK) cells. BriaCell believes this multipronged immune activation may enhance clinical efficacy and help prevent immune escape in patients with metastatic breast cancer. BriaCell’s Bria-BRES+ builds on its Bria-OTS™ breast cancer clinical program, where the first patient dosed experienced the sustained complete resolution of a lung metastasis . This 78-year-old woman with advanced metastatic breast cancer and multiple prior treatment failures achieved complete (100%) resolution of a lung metastasis following four doses of Bria-OTS single agent therapy. The complete response of the lesion, initially observed at 2 months, was subsequently confirmed at 4 months, 6 months, and at 11 months. The patient received 17 cycles of Bria-OTS, completed 12 months of the study, and remains in survival follow-up. Figure 1: As previously reported in January 2026, treatment with Bria-OTS monotherapy resulted in 100% resolution of tumor in the right lung of the metastatic breast cancer (MBC) patient following 2 months of therapy and confirmed at 4, 6, and 11 months of therapy 1 (axial and coronal views) 1 Note that the other white dots in the lungs are blood vessels. About BriaCell Therapeutics Corp. BriaCell is an immuno-oncology-focused biotechnology company developing targeted and effective approaches for the management of cancer. 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 the FDA clearance of the IND application and the planned initiation of a Phase 1/2a clinical study of Bria‑BRES+, and expectations regarding the potential clinical benefits of the Bria‑OTS+ platform, 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 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 Investor Relations Contact: investors@briacell.com A photo accompanying this announcement is available at

免疫疗法临床结果临床申请

2026-04-21

·briacell.com

Re-Engineering Cancer Vaccines: Bria-OTS+ Integrates Innate and Adaptive Immunity for Broad and Persistent Anti-Tumor Responses

Bria-OTS+ platform provides early, potent and durable activation of innate and adaptive immunity in in-vitro cancer cell line models Immune cells activated by Bria-OTS+ exhibit serial killing activity across multiple rounds of tumor cell challenge PHILADELPHIA and VANCOUVER, British Columbia, April 21, 2026 (GLOBE NEWSWIRE) — BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, is presenting positive data from its preclinical Bria-OTS+ platform at the 2026 American Association for Cancer Research (AACR) Annual Meeting taking place April 17–22 at the San Diego Convention Center in San Diego, California. The poster is summarized below and linked here: https://briacell.com/scientific-publications/. Title: Re-Engineering Cancer Vaccines: Bria-OTS+ Integrates Innate and Adaptive Immunity for Broad and Persistent Anti-Tumor Responses Session Category: Clinical Research Session Title: Vaccines and Other Immunomodulatory Agents Session: 4/21/2026 2:00-5:00 PM Location: Poster Section 49 Poster Board Number: 12 Poster Number: 6701 Summary: Bria-OTS+ is a personalized, off-the-shelf, next-generation genetically engineered whole-cell cancer immunotherapy platform designed to enhance efficacy and safety. Our results demonstrate that Bria-OTS+ activates key components of both the innate and adaptive immune systems to broadly target and destroy cancer cells across solid tumors. These effects include coordinated activation of CD4⁺ and CD8⁺ T cells, NK cells, NKT cells, dendritic cells, and B cells, together with increased cytokine release and sustained immune competence without exhaustion—helping address an important mechanism of cancer progression. Data presented includes the following: Rapid activation of innate and adaptive immune responses: Bria-BRES+ (breast cancer) and Bria-PROS+ (prostate cancer) drove early activation and proliferation of key immune cells including CD4+ and CD8+ T cells, NK cells, and NKT cells, enhanced cytotoxic activity against parental tumor targets, and increased CD80/CD86 expression on dendritic and B cells, consistent with improved antigen-presentation. Sustained, long-lasting and targeted anti-tumor activity: Bria-BRES+ and Bria-PROS+ generated durable cytokine responses and maintained cytotoxic, serial killing activity through repeated cancer cell challenges without evidence of functional exhaustion. Bria-OTS+ also showed limited induction of immunosuppressive cell populations including regulatory T cells (Tregs) and myeloid-derived suppressor cells (MDSCs). Broad tumor recognition may reduce escape risk: Bria-BRES+ and Bria-PROS+ cells demonstrated anti-tumor activity against multiple tumor targets, supporting the potential of Bria-OTS+ to drive broad, cross-tumor immune responses, reduce immune escape, and limit cancer progression. Bria-OTS+ proposed mechanism of action: Following intradermal administration, Bria-OTS+ is designed to activate T cells and NK cells directly, while professional antigen-presenting cells (APCs) take up tumor specific antigens, migrate to regional lymph nodes and prime tumor-specific T cells to drive a systemic anti-tumor immune response. Miguel A. Lopez-Lago, PhD, BriaCell’s Chief Scientific Officer, commented, “We are thrilled with our data showing early, strong, and long-lasting anti-cancer activity of Bria-OTS+ in multiple cancer models, boosting the immune system response, and potentially overcoming common cancer cell resistance mechanisms. Our findings strongly support targeted anti-cancer effects of Bria-OTS+ and warrant additional testing of the Bria-OTS+ platform in clinical settings.” “Based on these promising preclinical findings, we are advancing Bria-OTS+ with the goal of entering the clinic for our first indications of metastatic breast cancer and prostate cancer later this year, with additional indications (lung cancer and melanoma) planned for 2027,” added Dr. William V. Williams, BriaCell’s President and CEO. 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: BriaCell presenting positive data from its preclinical Bria-OTS+ platform at the AACR , and BriaCell’s expectations that the Bria-OTS+ platform will enable the delivery of powerful and long-lasting immune activity against cancer; whether additional immune activating factors will enhance efficacy of the Bria-OTS+ platform; whether prior results will be replicated in clinical studies of the next generation Bria-BRES+ breast cancer and Bria-PROS+ prostate cancer programs utilizing the Bria‑OTS+ platform; and expectations for what will be investigated in BriaCell’s planned Phase 1/2a clinical studies of Bria-OTS+; 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, MD President & CEO 1-888-485-6340 info@briacell.com Investor Relations Contact: investors@briacell.com

免疫疗法AACR会议疫苗

2026-04-21

·BioSpace

BriaCell Presents Robust Anti-Cancer Activity of Bria-OTS+™ in Preclinical Cancer Models

Bria-OTS+ platform provides early, potent and durable activation of innate and adaptive immunity in in-vitro cancer cell line models Immune cells activated by Bria-OTS+ exhibit serial killing activity across multiple rounds of tumor cell challenge PHILADELPHIA and VANCOUVER, British Columbia, April 21, 2026 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, is presenting positive data from its preclinical Bria-OTS+ platform at the 2026 American Association for Cancer Research (AACR) Annual Meeting taking place April 17–22 at the San Diego Convention Center in San Diego, California. The poster is summarized below and linked here: . Title: Re-Engineering Cancer Vaccines: Bria-OTS+ Integrates Innate and Adaptive Immunity for Broad and Persistent Anti-Tumor Responses Session Category: Clinical Research Session Title: Vaccines and Other Immunomodulatory Agents Session: 4/21/2026 2:00-5:00 PM Location: Poster Section 49 Poster Board Number: 12 Poster Number: 6701 Summary: Bria-OTS+ is a personalized, off-the-shelf, next-generation genetically engineered whole-cell cancer immunotherapy platform designed to enhance efficacy and safety. Our results demonstrate that Bria-OTS+ activates key components of both the innate and adaptive immune systems to broadly target and destroy cancer cells across solid tumors. These effects include coordinated activation of CD4⁺ and CD8⁺ T cells, NK cells, NKT cells, dendritic cells, and B cells, together with increased cytokine release and sustained immune competence without exhaustion—helping address an important mechanism of cancer progression. Data presented includes the following: Rapid activation of innate and adaptive immune responses : Bria-BRES+ (breast cancer) and Bria-PROS+ (prostate cancer) drove early activation and proliferation of key immune cells including CD4+ and CD8+ T cells, NK cells, and NKT cells, enhanced cytotoxic activity against parental tumor targets, and increased CD80/CD86 expression on dendritic and B cells, consistent with improved antigen-presentation. Sustained, long-lasting and targeted anti-tumor activity : Bria-BRES+ and Bria-PROS+ generated durable cytokine responses and maintained cytotoxic, serial killing activity through repeated cancer cell challenges without evidence of functional exhaustion. Bria-OTS+ also showed limited induction of immunosuppressive cell populations including regulatory T cells (Tregs) and myeloid-derived suppressor cells (MDSCs). Broad tumor recognition may reduce escape risk: Bria-BRES+ and Bria-PROS+ cells demonstrated anti-tumor activity against multiple tumor targets, supporting the potential of Bria-OTS+ to drive broad, cross-tumor immune responses, reduce immune escape, and limit cancer progression. Bria-OTS+ proposed mechanism of action: Following intradermal administration, Bria-OTS+ is designed to activate T cells and NK cells directly, while professional antigen-presenting cells (APCs) take up tumor specific antigens, migrate to regional lymph nodes and prime tumor-specific T cells to drive a systemic anti-tumor immune response. Miguel A. Lopez-Lago, PhD, BriaCell’s Chief Scientific Officer, commented, “We are thrilled with our data showing early, strong, and long-lasting anti-cancer activity of Bria-OTS+ in multiple cancer models, boosting the immune system response, and potentially overcoming common cancer cell resistance mechanisms. Our findings strongly support targeted anti-cancer effects of Bria-OTS+ and warrant additional testing of the Bria-OTS+ platform in clinical settings.” “Based on these promising preclinical findings, we are advancing Bria-OTS+ with the goal of entering the clinic for our first indications of metastatic breast cancer and prostate cancer later this year, with additional indications (lung cancer and melanoma) planned for 2027,” added Dr. William V. Williams, BriaCell’s President and CEO. 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 presenting positive data from its preclinical Bria-OTS+ platform at the AACR , and BriaCell’s expectations that the Bria-OTS+ platform will enable the delivery of powerful and long-lasting immune activity against cancer; whether additional immune activating factors will enhance efficacy of the Bria-OTS+ platform; whether prior results will be replicated in clinical studies of the next generation Bria-BRES+ breast cancer and Bria-PROS+ prostate cancer programs utilizing the Bria‑OTS+ platform; and expectations for what will be investigated in BriaCell’s planned Phase 1/2a clinical studies of Bria-OTS+; 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 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 Investor Relations Contact: investors@briacell.com

免疫疗法AACR会议疫苗

100 项与 Bria-OTS 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
复发性乳腺癌	临床2期	美国	BriaCell Therapeutics Corp.	2024-05-29
转移性乳腺癌	临床申请批准	美国	BriaCell Therapeutics Corp.	2026-05-06
乳腺癌	临床前	美国	BriaCell Therapeutics Corp.	2023-04-16

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06471673 (Biospace) 人工标引	临床1/2期	HR阳性/HER2阴性乳腺癌 HR Positive \| HER2 Negative	1	Bria-OTS	糧構憲襯鏇鬱衊顧製壓(餘鹽壓艱膚醖壓網遞積) = 積糧積壓壓廠艱選窪鹽窪餘繭淵顧蓋觸網窪衊 (鹹膚餘廠淵網廠膚鏇顧 )	积极	2026-01-13
NCT06471673 (Company_Website 1 \| Company_Website 2 \| GlobeNewswire) 人工标引	临床1/2期	HR阳性/HER2阴性乳腺癌 HR Positive \| HER2 Negative	1	Bria-OTS	築廠窪襯糧膚網顧遞構(夢製蓋淵繭顧鑰艱鹽廠) = 簾壓製選願齋襯廠網膚選鑰觸繭壓艱襯鬱夢範 (願選選鬱醖獵製憲衊鹽 )	积极	2025-04-24