This is a multicenter randomized, open label study to evaluate overall survival with the Bria-IMT regimen in combination with Checkpoint Inhibitor [Retifanlimab], versus Treatment of Patients'/Physicians' Choice (TPC) in advanced metastatic or locally recurrent breast cancer (aMBC) patients with no approved alternative therapies available.

Start Date05 Dec 2023

Sponsor / Collaborator

BriaCell Therapeutics Corp.

NCT03328026

/ Enrolling by invitationPhase 1/2

A Phase I/II Study of the SV-BR-1-GM Regimen in Metastatic or Locally Recurrent Breast Cancer Patients in Combination With Retifanlimab

This is an open-label, phase I/II double arm study of the SV-BR-1-GM regimen in combination with retifanlimab in patients with metastatic or locally recurrent breast cancer who have failed standard therapy.
Patients will receive the SV-BR-1-GM regimen with combination immunotherapy. There will be an initial evaluation of the combination of the SV-BR-1-GM regimen with retifanlimab every 3 weeks. If this is found to be safe and well tolerated in a cohort of at least 12 patients (dose-limiting toxicities (DLTs) in less than 30% of the patients evaluated), then an expansion cohort of up to 24 patients will be treated with that combination. These will be randomized to two regimens differing in the timing of checkpoint inhibitor administration.

Start Date16 Mar 2018

Sponsor / Collaborator

BriaCell Therapeutics Corp.

[+1]

NCT03066947

/ CompletedPhase 1/2

A Phase I/IIa Study of SV-BR-1-GM in Metastatic or Locally Recurrent Breast Cancer Patients

This is a single arm, open label study of SV-BR-1-GM, a targeted immunotherapy for breast cancer. Eligible patients will have histological confirmation of breast cancer with recurrent and/or metastatic lesions. The treatment regimen includes a pre-treatment with low-dose cyclophosphamide 2-3 days before the inoculation; inoculation in 4 sites on the thighs and upper back; and post-treatment inoculation of Interferon-alpha-2b into the sites of inoculation
2 and
4 days after the inoculation. These is repeated every 2 weeks for one month (3 treatments), then monthly for up to one year. Standard tumor assessments are performed at baseline and then every 2-3 months.

Start Date05 May 2017

Sponsor / Collaborator

BriaCell Therapeutics Corp.

[+1]

100 Clinical Results associated with SV BR 1 GM cancer vaccine ( BriaCell Therapeutics)

100 Translational Medicine associated with SV BR 1 GM cancer vaccine ( BriaCell Therapeutics)

100 Patents (Medical) associated with SV BR 1 GM cancer vaccine ( BriaCell Therapeutics)

Literatures (Medical) associated with SV BR 1 GM cancer vaccine ( BriaCell Therapeutics)

31 Dec 2024·Human Vaccines & Immunotherapeutics

Results of a phase I/IIa trial of SV-BR-1-GM inoculation with low-dose cyclophosphamide and interferon alpha (Bria-IMT) in metastatic breast cancer

Article

Author: Lopez-Lago, Miguel ; Adams, Daniel L. ; Williams, William V. ; Holmes, Jarrod P. ; Calfa, Carmen ; Bhattacharya, Saveri ; Lacher, Markus D. ; Chang, Mingjin ; Del Priore, Giuseppe ; Kharazi, Alex ; Dakhil, Shaker R. ; Peoples, George E. ; Wiseman, Charles L.

This Phase I/IIa open-label, single-arm clinical trial addressing advanced, refractory, metastatic breast cancer was conducted at six medical centers in the United States. We repeated inoculations with irradiated SV-BR-1-GM, a breast cancer cell line with antigen-presenting activity engineered to release granulocyte-macrophage colony-stimulating factor (GM-CSF), with pre-dose low-dose cyclophosphamide and post-dose local interferon alpha. Twenty-six patients were enrolled; 23 (88.5%) were inoculated, receiving a total of 79 inoculations. There were six Grade 4 and one Grade 5 adverse events noted (judged unrelated to SV-BR-1-GM). Disease control (stable disease [SD]) occurred in 8 of 16 evaluable patients; 4 showed objective regression of metastases, including 1 patient with near-complete regressions in 20 of 20 pulmonary lesions. All patients with regressions had human leukocyte antigen (HLA) matches with SV-BR-1-GM; non-responders were equally divided between matching and nonmatching (p = .01, Chi-squared), and having ≥2 HLA matches with SV-BR-1-GM (n = 6) correlated with clinical benefit. Delayed-type hypersensitivity (DTH) testing to candida antigen and SV-BR-1-GM generated positive responses (≥5 mm) in 11 (42.3%) and 13 (50%) patients, respectively. Quantifying peripheral circulating tumor cells (CTCs) and cancer-associated macrophage-like cells (CAMLs) showed that a drop in CAMLs was significantly correlated with an improvement in progression-free survival (PFS; 4.1 months vs. 1.8 months, p = .0058). Eight of 10 patients significantly upregulated programmed cell death ligand 1 (PD-L1) on CTCs/CAMLs with treatment (p = .0012). These observations support the safety of the Bria-IMT regimen, demonstrate clinical regressions, imply a role for HLA matching, and identify a possible value for monitoring CAMLs in peripheral blood.

01 May 2023·Recent patents on anti-cancer drug discovery

Regression of Breast Cancer Metastases Following Treatment with Irradiated SV-BR-1-GM, a GM-CSF Overexpressing Breast Cancer Cell Line: Intellectual Property and Immune Markers of Response

Author: Sunkari, Vivekananda G. ; Williams, William V. ; Lacher, Markus D. ; Macúchová, Eva ; Hashwah, Hind ; Dozio, Vito ; Galeas, Jacqueline L. ; Kharazi, Alexander ; Wiseman, Charles L.

Background::

SV-BR-1-GM, derived from a patient with grade 2 (moderately differentiated) breast cancer, is a GM-CSF-secreting breast cancer cell line with properties of antigen-presenting cells. SV-BR-1-GM and next-generation versions are covered by several pending and granted patents.

Methods::

We report findings from an open-label phase I, single-arm pilot study with irradiated SV-BR-1-GM cells in 3 breast and 1 ovarian cancer subjects. Inoculations were preceded by low-dose intravenous cyclophosphamide and followed by interferon-alpha2b injections into the SV-BR-1-GM inoculation sites. We assessed both cellular and humoral immune responses, and measured expression levels of SV-BR-1-GM HLA alleles.

Results::

Treatment was generally safe and well tolerated. Immune responses were elicited universally. Overall survival was more than 33 months for three of the four patients. As previously reported, one patient had prompt regression of metastases in lung, breast, and soft tissue. Following cessation of treatment, the patient relapsed widely, including in the brain. Upon retreatment, rapid tumor response was again seen, including complete regression of brain metastases. Consistent with a role of Class II HLA in contributing to SV-BR-1-GM’s mechanism of action, this patient allele-matched SV-BR-1-GM at the HLA-DRB1 and HLA-DRB3 loci. We are in the process of developing next-generation SV-BR-1-GM, expressing patient-specific HLAs. Patent applications were filed in various jurisdictions. Thus far, one is granted, in Japan.

Conclusion::

A whole-cell immunotherapy regimen with SV-BR-1-GM cells induced regression of met-astatic breast cancer. We develop intellectual property based on SV-BR-1-GM’s predicted mechanism of action to develop additional whole-cell immunotherapies for cancer patients.

Clinical Trail Registration::

This clinical trial was registered under ClinicalTrials.gov Identifier NCT00095862.

01 Jul 2015·AnesthesiologyQ1 · MEDICINE

Effects of an Innovative Psychotherapy Program for Surgical Patients

Q1 · MEDICINE

Article

Author: Neuner, Bruno ; Balzer, Felix ; Kerper, Léonie F ; Brähler, Elmar ; Spies, Claudia D ; Krampe, Henning ; Salz, Anna-Lena ; Tafelski, Sascha ; Neumann, Tim ; Wei-Gerlach, Edith ; Wernecke, Klaus-Dieter ; Glaesmer, Heide ; Romanczuk-Seiferth, Nina ; Lau, Alexandra

AbstractAbstract:

In 220 surgical patients with comorbid mental disorders (primarily mood, anxiety and adjustment disorders, or alcohol or tobacco abuse), those randomized to psychotherapy sessions perioperatively and up to 3 months postoperatively were more likely to participate in psychosocial mental health care 6 months after surgery than those randomized to brief written advice only.

Background::

The stepped care program Bridging Intervention in Anesthesiology (BRIA) aims at motivating and supporting surgical patients with comorbid mental disorders to engage in psychosocial mental healthcare options. This study examined the efficacy of BRIA.

Methods::

This randomized, parallel-group, open-label, controlled trial was conducted in the preoperative anesthesiological assessment clinics and surgical wards of a large university hospital in Germany. A total of 220 surgical patients with comorbid mental disorders were randomized by using the computer-generated lists to one of two intervention groups: BRIA psychotherapy sessions up to 3 months postoperatively (BRIA) versus no psychotherapy/computerized brief written advice (BWA) only. Primary outcome was participation in psychosocial mental healthcare options at month 6. Secondary outcome was change of self-reported general psychological distress (Global Severity Index of the Brief Symptom Inventory) between baseline and month 6.

Results::

At 6-month follow-up, the rate of patients who engaged in psychosocial mental healthcare options was 30% (33 of 110) in BRIA compared with 11.8% (13 of 110) in BWA (P = 0.001). Number needed to treat and relative risk reduction were 6 (95% CI, 4 to 13) and 0.21 (0.09 to 0.31), respectively. In BRIA, Global Severity Index decreased between baseline and month 6 (P < 0.001), whereas it did not change significantly in BWA (P = 0.197).

Conclusions::

Among surgical patients with comorbid mental disorders, BRIA results in an increased engagement in subsequent therapy options and a decrease of general psychological distress. These data suggest that it is reasonable to integrate innovative psychotherapy programs into the context of interdisciplinary surgical care.

News (Medical) associated with SV BR 1 GM cancer vaccine ( BriaCell Therapeutics)

03 Feb 2025

·briacell.com

BriaCell Announces Resolution of Lung Metastasis in First Patient treated with Bria-OTS(TM)

Lung metastasis (from metastatic breast cancer) resolved – after only 2 months (4 doses) of treatment with Bria-OTS™ monotherapy No toxicity related to the treatment; Patient remains on study Unprecedented result in first patient dosed supports Bria-OTS™ personalized immunotherapy approach Ongoing Phase 1/2a dose escalation study to evaluate Bria-OTS™, BriaCell’s personalized off-the-shelf immunotherapy in metastatic breast cancer PHILADELPHIA and VANCOUVER, British Columbia, Feb. 03, 2025 (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 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™. Bria-OTS™ is a personalized off-the-shelf immunotherapy, currently under investigation in a Phase 1/2a dose escalation study (ClinicalTrials.gov identifier: NCT06471673 ) in metastatic recurrent breast cancer. Bria-OTS™ represents a personalized, next generation, advancement of BriaCell’s lead candidate Bria-IMT™ which is currently in a pivotal Phase 3 study for metastatic breast cancer. Figure 1: Treatment with Bria-OTS™ monotherapy resulted in 100% resolution of tumor in the lung of the MBC patient following 4 injection cycles[1] As shown in Figure 1, the lesion in the patient’s right lung (left side of the image) is no longer detectable on the images taken 2 months after treatment with Bria-OTS™ monotherapy. 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. “Despite recent advancements in cancer treatment with antibody-drug-conjugates (ADCs) and immune check point inhibitors (CPIs), metastatic breast cancer remains an unmet medical need as many patients do not respond to these treatments,” stated Dr. Neal Chawla, Associate Director of Clinical Research at the Sarcoma Oncology Center, and Principal Investigator for the Bria-OTS™ study. “We are very impressed by the clinical response observed showing rapid and robust clinical activity in addition to excellent tolerability in the first patient treated with Bria-OTS™ and look forward to reproducing these results in other cancer patients in the study.” “This data supports our hypothesis of personalized immunotherapy with Bria-OTS™, potentially leading to new and effective treatment of metastatic breast cancer,” stated Dr. William V. Williams, BriaCell’s President and CEO. “We hope to transform the way we treat cancer patients with our novel personalized off-the-shelf immunotherapy approach.” “Resolution of metastatic lung disease in this breast cancer patient highlights the clinical effectiveness of Bria-OTS™, and its therapeutic potential in MBC,” commented Dr. Giuseppe Del Priore, BriaCell’s Chief Medical Officer. “This result represents a major step towards advancing our innovative technology platform and our goal of offering safe and effective treatment to MBC patients and our plans to extend into prostate cancer, melanoma, and lung cancer.” The Phase 1/2a clinical trial is initially evaluating the safety and efficacy of Bria-OTS™ as monotherapy and, later, in combination with an immune checkpoint inhibitor in metastatic breast cancer. Key inclusion criteria include recurrent metastatic breast cancer and at least two failed prior attempts of systemic therapy (e.g., chemotherapy). The study design includes a dose escalation monotherapy phase followed by an expansion phase that will include combination therapy with an immune check point inhibitor. 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 include statements regarding: BriaCell reproducing similar results in other cancer patients in BriaCell’s Phase 1/2a Bria-OTS™ study; Bria-OTS™ potentially leading to new and effective treatment of metastatic breast cancer; BriaCell transforming the way we treat cancer patients with its novel personalized off-the-shelf immunotherapy approach; the clinical effectiveness of Bria-OTS™ and its therapeutic potential in MBC; BriaCell’s technology offering a safe and effective treatment to MBC patients; BriaCell’s plans to extend into prostate cancer, melanoma, and lung cancer; and BriaCell’s Phase 1/2a clinical trial initially evaluating the safety and efficacy of Bria-OTS™ as monotherapy and later in combination with an immune checkpoint inhibitor in metastatic breast cancer. Forward-looking statements 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. 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 Media Relations: Jules Abraham CORE IR julesa@coreir.com Investor Relations Contact: CORE IR investors@briacell.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/90d9b907-91ef-40c5-ac9f-87ff883327f6 [1]Note that the other white dots in the lungs are blood vessels.

ImmunotherapyPhase 3Clinical Result

13 Dec 2024

·www.globenewswire.com

BriaCell 2024 SABCS® Poster Highlights Ability of Bria-IMT™ Regimen to Increase Cancer-Fighting Immune Cells in Metastatic Breast Cancer

BriaCell reports influx of cancer fighting CD8+ “killer” T cell into metastatic breast cancer tumors and lymph organs turning “Cold” tumors and lymph nodes “Hot” on ImmunoPET imaging in cancer patients treated with Bria-IMT™ plus an immune checkpoint inhibitor (CPI)Imaging confirms clinical responses seen in metastatic breast cancer correlate with increase in CD8+ “killer” T Cells in lesions and lymph nodes PHILADELPHIA and VANCOUVER, British Columbia, Dec. 13, 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, highlights the infiltration of cancer fighting immune cells into tumors, using leading CD8 ImmunoPET imaging technology, in its poster presentation at the 2024 San Antonio Breast Cancer Symposium ® at Henry B. Gonzalez Convention Center, San Antonio, TX. Today’s poster shows influx of cancer fighting immune cells into tumors and lymphatic tissue leading to cancer cell destruction following treatment with the Bria-IMT™ plus CPI regimen. 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. These results suggest a potential value of CD8 ImmunoPET in identifying pseudo progression in patients with clinical benefit vs tumor progression. CD8+ T cell infiltration also correlated with a marked reduction in tumor markers, indicating clinical benefit, in some patients. “We are excited to successfully utilize innovative technology such as CD8 ImmunoPET imaging to gain insight into the mechanism of action and potential strength of the BriaCell immunotherapy program,” stated Russ Kuker, MD, Associate Professor of Clinical Radiology at the University of Miami Miller School of Medicine and author of the P5-10-12 poster. “By employing more accurate precision imaging techniques, we have been able to document the mechanism of action of the Bria-IMT™ regimen as we progress this therapy to revolutionize the way we treat cancer patients and improve patient outcomes,” noted Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. The details about the poster presentation are as follows:Abstract Number: SESS-1069Title: Bria-IMT CD8+ tumor infiltrating lymphocytes turn “Cold” tumor “Hot” in metastatic breast cancerTime: Friday, December 13, 2024 12:00 PM – 2:00 PM CSTPresentation ID: P5-10-12CD8 ImmunoPET imaging, an imaging analysis technology, is used to mark CD8+ T-cells (also known as cytotoxic “killer” T cells) that are important components of the immune system and key to cancer cell detection and destruction. Bria-IMT™ plus CPI produced cancer-fighting CD8+ T cells infiltration into metastatic tumors and lymphoid tissue, leading to cancer destruction - turning “Cold” tumors and lymph nodes “Hot” on ImmunoPET imaging 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 toleratedReduction in tumor markers in 2 patients who had cold tumors turn hot3 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 patientsEvidence of “cold” tumors and lymph nodes becoming “hot” suggesting immune system activation in the patientsImmune system activation results in increased migration of cancer-fighting CD8+ T-cells into MBC tumors and lymphatic tissue, leading to destruction of cancer cellsImmune response following peripheral non-lesional Bria-IMT™ therapy suggests systemic activation of the immune systemClinical and CD8+ T cell response support the clinical benefit of the Bria-IMT™ plus CPI regimen in cancer patients In summary, advanced ImmunoPET imaging technology correlates with clinical benefit with the Bria-IMT™ combination regimen in metastatic breast cancer and suggests possible use in identifying immunotherapy responsive tumors. These findings support the continued use of the Bria-IMT™ combination regimen in BriaCell’s ongoing pivotal Phase 3 study (listed on ClinicalTrials.gov as NCT06072612) in MBC. To view the posters, please visit https://briacell.com/scientific-publications/. 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’s phase 2 study results suggesting a potential value of CD8 ImmunoPET in identifying pseudo progression in patients with clinical benefit vs tumor progression; the Bria-IMT™ regimen having the ability to revolutionize the treatment of cancer patients and improve patient outcomes; and the potential use of the Bria-IMT™ combination regimen in identifying immunotherapy responsive tumors 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

ImmunotherapyPhase 2Clinical ResultPhase 3

13 Dec 2024

·briacell.com

BriaCell 2024 SABCS® Poster Highlights Ability of Bria-IMT(TM) Regimen to Increase Cancer-Fighting Immune Cells in Metastatic Breast Cancer

BriaCell reports influx of cancer fighting CD8+ “killer” T cell into metastatic breast cancer tumors and lymph organs turning “Cold” tumors and lymph nodes “Hot” on ImmunoPET imaging in cancer patients treated with Bria-IMT™ plus an immune checkpoint inhibitor (CPI) Imaging confirms clinical responses seen in metastatic breast cancer correlate with increase in CD8+ “killer” T Cells in lesions and lymph nodes PHILADELPHIA and VANCOUVER, British Columbia, Dec. 13, 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, highlights the infiltration of cancer fighting immune cells into tumors, using leading CD8 ImmunoPET imaging technology, in its poster presentation at the 2024 San Antonio Breast Cancer Symposium ® at Henry B. Gonzalez Convention Center, San Antonio, TX. Today’s poster shows influx of cancer fighting immune cells into tumors and lymphatic tissue leading to cancer cell destruction following treatment with the Bria-IMT™ plus CPI regimen. 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. These results suggest a potential value of CD8 ImmunoPET in identifying pseudo progression in patients with clinical benefit vs tumor progression. CD8+ T cell infiltration also correlated with a marked reduction in tumor markers, indicating clinical benefit, in some patients. “We are excited to successfully utilize innovative technology such as CD8 ImmunoPET imaging to gain insight into the mechanism of action and potential strength of the BriaCell immunotherapy program,” stated Russ Kuker, MD, Associate Professor of Clinical Radiology at the University of Miami Miller School of Medicine and author of the P5-10-12 poster. “By employing more accurate precision imaging techniques, we have been able to document the mechanism of action of the Bria-IMT™ regimen as we progress this therapy to revolutionize the way we treat cancer patients and improve patient outcomes,” noted Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. The details about the poster presentation are as follows: Abstract Number: SESS-1069 Title: Bria-IMT CD8+ tumor infiltrating lymphocytes turn “Cold” tumor “Hot” in metastatic breast cancer Time: Friday, December 13, 2024 12:00 PM – 2:00 PM CST Presentation ID: P5-10-12 CD8 ImmunoPET imaging, an imaging analysis technology, is used to mark CD8+ T-cells (also known as cytotoxic “killer” T cells) that are important components of the immune system and key to cancer cell detection and destruction. Bria-IMT™ plus CPI produced cancer-fighting CD8+ T cells infiltration into metastatic tumors and lymphoid tissue, leading to cancer destruction – turning “Cold” tumors and lymph nodes “Hot” on ImmunoPET imaging 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 Evidence of “cold” tumors and lymph nodes becoming “hot” suggesting immune system activation in the patients Immune system activation results in increased migration of cancer-fighting CD8+ T-cells into MBC tumors and lymphatic tissue, leading to destruction of cancer cells Immune response following peripheral non-lesional Bria-IMT™ therapy suggests systemic activation of the immune system Clinical and CD8+ T cell response support the clinical benefit of the Bria-IMT™ plus CPI regimen in cancer patients In summary, advanced ImmunoPET imaging technology correlates with clinical benefit with the Bria-IMT™ combination regimen in metastatic breast cancer and suggests possible use in identifying immunotherapy responsive tumors. These findings support the continued use of the Bria-IMT™ combination regimen in BriaCell’s ongoing pivotal Phase 3 study (listed on ClinicalTrials.gov as NCT06072612 ) in MBC. To view the posters, please visit https://briacell.com/scientific-publications/ . 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’s phase 2 study results suggesting a potential value of CD8 ImmunoPET in identifying pseudo progression in patients with clinical benefit vs tumor progression; the Bria-IMT™ regimen having the ability to revolutionize the treatment of cancer patients and improve patient outcomes; and the potential use of the Bria-IMT™ combination regimen in identifying immunotherapy responsive tumors 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, 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

ImmunotherapyPhase 2Clinical ResultPhase 3

100 Deals associated with SV BR 1 GM cancer vaccine ( BriaCell Therapeutics)

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Breast Cancer	Phase 3	US	BriaCell Therapeutics Corp.	05 Dec 2023
Metastatic breast cancer	Phase 2	US	LumaBridge LLCStartup	05 May 2017
Metastatic breast cancer	Phase 2	US	BriaCell Therapeutics Corp.	05 May 2017
Ovarian Epithelial Carcinoma	Phase 1	US	BriaCell Therapeutics Corp.	-

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03328026 (SABCS2024 \| GlobeNewswire) Manual	Phase 1/2	Metastatic breast cancer	54	Bria-IMT regimen with pembrolizumab/retifanlimab	ftgapocudm(wylrohveye) = vfjrvbvipq omgqnhwdwt (fcdpamnncf )	Positive	11 Dec 2024
NCT03328026 (SABCS2024 \| GlobeNewswire) Manual	Phase 1/2	Metastatic breast cancer	54	Bria-IMT regimen with pembrolizumab/retifanlimab (without IFN incubation; phase 3 formulation)	ftgapocudm(wylrohveye) = cqtrvxqsqh omgqnhwdwt (fcdpamnncf ) View more	Positive	11 Dec 2024
NCT06072612 (GlobeNewswire) Manual	Phase 2	Metastatic breast cancer	54	Bria-IMT™ regimen + immune checkpoint inhibitor (since 2022)	qrknvhhciv(gcmshmtjwl) = ylccessqpf zwvsfmdswn (yizastpbwd ) View more	Positive	11 Sep 2024
NCT06072612 (GlobeNewswire) Manual	Phase 2	Metastatic breast cancer	54	Bria-IMT™ regimen + immune checkpoint inhibitor (total)	qrknvhhciv(gcmshmtjwl) = gceetfzkbr zwvsfmdswn (yizastpbwd ) View more	Positive	11 Sep 2024
NCT03328026 (ASCO2024) Manual	Phase 1/2	Metastatic breast cancer \| Advanced breast cancer CAMLs \| CTCs	54	SV-BR-1-GMegimen with oriretifanlimabce	kpbmkradcr(vlvgdwvxbg) = amzhxyqvvh sahlagusoi (fsbjlydgaj ) View more	Positive	24 May 2024
NCT03328026 (SV-BR-1-GM, ASCO2024)	Phase 2	Metastatic breast cancer	54	Bria-IMT + CPI	rjtpolpfuv(maxjppkbui) = 43% (10/23) reported grade 3 or 4 AEs, independent of study drug causality. AEs included injection site reaction (39%), fatigue (26%), and nausea/vomiting (43%), mostly mild to moderate. One case of elevated lipase was the most clinically significant grade 4 AE. No interstitial lung disease (ILD) was reported. kqgyidxcrx (yowiekvvmr ) View more	Positive	24 May 2024
AACR2024	Not Applicable	Neoplasm Metastasis ER+/PR+ \| HER2- \| ER-/PR- ... View more	-	Bria-IMT monotherapy	pclgowmlpi(zsrjlplbwu) = myddeupnct vhhlcqhucu (sekemxvsus )	-	05 Apr 2024
AACR2024	Not Applicable	Neoplasm Metastasis ER+/PR+ \| HER2- \| ER-/PR- ... View more	-	Bria-IMT + immune checkpoint inhibitor	pclgowmlpi(zsrjlplbwu) = gfrrjbxrwg vhhlcqhucu (sekemxvsus )	-	05 Apr 2024
AACR2024	Phase 2	Metastatic breast cancer	23	Bria-IMT™ + CPI	jskqxgyogo(fbmasmxvhi) = 43% (10/23) reported grade 3 or 4 AEs, independent of study drug causality. No interstitial lung disease (ILD) reported. AEs included injection site reaction (39%), fatigue (26%), and nausea/vomiting (43%), mostly mild to moderate. One case of elevated lipase was the most clinically significant grade 4 AE. grcrnfmzye (oozzgcswkm ) View more	-	05 Apr 2024
GlobeNewswire Manual	Not Applicable	Advanced breast cancer	-	Bria-IMT±Checkpoint Inhibitor	eteljgehlc(gjximgyqmm) = agtvgjtwvj syrujzowvp (iyxgxbvbjc )	Positive	28 Dec 2023
NCT03328026 (Biospace) Manual	Phase 2	Metastatic breast cancer	54	Bria-IMT+CPI	tnnzwnatcn(hglzuvmyfa) = ipjtuvxeoi zbctyifnqj (slzjopkvdd ) View more	Positive	06 Dec 2023
GlobeNewswire Manual	Phase 2	Hormone receptor positive HER2 positive breast cancer Hormone Receptor/HER2 Positive \| Hormone Receptor Positive	1	Bria IMT	wnmdpcijwo(gdwpwecsqu) = After only 3 cycles, patient experienced a remarkable improvement of eye-bulging “proptosis” caused by orbital metastatic breast cancer tumor behind the eye. ekaydhjvzd (fklpyimbck ) View more	Positive	30 Nov 2023
NCT03066947 \| NCT03328026 (AACR2023) Manual	Phase 1/2	Metastatic breast cancer	51	SV-BR-1-GM	mhecfyfkax(kjeafdpcqj) = xqdpvkcoor pqkjbngabw (tysgeutrcq ) View more	Positive	14 Apr 2023
NCT03066947 \| NCT03328026 (AACR2023) Manual	Phase 1/2	Metastatic breast cancer	51	SV-BR-1-GM+Pembrolizumab or Retifanlimab	mhecfyfkax(kjeafdpcqj) = hrnxafjrkx pqkjbngabw (tysgeutrcq ) View more	Positive	14 Apr 2023

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