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

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

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

AbstractAbstractIn 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)

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

11 Dec 2024

·www.globenewswire.com

BriaCell Presents Unprecedented Overall Survival Data in Metastatic Breast Cancer in Spotlight Poster at 2024 SABCS®

Median overall survival (OS) to date of 13.4 months for Phase 2 patients treated with the Phase 3 formulation (15.6 months for those treated since 2022), double that of comparable patients in the literatureFinal Phase 2 OS calculation is pending as many patients remain alive well over 1 year after starting the studyMedian OS of 13.7 months in breast cancer patients with central nervous system (CNS) metastasis treated with the Bria-IMT™ regimen alone or in combination with an immune check point inhibitor (CPI)Five BriaCell posters (four today and one on Dec 13th) showcase robust survival and clinical benefit data, plus key biomarker data from Phase 2 trial of Bria-IMT™ in metastatic breast cancer (MBC)Biomarkers identify patients who benefit from treatments with the Bria-IMT™ regimenNo toxicity related discontinuations PHILADELPHIA and VANCOUVER, British Columbia, Dec. 11, 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 showcase its impressive survival and clinical benefit data in MBC patients, including those with CNS metastases, treated with the Bria-IMT™ plus CPI regimen. The data is featured in BriaCell’s “Spotlight” poster presentation session, at the 2024 San Antonio Breast Cancer Symposium® (SABCS®) held at Henry B. Gonzalez Convention Center, San Antonio, TX. “Metastatic breast cancer remains an essentially incurable disease, with a significant unmet medical need in patients who are relapsed/refractory to recently approved therapies such as CPIs and antibody-drug conjugates (ADCs),” stated Dr. William V. Williams, BriaCell’s President & CEO. “We are very pleased with the Bria-IMT™ combination regimen’s tolerability profile, and most importantly its outstanding clinical activity in heavily pre-treated patients who failed other therapeutic options.” “In addition to our striking survival data in MBC patients, we are excited by potential biomarkers for early identification of patients who would benefit from treatment with the Bria-IMT™ combination regimen,” noted Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. “We expect to replicate Phase 2’s impressive survival and clinical benefit data in our ongoing pivotal Phase 3 study.” “While CNS metastatic disease has historically had a very poor prognosis, our clinical data to date, shows solid survival and clinical benefit in patients with CNS metastasis,” stated Sailaja Kamaraju, MD, Assistant Professor of Medicine at the Medical College of Wisconsin, Division of Hematology and Oncology. “We are optimistic that the Bria-IMT™ combination regimen, with its unique targeted mechanism of action, may be able to produce meaningful clinical and survival benefits in other cancer patients with CNS metastases who have lost hope with little to no other therapeutic options.” The data presented is from the fully enrolled BriaCell Phase 2 combination study of Bria-IMT™ plus CPI. An aggregate of 54 MBC patients were enrolled in the study – all treated with the Bria-IMT™ combination regimen {11 patients received KEYTRUDA® (pembrolizumab), and 43 patients received Incyte’s retifanlimab with one patient cross over from the KEYTRUDA® study to retifanlimab}. Data is available on all 54 of these heavily pre-treated metastatic breast cancer patients (average number of prior treatments = 6). Of these 54 patients, 37 were treated with the formulation currently under investigation in BriaCell’s ongoing pivotal Phase 3 study in metastatic breast cancer (listed on ClinicalTrials.gov as NCT06072612). Final median overall survival calculation for the patients in the Phase 2 portion of the study is pending, as most of these patients remain alive over 1 year following their start on the study. No Bria-IMT™ related discontinuations have been reported to date. The details about the Spotlight presentation and other poster sessions are as follows: Abstract Number: SESS-1071 (Spotlight Poster)Title: Overall survival results of Bria-IMT™ allogenic whole cell-based cancer vaccineTime: Wednesday, December 11, 2024 7:00 AM – 8:30 AM CSTPresentation ID: PS3-06 Bria-IMT™ regimen’s impressive OS and tolerability in MBC patients Median overall survival (OS) to date of 13.4 months for Phase 2 patients treated with the Phase 3 formulation (15.6 months for those treated since 2022 with the Phase 3 formulation) double that of comparable patients in the literature (Cortes J, et al. Annals of Oncology 2018; Kazmi S, et al. Breast Cancer Res Treat. 2020; O’Shaughnessy J et al. Breast Cancer Res Treat. 2022; Tripathy D, et al. JAMA Oncol. 2022; Bardia A, et al. J Clin Oncol. 2024)Final Phase 2 OS calculation is pending as many patients remain alive well over 1 year after starting the studyMedian overall survival (OS) for patients who received the Phase 3 formulation in the Phase 2 portion of the study who also developed an immune response to the vaccine as measured by delayed-type hypersensitivity (DTH) not yet reached with >1 year follow-up13.7 months median OS in MBC patients with central nervous system (CNS)/intracranial tumors treated with the Bria-IMT™ regimen with or without a CPIObjective response rates (ORR) and clinical benefit rates (CBR) were observed across all MBC patient subsets, but positive clinical outcomes were more prominent in HER2+ and HR+/HER2- patient subsetsBria-IMT™ regimen was well-tolerated and produced clinical benefit in heavily pretreated MBC patientsPatients who developed a DTH response had lower neutrophil to lymphocyte ratio (NLR), suggesting improved clinical benefit in these patientsDelayed-type hypersensitivity (DTH) response, and circulating tumor cells (CTC) levels were significantly different between patients who responded vs those who did not respond to the Bria-IMT™ combination regimen In conclusion, clinical findings to date support the potential safety and efficacy of Bria-IMT™, along with its potential use in CNS metastases, as well as the possible use of biomarkers to predict clinical outcomes in BriaCell’s ongoing pivotal Phase 3 study in MBC. Abstract Number: SESS-1431Title: Identification of antigenic determinants in SV-BR-1 derived cellular breast cancer vaccinesTime: Wednesday, December 11, 2024 5:30 – 7:00 PM CSTPresentation ID: P2-06-02 Summary: BriaCell successfully identified immunogenic (i.e. immune system activating) peptides in patients treated with Bria-IMT™, a cell-based cancer vaccine, and showed Bria-IMT™’s ability to produce a targeted immune response against tumor antigens. Key immunogenic peptides detected included those with post-translational modifications (PTMs), such as citrullination and cysteinylation, an important type of neoantigen that may be shared across many patients with cancerHighlighted the advantage of cell-based cancer vaccines over RNA and peptide-based vaccines including their ability to present a broad and diverse repertoire of antigens (i.e. both conventional and unconventional types)Cell-based cancer vaccines also display unknown, patient-specific neoantigens that are hard to reproduce with RNA or peptide vaccinesDiverse antigen presentation produces a robust, polyclonal immune response, engaging both CD8+ and CD4+ T cells against multiple tumor target In conclusion, scientific data presented suggests that the unique mechanism of cell-based cancer vaccines may reduce cancer cells’ immune escape and may potentially lead to strong and long-lasting clinical outcomes in cancer patients. Abstract Number: SESS-2217Title: PD-L1 upregulation in circulating tumor associated cells predicts for clinical outcomes in a phase I/II clinical trial using SV-BR-1-GM vaccine with the checkpoint inhibitor retifanlimab in metastatic breast cancer patients, an interim analysisTime: Wednesday, December 11, 2024 12:00 – 2:00 PM CSTPresentation ID: P1-01-17 Summary:Interim analysis after at least one year of Bria-IMT™ plus CPI regimen shows the following: Significantly lowered levels of circulating tumor cells (CTCs) and cancer associated macrophage-like cells (CAMLs) in 40% of heavily pre-treated MBC patientsLower CTCs/CAMLs levels were significantly correlated with better survival outcomes (i.e. better PFS and trended for better OS)Bria-IMT™ appeared to increase PD-L1 levels in 15 patients which correlated with better clinical responses to combination treatment with the anti-PD-1 check point inhibitor retifanlimab In conclusion, clinical data support the combination regimen in our ongoing pivotal Phase 3 study and suggests CTCs and CAMLs and PD-L1 levels may be relevant indicators of clinical outcome in MBC patients treated with Bria-IMT™ plus CPI. Abstract Number: SESS-1068Abstract Title: ASTRO-VAC CNS: Bria-IMT™ in the management of tumor agnostic metastatic CNS lesionsTime: Wednesday, December 11, 2024 5:30 – 7:00 PM CSTPresentation ID: P2-10-24 Results: The poster provides the details of a planned Phase 2 study design expanding the use of Bria-IMT™ + CPI to tumor agnostic cancer patients (i.e. kidney cancer, brain cancer, etc.) with central nervous system (CNS) metastasis. 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 the potential safety and efficacy of Bria-IMT™, along with its potential use in CNS metastases; biomarkers assisting with early identification of patients who would benefit from treatment with the Bria-IMT™ combination regimen; BriaCell expecting to replicate Phase 2’s survival and clinical benefit data in its ongoing pivotal Phase 3 study and the Company’s plans to share the data in the coming months; the Bria-IMT™ combination regimen’s ability to produce meaningful clinical and survival benefits in other cancer patients with CNS metastasis; the Company’s ongoing evaluation of biomarkers to predict clinical outcomes in its ongoing pivotal Phase 3 study in MBC; cell-based cancer vaccines potentially reducing cancer cells’ immune escape and leading to strong and long-lasting clinical outcomes in cancer patients; and CTCs, CAMLs and PD-L1 levels having the potential to be relevant indicators of clinical outcomes in MBC patients treated with Bria-IMT™ plus CPI 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

Phase 2ImmunotherapyPhase 3Clinical ResultVaccine

02 Dec 2024

·www.prnewswire.com

Biotech Advances Drive Cancer Research as Global Rates Continue Upward Trend

USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Dec. 2, 2024 /PRNewswire/ -- USA News Group News Commentary – Despite death rates for some cancers being on the decline, there is a global surge in cancer cases among people under 50, with new cases up by 79% overall. Windpipe and prostate cancers are rising fastest, while breast, windpipe, lung, bowel, and stomach cancers have the highest death tolls. The United Nations projects cancer rates to increase by 77% by 2050. To combat this trend, researchers are advancing new therapies, with the FDA approving 16 oncology treatments between July and September 2024. Behind the scenes, biotech developers are making strides, with recent market updates from: O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Akoya Biosciences, Inc. (NASDAQ: AKYA), Checkpoint Therapeutics, Inc. (NASDAQ: CKPT), BriaCell Therapeutics Corp. (NASDAQ: BCTX), and Arcus Biosciences, Inc. (NYSE: RCUS). There's plenty of tech advancements as well, with the Global AI in Oncology Market growing at a rapid 35% CAGR, towards US$13.6 billion by 2032. Analysts at Spherical Insights project the global oncology drug market is poised to grow at a CAGR of 11.5% towards US$564.50 billion by 2033. Oncolytics Biotech® Announces Key Progress and Upcoming Studies for Breast and Pancreatic Cancer Treatments, Prepares for FDA Accelerated Approval Path Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, recently announced key progress and upcoming studies for pelareorep, its lead intravenously administered immunotherapy, in ongoing breast and pancreatic cancer trials. Recent clinical efficacy results from Oncolytics' BRACELET-1 trial in HR+/HER2- breast cancer set the stage for a clinical study aimed at supporting accelerated FDA approval. Additionally, Oncolytics' corporate update highlights key milestones anticipated in its gastrointestinal cancer trials in 2025, with the potential for new registration-enabling studies. "We're excited by the recent BRACELET-1 results, which exceeded our expectations and substantiate the strong efficacy signal previously observed in breast cancer patients treated with pelareorep," said Wayne Pisano, Interim CEO and Chair of Oncolytics' Board of Directors. "Having treated well over 100 HR+/HER2- metastatic breast cancer patients in multiple clinical studies, these results provide the basis for a development path leading to an accelerated approval. The BRACELET-1 results, combined with recent feedback from the FDA, give us confidence in our development approach, and we look forward to initiating a clinical trial designed to support the approval of pelareorep as a novel breast cancer therapeutic." The promising efficacy results from BRACELET-1 lay the groundwork for a large clinical trial aimed at supporting accelerated FDA approval. In early 2025, Oncolytics plans to submit a pelareorep + paclitaxel combination therapy trial for breast cancer. The study will enroll around 180 patients with HR+/HER2- advanced or metastatic breast cancer who have progressed on, are ineligible for, or cannot tolerate antibody-drug conjugates (ADCs) like Enhertu—representing an approximately 55,000 patients in the US. The study is designed with sufficient statistical power to achieve a p-value of < 0.05 for a progression-free survival (PFS) benefit of at least 4.3 months. Notably, the BRACELET-1 study showed a 5.7-month PFS advantage for the pelareorep + paclitaxel combination over chemotherapy alone. Enrollment for this registration-enabling study is anticipated to begin in the first half of 2025. "With the continuing evolution of breast cancer treatment, we have designed our breast cancer program with the guidance of leading experts in the field," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "Our plan is designed to obtain a regulatory approval with fewer patients, in a shorter time, and requiring less funding than traditional regulatory pathways. Our thorough understanding of pelareorep's mechanism of action makes us confident that pelareorep-based combination therapy will continue to deliver strong clinical benefits to HR+/HER- breast cancer patients within the current treatment approach." Oncolytics has several major milestones planned for 2025. In the first half of the year, the company aims to launch a registrational study of pelareorep with paclitaxel in HR+/HER2- breast cancer and expects safety run-in data from cohort 5 of the GOBLET study, which examines pelareorep and modified FOLFIRINOX (mFOLFIRINOX), with or without atezolizumab, in newly diagnosed pancreatic cancer. Additionally, updated efficacy data from cohort 4 of the GOBLET study on pelareorep and atezolizumab in later-line anal cancer is anticipated. Once the master protocol is finalized with the Global Coalition for Adaptive Research (GCAR), Oncolytics plans to approach the FDA by year-end. In the second half of 2025, initial efficacy results from cohort 5 of the GOBLET study in pancreatic cancer patients are expected. CONTINUED… Read this and more news for Oncolytics Biotech at: In other industry developments and happenings in the market this week include: Akoya Biosciences, Inc. (NASDAQ: AKYA), which calls itself the Spatial Biology Company®, recently announced that its PhenoCycler® Fusion and PhenoImager® HT platforms will support the UK-funded MANIFEST program. This multimillion-dollar initiative, backed by the Office of Life Sciences and the Medical Research Council, aims to enhance cancer immunotherapy research by examining immune cell interactions in tumors. Akoya's technology will help identify biomarkers that may predict patient responses and potential side effects. " Akoya Biosciences is proud to be a part of the MANIFEST consortium, contributing our spatial proteomics leadership and expertise with the aim of improving patient care through this groundbreaking effort," said Brian McKelligon, CEO of Akoya Biosciences. "Our technology can help to identify key biomarkers, supporting the consortium's efforts to advance personalized medicine and ensure that more cancer patients can benefit from the potential of immunotherapy." Checkpoint Therapeutics, Inc. (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, recently presented longer-term data from its pivotal trial of cosibelimab, its anti-programmed death ligand-1 ("PD-L1") antibody, in locally advanced and metastatic cutaneous squamous cell carcinoma ("cSCC"). With 16 months of additional follow-up, cosibelimab achieved objective response rates of 54.8% in locally advanced and 50.0% in metastatic cutaneous squamous cell carcinoma (cSCC), with durable responses still ongoing. The treatment showed a manageable safety profile, with low rates of severe adverse events and a 6.3% treatment discontinuation rate, mostly due to COVID-19. "These longer-term results for cosibelimab presented at the ESMO Congress demonstrate a deepening of response over time, with higher objective response and complete response rates than initially observed at the primary analyses, and continue to expand the evidence supporting the efficacy and safety of cosibelimab as a potential new treatment for advanced cSCC," said James Oliviero, President and CEO of Checkpoint. "We look forward to our upcoming December 28, 2024, Prescription Drug User Fee Act ("PDUFA") goal date for our Biologics License Application for cosibelimab, and believe, if approved, cosibelimab's dual mechanisms of action and safety profile may position the product, over time, as the preferred immunotherapy of U.S. oncologists." BriaCell Therapeutics Corp. (NASDAQ: BCTX), a clinical-stage biotech company developing novel immunotherapies to transform cancer care, recently reported dramatic anti-tumor response, including complete resolution of temporal lobe breast cancer metastasis in a patient treated in the Phase 2 study of BriaCell's Bria-IMT™ plus an immune checkpoint inhibitor regimen. The patient demonstrated an initial partial response at 2 months in the brain lesion with no detectable disease following 8 and 11 months of treatment. "We believe that the complete tumor resolution in this patient with brain metastasis, plus other cases of significant anti-cancer clinical responses in our Phase 2 MBC patients with brain metastasis, highlight the potential application of Bria-IMT™ in treating similar MBC patients," said Dr. Giuseppe Del Priore, Chief Medical Officer of BriaCell. "The protracted time on therapy, now one year, attests to the excellent tolerability of the Bria-IMT™ regimen in combination with an immune checkpoint inhibitor which is being used in our pivotal Phase 3 study." Arcus Biosciences, Inc. (NYSE: RCUS), a clinical-stage global biopharmaceutical company, recently announced a clinical trial agreement with AstraZeneca to evaluate Arcus's investigational HIF-2a inhibitor casdatifan (AB51) in combination with volrustomig, AstraZeneca's investigational PD-1/CTLA-4 bispecific antibody, in patients with clear cell renal cell carcinoma (ccRCC). "We believe casdatifan has best-in-class potential, based on the observed PK and PD profiles and the emerging clinical data from our ARC-20 study in patients with ccRCC," said Terry Rosen, Ph.D., CEO of Arcus. "This agreement will enable Arcus and AstraZeneca to collaborate and assess the potential for the novel combination of casdatifan with volrustomig to improve outcomes for patients with ccRCC." Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. SOURCE USA News Group WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyClinical ResultPhase 2

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

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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	BriaCell Therapeutics Corp.	05 May 2017
Metastatic breast cancer	Phase 2	US	LumaBridge LLCStartup	05 May 2017
Ovarian Epithelial Carcinoma	Phase 2	US	BriaCell Therapeutics Corp.	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06072612 (GlobeNewswire) Manual	Phase 2	Metastatic breast cancer	54	Bria-IMT™ regimen + immune checkpoint inhibitor (since 2022)	(aoqtiswfgd) = hsoqgquyou gwyyuaseoz (bnhkhqdgbq ) View more	Positive	11 Sep 2024
				Bria-IMT™ regimen + immune checkpoint inhibitor (total)	(aoqtiswfgd) = xrjurofico gwyyuaseoz (bnhkhqdgbq ) View more
NCT03328026 (ASCO2024) Manual	Phase 1/2	Metastatic breast cancer \| Advanced breast cancer CAMLs \| CTCs	54	SV-BR-1-GMegimen with oriretifanlimabce	(ttczaxcrcr) = gzxrobofdx obanmggfqw (uasjvxfmay ) View more	Positive	24 May 2024
NCT03328026 (SV-BR-1-GM, ASCO2024)	Phase 2	Metastatic breast cancer	54	Bria-IMT + CPI	ftnuxtxpjq(begppwmdru) = 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. nvpagreloc (cdoecetpub ) View more	Positive	24 May 2024
AACR2024	Not Applicable	Neoplasm Metastasis ER+/PR+ \| HER2- \| ER-/PR- ... View more	-	Bria-IMT monotherapy	rbksewvzee(enmajzacqd) = ibiemdcspr vgpxqnadfw (qqiuzwctxt )	-	05 Apr 2024
				Bria-IMT + immune checkpoint inhibitor	rbksewvzee(enmajzacqd) = vxnghodtru vgpxqnadfw (qqiuzwctxt )
GlobeNewswire Manual	Not Applicable	Advanced breast cancer	-	Bria-IMT±Checkpoint Inhibitor	(urcjpwyxcd) = ykrfpnkhda gaednyqnbk (bujhdvvpzk )	Positive	28 Dec 2023
NCT03066947 \| NCT03328026 (AACR2023) Manual	Phase 1/2	Metastatic breast cancer	51	SV-BR-1-GM	(nigdxilvgt) = rsftcmfofo aqlrrteivq (mdtjeukrbk ) View more	Positive	14 Apr 2023
				SV-BR-1-GM+Pembrolizumab or Retifanlimab	(nigdxilvgt) = vuryviesla aqlrrteivq (mdtjeukrbk ) View more
NCT03066947 \| NCT03328026 (P1-05-28, SABCS2023)	Phase 1	Metastatic breast cancer CTCs \| CAMLs \| CAML PD-L1	33	SV-BR-1-GM monotherapy	xukvqzkuxp(wdlxmhtdux) = stuzmqeafk bbvfvbduud (bclmhntsuk ) View more	Positive	01 Mar 2023
				SV-BR-1-GM + anti-PD-1 combination therapy	xukvqzkuxp(wdlxmhtdux) = wvsrwhgtjz bbvfvbduud (bclmhntsuk ) View more
NCT03066947 \| NCT03328026 (AACR 12021 \| AACR 22021) Manual	Phase 1/2	Advanced breast cancer	23	SV-BR-1-GM	(yobtjudzip) = zqjaxuucjb ewamairshz (apennnwkhd ) View more	Positive	01 Jul 2021
				SV-BR-1-GM +pembrolizumab or INCMGA00012	(yobtjudzip) = nnnysnqfki ewamairshz (apennnwkhd ) View more
ASCO2009	Not Applicable	Gastrointestinal Stromal Tumors First line	85	IMT 400 mg daily	(hbfqgxxxuc) = ephpzymphb kvvjkuztdd (dsfvoikmlt ) View more	-	20 May 2009

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SV BR 1 GM cancer vaccine ( BriaCell Therapeutics)

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