On December 10, 2025 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, reported positive Phase 2 survival, and Phase 3 biomarker data across three clinical posters at the 2025 San Antonio Breast Cancer Symposium (SABCS ) taking place December 9-12, 2025 at Henry B. Gonzalez Convention Center, 900 E. Market Street, San Antonio, Texas.

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"We are very excited to see the robust and positive biomarker data, which may enable us to more confidently predict clinical responses in patients treated with the Bria-IMT regimen early in their treatment course," stated Kelly E. McCann, MD, PhD, breast medical oncologist at UCLA Health Jonsson Comprehensive Cancer Center, and lead investigator at UCLA for the Bria-ABC pivotal Phase 3 study. "These biomarkers could serve as highly valuable tools for clinicians, helping them inform treatment decisions for metastatic breast cancer, a complex disease in which many patients have limited or no remaining treatment options."

"BriaCell’s data shows the promise of the Bria-IMT regimen to address major unmet needs in the treatment of metastatic breast cancer, including in patients with CNS metastasis who have progressed on several lines of therapy – median 6 prior treatments," stated Chaitali S. Nangia, MD, Partner, Hoag Medical Group and first author of the poster.

"Our findings support further evaluation of cytokine and chemokine biomarkers as potential predictors of survival and clinical benefit with our Bria-IMT regimen, establishing a path towards more personalized therapeutic strategies in metastatic breast cancer patients with limited treatment options," commented Miguel A. Lopez-Lago, PhD, BriaCell’s Chief Scientific Officer.

The details of the poster presentations are listed below.

Late-Breaking Abstract Number: 3688
Presentation Number: PS1-13-22
Presentation Title: Impact of Prior Therapy, Genotype Matching, and Biomarkers in the Bria-ABC Phase 3 Trial
Poster Presentation Date/Time: Wednesday, December 10, 2025, 12:30 PM – 2:00 PM CST

Summary
In BriaCell’s pivotal Phase 3 study in metastatic breast cancer, patients are randomized 1:1:1 to receive Bria-IMT plus an immune check point inhibitor (CPI), Bria-IMT monotherapy or Treatment of Physician’s Choice (TPC). A pooled interim analysis of 116 patients with available MHC subtyping and median 6 prior lines of therapy assessed safety, biomarker correlations and progression-free-survival (PFS) per imaging. All data remains blinded to date.

Key Findings

Favorable safety profile: The Bria-IMT regimen was well tolerated with no treatment-related discontinuations due to adverse events (AEs). The most common AEs were fatigue, anemia, and nausea and were predominantly low grade.
Early PFS signals by subtype: Median PFS values appeared highest in patients with HR+/HER2- disease (3.7 months) and HER2-Low disease (3.9 months).
Neutrophil-to-Lymphocyte Ratio (NLR) as a potential predictive biomarker: Consistent with findings from the Phase 2 study , the Neutrophil to Lymphocyte Ratio (NLR) continues to show potential as a biomarker of clinical benefit. Patients with favorable NLR of 0.7 – 2.3 demonstrated longer PFS with a median of 4.4 months vs 2.6 months in those with NLR <0.7 or >2.3.
Conclusion
Biomarkers previously associated with PFS and overall survival (OS) in BriaCell’s phase 2 study continue to show a direct relationship with PFS in this ongoing phase 3 study. Further analysis is planned as enrolment progresses, and as OS data mature.

Late-Breaking Abstract Number: 3713
Presentation Number: PS1-13-23
Presentation Title: Survival Results of Phase II Bria-IMT Allogenic Whole Cell-Based Cancer Vaccine
Poster Presentation Date/Time: Wednesday, December 10, 2025, 12:30 PM – 2:00 PM CST

The data analysis of Phase 1/2 study evaluating the Bria-IMT regimen in combination with an anti–PD-1 checkpoint inhibitor (CPI) in 54 metastatic breast cancer is presented below. Six patients had Central Nervous System (CNS) metastasis.

Summary
Positive Delayed Type Hypersensitivity (DTH) may be key predictor of clinical benefit as median overall survival (OS) was significantly (P=0.0001) higher in patients who were DTH+ (11.3 months) vs those who were DTH- (4.7 months).

In four evaluable patients with CNS metastasis, best clinical benefit Rate (CBR) including complete response (CR), partial response (PR), or stable disease (SD) in patients was 100% in HER2+ patients, 100% in HR+ patients, 50% in patients with TNBC, and 75% overall.

Conclusion
Maturing positive Phase 2 data continue to support the potentially meaningful clinical benefit of the Bria-IMT regimen and the ongoing pivotal Phase 3 study is further evaluating this immunotherapy and the role of biomarkers in predicting patient response.

Abstract Number: 1614
Presentation Number: PS2-09-03
Presentation Title: Th1-biased cytokine signatures as biomarkers of clinical benefit following SV-BR-1-GM cancer vaccination in breast cancer.
Poster Presentation Date/Time: Wednesday, December 10, 2025, 5:00 PM – 6:30 PM CST

Analysis of 35 different blood cytokines/chemokines from 30 patients enrolled in the Phase 1/2 studies of Bria-IMT alone or in combination with an immune checkpoint inhibitor (CPI).

Summary

Bria-IMT immunotherapy produced Th1 biased cytokine and chemokine changes consistent with immune activation suggesting their use as potential biomarkers to predict clinical responses of cancer patients to Bria-IMT regimen.
Patients with Stable Disease (SD) or PR (Partial Response) showed significantly higher levels of immune activating factors including IL-2, IL-15, IL-27, TNF-α, CXCL10, CCL2, CCL13, CCL26, and IL-17Apost-treatment, suggesting enhanced T-cell activation and pro-inflammatory signaling.
No induction of Th2- or regulatory-associated cytokines was observed suggesting that the Bria-IMT regimen did not suppress immune activation.
Elevated post-treatment levels of IL-1β, IL-6, IL-8, TNF-α, and MCP-4 were associated with better Overall Survival (OS).
Conclusion
BriaCell’s data suggests that Th1 biased cytokines and chemokines may serve as potential predictive biomarkers of clinical responses to the Bria-IMT regimen in metastatic breast cancer.

Copies of the posters will be made available at View Source

(Press release, BriaCell Therapeutics, DEC 10, 2025, View Source [SID1234661342])

On December 9, 2025, GlaxoSmithKline Intellectual Property (No. 4) Limited ("GSK") delivered written notice to IDEAYA Biosciences, Inc. (the "Company") of its election to terminate the Collaboration, Option and License Agreement, dated June 15, 2020 (as amended, the "Agreement"). This written notice constituted GSK’s formal written follow-up to its December 4 communication to the Company regarding the termination, as referenced in the Company’s Form 8-K filed on December 5, 2025. Pursuant to the terms of the Agreement, such termination will be effective ninety (90) days following the date of GSK’s notice, which is March 9, 2026. During the ninety-day transition period, GSK will transfer the Werner Helicase (IDE275) and Pol Theta (IDE705) clinical programs to the Company in accordance with the applicable provisions of the Agreement. The Company will evaluate its strategic options for these two programs in 2026, and the update does not change its expectation of cash runway into 2030.

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The Agreement is filed as Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 12, 2020, Exhibit 10.18 to the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 18, 2022 and Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 10, 2022. For a summary of the material terms of the Agreement, please see Note 10, Significant Agreements, to Company’s financial statements for the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on February 18, 2025, which summary is incorporated by reference herein.

(Filing, 8-K, Ideaya Biosciences, DEC 9, 2025, View Source [SID1234661403])

On December 9, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported its Phase 3 clinical study has screened over 230 and enrolled over 160 patients. BriaCell anticipates reporting topline data as early as 1H2026.

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Interim data will be analyzed once 144 patient events (deaths) occur. Positive results from this pivotal study could support full approval and marketing authorization of Bria-IMT in patients with metastatic breast cancer.

BriaCell’s pivotal Phase 3 clinical study is evaluating BriaCell’s lead clinical candidate, Bria-IMT, plus an immune check point inhibitor versus physician’s choice in a dvanced metastatic b reast c ancer (Bria-ABC).

"The pace of patient enrollment in our pivotal Phase 3 study has exceeded expectations underscoring the strong engagement of participating sites and the high level of interest from patients and investigators," stated Dr. William V. Williams, BriaCell’s President & CEO. "We look forward to collecting, analyzing and sharing the Phase 3 data with the U.S. FDA in the coming months as we continue working to bring hope to patients with metastatic breast cancer who face an urgent medical need."

About BriaCell’s Pivotal Phase 3 Clinical Study of Bria-IMT Combination Regimen in MBC patients

BriaCell’s pivotal Phase 3 study of Bria-IMT plus an immune check point inhibitor (CPI) in metastatic breast cancer is ongoing.

Interim data from BriaCell’s ongoing pivotal Phase 3 study of Bria-IMT plus an immune check point inhibitor in metastatic breast cancer will be analyzed once 144 patient events (deaths) occur. This interim analysis will assess overall survival (OS) as the primary endpoint, comparing patients treated with the Bria-IMT combination regimen to those receiving physician’s choice therapy. Positive results from this pivotal study could support full approval and marketing authorization of Bria-IMT in patients with metastatic breast cancer. The Bria-IMT combination regimen has been granted FDA Fast Track designation.

For additional information on BriaCell’s pivotal Phase 3 study, please visit ClinicalTrials.gov NCT06072612.

(Press release, BriaCell Therapeutics, DEC 9, 2025, View Source [SID1234661341])

On December 9, 2025 Promega reported a new study published in Nature Communications reveals technological advances that accelerate breakthroughs in precision medicine. Conducted as a collaboration between Promega, the Center for Advanced Study of Drug Action at the State University of New York at Stony Brook, and the Centre for Medicines Discovery at the University of Oxford, the work leverages bioluminescent NanoBRET Target Engagement (TE) technology developed by Promega to characterize inhibitors that selectively target cancer cells without harming noncancerous cells. Their results demonstrate a connection between drug efficacy and tumor metabolic state, offering a mechanistic bridge between cancer metabolism and precision oncology.

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"To our knowledge, this is the first time anyone has characterized this type of uncompetitive inhibitor mechanism directly in live cells." -Ani Michaud, Sr Research Scientist at Promega

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"The methods in this study enable us to characterize inhibitors that bind much more tightly in tumor cells with specific mutations," says Ani Michaud, Sr Research Scientist at Promega and co-first author of the Nature Communications paper. "To our knowledge, this is the first time anyone has characterized this type of uncompetitive inhibitor mechanism directly in live cells."

PRMT5: Top Target for Drug Discovery

The published study focuses on a gene-regulating protein called PRMT5, which has long been considered a top target for drug discovery. In normal cells, PRMT5 interacts with a molecule called SAM. However, in the tumor cells of approximately 10-15% of cancers, a deletion of the MTAP gene leads to PRMT5 interacting with the molecule MTA instead, reducing its function. This difference creates a key vulnerability for targeting cancer cells with a mutation to MTAP while leaving normal cells unaffected.

The University of Oxford team designed and developed CBH-002, a cell-permeable BRET probe that binds to a genetically encoded PRMT5-NanoLuc biosensor to report drug target engagement in live cells.

Dr Elisabeth Mira Rothweiler, Postdoctoral Researcher, Centre for Medicines Discovery, University of Oxford and co-first author, says: "CBH-002 could measure various PRMT5 inhibitor types in live cells, prompting us to test its sensitivity to the cofactor SAM. When we discovered the probe’s ability to sense metabolite levels, it established its utility as a metabolic biosensor. Through collaboration with Promega, we demonstrated how MTA influences drug selectivity, revealing why certain inhibitors are so effective in MTAP-deleted cancers."

Dr Rothweiler’s research further enables a strategy for developing molecules that exploit the metabolic vulnerabilities specific to MTAP-deleted cancers, potentially offering highly targeted treatments with minimal effects on healthy tissue.

Uncompetitive Binding in Live Cells

While past studies have characterized this mechanism-of-action (MoA) in biochemical assays, this is the first to use NanoBRET TE technology to characterize uncompetitive, or cooperative, binding in live cells. Biochemical assays can reveal uncompetitive MoAs, but there is often a discrepancy between biochemical data and functional assays like selective cell killing. The NanoBRET TE assay used in this study bridges the two modalities, showing binding MoA in a cellular context that aligns with functional assay results.

Professor Kilian Huber, Associate Professor, Centre for Medicines Discovery, University of Oxford and co-senior author of the study, says, "The biosensor lets us examine, in living cells, how different PRMT5 inhibitors behave under the specific metabolic conditions that make some tumors uniquely vulnerable. This provides unprecedented insight into why certain inhibitors are much more effective in cancers lacking MTAP and paves the way for highly targeted cancer treatment in the future. It’s like turning on the lights inside the cell so we can finally see which key actually fits the lock."

"Selectivity is one of the most critical challenges in cancer therapy, as most treatments also damage healthy cells, leading to dose-limiting toxicities and reduced therapeutic effectiveness," says Peter Tonge, distinguished professor of chemistry and director of the Center for Advanced Study of Drug Action at the State University of New York at Stony Brook and visiting professor at the University of Rochester. "A new class of tumor-specific drugs addresses this by acting uncompetitively with a metabolite that accumulates only in cancer cells, limiting activity to tumor tissue. We have now developed the first technology to quantify the activity of these drugs directly in live cells, providing a foundation for optimizing and advancing next-generation precision oncology therapeutics."

Collaboration Between Academia and Industry

This study was the result of collaboration between Promega, the Center for Advanced Study of Drug Action at the State University of New York at Stony Brook, and the Centre for Medicines Discovery at the University of Oxford, with additional contributions from researchers at Boston University and the Structural Genomics Consortium at the University of Toronto.

"This work underscores the value of research collaborations between academia and industry," says Matt Robers, Associate Director of R&D at Promega and co-senior author of the study. "By combining our complementary expertise in chemical biology and assay design, we were able to dissect how cooperativity can drive cancer cell selectivity. These findings have real potential to guide the development of future precision medicines."

Read the paper "A BRET biosensor for measuring uncompetitive engagement of PRMT5 complexes in cells" in Nature Communications here: View Source

(Press release, Promega, DEC 9, 2025, View Source [SID1234661337])

On December 9, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported the results from two oral presentations that were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.

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Real-world Signatera Analysis: Oral Presentation on December 6

A real-world analysis of personalized circulating tumor DNA (ctDNA) detection in lymphoma evaluated 144 patients across 14 lymphoma subtypes, including aggressive and indolent lymphomas and patients undergoing chimeric antigen receptor T-cell (CAR-T) therapy. Signatera was used clinically to assess baseline ctDNA detection, track molecular clearance during first-line (1L) therapy, and evaluate end-of-treatment (EOT) ctDNA status and post-CAR-T response. Key findings included:

Across 14 subtypes of lymphoma, 94% of patients had detectable ctDNA in a pre-treatment sample.
ctDNA clearance during treatment was highly predictive of CAR-T response (p = 0.0028).
Rapid ctDNA clearance after one cycle of chemotherapy was more predictive of positive outcomes vs. delayed clearance after two cycles of therapy (HR: 20.95 vs. 7.45).
Signatera status at the end of 1L therapy was highly prognostic of event-free survival (HR: 49.77, p<0.0001), outperforming standard of care PET-CT response assessment across lymphoma subtypes.
HOVON Study: Oral Presentation on December 7

The HOVON study was conducted by Foresight Diagnostics, a subsidiary of Natera, in collaboration with Amsterdam University Medical Centers, the Hemato-Oncology Foundation for Adults in the Netherlands (HOVON) and the Netherlands Comprehensive Cancer Organization (IKNL). The study evaluated longitudinal molecular residual disease (MRD) surveillance in 166 patients with diffuse large B-cell lymphoma. The study provided one of the most detailed evaluations to date of ctDNA-MRD dynamics over a two-year surveillance period using the CLARITY ctDNA assay. Key findings included:

The CLARITY ctDNA assay showed early molecular response was associated with improved clinical outcomes, demonstrating its utility as an early risk-stratification marker.
Following any negative ctDNA test during surveillance, the probability of remaining relapse-free was 99% at 6 months and 97% at 12 months.
Early on-treatment molecular response could serve as a dynamic marker for therapy de-escalation or escalation trials, enabling adaptive trial designs.
"These presentations highlight the value of ctDNA in assessing treatment response and long-term risk across lymphoma subtypes, including diffuse large B-cell lymphoma," said Minetta Liu, M.D., chief medical officer of oncology and early cancer detection at Natera. "The findings reinforce how the detection of disease at the molecular level can support more personalized treatment and surveillance strategies for patients with cancer."

(Press release, Natera, DEC 9, 2025, View Source [SID1234661336])