On December 10, 2025 at the San Antonio Breast Cancer Symposium (SABCS), researchers reported the initial findings from a major multi-year collaboration between the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and Caris Life Sciences (Caris) focused on transforming recurrence risk assessment in early-stage breast cancer through artificial intelligence (AI). The public-private partnership pairs ECOG-ACRIN’s extensive clinical trial expertise and biorepository resources with Caris’ comprehensive MI Cancer Seek whole exome and whole transcriptome profiling, whole slide imaging, and advanced machine learning platforms.

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The research teams developed multimodal models to more precisely stratify recurrence risk in early-stage breast cancer. The models integrate histopathologic imaging, clinical, and molecular data generated from TAILORx, one of the world’s largest and most rigorously annotated breast cancer research repositories. This level of multimodal integration is unprecedented at this scale in early breast cancer prognostication.

Early-stage breast cancer represents a large and heterogeneous patient population in which treatment decisions frequently hinge on uncertain recurrence risk. Of the approximately 310,720 new cases diagnosed in the United States each year, an estimated 60% are early-stage (American Cancer Society), underscoring the broad application and clinical relevance of more accurate and individualized risk assessment.

"Realized through collaboration between ECOG-ACRIN, NCI, and Caris Life Sciences, this public-private partnership represents a methodological, logistical, and collaborative integration of datasets from the historically impactful TAILORx trial to further extend the benefits for breast cancer patients," said ECOG-ACRIN Group Co-Chair Peter J. O’Dwyer, MD. "The advance in personalized medicine afforded in this work, in turn, helps to advance the potential of AI to refine treatment and improve outcomes."

Across analytic evaluations, the multimodal AI models demonstrated enhanced prognostic performance compared to existing recurrence-risk assessment methods, highlighting their potential to support more personalized treatment decision-making in early-stage breast cancer.

"By integrating imaging, clinical data, and molecular profiling, we are advancing beyond single-dimension diagnostics to deliver a more precise and comprehensive understanding of recurrence risk in breast cancer," said Caris EVP and Chief Medical Officer George W. Sledge, Jr., MD. "The development of these models underscores the transformative power of multimodal AI and machine learning in precision oncology."

Both AI models-including development approaches, integrated biomarker features, and demonstrated prognostic improvements- were presented in today’s SABCS sessions.

Multimodal Artificial Intelligence (AI) Models Integrating Image, Clinical, and Molecular Data for Predicting Early and Late Breast Cancer Recurrence in TAILORx, presented by Joseph A. Sparano, MD (Mount Sinai Tisch Cancer Center). Late-Breaking Abstract GS1-08 was presented during SABCS General Session 1.

In this project, researchers developed and prospectively validated a multimodal model integrating pathomic imaging (I), clinical (C), and expanded molecular (M+) data from 4,462 TAILORx tumor specimens. The expanded M+ gene expression panel includes 42 tumor genes associated with breast cancer recurrence derived from five commercially available gene assays, including the Oncotype DX (ODX) 21-gene recurrence score and a set of highly variable genes. Based on the results of the TAILORx trial, ODX is widely used in clinical practice for its prognostic information on recurrence and predictive information on chemotherapy benefit; however, its ability to forecast recurrence beyond the 5-year mark is limited.

The findings from this study will ultimately provide crucial support for the development of a new diagnostic test for women with HR-positive, HER2-negative, node-negative breast cancer that more accurately estimates recurrence risk, especially late recurrence 5 or more years after diagnosis.

"Although the TAILORx trial was the first randomized trial to establish the role of the 21-gene recurrence score to guide chemotherapy use in early breast cancer, our goal was to take one step further in personalizing cancer therapy by developing a new diagnostic test using tumor specimens derived from the trial," said Dr. Sparano.

Dr. Sparano noted that the team developed an AI model that evaluates not only tumor gene expression but also uses deep learning of digitized H&E slides used for routine pathologic assessment to provide better prognostic information about cancer recurrence risk.

"We found that the expanded gene panel was a strong predictor of early recurrence within 5 years after diagnosis, the pathomic imaging was a strong predictor of late recurrence after 5 years, and when combined, a test which added both features to the prognostic information provided by clinicopathologic factors was the strongest predictor of distant recurrence out to 15 years," he said.

A Multimodal-Multitask Deep Learning Model Trained in NSABP B-42 and Validated in TAILORx for Late Distant Recurrence Risk in HR+ Early Breast Cancer, presented by Eleftherios (Terry) Mamounas, MD, MPH (NSABP Foundation, Inc. and AdventHealth Cancer Institute). Abstract RF3-07 was presented during SABCS Rapid Fire Session 3.

Patients with early-stage, hormone receptor–positive (HR+) breast cancer are at risk for distant recurrence several years after diagnosis and initial treatment, making long-term risk assessment critical. Assessment of clinical factors alone (tumor size, grade, node status) is insufficient for precise risk stratification. Furthermore, there is a lack of personalized tools to guide decisions about the use of extended endocrine therapy (EET) beyond the standard 5 years.

Dr. Mamounas presented a multimodal–multitask deep learning algorithm designed to estimate late distant recurrence (DR) risk and help identify patients most likely to benefit from EET. Originally developed and validated in the NSABP B-42 randomized phase 3 trial, the model demonstrated strong prognostic performance, identifying those with minimal recurrence risk after a standard 5-year course of adjuvant endocrine therapy who could be spared additional treatment.

The ECOG-ACRIN/Caris research team conducted a new external validation study of the model in 4,300 patients from the TAILORx trial. In TAILORx, the model demonstrated robust late distant recurrence prognostication independent of other known prognostic factors, supporting its potential clinical utility as a scalable, cost-effective alternative to genomic assays using routine H&E and clinical data.

(Press release, ECOG-ACRIN, DEC 10, 2025, View Source [SID1234661355])

On December 10, 2025 Diakonos Oncology Corp., a clinical-stage biotechnology company developing a new generation of immunotherapies to treat challenging and aggressive cancers, reported that the Company was selected for a Product Development Research Grant through The Cancer Prevention and Research Institute of Texas (CPRIT), an award valued at more than $7 million. The Company was selected for funding as one of nine awardees out of 164 applicants for its proposal titled ‘Advancing DOC1021: Phase 1/2 Refractory Melanoma Study,’ which aims to expand DOC1021 into early-stage clinical development in a third target indication.

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"We are honored to have CPRIT’s support as we bring DOC1021 into a new and critically underserved indication," said Jay Hartenbach, President and COO of Diakonos Oncology. "Across more than two dozen preclinical tumor models and multiple clinical indications, our personalized dendritic cell vaccine platform has shown a consistent pattern of potent immune activation and efficacy. With CPRIT’s support, we are now able to evaluate whether these same immune mechanisms can also benefit patients with refractory melanoma, a population with significant unmet medical need."

Melanoma is a serious and often aggressive form of skin cancer that arises from melanocytes, the pigment-producing cells in the skin. While many cases can be treated effectively when detected early, some patients experience disease progression despite available therapies such as immune checkpoint inhibitors or targeted therapies. In the case of refractory melanoma, the disease no longer responds to immune checkpoint inhibitors, resulting in limited options and poor clinical outcomes. Diakonos’ planned Phase 1/2 study will evaluate the safety and preliminary efficacy of DOC1021, along with ctDNA and immune biomarker responses, in this particularly high-need patient population.

"Despite the remarkable progress made with targeted therapies and immune checkpoint inhibitors, patients with refractory melanoma still have very limited options," said Ryan J. Sullivan, MD, Director of the Cutaneous Medical Oncology Program at Massachusetts General Brigham Cancer Institute. "DOC1021’s personalized dendritic cell approach, which presents each patient’s own tumor antigens in a viral-mimicking context, offers a compelling new way to re-engage the immune system against tumors that have escaped standard therapies. This trial will allow us to rigorously evaluate whether that biology can translate into meaningful benefit for this high-risk patient population."

Enrollment in the Phase 1 clinical study of DOC1021 for patients with refractory melanoma is expected to begin in January 2026, representing an important step forward in the Company’s efforts to advance this investigational therapy into early-stage clinical development.

About DOC1021

DOC1021 is a first-in-class, patient-derived double-loaded dendritic cell therapy that uniquely combines tumor lysate and amplified tumor-derived mRNA. The immunotherapy is made with a patient’s dendritic cells combined with mRNA and proteins prepared from freshly obtained patient tumor specimens.

The unique double-loading approach, which mimics a viral infection, unlocks a synergistic and exponentially more powerful tumor killing TH1 response driven by dual protein and RNA antigen sourcing, and it allows targeting of the complete cancer antigen pool. Moreover, the approach does not require any molecular modification of the patient’s immune cells for manufacturing and does not require preconditioning chemotherapy or high dose IL-2 for administration. DOC1021 allows for simple administration in the outpatient setting and broad reach via community cancer centers.

Diakonos currently has two active clinical trials with DOC102, a Phase 1 pancreatic cancer study (NCT04157127) and a Phase 2 glioblastoma (GBM) study (NCT06805305). Diakonos has received Fast Track designations from the FDA for both the GBM and pancreatic cancer programs, in October 2023 and May 2024, respectively. The company also received Orphan Drug Designation for the GBM program in January 2024. The refractory melanoma Phase 1/2 study with DOC1021 will be initiated with the facilitation and support of the Cancer Prevention and Research Institute of Texas (CPRIT).

(Press release, Diakonos Oncology, DEC 10, 2025, View Source [SID1234661356])

On December 10, 2025 Bantam Pharmaceutical, a clinical-stage company pioneering mitochondrial biology to develop first-in-class medicines for treating aggressive cancers, reported that the first patient was treated at The Princess Margaret Cancer Centre in Toronto, Canada in its Phase 1 clinical trial studying BTM-3566.

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This milestone is an important step as the company begins testing the safety, tolerability, and early signs of effectiveness of BTM-3566 in patients. BTM-3566 is a new type of medicine that targets aggressive cancers by modulating a stress pathway inside cells which may help patients whose cancer has worsened after other treatments.

This first-in-class small molecule works by activating the OMA1-ATF4 integrated stress response (ISR) pathway – a newly described mechanism that governs mitochondrial functions and how cells respond to stress. Instead of targeting an individual protein and its cancer-driver mutations, BTM-3566 specifically uses the machinery of the cancer cell to trigger cell death, making it an ideal treatment option for patients whose cancers no longer respond to standard therapies.

"Enrolling the first patient in our Phase 1 trial is a pivotal milestone in our clinical development efforts," said Michael Stocum, President & CEO of Bantam Pharmaceutical. "Princess Margaret Cancer Centre is an esteemed institution, and we are proud to collaborate with their expert investigators to advance this study for patients with limited treatment options."

Bantam’s Phase 1 program is active in both the U.S. and Canada to study BTM-3566 in lymphomas and solid tumors. The lymphoma cohort includes patients with relapsed/refractory mature B-cell lymphomas. The solid tumor cohort includes a broad range of cancers such as head and neck, lung, gastroesophageal/gastrointestinal, colorectal, sarcomas, uterine, renal and bladder, among others.

"Princess Margaret Cancer Centre is excited to be the first institution to enroll a patient in Bantam’s study of this novel therapeutic approach for those who no longer respond to standard treatments," said Dr. Albiruni Razak, Medical Oncology Lead, Sarcoma at the Princess Margaret Cancer Centre.

Bantam expects to have early information from the first patient available during J.P. Morgan Week in January 2026, along with a full summary of all non-clinical monotherapy and combination data underpinning its regulatory filings in the US and Canada.

For information about the ongoing U.S. trials, visit ClinicalTrials.gov and search NCT06792734 and NCT07266285. For information about the ongoing Canadian trial, visit ISRCTN.com and search ISRCTN15438979.

About BTM-3566

BTM-3566 is a first-in-class small molecule targeting aggressive cancers by activating the OMA1-ATF4 ISR pathway—a newly described mechanism that governs mitochondrial homeostasis and cell survival under stress. Unlike many therapies that target specific tumor mutations, this approach triggers intrinsic apoptotic pathways by modulating mitochondrial function, making it an ideal treatment option when patients progress.
In pre-clinical studies, BTM-3566 demonstrated potent anti-cancer activity, showing complete regressions in patient-derived xenograft (PDX) models of aggressive B-cell lymphomas, including double- and triple-hit DLBCL and in MCL PDX models from patient tumors that progressed on rituximab, BTK inhibitors and CAR-T therapies. BTM-3566 exhibits activity in solid tumors, including tumor regressions in multiple PDX models, where low FAM210B RNA expression is a potential biomarker for patient selection. BTM-3566 also exhibits strong synergy in combination with other drugs, including BH3 mimetics, hypomethylating agents and rituximab, enabling both monotherapy and combination development strategies.

(Press release, Bantam Pharmaceutical, DEC 10, 2025, View Source [SID1234661357])

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 10, 2025 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, reported the submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for IDE574, a potential first-in-class KAT6/7 dual inhibitor with high selectivity over related KAT5/8 enzymes. The company is targeting to begin a Phase 1 dose escalation trial of monotherapy IDE574 in the first quarter of 2026.

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"IDE574 is a promising potential first-in-class molecule that potently inhibits two tumor-promoting epigenetic modulators, KAT6 and KAT7, while sparing other structurally similar KAT family members. Preclinical studies demonstrate KAT6 and KAT7 collaboratively control lineage-specific tumorigenic transcription factor activity essential for tumor cell proliferation and survival. Dual KAT6/7 inhibition by IDE574 disrupts tumor lineage identity and delivers robust anti-tumor activity in patient-derived lung and breast cancer xenograft models dependent upon lineage-specific transcription factor activity," said Michael White, Ph.D., Chief Scientific Officer of IDEAYA Biosciences.

IDE574 is an equipotent, highly selective, small molecule dual inhibitor of the lysine acetyltransferase (KAT) 6 and 7, both of which have been shown to support cancer cell survival. IND-enabling studies support the potential clinical evaluation of IDE574 monotherapy in patients with hormone receptor-positive breast cancer, lung adenocarcinoma as well as additional opportunities associated with lineage addiction. IDEAYA is targeting to share data from its preclinical work with IDE574 at a medical conference in the first half of 2026.

(Press release, Ideaya Biosciences, DEC 10, 2025, View Source [SID1234661358])