On December 9, 2025 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, reported that ten abstracts have been accepted for presentation at the 2025 San Antonio Breast Cancer Symposium (SABCS). The meeting takes place December 9–12 at the Henry B. González Convention Center in San Antonio, Texas.

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"This year at SABCS, our research highlights the power of multimodal data to help unravel the complexity of breast cancer," said Ezra Cohen, MD, Chief Medical Officer of Oncology at Tempus. "By integrating genomic, transcriptomic, and real-world clinical data, we are moving beyond broad disease classifications to uncover specific molecular drivers of progression and resistance. These insights are essential for pinpointing patient populations who may benefit from novel therapies and for optimizing treatment strategies to ultimately improve outcomes for those with advanced disease."

Tempus will highlight its latest scientific and clinical research findings via ten poster presentations:

Integrative Modeling of Multimodal Real-World Data for Improved Risk Stratification of First-Line CDK4/6 Inhibitor Outcomes in Patients with Estrogen Receptor (ER)-Positive/Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Metastatic Breast Cancer
Date/Time: Wednesday, December 10, 2025, 12:30 p.m. – 2:30 p.m. CDT

Presentation Number: PS1-11-08

Summary: We developed a machine learning model that used clinical, genomic, and transcriptomic features to stratify patients with ER-positive/HER2-negative metastatic breast cancer, based on response to first-line CDK4/6 inhibitor plus endocrine treatment and identify predictors of response. This study demonstrated that multimodal real-world data collected during routine care can provide valuable insights into the biology of response to CDK4/6 inhibitors in patients with metastatic breast cancer and help improve patient stratification.
Distinct Transcriptional and Immunosuppressive Microenvironment Signatures in PIK3CA- and ESR1-Mutant Hormone Receptor Positive (HR+)/HER2- Metastatic Breast Cancer (MBC)
Date/Time: Wednesday, December 10, 2025, 12:30 p.m. – 2:30 p.m. CDT

Presentation Number: PS1-11-22

Summary: This study compared transcriptomic and immune profiles in HR+/HER2- metastatic breast cancer across wild-type, PIK3CA-mutant, ESR1-mutant, and co-mutant groups. SFRP2 downregulation was specific to ESR1-mutant tumors, while SCGB2A2 was robustly upregulated in PIK3CA-mutant and co-mutant tumors, suggesting its potential as a diagnostic and therapeutic target. Immune analysis revealed increased M2 macrophages and regulatory T cells in PIK3CA-mutant and co-mutant tumors, with the most pronounced immunosuppressive microenvironment in PIK3CA-mutant cases.

Clinical and Molecular Landscape of ESR1 and PIK3CA Co-Mutated Hormone Receptor–Positive Metastatic Breast Cancer (HR+ MBC): Insights from 8,626 Patients Including Polyclonality and TP53 Alterations
Date/Time: Wednesday, December 10, 2025, 12:30 p.m. – 2:30 p.m. CDT

Presentation Number: PS1-11-16

Summary: Distinct mutation groups—no-MUT, PIK3CA-MUT, ESR1-MUT, and co-MUT (PIK3CA + ESR1)—exhibited unique clinical and genomic features; co-MUT was linked to more bone metastases, elevated tumor mutational burden, increased polyclonality, and shorter real-world overall survival. Notably, the frequency of ESR1 and co-mutations was higher in patients who underwent late molecular testing, indicating these alterations often emerge after extended endocrine therapy and highlighting the importance of timing in molecular assessment for guiding treatment strategies.
Clinicogenomic and Immune Profiles of Male Breast Cancer by Race: Insights from a Large Real-World Cohort
Date/Time: Wednesday, December 10, 2025, 5:00 p.m. – 6:30 p.m. CDT

Presentation Number: PS2-06-28

Summary: Real-world analysis of male breast cancer revealed broadly similar clinicogenomic profiles between Black and White patients, with HR+/HER2-negative and luminal subtypes predominating. Notable immune microenvironment differences—lower M2 macrophage infiltration and higher PD-L1 negativity in Black patients—may impact immunotherapy response and warrant further research into racial variation.
Cathepsin Protease Expression and Therapeutic Outcomes to Trastuzumab Deruxtecan (T-DXd) in Metastatic Breast Cancer
Date/Time: Wednesday, December 10, 2025, 5:00 p.m. – 6:30 p.m. CDT

Presentation Number: PS2-08-18

Summary: This study characterized pre-treatment expression of cathepsin proteases prior to T-DXd (cleavable linker) vs. T-DM1 (non-cleavable linker) treatment to understand their impact on clinical outcomes in metastatic breast cancer using the Tempus real-world database. This study demonstrated that among T-DXd treated patients, high cathepsin B and L protease expression was associated with improved outcomes in patients with HR+/HER2- disease, whereas in HER2+ patients, high expression of these proteases was associated with worse survival. In contrast, in the T-DM1 cohort there were no significant associations between protease expression and OS in the overall cohort as well as in the HER2+ cohort. This highlights the potential role of proteases as biomarkers of response to T-DXd in HER2 low/ultralow, but not HER2+ metastatic breast cancer.
Treatment Sequencing in HR+ HER2- Metastatic Breast Cancer and Associated Real World Outcomes
Date/Time: Wednesday, December 10, 2025, 5:00 p.m. – 6:30 p.m. CDT

Presentation Number: PS2-04-11

Summary: This study investigates the impact of first-line and second-line therapy selections on real-world progression-free survival (rwPFS) and real-world overall survival (rwOS) in patients with HR+ HER2- mBC. CDK4/6i significantly outperforms taxane in first-line. Patients who received second-line CDK4/6i following first-line taxane had longer second-line rwPFS than those who received CDK4/6i first-line treatment. The findings suggest that taxane may cause sensitization to CDK4/6i, potentially conferring better survival outcomes in a subset of patients where first-line taxane is advised, or a potential advantage to chemo before CDK4/6i re-challenge.
Real-World Second-Line Treatment Use and Clinical Outcomes in Patients With HR-Positive/HER2-Negative Metastatic Breast Cancer and an ESR1 Mutation
Date/Time: Wednesday, December 10, 2025, 5:00 p.m. – 6:30 p.m. CDT

Presentation Number: PS2-06-18

Summary: The study objective was to characterize real-world second-line treatment use and clinical outcomes (rwPFS and rwOS) in a metastatic breast cancer patient population with positive ESR1m test after first-line treatment with AI+CDK4/6i. Findings show that this cohort describes a complex subgroup of patients to treat, with rwPFS outcomes highlighting the need for more effective strategies that address resistance to AI+CDK4/6i and improve patient outcomes. Results from Flatiron Health EHR and Tempus both indicated consistent findings.
Comparative Analysis of the Tumor Immune Microenvironment (TIME) and Primary and Metastatic Tissue in HR+/HER2- and Triple-Negative Breast Cancer (TNBC)
Date/Time: Thursday, December 11, 2025, 12:30 p.m. – 2:00 p.m. CDT

Presentation Number: PS3-12-27

Summary: Tempus Lens was leveraged to assess the Tumor Immune Microenvironment (TIME) across metastatic sites of disease in HR+/HER2- breast cancer compared to TNBC, finding significant differences by site in both subtypes, with HR+/HER2- cancer being less immunogenic overall. Lung, pleura, and peritoneum metastases, along with breast and lymph nodes, showed the highest CD8+ T cell proportions, suggesting a subset of HR+/HER2- patients with these sites may potentially respond to Immune Checkpoint Inhibitor (ICI) therapy. This high variability of TIME profiles across metastatic sites warrants further study in prospective trials to guide patient selection for ICI.
The Molecular and Immune Landscape of HER2 Positive Breast Cancer
Date/Time: Thursday, December 11, 2025, 5:00 p.m. – 6:30 p.m. CDT

Presentation Number: PS4-05-21

Summary: Tempus Lens was employed to evaluate the tumor immune microenvironment of HER2+ breast cancer, assessing immune cell infiltration, TMB, PD-L1 status, and HLA allele prevalence, to uncover biomarkers for treatment guidance. A notable percentage of patients with localized and de novo metastatic disease displayed TMB high status and/or PD-L1 positivity. Additionally, TMB-high and PD-L1 positive patients with de novo metastatic disease treated with first-line chemotherapy or anti-HER2 therapy had significantly worse real-world overall survival (rwOS), suggesting a potential therapeutic benefit of incorporating immunotherapy into the treatment paradigm, in both localized and metastatic disease settings. Furthermore, observed ethnic HLA polymorphisms in the cohort may contribute to differences in outcomes and could potentially guide the development of population-specific immunotherapeutic strategies.

Real-World Data (RWD) Outcome Analysis of ESR1 Mutation Emergence in HR+/HER2- Metastatic Breast Cancer Through the Continuum of Standard of Care Hormonal Therapy
Date/Time: Friday, December 12, 2025, 12:30 p.m. – 2:00 p.m. CDT
Presentation Number: PS5-05-02
Summary: This large multimodal RWD outcome analysis from longitudinal molecular surveillance testing (xF) in HR+/HER2- mBC pts treated with AI+CDK4/6i sheds light on the continuum of ESR1m emergence and patient outcomes from first-line and beyond outside of clinical trial data. Analyses show higher ESR1m incidence is associated with reduced survival regardless of line of therapy.

(Press release, Tempus, DEC 9, 2025, View Source [SID1234661335])

On December 9, 2025 Artera, a developer of multimodal AI-based prognostic and predictive cancer tests, reported the commercial launch of the ArteraAI Prostate Test (Post‑RP) for patients experiencing biochemical recurrence (BCR) following radical prostatectomy.

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The test builds on the established ArteraAI platform and delivers prognostic results and insights into short-term ADT benefit to optimize decision-making in the salvage therapy setting, where additional treatment is given if cancer returns after surgery.

After radical prostatectomy, PSA should be undetectable. A rising PSA after surgery can indicate biochemical recurrence, suggesting residual cancer cells may remain. With an estimated 20% to 40% of patients affected, the test now delivers personalized, AI-driven data to this previously underserved population, expanding access to advanced precision medicine.

"The launch of the ArteraAI Prostate Test (Post-RP) is a significant milestone in Artera’s continued growth," said Andre Esteva, CEO of Artera. "This expansion broadens our portfolio, extends our reach to an underserved patient population, and strengthens our partnerships across the healthcare ecosystem. As demand for responsible AI in oncology accelerates, we remain focused on scaling access, delivering measurable value to clinicians, and ensuring our technology reaches the patients who need it most."

This test is based on the robust data presented at the 2024 AUA Annual Meeting, which showed that ArteraAI’s MMAI-based prostate biomarker can accurately estimate the risk of metastasis and help predict which men may benefit from intensified salvage therapy, including hormone therapy plus radiation.

"There is a continued need to optimize treatment for men with post-prostatectomy BCR, especially in understanding which patients benefit from ADT when undergoing salvage radiation," said Todd Morgan, urological surgeon and Chief of Urologic Oncology at Michigan Medicine. "This test has substantial promise for helping individualize these treatment decisions."

As with all Artera products, the ArteraAI Prostate Test (Post‑RP) integrates seamlessly into standard pathology workflows, enabling rapid turnaround and broad accessibility. The test relies on the digitized image of the surgical specimen, preserving the resected tissue while delivering actionable insights to guide personalized treatment decisions.

The launch of the ArteraAI Prostate Test (Post-RP) reinforces Artera’s mission to advance the frontier of precision oncology, offering a timely, cost-effective tool that complements clinical assessments for patients with recurrent prostate cancer.

The ArteraAI Prostate Test (Post‑RP) is now available for commercial ordering nationwide. For more information, visit artera.ai.

(Press release, Artera, DEC 9, 2025, View Source [SID1234661334])

On December 9, 2025 CytoAgents, Inc., a clinical-stage biotechnology company developing CTO1681, a novel, steroid-sparing inhibitor of prostaglandin-mediated inflammation reported that data from two of its Investigational New Drug (IND) application enabling studies will be presented at the European Society for Medical Oncolgy (ESMO) (Free ESMO Whitepaper) Immuno-Oncology Congress 2025, taking place December 10-12, 2025 in London, United Kingdom.

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CTO1681 is an orally administered immune modulator that targets inflammation in the tumor microenvironment and mitigates cell therapy induced toxicities frequently seen in lymphoma patients receiving CAR T-Cell Therapy. CytoAgents is currently enrolling patients in a Phase 1b/2a clinical trial evaluating CTO1681 in lymphoma patients receiving CAR T-Cell Therapy at risk for inflammatory driven toxicities.

At ESMO (Free ESMO Whitepaper), the company will present data from two non-clinical studies demonstrating that CTO1681 attenuates key cytokines known to drive Cytokine Release Syndrome (CRS) without compromising the CAR T-Cell mediated tumor killing in vitro and in vivo. These studies demonstrate that CTO1681 does not interfere with CD19 CAR T-Cell expansion and anti-tumor activity in vivo while reducing the inflammatory cytokines associated with CRS and ICANS.

"These data suggest CTO1681 could enable safer CAR T-Cell Therapy administration, support outpatient treatment paradigms and broaden patient access without compromising anti-tumor efficacy," said Teresa Whalen, Chief Executive Officer at CytoAgents. "We look forward to sharing these data at ESMO (Free ESMO Whitepaper) and to continuing our advancement of CTO1681."

Poster Presentation Details:

Title: CTO1681 Does Not Interfere with CAR T-Cell Anti-Tumor Efficacy In Vivo

Presenter: Michael Howell, PhD, Founder and President Mountaineer Biosciences, San Diego, CA, USA

Final Poster Number (FPN): 109P

Session Date and Time: Wednesday, December 10, 2025, 5:15 PM – 6:30 PM GMT

Location: Queen Elizabeth II Centre – Churchill Room

Title: CTO1681 Attenuates CRS-Driving Cytokines Without Compromising CAR T-Cell-Mediated Tumor Killing In Vitro

Presenter: Michael Howell, PhD, Founder and President Mountaineer Biosciences, San Diego, CA, USA

Final Poster Number (FPN): 113P

Session Date and Time: Wednesday, December 10, 2025, 5:15 PM – 6:30 PM GMT

Location: Queen Elizabeth II Centre – Churchill Room

(Press release, CytoAgents, DEC 9, 2025, View Source [SID1234661333])

On December 9, 2025 CREATE Medicines Inc., a clinical-stage biotechnology company pioneering in vivo multi-immune programming, reported that the first patient has been dosed in the frontline cohort of its metastatic hepatocellular carcinoma (HCC) clinical trial evaluating MT-303. The study is assessing MT-303, an investigational in vivo GPC3-targeted CAR therapy delivered by the company’s proprietary mRNA-LNP platform, in combination with atezolizumab and bevacizumab, the current global standard-of-care regimen for frontline HCC.

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This milestone marks the first time MT-303 is being evaluated in systemic treatment-naïve patients, where immune fitness is better preserved and there is greater potential for deep, durable responses to immunotherapy. Clinical correlative data from CREATE’s ongoing monotherapy programs, including MT-302 and MT-303, have demonstrated in vivo CAR expression, immune activation, and tumor infiltration across more than 40 treated patients. These findings provide strong biological rationale for combination therapy and support the potential for additive or synergistic benefit when MT-303 is paired with atezolizumab and bevacizumab in the frontline setting.

In addition, MT-303 has shown a manageable and differentiated safety profile as a monotherapy, reinforcing the suitability of CREATE’s mRNA-LNP in vivo CAR approach for use alongside established immunotherapies. The platform’s flexibility, redosability, and absence of lymphodepletion requirements position MT-303 well for combination regimens in earlier-line settings where coordinated immune activation is essential.

"Advancing MT-303 into a frontline combination study represents an important evolution for the in vivo CAR field," said Matthew Maurer, M.D., Chief Medical Officer of CREATE Medicines. "Our monotherapy experience across MT-302 and MT-303 has generated compelling correlative evidence of immune activation, myeloid engagement, and tumor infiltration. These data, combined with MT-303’s favorable safety and tolerability profile, support our confidence in evaluating the therapy alongside atezolizumab and bevacizumab. We believe MT-303 is well-positioned to drive deeper and more durable responses for patients with HCC."

"New modalities capable of expanding the benefit of the current treatment options for hepatocellular carcinoma are urgently needed," said Vladimir Andelkovic, M.D., FRACP, Principal Investigator, ICON Cancer Centre, Brisbane, Australia. "Adding the immune engagement potential of MT-303 to atezolizumab and bevacizumab in frontline systemic therapy, where immune fitness is more preserved, is both scientifically compelling and potentially clinically meaningful."

About MT-303

MT-303 is an experimental, in vivo GPC3-targeted CAR therapy that selectively programs myeloid cells using CREATE’s redosable mRNA-LNP system. MT-303 is designed to produce:

CAR expression in circulating and tumor-infiltrating myeloid cells
Direct cytotoxicity against GPC3-positive tumor cells
Immune-modulating effects that recruit adaptive immunity
Repeat-dose capability with improved durability, requiring no lymphodepletion or ex vivo manufacturing
GPC3 is highly expressed across a majority of HCC cases and absent in normal adult tissue, making it an ideal target for directed immunotherapy. In the monotherapy dose escalation cohort of the MT-303 Phase 1/2 trial, the therapy demonstrated human proof-of-mechanism for in vivo CAR expression, myeloid-cell activation, tumor infiltration, evidence of clinical activity and the feasibility of repeat-dose regimens. These results provide the foundation for advancing MT-303 into combination and earlier-line settings.

About the Frontline HCC Study Evaluating MT-303

The frontline HCC study evaluating MT-303 (NCT06478693) is a multi-center, open-label, dose-escalation and expansion trial designed to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of MT-303 in combination with atezolizumab and bevacizumab. The trial will evaluate MT-303 in adults with unresectable or metastatic HCC who have not received prior systemic therapy.

The study will also characterize markers of immune activation, including CAR expression kinetics, cytokine/chemokine profiles, tumor infiltration by innate and adaptive immune cells, and early signs of antitumor activity. Data generated from this trial will inform recommended Phase 2 dose selection, further combination strategies, and potential expansion into additional earlier-line or biomarker-defined patient populations.

About Hepatocellular Carcinoma

Liver cancer is among the fastest-growing causes of cancer-related mortality globally, with more than 850,000 new cases diagnosed each year. Hepatocellular carcinoma accounts for most liver cancer cases and often arises in the context of chronic liver disease, viral hepatitis, metabolic syndrome, or cirrhosis. Although recent advances in targeted agents and immunotherapies have improved patient outcomes, durable, long-term benefit remains limited for most patients. Once frontline therapies fail, treatment options become scarce, and prognosis worsens sharply. Novel therapeutic approaches capable of generating coordinated and sustained immune responses represent an urgent and unmet need for the global HCC patient community.

(Press release, Create Medicines, DEC 9, 2025, View Source [SID1234661332])

On December 9, 2025 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that data from the Phase II study (COMPASSION-25) for its first-in-class PD-1/CTLA-4 bispecific antibody, cadonilimab, in combination with SOX regimen (oxaliplatin + tegafur/gimeracil/oteracil) as neoadjuvant therapy for resectable gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, was presented at the 2025 ESMO (Free ESMO Whitepaper) Asia Congress.

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Currently, Akeso is running the pivotal Phase III study (AK104-310/COMPASSION-33) investigating cadonilimab combined with the SOX regimen for perioperative treatment of resectable G/GEJ adenocarcinoma. This regimen is expected to further push the efficacy boundaries beyond existing single-target immunotherapies and establish a new standard for perioperative immunotherapy in gastric cancer.

Promising Pathologic Complete Response (pCR) Rate

Among all evaluable patients, the overall pCR rate was 28.6%. Notably, in patients receiving the cadonilimab Q3W dosing regimen, the pCR rate reached 50.0%. pCR, defined as the absence of viable tumor cells in both the primary tumor site and regional lymph nodes upon surgical resection, is considered the "gold standard" surrogate endpoint for evaluating neoadjuvant treatment efficacy and predicting long-term survival benefits.

High Rate of Major Pathologic Response (MPR)

The overall MPR rate (defined as ≤10% residual viable tumor cells) across all evaluable patients was 71.4%. For the cadonilimab Q3W regimen, the MPR rate was as high as 85.7%. This suggests that the cadonilimab-based regimen induces substantial tumor regression in the majority of patients.

100% R0 Resection Rate

All patients who underwent surgery achieved an R0 resection (microscopically margin-negative resection), providing a solid foundation for curative intent and potentially reducing the risk of recurrence.

Significant Tumor Downstaging

Among all evaluable patients, 85.7% achieved downstaging of the primary tumor (ypT), and 75.0% achieved nodal downstaging (ypN). These results confirm the efficacy of the cadonilimab regimen in reducing tumor burden and lowering the pathological stage, thereby improving the conditions for successful surgical intervention.

Manageable Safety Profile with Good Tolerability

Treatment-related adverse events were consistent with the known safety profiles of the SOX regimen and immune checkpoint inhibitors. No new or unexpected safety signals were observed, indicating an overall manageable and favorable safety profile.

In perioperative treatment of resectable G/GEJ adenocarcinoma, chemotherapy remains the standard therapy for locally advanced gastric cancer. However, chemotherapy has limited efficacy. Cadonilimab, the first PD-1/CTLA-4 bispecific antibody, works by synergistically activating the immune system, achieving a dual blockade of the tumor immune suppressive microenvironment. This mechanism provides a stronger anti-tumor effect compared to PD-1/L1 monotherapies.

Currently, cadonilimab’s clinical value in gastric cancer is scientifically well-established. Beyond its ongoing phase III clinical trial in the perioperative setting, cadonilimab combined with chemotherapy as a first-line treatment for advanced gastric cancer (with survival benefits across the PD-L1 expression levels) has been approved for commercialization in China. Additionally, a pivotal phase III trial exploring cadonilimab in combination with pulocimab (VEGFR-2) for immune therapy-resistant advanced gastric cancer is currently ongoing and is expected to offer a new therapeutic option for later-line gastric cancer. Collectively, these pivotal phase III studies will expand the use of cadonilimab, paving the way for a comprehensive gastric cancer treatment options that spans from advanced, unresectable gastric cancer to early-stage, resectable disease.

(Press release, Akeso Biopharma, DEC 9, 2025, View Source [SID1234661331])