On December 4, 2025 Caris Life Sciences (NASDAQ: CAI), a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, reported that the company and collaborators from leading cancer centers, including those within the Caris Precision Oncology Alliance (Caris POA), will collectively present 19 studies across a range of breast cancer types at the San Antonio Breast Cancer Symposium (SABCS) from December 9-12, 2025.

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The studies investigated seven distinct breast cancer subtypes, including HR+/HER2–, HER2-positive, HER2-low/ultralow/null, triple-negative, invasive lobular carcinoma, male and metastatic. The range of studies demonstrates how multi-omics-driven profiling, subtyping and biomarker discovery accelerate precision oncology and improve patient outcomes. The studies represent 40+ collaborating institutions, including leading NCI-designated cancer centers.

"SABCS is the premier global stage for advancing breast cancer research, and we are excited to share how Caris’ multi-omic tumor profiling is helping define molecularly distinct patient groups," said George W. Sledge, Jr., MD, Caris EVP and Chief Medical Officer. "By integrating whole exome and whole transcriptome sequencing with IHC profiling and AI-driven signatures, we are uncovering new insights into therapeutic resistance and real-world outcomes that bring us closer to truly personalized cancer care."

"The selection of two studies we collaborated on for oral and rapid oral presentations underscores Caris’ leadership in multimodal AI for recurrence prediction and risk stratification in early and late breast cancer," said Caris President David Spetzler, MS, PhD, MBA.

Oral Presentation:

Multimodal Artificial Intelligence (AI) Models Integrating Image, Clinical, and Molecular Data for Predicting Early and Late Breast Cancer Recurrence in TAILORx. Oral #GS1-09
General Session 1. December 10, 2025. 11:30 AM-11:45 AM CST
Rapid Oral Presentation:

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. Rapid Oral #RF3-07
Rapid Fire 3. December 10, 2025. 5:18-5:26 PM CST
Spotlight Posters Include:

Personalized Acquired CDK4/6i Resistance: Associations with Baseline Characteristics Like Obesity in Real-World (RW) Clinical-Multiomics Data. #PD3-02
Poster Spotlight 3. December 10, 2025. 7:33-7:36 AM CST
Overcoming ADC Resistance: Payload Diversification as a Strategy for Sequential Therapy.
#PD3-11
Poster Spotlight 3. December 10, 2025. 8:12-8:15 AM CST
The Genomic, Transcriptomic, and Immune characterization of Metastatic Lobular Breast Cancer. #PD9-07
Poster Spotlight 9. December 11, 2025. 8:00-8:03 AM CST
Differential Benefit to Elacestrant in a Large Cohort of ER+ Breast Cancer: Impact of ESR1 mutants and prior therapy. #PD10-11
Poster Spotlight 10. December 12, 2025. 8:12-8:15 AM CST
Posters Include:

Outcomes in patients with PIK3CA-mutated breast cancer treated with metformin. #PS1-11-11
Poster Session 1. December 10, 2025. 12:30-2:00 PM CST
Evaluation of steroid hormone receptor expression and clinical outcomes in ER-positive breast cancer bone metastases. #PS1-11-27
Poster Session 1. December 10, 2025. 12:30-2:00 PM CST
Comprehensive Characterization of PTEN loss by IHC and PTEN alteration by NGS in Metastatic HR-Positive, HER2-Negative Breast Cancer– An Exploratory Analysis of Biomarker Concordance and Co-Occurrence. #PS2-08-02
Poster Session 2. December 10, 2025. 5:00 – 6:30 PM CST
Site specific Genomic and Immune Landscapes Underpinning in metastatic Male Breast Cancer. #PS2-08-04
Poster Session 2. December 10, 2025. 5:00 – 6:30 PM CST
Chemokine signatures improve PD-L1-based prediction of pembrolizumab response in triple-negative breast cancer. #PS2-08-14
Poster Session 2. December 10, 2025. 5:00 – 6:30 PM CST
Tertiary lymphoid structure (TLS)-related gene expression and outcomes in HER2-Positive (HER2+) breast cancer (BC) in the Real-World Database. #PS2-09-08
Poster Session 2. December 10, 2025. 5:00 – 6:30 PM CST
TONSL, an immortalizing oncogene on Chr.8q24.3 amplicon, confers intrinsic resistance to CDK4/6 inhibitors in breast cancer. #PS2-09-19
Poster Session 2. December 10, 2025. 5:00 – 6:30 PM CST
Combined T and B Cell Signatures as Prognostic Biomarkers in Triple-Negative Breast Cancer (TNBC). #PS2-10-25
Poster Session 2. December 10, 2025. 5:00 – 6:30 PM CST
Metabolic and Immune Reprogramming via SCD1 Inhibition Enhances Chemo-Immunotherapy Response in TNBC. #PS2-12-07
Poster Session 2. December 10, 2025. 5:00 – 6:30 PM CST
Immune microenvironment and survival differences among Hispanic and African American breast cancer cases by biopsy site. #PS3-12-06
Poster Session 3. December 11, 2025. 12:30-2:00 PM CST
Comparative efficacy of antibody drug conjugates (ADCs) in male versus female breast cancer across the spectrum of HER2 expression. #PS4-01-13
Poster Session 4. December 11, 2025. 5:00 – 6:30 PM CST
Evaluation of Metabolic Dysregulation, Endocrine Therapy Outcomes, and Tumor Biology in HER2-/HR+ Breast Cancer using a Multi-Omic, Real-World Analysis. #PS4-01-14
Poster Session 4. December 11, 2025. 5:00 – 6:30 PM CST
EGFR amplification and PI3K pathway mutations identify a subset of breast cancers that synergistically respond to EGFR and PI3K inhibition. #PS4-05-05
Poster Session 4. December 11, 2025. 5:00 – 6:30 PM CST
Poster and abstract summaries highlighting this research will be available onsite at Caris’ booth #209. The full abstracts will be available on the Caris website following the presentations.

The Caris Precision Oncology Alliance consists of 98 cancer centers, academic institutions, research consortia and healthcare systems, including 45 NCI-designated cancer centers, all collaborating to advance precision oncology and biomarker-driven research. Caris and Caris POA members collaborate to establish and optimize standards of care for molecular testing through innovative research focused on predictive and prognostic markers, aiming to improve clinical outcomes for cancer patients.

(Press release, Caris Life Sciences, DEC 4, 2025, View Source [SID1234661136])

On December 4, 2025 Estrella Immunopharma, Inc. (NASDAQ: ESLA) ("Estrella" or the "Company"), a clinical stage biopharmaceutical company developing CD19 and CD22-targeted ARTEMIS T-cell therapies to treat cancer and autoimmune diseases, reported that an independent Data Safety Monitoring Board (DSMB) has completed its review of safety data from the Phase I dose escalation portion of the STARLIGHT-1 trial. Based on the favorable safety profile observed, the DSMB recommended advancing the trial to Phase II, or the expansion phase, at the Recommended Phase II Dose (RP2D). The expansion phase will further evaluate the safety and preliminary efficacy of EB103, the Company’s CD19-redirected ARTEMIS T-cell therapy, in patients with relapsed/refractory (R/R) B-cell non-Hodgkin’s lymphoma (NHL).

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In the Phase I dose escalation phase, no treatment-related serious adverse events (SAEs) were reported (n=9). Notably, the majority of patients treated are considered high-risk, including one with Central Nervous System (CNS) lymphoma. The high-dose cohort achieved a 100% complete response (CR) rate at Month 1 in all evaluable patients.

"The advancement of EB103 into the expansion phase of STARLIGHT-1 is a pivotal milestone for Estrella," said Cheng Liu, PhD, Chief Executive Officer of Estrella. "The excellent safety profile and a 100% complete response rate observed in the high-dose cohort in Phase I demonstrated EB103’s potential to overcome the toxicity barriers that have historically restricted CD19 CAR-T use. We believe EB103 may significantly expand the commercial reach of cell therapy and deliver a best-in-class solution to a broader NHL population, including high-risk subgroups previously ineligible for commercial CAR-T."

The expansion phase is designed as a multi-center, open-label study intended to further evaluate the safety and efficacy of EB103 at the RP2D in subjects (≥ 18 years of age) who have R/R B-cell NHL. Data from this expansion cohort will be used to determine the pivotal trial strategy for EB103. Current active sites include UC Davis Comprehensive Cancer Center and Baylor Scott & White Research Institute. Further details of the trial can be found at www.clinicaltrials.gov under NCT identifier: NCT06343311.

About EB103

EB103, a T-cell therapy, also referred to as Estrella’s "CD19-Redirected ARTEMIS T-Cell Therapy," utilizes ARTEMIS technology licensed from Eureka Therapeutics, Inc. ("Eureka"), Estrella’s parent company. Unlike a traditional CAR-T cell, the unique design of an ARTEMIS T-Cell, like EB103 T-cell, allows it to be activated and regulated upon engagement with cancer targets that use a cellular mechanism more closely resembling the one from an endogenous T-cell receptor. Once infused, EB103 T cells bind to and destroy CD19-positive cancer cells.

(Press release, Estrella Biopharma, DEC 4, 2025, View Source [SID1234661152])

On December 4, 2025 NovaBridge Biosciences (Nasdaq: NBP) (NovaBridge or the Company) a global biotechnology platform company committed to accelerating access to innovative medicines, reported that new data from the expanded Phase 1 dosing study for ragistomig, a 4-1BB X PD-L1 bispecific antibody, will be presented in a poster at the European Society for Medical Oncology – Immuno-Oncology Congress 2025 (ESMO-IO 2025) by co-developer ABL Bio. The poster (Abstract #688) will be presented by Gerald Falchook, MD, Director of the Sarah Cannon Research Institute (SCRI) at HealthONE Denver, on Wednesday, December 10th at 5:30 PM GMT.

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"The expanded Phase 1 dosing study achieved its objective of extending the therapeutic window for ragistomig by defining a new dosing schedule that could provide strong anti-tumor efficacy and a more manageable tolerability profile, including improved hepatic safety. The data build on promising Phase 1 data presented at ASCO (Free ASCO Whitepaper) 2024 and support progression to combination studies which could significantly advance patient care," said Phillip Dennis, MD, PhD, Chief Medical Officer of NovaBridge.

"Ragistomig was designed to deliver new therapeutic options for patients who have developed resistance or relapsed after treatment with checkpoint inhibitors, a multi-billion dollar drug class that serves as the cornerstone of care for many cancers. We are encouraged by the promising ragistomig advancements and data that will be presented at ESMO (Free ESMO Whitepaper)-IO and look forward to continuing the program in collaboration with our partner, ABL Bio," said Sean Fu, PhD, Chief Executive Officer of NovaBridge.

ESMO-IO Meeting information:

•
Title: Phase 1 Clinical Trial of Ragistomig (ABL503/TJ-L14B: PD-L1 × 4-1BB bispecific antibody) Q6W Dosing Balances Favorable Safety and Sustained Efficacy Through Extended Immunologic Memory and Reinvigoration of CD8+ T Cells
•
Abstract #688
•
Date and Time: Wednesday, December 10th at 5:30 PM GMT
A copy of the poster will be available here after the session. To review an overview of the Phase 1 dose escalation data, click here.

About Ragistomig

Ragistomig (also known as ABL503) is a differentiated novel bispecific that integrates a single-chain, Fc-silent PD-L1 segment as a tumor engager and 4-1BB segment as a conditional T cell activator. It was developed using ABL Bio’s "Grabody-T" bispecific antibody platform technology to overcome resistance to PD-(L)1 inhibition and stimulate 4-1BB activation only in the presence of PD-L1 expressing tumor cells, to minimize the risk of off-tumor toxicity. Preclinical studies demonstrated that the bispecific antibody showed better anti-tumor activity than its single-agent components. A Phase 1 dose expansion study (NCT04762641) is currently being conducted in the U.S. and South Korea. The study was designed with a primary endpoint of defining the dose-limiting toxicity and adverse event profile of ragistomig, as well as to observe the objective response rate, pharmacokinetic and immunogenicity profiles and other secondary endpoints.

Ragistomig (also known as ABL503) is being jointly developed with ABL Bio

ASCO 2024: the 2024 American Society for Clinical Oncology Annual Meeting; Q6W: every six weeks

(Press release, NovaBridge Biosciences, DEC 4, 2025, View Source [SID1234661123])

On December 4, 2025 Alpha-9 Oncology, a clinical-stage radiotherapeutic company developing targeted cancer therapies, reported the initiation of dosing in a Phase 1 study evaluating A9-3408, a novel Actinium-225-based radiotherapeutic targeting melanocortin 1 receptor (MC1R) for the treatment of patients with melanoma. The Phase 1 study is a multi-center, open-label trial designed to evaluate the safety, dosimetry, and dose escalation of A9-3408 in patients with MC1R-positive melanoma, who have progressed on standard-of-care therapies.

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This milestone advances Alpha-9’s melanoma program, which first entered the clinic last year with A9-3202, a Gallium-68-based imaging agent used to assess MC1R expression and identify patients for the A9-3408 therapeutic study.

"Dosing the first patient with our MC1R radiotherapeutic marks an important milestone for the company and validates our internal R&D platform," said Paul Blanchfield, Chief Executive Officer, Alpha-9 Oncology. "We are excited to have initiated trials for our first therapeutic program and look forward to advancing additional best-in-class assets into the clinic as we aim to bring novel, life-improving treatments to people living with cancer."

"MC1R is an ideal target due to its high expression in melanoma and limited presence in healthy tissue," said Robert Meehan, M.D., Chief Medical Officer at Alpha-9. "Despite advances in immunotherapy, significant unmet needs remain for patients who progress on current standard of care. In our A9-3202 imaging study, 92% of patients had strong MC1R expression after progression on immunotherapy, demonstrating the potential for this program to provide a new modality for patients."

Dr. Meehan recently joined Alpha-9 as Chief Medical Officer, bringing progressive leadership experience in biopharma and biotechnology, specializing in the creation of complex, novel development programs. Dr. Meehan is a board-certified physician trained in hematology and oncology, with expertise in all phases of drug development across multiple modalities. Prior to Alpha-9, Dr. Meehan was the Senior Vice President, Clinical Development at Dragonfly Therapeutics, held multiple senior clinical leadership roles at Moderna, and was a staff clinician in the Developmental Therapeutics Clinic at the National Cancer Institute.

Alpha-9’s platform is built on a systematic approach to molecule design, optimizing binders, linkers, and chelators to create radiotherapeutics with superior uptake and retention in tumors while minimizing off-target effects. The advancement of the MC1R program highlights the company’s capability to develop best-in-class molecules and deliver on the promise of precision oncology.

(Press release, Alpha9 Oncology, DEC 4, 2025, View Source [SID1234661138])

On December 4, 2025 Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company focused on transforming breast cancer treatment and prevention, reported the completion of a Type C meeting with the U.S. Food and Drug Administration ("FDA") on November 17, 2025, to review regulatory strategy for advancing (Z)-endoxifen. During the meeting, the FDA provided the Company feedback on potential expedited regulatory pathways and development options across metastatic disease, neoadjuvant treatment, and breast cancer risk-reduction settings.

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The meeting focused on clinical development design, endpoint strategy, and pathways that could support a streamlined registrational approach. Atossa believes the FDA interaction meaningfully clarified potential routes to accelerate clinical development and regulatory review for (Z)-endoxifen, helping to position the Company to pursue a faster and more focused development strategy across multiple breast cancer indications.

"This meeting was a meaningful development milestone for our programs," said Steven Quay, M.D., Ph.D., Atossa’s President and Chief Executive Officer. "We used this discussion to incorporate FDA feedback into our development planning that could meaningfully shorten our regulatory timeline. We continue to aggressively execute the advancement of (Z)-endoxifen across the breast cancer continuum and toward potential registration pathways."

This includes multiple high-value clinical settings, including:

Metastatic breast cancer (mBC): A dose-ranging study is in preparation as part of the Company’s strategy to support registrational development.
Neoadjuvant ER+/HER2- breast cancer: Enrollment and data generation continue in the Phase 2 EVANGELINE trial.
Breast cancer risk-reduction: Development includes a low-dose strategy targeting mammographic breast density and overall breast cancer risk.
In support of its metastatic breast cancer program, Atossa recently submitted an Investigational New Drug application ("IND") to the FDA and is awaiting feedback. The Company also anticipates additional IND submissions in 2026 to advance combination strategies and explore opportunities beyond monotherapy and breast cancer.

"Our clinical program is now structured around decisive value-creating milestones," said Janet Rea, MSPH, Senior Vice President of Research and Development. "We have completed multiple clinical trials involving nearly 800 participants, and are optimistic that this foundation, combined with anticipated upcoming data, and FDA input supports an active push towards multiple regulatory endpoints."

About (Z)-Endoxifen

(Z)-endoxifen is a highly potent Selective Estrogen Receptor Modulator/Degrader (SERM/D) with demonstrated ability to inhibit and potentially degrade estrogen receptors. It has shown activity even in tumors that have developed resistance to other endocrine therapies. Beyond its anti-estrogenic properties, (Z)-endoxifen also targets the oncogenic signaling pathway, protein kinase C beta 1 (PKCβ1), at clinically achievable blood and tumor levels. (Z)-endoxifen also seems to deliver comparable or superior bone-protective effects relative to tamoxifen.

Atossa is developing a proprietary enteric oral formulation of (Z)-endoxifen that bypasses stomach acid, which would otherwise partially convert the active (Z)-isomer to its inactive (E)-form. We believe this innovation allows for optimal bioavailability and therapeutic integrity. Clinical studies have shown Atossa’s (Z)-endoxifen to be well tolerated in both healthy women and those with breast cancer. In nearly 800 adults (healthy volunteers and breast cancer patients) receiving doses up to 360 mg/day, no maximum tolerated dose (MTD) has been identified, supporting continued dose-range exploration.

Atossa’s (Z)-endoxifen program is supported by a growing global intellectual property portfolio, including four recently issued U.S. patents and numerous pending applications worldwide.

(Press release, Atossa Therapeutics, DEC 4, 2025, View Source [SID1234661139])