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Oncotelic Therapeutics and Brush and Key Foundation Announce Publication in International Journal of Molecular Sciences Highlighting Context-Dependent Biomarkers in Liver and Pancreatic Cancer

On December 15, 2025 Oncotelic Therapeutics, Inc. (OTCQB: OTLC) in collaboration with the Brush and Key Foundation, reported the publication of a peer-reviewed research article in the International Journal of Molecular Sciences titled "Comparative Tumor Microenvironment Analysis for HCC and PDAC Using KMplotter." Chang, W.-H.; Shah, D.; Myers, S.; Potts, M.; Qazi, S.; Trieu, V. International Journal of Molecular Sciences 2025, 26, 11920.

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The study presents a comprehensive, data-driven analysis of two emerging biomarkers-DNMT3A (DNA methyltransferase 3A) and GMPS (guanine monophosphate synthetase)-across hepatocellular carcinoma (HCC) and pancreatic ductal adenocarcinoma (PDAC). By integrating survival outcomes, transcriptomic profiling, and tumor microenvironment (TME) analyses from more than 7,000 patients, the authors demonstrate that the prognostic significance of these biomarkers is highly context-dependent, shaped by immune composition, metabolic reprogramming, and innate immune sensing pathways.

Training the Next Generation of Scientists

The publication also reflects the educational mission of the Brush and Key Foundation, which supports young scholars through mentored research experiences that bridge scientific inquiry, critical thinking, and professional development.

The paper’s author- Drashya Shah, an intern supported by the Brush and Key Foundation, shared the following reflection: "My experience working with the Brush and Key Foundation for Young Artists has been truly valuable and enriching. Throughout the research and writing process, I received consistent guidance and insightful feedback at every stage, which helped me refine my ideas and present my findings with clarity and precision. This collaborative environment not only strengthened the quality of my paper but also significantly boosted my confidence as a researcher. The skills and knowledge I gained through this journey are lifelong, and I will undoubtedly carry them forward into my future education and professional work. I am deeply grateful to everyone involved for their unwavering support and encouragement."

"This work exemplifies how advanced bioinformatics, translational oncology, and structured mentorship can intersect to generate meaningful scientific insight," said Dr. Vuong Trieu, co-author and contributor to the study. "Equally important, it demonstrates how hands-on research training helps prepare the next generation of scientists."

Dr. Wen-Han Chang, corresponding author, added, "The work highlights why biomarkers cannot be interpreted in isolation. Tumor context-immune composition, metabolic state, and innate sensing-fundamentally alters prognostic meaning and therapeutic opportunity."

(Press release, Oncotelic, DEC 15, 2025, View Source [SID1234661444])

Anixa Biosciences Announces Transfer of IND for Breast Cancer Vaccine from Cleveland Clinic

On December 15, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that it has completed the transfer of the Investigational New Drug application ("IND") for its breast cancer vaccine from Cleveland Clinic. Anixa is now the trial sponsor for future development of its breast cancer vaccine. The transfer of the IND is a natural and planned step in the progresson of the vaccine’s development.

With enrollment completed and encouraging immune response and safety data observed in the Phase 1 trial, Anixa plans to advance the vaccine into a Phase 2 clinical trial and has assumed full sponsorship of the IND. Anixa plans to utilize multiple clinical sites, including Cleveland Clinic, for the Phase 2 and other clinical trials.

Anixa’s breast cancer vaccine, developed in collaboration with Cleveland Clinic, targets α-lactalbumin—a lactation-associated protein that is typically expressed only in breast tissue during lactation, but which re-emerges in many forms of breast cancer. By establising an immune response against α-lactalbumin-expressing cells, the vaccine may offer both therapeutic and preventive benefits for patients with tumors expressing this protein. The vaccine is based on preclinical research led by the late Vincent Tuohy, Ph.D., who served as the Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research at Cleveland Clinic.

"We are excited about assuming sponsorship of the breast cancer vaccine IND, and we look forward to advancing this potentially game-changing cancer vaccine into future clinical trials," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "We are pleased with the progress and findings from our Phase 1 clinical trial, which were presented at the San Antonio Breast Cancer Symposium on December 11."

(Press release, Anixa Biosciences, DEC 15, 2025, View Source [SID1234661443])

Roche receives FDA approval for first diagnostic tests to identify HER2-positive metastatic breast cancer patients eligible for ENHERTU

On December 15, 2025 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the U.S. Food and Drug Administration (FDA) has approved additional indications for its PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody and VENTANA HER2 Dual ISH DNA Probe Cocktail tests. These tests are now approved to aid in identifying HER2-positive metastatic breast cancer (mBC) patients who may be eligible for treatment with ENHERTU (trastuzumab deruxtecan), a specifically engineered HER2-directed antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by Daiichi Sankyo and AstraZeneca.

Until now, Roche’s PATHWAY HER2 (4B5) test had been approved for identifying mBC patients with HER2-low and HER2-ultralow expression. With this expanded approval, Roche’s PATHWAY HER2 (4B5) test in combination with the VENTANA HER2 Dual ISH DNA Probe Cocktail can now be used to identify patients across the full spectrum of HER2 expression for potential eligibility for ENHERTU. This approval reflects the vital role of advanced diagnostics in guiding precise treatment decisions to address the diverse needs of mBC patients.

"Metastatic breast cancer remains a significant challenge," said Laura Apitz, Head of Pathology Lab at Roche Diagnostics. "Diagnostic advances like these bring much-needed hope for patients. With this approval, our breast diagnostic portfolio can further guide therapy decisions for clinicians, enabling a more personalised approach."

Advancing Science in HER2 Breast Cancer
Breast cancer now represents one in four of all cancers diagnosed in women worldwide.1 Despite advances in care, metastatic breast cancer poses a growing challenge, especially in younger populations,2,3 where cases among women aged 25 to 39 increased by 32% between 2009 and 2015.2,3

However, treatment for metastatic breast cancer is evolving alongside a deeper understanding of HER2 biology, which now shows that HER2 expression exists on a continuous spectrum rather than as distinct "positive" or "negative" categories.4

These diagnostics strengthen Roche’s broader breast cancer portfolio, which offers solutions that cover the full spectrum of breast cancer management, including important predictive assays. Roche remains committed to supporting patients with advanced diagnostic tools that help clinicians improve outcomes and deliver more personalized care at every stage of the disease.

About PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody
The PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody delivers timely, clear and reliable results, driving diagnostic certainty and enabling therapeutic decisions that can lead to better outcomes for patients. Previously indicated as an aid to identify certain breast cancer patients eligible for HER2-targeted treatment with Herceptin, KADCYLA, or ENHERTU,5 the test is used in combination with the fully automated BenchMark ULTRA and BenchMark ULTRA PLUS staining platforms.

The assay standardizes all IHC processes from baking through staining, and reduces the possibility of human error.5 It also minimizes inherent variability resulting from individual reagent dilution and other processes found in manual and semi-automated IHC methods. The HER2 (4B5) clone achieves consistently high proficiency assessment scores compared to other clones6 and demonstrates high concordance with HER2 FISH,7.8 empowering laboratories to employ the most widely adopted and reliable HER2 IHC primary antibody.

About the VENTANA HER2 Dual ISH DNA Probe Cocktail assay
The VENTANA HER2 Dual ISH DNA Probe Cocktail assay is a fully automated, ready-to-use brightfield solution for determining HER2 gene status. VENTANA HER2 Dual ISH helps identify breast cancer patients eligible for personalized treatment with HER2-targeted therapies. The VENTANA HER2 Dual ISH DNA Probe Cocktail assay is optimised for use with the VENTANA Silver ISH DNP Detection Kit and the VENTANA Red ISH DIG Detection Kit on the fully-automated BenchMark ULTRA and BenchMark ULTRA PLUS staining platforms.9

The VENTANA HER2 Dual ISH DNA Probe Cocktail assay is an enhanced version of the previous-generation test. New oligonucleotide probes and highly sensitive detection kits provide clear results to pathology labs more quickly, allowing clinicians to make treatment decisions earlier.

(Press release, Hoffmann-La Roche, DEC 15, 2025, View Source [SID1234661442])

TuHURA Biosciences Announces its Release of Kintara’s Contingent Value Right (CVR) as Kintara’s REM-001 Meets Primary Safety Endpoint Achieving Contractual Milestone

On December 15, 2025 TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immuno-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, reported that Kintara’s REM-001 clinical trial of ten metastatic cutaneous breast cancer patients met its primary endpoint demonstrating safety with signs of clinical efficacy following eight weeks of follow-up for such patients.

Pursuant to the terms of the Contingent Value Rights Agreement dated as of October 18, 2024, by and between TuHURA Biosciences, Inc. and the rights agent, Equiniti Trust Company, LLC (the "CVR Agreement"), as a result of the trial and the completion of the follow-up, the milestone required for the release of an aggregate of 1,539,958 shares of TuHURA common stock to legacy Kintara Therapeutics stockholders has been achieved. The holders of CVRs are entitled to receive shares of TuHURA common stock, subject to the terms of the CVR Agreement and any applicable withholding. Pursuant to the CVR Agreement, the shares of TuHURA common stock are expected to be distributed to the CVR holders within the next ten business days.

(Press release, TuHURA Biosciences, DEC 15, 2025, View Source [SID1234661441])

Atossa Therapeutics Presents Four Clinical Trial Updates Highlighting (Z)-Endoxifen Research at the 2025 San Antonio Breast Cancer Symposium

On December 15, 2025 Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing innovative medicines in oncology and other areas of high unmet need, reported four clinical trial updates on (Z)-endoxifen at the San Antonio Breast Cancer Symposium (SABCS), held December 9-12, 2025, in San Antonio, TX.

"Clinical trial updates and data presented at SABCS 2025 reinforce our focus on the therapeutic value of (Z)-endoxifen across the breast care continuum," said Steven Quay, M.D., Ph.D., Atossa Therapeutics’ President and Chief Executive Officer. "With support from our growing body of clinical evidence, we continue to advance our high value clinical programs. Following our more streamlined pathway for our Phase 2 EVANGELINE study, we expect continued enrollment and data generation for neoadjuvant ER+/HER2- breast cancer. Finally, we are committed to advancing a low-dose treatment strategy designed to reduce mammographic breast density. High mammographic breast density has been associated with a higher risk of developing future breast cancer."

Presentation Highlights:

Initial results from RECAST DCIS: Multicenter platform trial testing active surveillance and novel endocrine therapy agents for DCIS management

Clinical significance
Early RECAST findings suggest that short-term endocrine therapy combined with MRI response assessment may identify patients with low-risk DCIS who can avoid surgery and pursue active surveillance, offering a potential pathway to reduce overtreatment while personalizing care

Key takeaways

RECAST is testing whether short-term endocrine therapy plus MRI response can identify appropriate DCIS patients for long-term active surveillance while avoiding surgery
Early results show excellent tolerability and steady enrollment, with many patients electing to continue active surveillance, suggesting feasibility of this patient-centered "window of opportunity" approach
Future work focuses on integrating imaging and molecular biomarkers to refine prediction of progression risk, guide personalized care pathways, improve patient experience and quality of life, and assess long-term outcomes including durability of active surveillance and invasive recurrence
Low dose (Z)-endoxifen in the I-SPY2 Endocrine Optimization Pilot

Clinical significance
The excellent tolerability and biologic activity of low-dose (Z)-endoxifen, demonstrated by reductions in Ki-67, MRI tumor volume, and ctDNA, support its potential as an effective neoadjuvant endocrine therapy for HR+/HER2- early breast cancer and justifies dose escalation and combination strategies to further improve patient outcomes

Key takeaways

The daily 10 mg (Z)-endoxifen dose was well tolerated, with 95% of patients completing ≥75% of therapy and low-grade side effects, demonstrating strong feasibility in an endocrine-naïve HR+/HER2- population
Biologic activity was evident, with meaningful reductions in Ki-67, MRI functional tumor volume (–72% median), and ctDNA clearance observed in 70% of patients who were initially ctDNA-positive, indicating endocrine responsiveness
Clinical impact was modest but supportive, with one mPEPI-0 outcome; the program is now escalating to 40 mg/day (targeting both ERα and PKCβ1) with or without abemaciclib to further optimize neoadjuvant endocrine therapy
(Z)-Endoxifen Maintains ERα Antagonist Function Against ESR1 Mutants via Inactive Conformation Stabilization and Reversal of Mutant ESR1-Associated Transcriptional Signatures

Clinical significance
Findings demonstrate (Z)-endoxifen as a promising therapeutic option for patients with ER+/ESR1 mutant breast cancer, a population with limited effective endocrine treatments and high unmet need

Key Takeaways

(Z)-Endoxifen shown to maintain potent ERα antagonist activity across key ESR1 mutations (Y537S, D538G) by stabilizing inactive receptor conformations, with computational, energetic, and metadynamics analyses showing ESR1 mutants still retain antagonist-compatible states
Functional assays confirmed strong suppression of ER signaling in both wild-type and mutant ESR1 backgrounds, demonstrating robust inhibitory activity even under estrogen-rich conditions and validating the mechanistic modeling findings
Transcriptomic analyses showed that (Z)-endoxifen reverses multiple mutant ESR1–associated oncogenic pathways (e.g., estrogen response, E2F, Myc) while restoring beneficial programs (oxidative phosphorylation, p53), highlighting its therapeutic potential for ER+ / ESR1 mutant breast cancer
A Randomized Phase 2 Non-Inferiority Trial of (Z)-Endoxifen + Goserelin vs Exemestane + Goserelin as a Neoadjuvant Treatment for Premenopausal Women with ER+/HER2- Breast Cancer (EVANGELINE)

Clinical Significance
(Z)-endoxifen with Ovarian Function Suppression (OFS) may offer a more tolerable and biologically potent alternative to aromatase-inhibitor (AI)-based regimens for premenopausal ER+/HER2– patients, potentially expanding endocrine therapy options and improving adherence while maintaining robust neoadjuvant efficacy

Key Takeaways

EVANGELINE is the first trial to evaluate (Z)-endoxifen with OFS as a neoadjuvant therapy for patients with premenopausal ER+/HER2– breast cancer, addressing a major unmet need for patients who cannot tolerate AI with OFS therapy
Pharmacodynamic run-in data showed strong early biologic activity, with 86% of patients achieving a Week 4 Ki-67 ≤10%, supporting the selection of 40 mg (Z)-endoxifen with OFS for Phase II, and demonstrating promising antiproliferative efficacy
The study design incorporates a Simon two-stage approach to test whether (Z)-endoxifen with OFS can meet or exceed a 65% Ki-67 response threshold, with secondary endpoints including safety, RCB, PEPI score, and MRI-based tumor response

(Press release, Atossa Therapeutics, DEC 15, 2025, View Source [SID1234661440])