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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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])

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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])

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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])

On December 15, 2025 Diakonos Oncology Corp., a clinical-stage biotechnology company developing a new generation of immunotherapies to treat challenging and aggressive cancers, reported it will participate in the Biotech Showcase in San Francisco, CA, from January 13-15, 2026. This premier event is for private and micro-mid-cap biotechnology companies to highlight their innovation, connect with global investors, and engage with executives from prominent biopharmaceutical companies.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Diakonos Oncology will be represented by Jay Hartenbach, President and COO, who will provide a company presentation on the latest clinical developments of DOC1021, a first-in-class, patient-derived double-loaded dendritic cell investigational therapy for aggressive cancers. Mr. Hartenbach will also join industry-leading C-suite executives on a panel to discuss how technological advancements are driving paradigm shifts in the cell and gene therapy landscape.

"Diakonos is advancing immunotherapy through our innovative double-loading dendritic cell treatments that harness the body’s immune system to target cancer with specificity and rigor," said Jay Hartenbach, President and COO of Diakonos Oncology. "I’m honored to join this discussion on the breakthroughs transforming medicine and excited to showcase Diakonos’ leadership in the field."

Details of the company presentation and panel participation are as follows:

Company Overview Presentation
Date: Monday, January 12, 2026, at 2:15 PM Pacific Standard Time
Location: Franciscan B (Ballroom Level), Hilton Union Square, 333 O’Farrell St, San Francisco, CA 94102

Panel Participation
Session Title: Engineering the Future: Advances in Cell and Gene Therapies
Description: Explore cutting-edge advances in cell and gene therapies that reshape the treatment landscape and create new investment opportunities. This session highlights emerging technologies driving transformative therapeutics.
Date: Tuesday, January 13, 2026, at 8:00-9:00 AM Pacific Standard Time
Location: Yosemite A, Hilton Union Square, 333 O’Farrell St, San Francisco, CA 94102

Diakonos’s management team will be available for one-on-one meetings during the Biotech Showcase for interested parties.

To learn more about the event, please visit https://informaconnect.com/biotech-showcase, or to schedule one-on-one meetings, please email [email protected]

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 15, 2025, https://www.prnewswire.com/news-releases/diakonos-oncology-to-present-corporate-overview-and-participate-in-panel-at-2026-biotech-showcase-302641688.html [SID1234661439])

On December 15, 2025 Leucid Bio ("Leucid" or the "Company"), a privately-held biotechnology company developing innovative Chimeric Antigen Receptor T-cell (CAR-T) therapies using its proprietary lateral CAR platform, and Syenex, an open-science genetic medicines platform company, reported a strategic collaboration to access Syenex’s VivoCell Platform for the precise in vivo delivery of Leucid’s CAR-T assets including LEU011 for the treatment of solid tumours.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In vivo CAR-T cell engineering, which generates CAR-T cells directly within the body, addresses many limitations of conventional CAR-T cell therapies. Enabling in vivo delivery removes the need for extensive and complex ex vivo cell processing and logistics, enhancing overall clinical outcomes.

The collaboration is focused on harnessing Syenex’s VivoCell Platform to precisely deliver the LEU011 construct to T-cells in vivo when systemically administered. This represents a next-generation approach, fundamentally transforming the therapeutic profile of Leucid’s lateral CAR platform, moving toward a simpler, potentially off-the-shelf administration route. By addressing the logistical hurdles of ex vivo cell administration – this collaboration is poised to unlock the full potential of the lateral CAR-T platform, including LEU011.

Under the non-exclusive agreement, Syenex will provide Leucid access to its VivoCell Platform and support the development of precision in vivo delivery vehicles tailored to Leucid’s lateral CAR-T candidates. The aim of the collaboration is to accelerate the timeline of Leucid’s in vivo programme, advancing from in vitro proof-of-concept to IND-enabling studies, while enabling Leucid to continue to clinically validate LEU011 in the ongoing Phase I/IIa AERIAL trial in patients with relapsed/refractory solid tumours.

Filippo Petti, Chief Executive Officer of Leucid Bio, said: "LEU011 has been well tolerated and demonstrated functional activity in our ongoing AERIAL trial for relapsed/refractory solid tumours. Gaining access to Syenex’s innovative VivoCell Platform will enable precise in vivo delivery of our CAR-T assets and will be key to maximising the therapeutic impact and accelerate our reach. This partnership with Syenex is key to advancing this powerful therapeutic into a more scalable, patient-friendly format, bringing us closer to addressing one of the greatest challenges in oncology."

Jay Rosanelli, Co-Founder and Chief Executive Officer of Syenex, commented, "We are thrilled to partner with Leucid Bio to apply our precision delivery technology to their cutting-edge cell therapy. This collaboration advances our mission to Cure More and validates the power of our platform to enable the development of complex, next-generation CAR-T therapies, establishing the pathway toward an off-the-shelf product in a much more scalable and efficient in vivo format. By combining Leucid Bio’s pan-cancer CAR-T with our targeted delivery system, we aim to significantly improve treatment options for patients battling solid tumours."

(Press release, Leucid Bio, DEC 15, 2025, View Source [SID1234661438])