On December 9, 2025 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported that the Japan Patent Office has issued Patent No. 7783866 for PDS0101 granting broad composition of matter and methods of use claims. The new patent expands previously granted patents in Japan, and adds to the Company’s robust intellectual property estate, which includes previously granted patents in the United States, China, Australia, and Hong Kong. The Company has additional patent applications pending in several other countries. Together with anticipated biologics exclusivity in the United States, the Company has patent and market protections for PDS0101 into the 2040s.

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The incidence of HPV16-related cancers is rapidly increasing in the US and Europe and also increasing globally.* PDS0101 is currently being studied in the Company’s Phase 3 trial for PDS0101 + pembrolizumab in HPV16-positive recurrent/metastatic head and neck cancer.

"The issuance of an additional patent for PDS0101 in Japan further strengthens our global IP portfolio and reinforces the robust intellectual property position supporting our growth. This marks an important step in protecting the value of our innovative immunotherapies as we advance our pipeline worldwide." said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotechnology.

The Company intends to continue to advance broad intellectual property protections for PDS0101 and its other investigational agents in development.

(Press release, PDS Biotechnology, DEC 9, 2025, View Source [SID1234661318])

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 Pulse Biosciences, Inc. (Nasdaq: PLSE)(the "Company" or "Pulse Biosciences"), a company leveraging its novel nPulse technology using its proprietary Nanosecond Pulsed Field Ablation (nanosecond PFA or nsPFA) energy, reported a research collaboration with The University of Texas MD Anderson Cancer Center to examine the use of the Company’s nPulse Vybrance Percutaneous Electrode System for treatment of thyroid cancers. The Investigational Device Exemption (IDE) submitted for this first-in-human clinical feasibility study has been approved by the FDA.

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Under the agreement, MD Anderson researchers led by Victoria Banuchi, M.D., Associate Professor of Head & Neck Surgery, will conduct a clinical study to assess the safety and effectiveness of using nPulse technology to treat papillary thyroid microcarcinoma, a common cancer affecting hundreds of thousands of US patients. The trial is planned to commence early in 2026. The study will be conducted at two sites and is planned to enroll 30 subjects. Under an existing material transfer agreement, preclinical studies with MD Anderson researchers are ongoing to assess the effect of nsPFA energy on anaplastic thyroid carcinoma. With a five-year survival rate of less than 5%, anaplastic thyroid carcinoma is one of the deadliest types of cancer.

"We believe the nonthermal mechanism of action of nsPFA, which limits scarring, fibrosis, and damage to critical surrounding structures, positions our nPulse technology as potentially the ideal treatment for benign and malignant thyroid tumors. We look forward to carrying this collaborative work forward to evaluate how our game-changing technology may benefit these patients," said Paul LaViolette, Co-Chairman and CEO of Pulse Biosciences.

About the Company’s nPulse Vybrance Percutaneous Electrode System

The Company’s nPulse Vybrance Percutaneous Electrode System consists of a percutaneous needle electrode for use with the Company’s proprietary nPulse Console. The novel electrode is designed to harness and deliver the key advantages of nsPFA energy, enabling precise, nonthermal removal of cellular tissue without damage to noncellular structures or inducing thermal necrosis. The system has received U.S. Food and Drug Administration (FDA) 510(k) clearance for use in the ablation of soft tissue in percutaneous and intraoperative surgical procedures. This proprietary system is designed for non-cardiac applications.

(Press release, Pulse Biosciences, DEC 9, 2025, View Source [SID1234661319])

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 Daiichi Sankyo reported that the first patient has been dosed in the randomization phase of the DESTINY-Ovarian01 phase 3 trial evaluating ENHERTU (trastuzumab deruxtecan) in combination with bevacizumab versus bevacizumab monotherapy as first-line maintenance therapy in patients with HER2 expressing (IHC 3+/2+/1+) advanced high-grade epithelial ovarian cancer following treatment with first-line platinum-based chemotherapy in combination with bevacizumab.

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DESTINY-Ovarian01 is being conducted in collaboration with the European Network of Gynecological Oncological Trial Groups (ENGOT), with the Spanish cooperative group (GEICO) as the lead ENGOT group, The GOG Foundation, Inc. (GOG-F) and Asia-Pacific Gynecologic Oncology Trials Group (APGOT).

ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).

The prognosis for patients with ovarian cancer is poor with an estimated five-year survival rate of 31.8% for those with advanced disease.1 Approximately 70% to 80% of patients with advanced ovarian cancer (Stage 3 or 4) will experience disease recurrence following standard treatment with surgery and platinum-based chemotherapy regimens.2 Maintenance therapy may be given to delay relapse and current recommended treatment strategies include bevacizumab or PARP inhibitor monotherapy or bevacizumab/PARP inhibitor combination treatment, depending on the biomarker status of the tumor. 3 There currently are no HER2 directed medicines approved as maintenance therapy despite HER2 expression being present in up to 55% of ovarian cancers.

"Results from the ovarian cancer cohort of DESTINY-PanTumor02 demonstrated clinically meaningful and durable responses in previously treated patients with HER2 expressing advanced ovarian cancer, supporting the development of ENHERTU in earlier lines of therapy," said Abderrahmane Laadem, MD, Head, Late- 2 Stage Oncology Clinical Development, Daiichi Sankyo. "Given the important role first-line maintenance therapy can play in disease control, we have initiated this first phase 3 trial in ovarian cancer to evaluate whether ENHERTU combined with bevacizumab could become a new maintenance strategy for patients with HER2 expressing advanced high-grade epithelial ovarian cancer."

About DESTINY-Ovarian01

DESTINY-Ovarian01 is a global, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) in combination with bevacizumab versus bevacizumab monotherapy as first-line maintenance therapy in patients with HER2 expressing (IHC 3+/2+/1+) advanced high-grade epithelial ovarian cancer following treatment with first-line platinum-based chemotherapy in combination with bevacizumab. The randomized period of the trial was preceded by a non-randomized safety run-in phase to evaluate the safety of ENHERTU in combination with bevacizumab.

The primary endpoint is progression-free survival (PFS) as assessed by blinded independent central review (BICR) in the HER2 IHC 3+/2+ population. The key secondary endpoint is overall survival (OS) in the HER2 IHC 3+/2+ population. Additional secondary endpoints include PFS as assessed by BICR and OS in the HER2 IHC 3+/2+/1+ population as well as PFS as assessed by investigator in both the HER2 IHC 3+/2+ and HER2 IHC 3+/2+/1+ populations.

DESTINY-Ovarian01 will enroll approximately 580 patients across multiple sites in Asia, Europe, North America and South America. For more information about the trial, visit ClinicalTrials.gov

About Ovarian Cancer

Ovarian cancer is the third most common gynecologic cancer and the seventh most common cancer among women worldwide. 7 More than 324,000 women were diagnosed with ovarian cancer worldwide in 2022.8 The prognosis for ovarian cancer is poor with an estimated five-year survival rate of 31.8% for those with advanced disease.1 Epithelial ovarian cancer accounts for approximately 90% of ovarian cancer cases and the majority are diagnosed at an advanced stage (Stage 3 or 4).

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors.10 HER2 expression (IHC 3+/2+/1+) is present in up to 55% of ovarian cancers and is associated with advanced stages, higher frequency of recurrence, shorter survival time and lower response to platinum-based chemotherapy.

Approximately 70% to 80% of patients with advanced ovarian cancer (Stage 3 or 4) will experience disease recurrence following standard treatment with surgery and platinum-based chemotherapy regimens.2 Maintenance therapy may be given to delay relapse and current recommended treatment strategies include 3 bevacizumab or PARP inhibitor monotherapy or bevacizumab/PARP inhibitor combination treatment, depending on the biomarker status of the tumor. 3 As a majority of patients will experience disease progression on or after these therapies, new treatment strategies are needed. 12,13,14,15 Currently, there are no HER2 targeted medicines approved as first-line maintenance therapy for patients with HER2 expressing advanced epithelial ovarian cancer.

About ENHERTU

ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. ENHERTU consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

ENHERTU (5.4 mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization [ISH]+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

ENHERTU (5.4 mg/kg) is approved in more than 85 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

ENHERTU (5.4 mg/kg) is approved in more than 45 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ISH- ) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial.

ENHERTU (5.4 mg/kg) is approved in more than 60 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ENHERTU (6.4 mg/kg) is approved in more than 70 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric06 trials. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ENHERTU (5.4 mg/kg) is approved in more than 10 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 trials. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

About the ENHERTU Clinical Development Program

A comprehensive global clinical development program is underway evaluating the efficacy and safety of ENHERTU as a monotherapy or in combination or sequentially with other cancer medicines across multiple HER2 targetable cancers.

(Press release, Daiichi Sankyo, DEC 9, 2025, View Source [SID1234665025])