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Novocure Appoints Company President Frank Leonard as Chief Executive Officer

On December 1, 2025 Novocure (NASDAQ: NVCR) reported the appointment of Frank Leonard as Chief Executive Officer (CEO), effective immediately. Mr. Leonard previously served as President of Novocure and succeeds Ashley Cordova who has resigned from the company.

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"During his more than 15-year career at Novocure, Frank has led many of our global business operations developing deep expertise in delivering our unique, device-based cancer therapy to patients to extend their survivals. Frank has been instrumental in creating Novocure’s culture and guiding the organization at critical points, including preparing the company for its first commercial launch and establishing the business functions that continue to drive our growth," said William Doyle, Executive Chairman, Novocure. "Frank embodies Novocure’s core values and has an unwavering commitment to our patient-forward mission. He is the ideal person to lead our organization through the exciting, transformative milestones anticipated in the years ahead. We are thrilled for him to step into the CEO role.

"On behalf of the Novocure Board of Directors, I want to thank Ashley Cordova for the contributions she made to our organization during her career at Novocure. She was unquestionably dedicated to our mission and helped build Novocure into the company it is today. We wish her success in her future endeavors," continued Mr. Doyle.

Mr. Leonard joined Novocure in 2010 to prepare the company for its first commercial launch and he has held various leadership roles including establishing Novocure’s finance, reimbursement, and business development functions, and led the company’s early innovation and product development teams. In his role as Novocure’s President, Frank led global sales, marketing, field medical affairs, patient experience, public affairs, market access, and product and portfolio strategy functions.

"The patient is at the center of what we do and why we are committed to extending survival in the most aggressive cancers," said Mr. Leonard. "I am honored to lead Novocure and partner with our incredible employees around the world as we prepare to launch products in new indications, complete multiple clinical trials, and work to deliver the full potential of our innovative therapy."

(Press release, NovoCure, DEC 1, 2025, View Source [SID1234661036])

SAGA Diagnostics Showcases New Pathlight™ MRD Data at SABCS 2025

On December 1, 2025 SAGA Diagnostics, a pioneer in blood-based cancer detection and precision medicine redefining the standard for ultra-sensitive and early molecular residual disease (MRD) detection, reported it will present five posters—three new studies and two trials in progress—at the 2025 San Antonio Breast Cancer Symposium (SABCS), December 9-12, 2025 in San Antonio, TX.

The posters build on the TRACER clinical study findings published in Clinical Cancer Research, which demonstrated 100% sensitivity, 100% specificity, and a 13.7-month lead time to recurrence across all subtypes of stage I–III breast cancer. The data presented at SABCS further validates the best-in-class performance of Pathlight, SAGA’s structural-variant (SV)–based MRD test. This clinical validation data provided the basis for a positive coverage determination for Pathlight under the US Centers for Medicare Services MolDx program. SAGA’s collaborating investigators will also present posters introducing a prospective interventional study designed to evaluate clinical utility using Pathlight.

"Building on the very compelling TRACER data, we are advancing into prospective interventional trials to address the critical question of clinical utility," said Dr. David Cescon, Medical Oncologist and Clinician Scientist at Princess Margaret Cancer Centre, University of Toronto. "Our CLAIRE and CATER studies are now enrolling participants to evaluate whether ctDNA-based surveillance and intervention can improve outcomes in early-stage breast cancer. This is an important step toward integrating MRD-guided strategies into standard clinical care."

Updated TRACER Study Analysis

The retrospective analysis of an expanded set of 121 patients with TNBC, HER2+, or ER+/HER2– early breast cancer showed 100% sensitivity, 100% specificity, and a median 12-month lead time from ctDNA detection to clinical recurrence. Rising ctDNA ("molecular progression") preceded radiographic progression in all patients, and baseline SVs were reproducibly detected across longitudinal timepoints in both early-stage and metastatic disease.

Studies Advancing Clinical Utility

Pathlight is being used in two studies to evaluate the impact of MRD detection on clinical decision-making:

Circulating Liquid Biomarkers for Assessment and Identification in Early BREast Cancer (CLAIRE): A multicenter surveillance study using Pathlight every three months for up to five years in intermediate- to high-risk ER+/HER2– early breast cancer, to prospectively characterize the surveillance process and identify candidates for interventional MRD trials.
CApecitabine for Targeted Eradication of Rising ctDNA Molecular Residual Disease in ER+/HER2- Breast Cancer (CATER): An open-label, Phase II study testing whether secondary adjuvant metronomic capecitabine can eradicate ctDNA in patients previously diagnosed with high-risk ER+/HER2– early breast cancer who have detectable MRD despite standard curative intent therapies. Pathlight will be used to assess ctDNA clearance at 16 weeks as the primary endpoint.
Additional posters will be presented focusing on TNBC, including a poster spotlight, highlighting Pathlight’s performance in the neoadjuvant setting.

"The studies presented at SABCS 2025 continue to validate what we consistently see with Pathlight—ultra-sensitive ctDNA detection that can meaningfully improve early breast-cancer management," said Wendy Levin, MD, MS, Chief Clinical Officer of SAGA Diagnostics. "By leveraging truncal SVs, Pathlight provides a dependable signal clinicians can trust. The new prospective studies take us beyond analytical performance into demonstrating true clinical utility."

SAGA Diagnostics also celebrates the recognition of Dr. Mitchell J. Elliott, first author of the TRACER study, who has been selected to receive the prestigious Margaret Foti Foundation Scholar-in-Training Award at SABCS. This award honors outstanding young scientists conducting high-quality cancer research, and Dr. Elliott’s contributions to advancing ultra-sensitive MRD detection in breast cancer exemplify that standard.

Key SAGA Diagnostics presentations during SABCS 2025:

Abstract title

Presentation details

Prevalence and Dynamics of Circulating Tumor DNA Among Patients with Triple-negative Breast Cancer Undergoing Preoperative Systemic Therapy With or Without Immunotherapy

Poster presentation PS2-07-06

Date: December 10, 2025

Time: 5:00-6:30 PM CST

Presenter: Tae-Kyung Robyn Yoo, Asan Medical Center, Seoul, Republic of Korea

Longitudinal ctDNA Tracking in Early and Recurrent Breast Cancer Using an Ultra-Sensitive Structural Variant-Based Assay: An Updated Analysis from the TRACER Study

Poster Presentation PS2-07-08

Date: December 10, 2025

Time: 5:00-6:30 PM CST

Presenter: Mitchell J Elliott, Princess Margaret Cancer Centre, Toronto, ON, Canada

Neo-N (neon) – Three-year Event-free Survival and Ultra-Sensitive ctDNA Dynamics in Early Triple-negative Breast Cancer Treated with Neoadjuvant Carboplatin/Paclitaxel and Nivolumab

Poster Spotlight 7 (PD7-10): Early Triple Negative Breast Cancer—Biomarkers and Novel Approaches

Date: December 11, 2025

Time: 7:00-8:30 AM CST

Presenter: Sherene Loi, Peter MacCallum Cancer Centre, Melbourne, Australia

CLAIRE – a multicenter, prospective single-arm phase II trial, evaluating liquid biopsy guided intensified follow-up surveillance in women with intermediate to high-risk ER+/HER2-negative early-stage breast cancer

Poster Presentation: PS2-07-08

Date: December 12, 2025

Time: 12:30-2:00 PM CST

Presenter: Mitchell J Elliott, Princess Margaret Cancer Centre, Toronto, ON, Canada

CATER-MRD: Capecitabine for Targeted Eradication of ctDNA Molecular Residual Disease in ER-positive/HER2-negative Early-stage Breast Cancer

Poster Presentation: PS5-09-28

Date: December 12, 2025

Time: 12:30-2:00 PM CST

Presenter: Mitchell J Elliott, Princess Margaret Cancer Centre, Toronto, ON, Canada

The full posters will be available on SAGA Diagnostics’ website after they are presented.

(Press release, SAGA Diagnostics, DEC 1, 2025, View Source [SID1234661035])

FDA Approves IsoPSA® — Cleveland Diagnostics’ Novel Blood-Based Prostate Cancer Test

On December 1, 2025 Cleveland Diagnostics, Inc., a pioneering, commercial-stage precision oncology company, reported that the U.S. Food and Drug Administration (FDA) has approved the company’s IsoPSA in vitro diagnostic (IVD) kit through the Premarket Approval (PMA) process. IsoPSA is a blood-based test indicated as an aid in the decision for prostate biopsy for men ≥ 50 years of age with elevated PSA levels.

"FDA approval of our IsoPSA kit marks a significant milestone in Cleveland Diagnostics’ mission to help physicians and patients detect cancer early when it is most treatable and survivable," shared Arnon Chait, PhD, company president and CEO. "We remain focused on executing our commercial strategy and expanding access to IsoPSA, to the benefit of patients nationwide."

FDA approval of the IsoPSA test was based on clinical evidence from a large-scale, prospective study conducted at 14 sites across the U.S. and data from supporting analytical validation studies.

Prostate cancer is the second most common cancer in American men, with 1 in 8 diagnosed during their lifetime. In the U.S., greater than 1 million men undergo prostate biopsies each year, yet up to 75% of those follow-up tests are negative for high-grade disease. This diagnostic gap subjects millions to invasive, costly procedures that can produce physical risks, emotional stress, and significant healthcare costs. IsoPSA helps close this gap, giving clinicians and patients a more accurate risk assessment and greater confidence in biopsy decision-making.

"As a practicing urologist, I see firsthand how the limitations of current PSA testing can lead to unnecessary procedures and anxiety for patients and appreciate the critical need for early and accurate risk assessment and testing," added Dr. Aaron Berger, Chief Medical Officer and Director of Clinical Research at Associated Urological Specialists in Chicago. "IsoPSA represents a meaningful advancement, giving physicians a tool that improves risk assessment and helps us make more informed biopsy decisions with greater confidence."

"FDA approval underscores the value and clinical utility of IsoPSA in distinguishing benign elevations of PSA from those due to high grade cancer," said Dr. Eric Klein, Emeritus Chair of the Glickman Urological & Kidney Institute at Cleveland Clinic and Distinguished Scientist at GRAIL, Inc.* "I’m very pleased to see this milestone achieved; it represents the culmination of extensive study and test development over the past decade."

The IsoPSA IVD kit leverages Cleveland Diagnostics’ IsoClear platform. This proprietary technology investigates protein biomarkers at a structural level in the blood to provide clinically relevant insights into disease state.

Cleveland Diagnostics has offered IsoPSA as a Laboratory-Developed Test (LDT) since 2020, and Medicare and a growing number of commercial payors now cover the test. IsoPSA is included in leading clinical practice guidelines, including the National Comprehensive Cancer Network (NCCN) Prostate Cancer Early Detection Guideline (2025) and the Early Detection of Prostate Cancer: American Urology Association/Society of Urologic Oncology Guideline (2023).

(Press release, Cleveland Diagnostics, DEC 1, 2025, View Source;-Cleveland-Diagnostics-Novel-Blood-Based-Prostate-Cancer-Test [SID1234661034])

Flatiron Health announces research to be presented at the 2025 San Antonio Breast Cancer Symposium

On December 1, 2025 Flatiron Health reported its presence at the San Antonio Breast Cancer Symposium (SABCS) happening from December 9-12, 2025, in San Antonio, Texas. Flatiron’s real-world data and research capabilities are featured across multiple acceptances, including three spotlight presentations and four poster presentations that leverage the breadth of Flatiron’s breast cancer solutions."Breast cancer is the most common cancer in women worldwide, and every patient’s journey raises critical questions—about treatment effectiveness, biomarker-driven approaches, clinical outcomes, and real-world access," said Emily Castellanos, MD, MPH, Senior Medical Director and Head of Research Oncology at Flatiron Health. "At Flatiron, we’ve built a comprehensive, integrated ecosystem of breast cancer solutions that serve every stage of the oncology development life cycle and our research at SABCS demonstrates that when you have the right data infrastructure, analytics, and clinical expertise working together, you can answer virtually any question about breast cancer care and outcomes."

Research highlights include:

A Spotlight poster presentation leveraging the Flatiron Health–Caris Life Sciences Clinical-Molecular Database, the largest and most robust multimodal dataset of its kind, to identify key genetic alterations and expression changes linked to CDK4/6i treatment resistance.
A Spotlight poster presentation utilizing large language models to explore the real-world use of GLP-1 medications among breast cancer patients and their potential impact on treatment outcomes.
Multiple posters using Flatiron’s Panoramic breast cancer dataset to answer critical research questions on treatment patterns and the effectiveness of novel treatments in improving overall survival and progression-free survival in large, representative patient cohorts.
Learn more about our presence on Flatiron.com and follow Flatiron Health on X and LinkedIn for more updates from #SABCS25.

Abstracts and Poster Presentations
Personalized acquired CDK4/6i resistance: Associations with baseline characteristics like obesity in real-world (RW) clinical-multiomics data
Spotlight Poster Presentation
Kristin M. Zimmerman Savill, Lilia Bouzit, Noelle Liao, Cheryl Cho-Phan, Simon Papillon-Cavanagh
Author Affiliations: Caris Life Sciences, Flatiron Health
Presentation Number: PD3-02
Poster Spotlight 3: Emerging Paradigms of CDK Inhibitor and Antibody Drug Conjugate Resistance in Metastatic Breast Cancer
Presentation Date/Time: Wednesday, December 10, 2025, 7:33 AM – 7:36 AM
Location: 302 ABC

Racial/ethnic inequities in access to novel therapies and outcomes in triple negative breast cancer
Spotlight Poster Presentation
Olive M. Mbah, Gene G. Ho, Catherine Keane, Aaron Dolor, Cleo Ryals
Presentation Number: PD1-06
Poster Spotlight 1: Addressing breast cancer disparities and treatment related toxicities
Presentation Date/Time: Wednesday, December 10, 2025, 7:45 AM – 7:48 AM
Location: Hemisfair 3

Real-world glucagon-like peptide-1 use and association with clinical characteristics, social determinants, and circulating tumor DNA positivity in patients with breast cancer
Spotlight Poster Presentation
Cleo A. Ryals, Auriane Blarre, Blythe Adamson, Daniel Bower, Gene G. Ho, Olive Mbah, Selina Radlein, Erin Fidyk, Fatima Cody Stanford, Aaron B. Cohen
Author Affiliations: Massachusetts General Hospital, Flatiron Health
Presentation Number: PD8-08
Poster Spotlight 8: Beyond the Scale- Obesity and GLP-1 Therapies in Breast Cancer
Presentation Date/Time: Thursday, December 11, 2025, 8:03 AM – 8:06 AM
Location: 221 ABC

Real-world progression-free survival 2 (rwPFS2) and tumor response with CDK4/6is + aromatase inhibitor (AI) in patients (pts) with HR+/HER2– metastatic breast cancer (MBC)
Hope M. Rugo, Adam Brufsky, Rachel M. Layman, Xianchen Liu, Benjamin Li, Lynn McRoy, Aaron B. Cohen, Melissa Estevez, Paul Cottu, Marc Thill, Giuseppe Curigliano
Author Affiliations: City of Hope Comprehensive Cancer Center, UPMC Hillman Cancer Center, The University of Texas MD Anderson Cancer Center, Pfizer, Université Paris Cité, Agaplesion Markus Krankenhaus, University of Milano, European Institute of Oncology, Flatiron Health
Presentation Number: PS1-11-10
Poster Session 1: Wednesday, December 10, 2025, 12:30 PM–2:00 PM

Real-world treatment patterns and clinical outcomes in patients with emerging estrogen receptor 1 (ESR1)-mutated ER+ metastatic breast cancer in the U.S., 2018-2024
Jane Meisel, Tim Pham, Clara Chen, Ayush Kris, James Roose
Author Affiliations: Emory Winship Cancer Institute, AstraZeneca, Flatiron Health
Presentation Number: PS2-02-04
Poster Session 2: Wednesday, December 10, 2025, 5:00 PM – 6:30 PM

Real-world treatment patterns in 1954 US patients with HER2-negative early breast cancer and germline BRCA mutations (2021–2025)
Sagar Sardesai, Meng Ru, Xinran Ma, Catherine Keane, Jingru Wang, Miguel Miranda, Xiaoqing Xu, Claudine Isaacs
Author Affiliations: The Ohio State University Comprehensive Cancer Center, Lombardi Comprehensive Cancer Center, AstraZeneca, Flatiron Health
Presentation Number: PS2-02-03
Poster Session 2: Wednesday, December 10, 2025, 5:00 PM – 6:30 PM

Real-world overall survival with palbociclib plus an aromatase inhibitor (AI) in patients with HR+/HER2− metastatic breast cancer (MBC) who are overweight/obese
Adam Brufsky, Neil M. Iyengar, Xianchen Liu, Benjamin Li, Doris Makari, Lynn McRoy, Aaron B. Cohen, Melissa Estevez, Vandana G. Abramson, Rachel M. Layman, Giuseppe Curigliano
Author Affiliations: UPMC Hillman Cancer Center, Emory University School of Medicine, Pfizer, Vanderbilt University Medical Center, The University of Texas MD Anderson Cancer Center, University of Milano, European Institute of Oncology, Flatiron Health
Presentation Number: PS2-04-12
Poster Session 2: Wednesday, December 10, 2025, 5:00 PM – 6:30 PM

(Press release, Flatiron Health, DEC 1, 2025, View Source [SID1234661033])

Janux Announces Encouraging Efficacy and Safety Profile from Ongoing Phase 1 Clinical Trial for JANX007 in mCRPC

On December 1, 2025 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technologies to its Tumor Activated T Cell Engager (TRACTr), Tumor Activated Immunomodulator (TRACIr), and Adaptive Immune Response Modulator (ARM) platforms, reported positive updated interim data for its JANX007, a PSMA-directed TRACTr, Phase 1 clinical program in patients with mCRPC. Janux will host a virtual event on Monday, December 1, 2025, at 4:30 PM ET.

"We are pleased JANX007 achieved durable responses with a manageable safety profile that compares favorably to both approved and investigational therapies in mCRPC. Additionally, we found that the ability to transition patients to Q2W dosing may provide meaningful convenience advantages," said David Campbell, Ph.D., President and CEO, Janux Therapeutics. "We look forward to evaluating the potential for JANX007 in earlier-line mCRPC, where improved tolerability and durability could have an even greater impact."

"The early data with JANX007 are highly encouraging. I am deeply committed to this program and inspired by its potential to transform care for mCRPC patients, especially as its potential in earlier-line mCRPC treatment is explored," said Dr. Eleni Efstathiou, Section Chief, Genitourinary Medical Oncology, Houston Methodist Cancer Center and investigator on the trial.

Updated Phase 1 interim clinical data for PSMA-TRACTr JANX007 in mCRPC

As of the October 15, 2025 data cutoff, a total of 109 patients have been treated across the Phase 1a dose escalation and Phase 1b expansion trials of JANX007. The patients enrolled in the Phase 1a trial were heavily pre-treated with a median of four prior lines of therapy. The patients enrolled in the Phase 1b expansion trial were taxane-naïve mCRPC.

Patients from the Phase 1 trials demonstrated high prostate-specific antigen (PSA) response rates and deep PSA declines. Anti-tumor activity was observed with confirmed and unconfirmed partial responses in 30% (8/27) of RECIST-evaluable patients.

Encouraging durability was observed in both the QW and every two week (Q2W) expansions with rPFS ranging from 7.9 to 8.9 months and the rPFS of the Q2W expansion group comparing favorably to the QW expansion group.

Preliminary Phase 1b data in taxane-naïve patients demonstrated rapid and deep PSA reductions with primarily grade 1 CRS. Additionally, tumor burden analysis suggests potential for improved rPFS in JANX007 treated earlier line patients.

JANX007 demonstrated a manageable safety profile with cytokine release syndrome (CRS) primarily limited to cycle 1 and grades 1 and 2. Additionally, a CRS mitigation strategy was identified that maintains the grade 1 and 2 CRS profile.

"These findings with JANX007 demonstrate strong efficacy and a CRS safety profile that is predictable and manageable, enabling clinicians to confidently anticipate and address CRS promptly and effectively during early treatment cycles," said Dr. Benjamin Garmezy, Associate Director, Genitourinary Cancer Research; Executive Co-Chair, Genitourinary Cancer Research Executive Committee, Sarah Cannon Research Institute (SCRI) and investigator on the trial.

Janux is advancing JANX007 with a focus on monotherapy and darolutamide combinations in taxane-naïve mCRPC patients. This is the largest and growing mCRPC setting due to increased use of ARPIs in HSPC. Janux also plans to evaluate JANX007 in PARP inhibitor refractory patients as a potential path to an expedited approval.

Webcast Information

Janux will host a live webcast today at 4:30 PM ET. A live analyst question and answer session will follow the formal presentation. To register for the event, please click here.

To access the live webcast, please visit the Investors section of the Company’s website. A replay of the webcast presentation will be available on the Company’s website at View Source for at least 30 days.

Janux’s TRACTr, TRACIr and ARM Pipeline

Janux’s first clinical candidate, JANX007, is a TRACTr that targets prostate-specific membrane antigen (PSMA) and is being investigated in a Phase 1 clinical trial in adult patients with mCRPC. Janux’s second clinical candidate, JANX008, is a TRACTr that targets epidermal growth factor receptor (EGFR) and is being studied in a Phase 1 clinical trial for the treatment of multiple solid cancers including colorectal carcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, renal cell carcinoma, small cell lung cancer, pancreatic ductal adenocarcinoma and triple-negative breast cancer. Janux is also advancing additional CD3-based TRACTr and CD28-based TRACIr programs for future clinical development, including a PSMA-TRACIr for use in combination with our PSMA-TRACTr JANX007, and a TROP2-TRACTr for the treatment of TROP2+ solid tumors. Janux is advancing its first ARM platform program candidate, a CD19-ARM for the potential treatment of autoimmune diseases toward clinical trials. Janux is also generating a number of additional TRACTr, TRACIr and ARM programs for potential future development.

(Press release, Janux Therapeutics, DEC 1, 2025, View Source [SID1234661032])