On November 25, 2024 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, reported that it will present new SignateraTM data at the San Antonio Breast Cancer Symposium (SABCS), taking place Dec. 10-13 in San Antonio, TX (Press release, Natera, NOV 25, 2024, View Source [SID1234648634]). Natera and its collaborators will present a total of six abstracts.

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"We are proud to share this new data on Signatera at SABCS that underscores our commitment to generating evidence on the clinical utility of Signatera for patients with breast cancer," said Angel Rodriguez, M.D., senior medical director at Natera.

The full list of abstracts with selected highlights are as follows:

ZEST Clinical Trial
Oral Presentation #GS3-01 | Dec. 13 | Presenter: Nicholas Turner, MD, PhD, FRCP, FMedSci
Circulating tumor DNA surveillance in ZEST, a randomized, phase 3, double-blind study of niraparib or placebo in patients with triple-negative breast cancer or HR+ HER2− BRCA-mutated breast cancer with molecular residual disease after definitive therapy

ZEST was a randomized, phase III, double-blind trial, sponsored by GSK, that evaluated whether niraparib can enhance disease-free survival in patients with breast cancer who are ctDNA-positive after completion of curative intent therapy and without evidence of radiographic recurrence. A total of 2,746 patients were pre-screened. Of patients who were ctDNA-positive, 40 were enrolled and randomized (niraparib, 18; placebo, 22); 36 patients (90%) had Triple Negative Breast Cancer (TNBC), and 4 patients (10%) had BRCA-mutated HR+ disease. An analysis of outcomes among randomized patients showed a median disease-free survival of 11.4 months in the niraparib arm versus 5.4 months in the placebo group (hazard ratio, 0.64; 95% CI, 0.30–1.39).

Clinical Genomics Database Experience
Poster Spotlight #PS9-01 | Dec. 12 | Presenter: Marla Lipsyc-Sharf, MD
Actionable Genomic Alterations in Localized Hormone Receptor Positive (HR+) Breast Cancer and Impact on Clinical Outcomes: Results from Comprehensive Whole Exome Sequencing (WES) and Tumor-Informed circulating tumor DNA (ctDNA) analysis

This real-world analysis evaluated the association of targetable tumor genomic alterations with ctDNA detection and distant recurrence-free survival (DRFS) in early-stage breast cancer. In the study, 44% of patients (127/287) who were Signatera-positive had at least one targetable genomic alternation, including 34.5% with the PIK3CA mutation. In addition, of patients with ctDNA-positivity within 2 years, those with mutated PIK3CA had an inferior DRFS (HR: 36.9), compared to patients with wild-type PIK3CA (HR=16.3).

Patient-Reported Outcomes
Four abstracts to be presented at SABCS evaluated patient reported outcomes when testing for circulating tumor DNA (ctDNA). The data indicates that ctDNA testing can provide valuable information for treatment planning while not causing increased anxiety in patients.

Poster #P2-03-21 | Dec. 11 | Presenter: Neil Carleton
Longitudinal Monitoring of ctDNA to Facilitate Surgical De-Escalation and Disease Surveillance in Older Women with ER+ Breast Cancer on Primary Endocrine Therapy: A Prospective, Pragmatic, Hybrid-Decentralized Trial with Correlative Analyses

Poster #P4-03-29 | Dec. 12 | Presenter: Devora Isseroff, MD
Patient (Pt) reported anxiety levels during ctDNA surveillance in early-stage triple negative (TNBC) and hormone receptor positive (HR+) breast cancer (BC)

Poster #P3-01-22 | Dec. 12 | Presenter: Mrinalini Ramesh, DO
Pilot feasibility study of ctDNA testing in breast cancer and its association with pain, stress and anxiety

Poster #P5-12-19 | Dec. 13 | Presenter: Mridula George, MD
Patient-reported outcomes from the CIPHER study

About Signatera
Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard-of-care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer, ovarian cancer, and muscle-invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 100 peer-reviewed papers.

On November 25, 2024 Agendia, Inc., reported that new data on its early-stage breast cancer genomic tests and their ability to inform treatment selection decisions will be presented at the San Antonio Breast Cancer Symposium 2024 (SABCS), taking place in San Antonio, TX, December 10th – 13th, 2024 (Press release, Agendia, NOV 25, 2024, View Source [SID1234648633]).

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The presented data highlights Agendia’s continued focus on expanding clinical utility of the tests and optimizing breast cancer management throughout the patient’s treatment journey. These studies further enhance the robust body of clinical research supporting the clinical utility of Agendia’s MammaPrint and BluePrint in providing reliable guidance for therapeutic decisions in early-stage breast cancer.

Five Agendia abstracts have been accepted, including two poster spotlight presentations and one late-breaking poster. The following are details of the abstracts that have been accepted, which can also be found on the SABCS website here:

Poster Spotlight Presentations:

MammaPrint and BluePrint Predict Pathological Response to Neoadjuvant Chemotherapy in Patients with HR+HER2- Early-Stage Breast Cancer Enrolled in FLEX.
Authors: O’Shaughnessy, J., et al.
Session: Poster Spotlight Session 4: Prediction of Chemotherapy Response
Date/Time: Wednesday, December 11 | 7:00 AM – 8:30 AM CST
Abstract #: 2091
Association of MammaPrint with Gene Expression Pathways Predictive of Resistance to Cyclin Dependent Kinase Inhibition
Authors: Brufsky, A., et al.
Session: Poster Spotlight Session 2: Personalizing CDK 4/6 Inhibitor Therapy for Patients with Metastatic Breast Cancer: Survival, QOL and Biomarkers
Date/Time: Thursday, December 12 | 7:00 AM – 8:30 AM CST
Abstract #: SESS-2068
Poster Presentations:

Neoadjuvant Chemotherapy for T3 Tumors in the Era of Precision Medicine – Biology is Still King
Authors: Rahman, R., et al.
Session: Poster Session 1
Date/Time: Wednesday, December 11 | 12:30 PM – 2 PM CST
Abstract #: 1879
FLEX: A Real-World Evidence, Full Transcriptome Study in 30,000 Patients with Early-Stage Breast Cancer
Authors: Maganini, R.
Session: Poster Session 2
Date/Time: Wednesday, December 11 | 5:30 PM – 7:00 PM CST
Abstract #: 2160
Late-Breaking Poster:

Prediction of Chemotherapy Benefit by MammaPrint in HR+HER2- Early-Stage Breast Cancer Revealed by the FLEX Registry of Real-World Data
Authors: Brufsky, A., et al.
Session: Poster Session 2
Date/Time: Wednesday, December 11 | 5:30 PM – 7:00 PM CST
Abstract #: 3660
In addition, William Audeh, MD, MS, Chief Medical Officer of Agendia, will be presenting at Agendia’s Product Theater session, titled "How Can Genomic Information From A Single Core Biopsy Sample Inform Multiple Therapy Decisions For Early-Stage ER+ Breast Cancer?," demonstrating how MammaPrint and BluePrint can inform early-stage ER+ breast cancer treatment decisions. The educational session will take place on December 11th at 5:30 PM – 6:30 PM CST. Registration details can be found here.

More information about the full program can be found at the SABCS 2024 website.

On November 25, 2024 Rznomics, Inc. reported to secure its expanded access program (EAP) from the United States Food and Drug Administration (FDA) for RZ-001, RNA editing gene therapy product for the treatment of patients aged 18 and older with Glioblastoma (GBM) (Press release, Rznomics, NOV 25, 2024, View Source [SID1234648631]).

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Generally, the EAP also known as ‘compassionate use,’ is a pathway provided by the U.S. FDA that allows patients with serious or immediately life-threatening conditions to gain access to investigational medical products (drugs, biologics, or medical devices) outside of clinical trials.

GBM is known as the most malignant tumor in Central Nervous system with high mortality rate but lacks effective therapies. TERT promoter mutations, which are associated with TERT upregulation, are found in up to 80% of glioblastoma (GBM) patients. This increased TERT expression is strongly linked to a poor prognosis, reflecting the aggressive nature of the disease. RZ-001, the RNA replacement enzyme-based cancer gene therapy, targets and cleaves hTERT mRNA and replaces the mRNA with the therapeutic gene RNA. This induces anti-cancer activity and cytotoxic effect by reducing hTERT expression and simultaneously trans-ligating an HSVtk-encoding sequence into the reprogrammed hTERT mRNA.

"We are excited to offer RZ-001 through this EAP, providing a potential new treatment option for GBM patients with limited alternatives," said Dr. Chiocca, Professor at Harvard Medical School executive Director of the Center for Tumors of the Nervous System at Mass General Brigham Cancer Institute.

Seong-Wook Lee, PhD, CEO of Rznomics, stated, "We hope RZ-001 can serve as a good alternative for patients who have had difficulty with existing treatments." He also assured that the Rznomics team is committed to expediting the clinical development process to secure timely market authorization.

In previous releases, Rznomics noted that RZ-001 has received Fast Track designations and Phase I/IIa IND approval for RZ-001 from the FDA and the South Korean Ministry of Food and Drug Safety (MFDS) in Glioblastoma and the clinical trial has been investigating the safety, tolerability, and efficacy of RZ-001 in patients with GBM. A clinical trial has recently commenced, marking the start of RZ-001 administration.

On November 25, 2024 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported the U.S. Food and Drug Administration (FDA) approval of a label expansion into biliary tract cancer (BTC) for the PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody* test (Press release, Hoffmann-La Roche, NOV 25, 2024, https://www.prnewswire.com/news-releases/roche-receives-fda-approval-for-first-companion-diagnostic-to-identify-patients-with-biliary-tract-cancer-eligible-for-her2-targeted-treatment-with-ziihera-302314548.html [SID1234648630]). This test is now the first and only FDA-approved companion diagnostic to aid in the assessment of HER2-positive status to identify BTC patients who are eligible for treatment with Jazz Pharmaceuticals’ ZIIHERA (zanidatamab-hrii).

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HER2 is a receptor protein expressed in a variety of cancers and serves as a predictive biomarker to help determine if a patient will respond to HER2-targeted therapy.1 No approved and validated HER2 test existed to identify eligible BTC patients until the approval of this expanded label for the PATHWAY HER2 (4B5) test.

"This test is a step forward in furthering access to personalised medicine," said Jill German, Head of Pathology Lab at Roche Diagnostics. "The prognosis for patients diagnosed with BTC is poor, as very few treatment options exist. Now, these patients have access to the first standardised test that could make them eligible for targeted therapy, potentially improving clinical outcomes."

ZIIHERA is the first FDA-approved treatment for adults with previously-treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer.

BTC accounts for 3% of all gastrointestinal cancers in the US.2,3 Prognosis is poor because of a lack of adequate early detection tools, challenging anatomical access, aggressive tumour biology, and only modest benefit from systemic treatments.4 With most cases diagnosed at an advanced stage,5 the five-year overall survival rate for all BTC cases is 19% for disease that is localised to the original tumour site, and just 3% for cancer that has spread to other areas.6

About the 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, enabling therapeutic decisions that can lead to better outcomes for patients. Already indicated as an aid to identify breast cancer patients eligible for HER2-targeted treatment with Herceptin, KADCYLA, or ENHERTU,7 the test is used in combination with the fully automated VENTANA BenchMark slide staining instrument. The introduction of the new indication for BTC represents a significant expansion of the test’s clinical utility. The assay forms an important part of Roche’s comprehensive gastrointestinal cancer solutions portfolio, which is aimed at driving diagnostic certainty for life-changing decisions in cancer care.

The assay standardises all immunohistochemistry (IHC) processes from baking through staining, and reduces the possibility of human error.8 It also minimises inherent variability resulting from individual reagent dilution and other processes found in manual and semi-automated IHC methods. The Roche HER2 (4B5) clone achieves consistently high proficiency assessment scores compared to other clones9 and demonstrates high concordance with HER2 FISH,10,11 empowering laboratories to employ the most widely adopted and reliable HER2 IHC primary antibody.

For more information about the portfolio, please visit the Roche Diagnostics Pathology Lab companion diagnostics page.

On November 25, 2024 J INTS BIO reported research findings on its innovative brain tumor treatment, ‘JIN-001,’ developed in collaboration with MD Anderson Cancer Center, at the 2024 Society of Neuro-Oncology (SNO) Annual Meeting in Texas, USA. MD Anderson is a globally renowned cancer research institution, and J INTS BIO has partnered with it since 2021 to advance this groundbreaking therapy (Press release, J INTS BIO, NOV 25, 2024, View Source;enhancing-radiation-and-chemotherapy-efficacy-302315138.html [SID1234648629]).

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JIN-001: Aiming to Revolutionize Brain Tumor Treatment

‘JIN-001’ targets glioblastoma (GBM) cells by significantly enhancing the efficacy of radiation therapy and chemotherapy. As a selective inhibitor of HSP90 (Heat Shock Protein 90), its primary advantage lies in its ability to cross the blood-brain barrier (BBB), which typically hinders therapeutic agents from reaching the brain. While the BBB serves as a protective mechanism for the brain, it also presents a major obstacle for drug delivery. JIN-001 overcomes this limitation, directly attacking brain tumors and addressing the low permeability issue of existing drugs.

The study also highlighted that JIN-001 demonstrated promising results when combined with standard therapies such as Radiation Therapy and Temozolomide, effectively suppressing tumor cell growth and inducing apoptosis (programmed cell death).

JIN-001: Pioneering Future Clinical Developments

Based on these promising findings, J INTS BIO plans to accelerate preclinical trials for JIN-001. The company intends to incorporate CRISPR gene-editing technology to identify the functional roles of specific genetic factors in treatment resistance, paving the way for precision medicine strategies. CRISPR-based techniques allow targeted modulation of gene expression, helping to predict and better understand tumor responses.

J INTS BIO is also advancing plans to commercialize JIN-001 through partnerships with global pharmaceutical companies, aiming to bring faster and more effective treatments to brain tumor patients. Furthermore, the potential applications of JIN-001 are being explored in treating a wide range of cancers beyond brain tumors, providing new hope for cancer patients worldwide.

JIN-001 represents a groundbreaking innovation that transcends the limitations of existing therapies, offering new treatment opportunities and hope for improved survival and quality of life for brain tumor patients.