On January 21, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, reported that the first set of abstracts have been released from several studies that will be shared at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s Gastrointestinal Cancers Symposium (ASCO GI) taking place Jan. 23 – 25, 2025 in San Francisco, CA (Press release, Natera, JAN 21, 2025, View Source [SID1234649807]).

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BESPOKE CRC Study

New data will be presented in an oral presentation on Jan. 25 from BESPOKE CRC, a multicenter, prospective, observational study in colorectal cancer (CRC). The study underscores Signatera’s capability as a prognostic and a predictive biomarker in a cohort of over 1,000 patients wherein post-surgical Signatera-positivity was predictive of inferior outcomes in stage II patients [disease-free survival (DFS) (HR=10.4; p<0.0001), and stage III patients (HR=10.1; p<0.0001)]. 24-month DFS estimates for stages II-III combined were 91.7% for Signatera-negative and 41.4% for Signatera-positive. Signatera-positive patients benefitted from adjuvant treatment while Signatera-negative patients did not, and clearance of ctDNA during and after treatment led to superior DFS outcomes.

Additional data from the study will be shared during the symposium illustrating the impact of MRD detection on clinical decision-making. The data show that even in the early days of MRD commercialization, a significant number of oncologists escalated or de-escalated post-surgical chemotherapy plans based on Signatera results, and the vast majority of oncologists found that Signatera results strengthened the treatment plan under consideration. In addition, surveillance with Signatera enabled a high rate of curative-intent surgery among recurrent patients.

Readouts in Tissue-Free MRD and Early Cancer Detection

Initial results from a clinical performance study on Natera’s novel tissue-free MRD detection test will be presented, where high sensitivity and specificity were observed in patients evaluable for clinical outcomes. The study demonstrated that the tissue-free MRD assay was prognostic, with MRD-positive patients showing inferior recurrence-free survival. The data also showed that the test was predictive, as MRD-positive patients benefited from adjuvant therapy whereas MRD-negative patients did not. In addition, the data showed strong concordance between the tissue-free MRD test and the gold standard Signatera test, with a positive percent agreement of 86% (95% CI:77-93%) and a negative percent agreement of 98% (95% CI: 95-100%).

Natera will also present case-control data in early cancer detection, including data from screen-detected colorectal cancer cases from the CIRCULATE study and controls from the PROCEED-CRC study, respectively. The data reports an overall sensitivity of 95% (95% CI: 92-99%) and a specificity of 91% (95% CI: 88-94%). Among patients with stage I disease, sensitivity was 92% overall. Stage-adjusted sensitivity was 91% in screen-detected individuals.

"This data at ASCO (Free ASCO Whitepaper) GI demonstrates the ongoing strength of Signatera complemented by our exciting innovation pipeline," said Adham Jurdi, MD, senior medical director in oncology at Natera. "The results from BESPOKE CRC highlight the potential value of Signatera-based MRD detection for treatment-decision making, with strong findings in clinical utility. Our readouts in early cancer detection and tissue-free MRD offer great promise for expanding Natera’s portfolio to help millions of additional patients with cancer."

Full list of Signatera presentations and activities during ASCO (Free ASCO Whitepaper) GI

Oral Presentations

Jan. 25, 1:00 PM PT | Abstract # 15 | Stage II-III Colorectal Cancer (Oral Presentation)
Presenter: Purvi K. Shah, MD, MBBS, Virginia Cancer Institute
Circulating Tumor DNA for Detection of Molecular Residual Disease (MRD) in Patients (pts) with Stage II/III Colorectal Cancer (CRC): Final Analysis of the BESPOKE CRC sub cohort

Jan. 25, 1:00 PM PT | Abstract # LBA14 | Colon Cancer (Oral Presentation)
Presenter: Jonathan A. Nowak, MD, PhD, Brigham and Women’s Hospital
Prognostic and predictive role of circulating tumor DNA (ctDNA) in stage III colon cancer treated with celecoxib: Findings from CALGB (Alliance)/SWOG 80702

Posters

Jan. 23, 11:30 AM PT | Abstract # TPS512 | Gastroesophageal adenocarcinoma (Poster)
Presenter: Elizabeth Catherine Smyth, MD, Oxford University Hospitals NHS Foundation Trust
A single arm phase II trial of trastuzumab deruxtecan in patients with gastroesophageal adenocarcinoma cancer who are ctDNA and HER2 posiative: DECIPHER

Jan. 23, 11:30 AM PT | Abstract # 836 | Gastrointestinal cancers (Poster)
Presenter: Sakti Chakrabarti, MD, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Short interval circulating tumor DNA (ctDNA) kinetics as a predictor of tumor response in patients with gastrointestinal (GI) cancer receiving immune checkpoint inhibitor (ICI)-based treatment

Jan. 25, 7:00 AM PT | Abstract # 266 | Tissue-free MRD testing (Poster)
Presenter: John Paul Y.C. Shen, MD, University of Texas MD Anderson Cancer Center
Development of a methylation-based, tissue-agnostic test for the detection of molecular residual disease by circulating tumor DNA

Jan. 25, 7:00 AM PT | Abstract # 232 | Early cancer detection: colorectal cancer (Poster)
Presenter: Yoshiaki Nakamura, MD, PhD, Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East
Performance of a blood-based screening test for the early detection of colorectal cancer

Jan. 25, 7:00 AM PT | Abstract # TPS306 | Early cancer detection: Trial in Progress (Poster)
Presenter: Sarah Sawyer, PhD, Clinical Trial Operations, Natera, Inc. Austin, TX, USA
Trial in progress for a colorectal cancer detection blood test

Jan. 25, 7:00 AM PT | Abstract # LBA 22 | Colorectal cancer (Poster)
Presenter: Hideaki Bando, MD, National Cancer Center Hospital Japan
A Randomized, Double-Blind, Phase III Study Comparing Trifluridine/Tipiracil (FTD/TPI) Versus Placebo in Patients with Molecular Residual Disease Following Curative Resection of Colorectal Cancer (CRC): The ALTAIR Study

Jan. 25, 7:00 AM PT | Abstract # 220 | Metastatic colorectal cancer (Poster)
Presenter: D.E. van Steijn, MSc, Netherlands Cancer Institute
Longitudinal ctDNA measurements for treatment response monitoring in patients with metastatic colorectal cancer undergoing systemic therapy: The ORCA trial

Jan. 25, 7:00 AM PT | Abstract # 284 | Locally advanced rectal cancer (Poster)
Presenter: Jun Watanabe, MD, PhD, Department of Colorectal Surgery, Kansai Medical University
Circulating tumor DNA for predicting complete response to total neoadjuvant therapy in locally advanced rectal cancer: ENSEMBLE-2

Jan 25, 7:00 AM PT | Abstract # 263 | Rectal adenocarcinoma (Poster)
Presenter: Seth Felder, MD, H. Lee Moffitt Cancer Center
Correlation of mid-chemoradiation ctDNA results and clinical complete response to total neoadjuvant therapy (TNT) for locally advanced rectal adenocarcinoma

Jan 25, 7:00 AM PT | Abstract # 48 | Colorectal cancer (Poster)
Presenter: Elisabeth Arrondo, BSc, Translational Research Support Office, National Cancer Center Hospital East
Molecular characteristics and prognostic impact of GNAS mutation in colorectal cancer: An international collaborative study between United States and Japan

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 over 100 peer-reviewed papers.

On January 21, 2025 Circio Holding ASA (OSE: CRNA), a biotechnology company developing powerful circular RNA technology for next generation nucleic acid medicine, reported that it has entered a partnership with 4basebio PLC of Cambridge, UK, for joint development and in vivo delivery testing of synthetic circVec DNA vectors (Press release, Circio, JAN 21, 2025, View Source [SID1234649789]).

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"The circVec technology achieves up to 70 times prolonged RNA half-life and 15-fold increase in protein levels vs. standard mRNA-based expression in vivo using plasmid DNA," said Dr. Thomas Hansen, CTO of Circio. "We have therefore now partnered with 4basebio, a world-leader in next-generation DNA vectors for therapeutic applications. Combining 4basebio´s vector and delivery expertise with Circio´s circVec powerful expression technology has the potential to create a durable, repeat-dosable, non-viral platform for future synthetic DNA gene therapies."

Dr. Emily Young, Head of Non-Viral Delivery for 4Basebio added: "We are delighted to partner with Circio to develop the next generation of DNA gene therapies and vaccines. 4Basebio’s synthetic DNA offers fast, scalable and cost-effective manufacturing advantages compared to plasmid DNA. Combining these capabilities with the superior expression of Circio’s circVec technology, in addition to 4Basebio’s Hermes DNA-delivery platform, promises to establish extremely robust and durable DNA therapeutics."

Under the collaboration, 4basebio has successfully developed and validated circVec vectors in their proprietary synthetic hpDNA and opDNA formats, including formulation into Hermes LNP formulations optimized for in vivo delivery of DNA payloads. Both parties will now in parallel proceed to test the performance of these circVec-op/hpDNA vectors in mouse models. If successful, the results will create the foundation for a continued collaboration to develop and test future therapeutic candidates for genetic medicine, vaccines and other potential applications.

On January 21, 2025 NiKang Therapeutics Inc. ("NiKang"), a clinical-stage biotech company focused on developing innovative small molecule oncology medicines to bring transformative therapies to patients in need, reported that the first patient has been dosed in the global randomized phase 1b/2 clinical study evaluating NKT2152, a highly potent, selective and orally bioavailable small molecule HIF2α inhibitor, in combination with standard-of-care regimen of atezolizumab (Tecentriq) and bevacizumab (Avastin) in the first-line treatment of patients with advanced or metastatic HCC (Press release, NiKang Therapeutics, JAN 21, 2025, View Source [SID1234649808]). This study is being conducted under a clinical trial collaboration with F. Hoffmann-La Roche Ltd ("Roche") as part of Roche’s MORPHEUS-liver platform trial (NCT04524871).

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"The commencement of this randomized study of NKT2152 in partnership with Roche represents a significant milestone in the advancement of NKT2152 for the treatment of tumors beyond ccRCC," said Zhenhai Gao, Ph.D., co-founder, president, and CEO of NiKang. "NKT2152 has demonstrated significant anti-tumor efficacy and a favorable safety profile not only in human ccRCC patients but also in preclinical xenograft models of solid tumors beyond ccRCC, underscoring its potential for broad application in human cancer treatments. HCC is of particular interest due to the compelling scientific rationale supporting NKT2152 and robust preclinical data. With high potency, selectivity, and unique human pharmacokinetic (PK) profile characterized by higher systemic exposure, a larger volume of distribution, and a longer half-life, NKT2152 emerges as an ideal candidate for combination with antibody-based regimens to treat solid tumors beyond ccRCC, where higher drug exposure may be necessary. We are enthusiastic about further exploring NKT2152’s potential in the first-line treatment of HCC patients through this randomized trial".

About NKT2152
NKT2152 is a potent, selective and orally available small molecule HIF2α inhibitor which binds to HIF2α allosterically and disrupts the HIF2α/HIF1β transcription factor complex, thereby reducing the production of proteins which lead to tumorigenesis. NKT2152 is currently under evaluation in a Phase 1/2 clinical study in ccRCC as a single agent (NCT05119335) and a Phase 2 clinical study in ccRCC in combination with palbociclib and sasanlimab (NCT05935748). A third clinical study, as part of Roche’s MORPHEUS-liver platform trial, evaluating the combination with standard-of-care atezolizumab and bevacizumab in first-line unresectable/advance hepatocellular carcinoma (HCC) (NCT04524871) is ongoing.

On January 21, 2025 Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, reported clinical validation data for its OncodetectTM MRD test at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI.) Results from Alpha-CORRECT, a study with one of the longest MRD surveillance monitoring periods to date, showed the Oncodetect test achieved 78% sensitivity at the post-surgical timepoint and 91% sensitivity during the surveillance monitoring period, with specificities of 80% and 94%, respectively (Press release, Exact Sciences, JAN 21, 2025, View Source [SID1234649790]). The complete findings of the study, which primarily included patients with stage III colon cancer, will be published in a peer-reviewed scientific journal on January 25.

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"We’re thrilled to bring our MRD solution to the rapidly growing molecular residual disease market, helping more patients get access to critical, high-quality testing," said Brian Baranick, general manager of Precision Oncology at Exact Sciences. "These data demonstrate the strong performance of Oncodetect. Building on the foundation of Oncotype DX and two decades of trust from physicians and patients, Exact Sciences is well positioned to lead the way with its robust commercial and operational infrastructure, to ensure patients across the U.S. have access to MRD testing."

In addition to the data shared at ASCO (Free ASCO Whitepaper) GI, Oncodetect achieved its primary endpoint in the Beta-CORRECT study. Results confirm a significant association between MRD positivity and recurrence in patients with stage III colon cancer. The data extend Oncodetect’s prognostic value to patients with stage II and IV colon cancer and rectal cancer. Findings from the independent Beta-CORRECT clinical validation study, which was a subset analysis from the GALAXY study, also demonstrated promising performance of Oncodetect as an MRD test. Results will be presented at an upcoming scientific conference.

"There is a critical need to better understand and monitor for residual cancer following surgery," said Takayuki Yoshino, MD, deputy director at the National Cancer Center Hospital East in Japan. "The Oncodetect test represents an exciting development in the field. I am pleased to partner with Exact Sciences, encouraged by the emerging data from the Beta-CORRECT study, and look forward to sharing further insights in the coming months."

The company plans to provide the Oncodetect test to patients across the United States through its Precision Oncology platform, combining 20 years of deep relationships with healthcare professionals through Oncotype DX, a broad portfolio of oncology solutions, and the advanced ExactNexusTM technology platform.

Strategic Partnerships Support Multi-Cancer Evidence Generation

Exact Sciences has partnered with the National Surgical Adjuvant Breast and Bowel Project (NSABP) and Flatiron Health to generate additional clinical evidence across multiple solid tumor types.

Exact Sciences is conducting multiple studies to strengthen evidence in colorectal cancer. The international-basedCORRECT-Istudy and the pivotal, US-basedCORRECT-IIstudy with the NSABP will assess the association between ctDNA and recurrence at specific post-surgical timepoints in patients with stage II and III colorectal cancer. These studies will further validate ctDNA’s role in colorectal cancer recurrence monitoring.
An additional study with the NSABP,EXActDNA-003, is one of the largest prospective MRD studies across all subtypes of early-stage breast cancer. Additional research in breast cancer waspreviously announced with the West German Study Group.
The company has also partnered withFlatiron Healthon a multi-year, prospective real-world study that will be integrated into routine clinical care, with the goal of accelerated enrollment across a broad range of solid tumors.
"The NSABP is committed to advancing colorectal and breast cancer care through innovative clinical studies that redefine diagnostics and treatments," said Dr. Norman Wolmark, MD, chairman of the NSABP Foundation and contact principal investigator and co-chair at NRG Oncology. "Both the CORRECT-II and EXActDNA-003 studies are designed to utilize ctDNA in addressing critical gaps left by previous MRD trials. Through our collaboration with Exact Sciences, we aim to integrate ctDNA analysis to deliver a more precise and comprehensive approach to recurrence detection."

About the Oncodetect test

Molecular residual disease (MRD) refers to the presence of tumor-specific DNA in the body. These fragments of genetic information, known as circulating tumor DNA (ctDNA), are shed into the bloodstream by tumors, and their presence may indicate that cancer is present . Exact Sciences’ MRD offering leverages our in-house capabilities in whole exome sequencing to offer a tumor-informed MRD test for a personalized approach to detecting and monitoring residual cancer in patients with solid tumors. By identifying somatic genomic alterations in tumor DNA and detecting a subset in ctDNA from blood, the Oncodetect test may enable the detection of ctDNA before, during, and after treatment. This critical information can guide therapy decisions and monitor for cancer recurrence.

On January 21, 2025 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that it will host an event for institutional investors and analysts dedicated to its Antibody-Drug Conjugate (ADC) strategy, and particularly Nectin-4, the target of its lead antibody-drug candidate program, IPH4502 (Press release, Innate Pharma, JAN 21, 2025, View Source [SID1234649791]). The event will be held in New York in a hybrid format on Wednesday, February 5, 2025, from 10:00 a.m. to 12:00 p.m. EDT.
"As we just updated our strategy with a focus on our ANKET platform and ADC programs, this meeting will be an opportunity to share the latest scientific and clinical advancements related to Nectin-4 and its potential in cancer treatment," said Jonathan Dickinson, Chief Executive Officer of Innate Pharma

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Event details:
Date: February 5, 2025, from 10:00 a.m. to 12:00 p.m. EDT
Registration: If you would like to attend the event, please register at this link: View Source

For those who are unable to attend in person, a live webcast and replay will be on Innate Pharma’s website at: View Source

About IPH4502
IPH4502 is a novel and differentiated topoisomerase I inhibitor ADC designed to precisely target Nectin-4, a cell adhesion molecule that is overexpressed in several types of solid tumors, including urothelial carcinoma, where Nectin-4 expression is highest, breast cancer, non-small cell lung cancer and gastro-intestinal cancer.
In non-clinical models, IPH45 is well tolerated and shows anti-tumor activity in vitro and in vivo.
In September 2024, the U.S Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to initiate a Phase 1 clinical study of IPH4502.