Cullinan Therapeutics to Host Virtual Analyst and Investor Event to Showcase Zipalertinib Plus Chemotherapy Phase 3 REZILIENT3 Data Presented at the IASLC 2026 World Conference on Lung Cancer

On September 10, 2026 Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, disease-modifying T cell engagers in autoimmune diseases and cancer, reported that it will host a virtual event for analysts and institutional investors on Monday, September 14, 2026, at 8:00 a.m. ET to discuss the results from the planned interim analysis of the Phase 3 REZILIENT3 trial presented in Presidential Symposium 2 at the International Association for the Study of Lung Cancer’s (IASLC) 2026 World Conference on Lung Cancer (WCLC), being held September 12-15, 2026 in Seoul, South Korea.

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As previously announced, the Phase 3 REZILIENT3 trial of zipalertinib plus chemotherapy in the first-line treatment of patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutation-positive non-small cell lung cancer (NSCLC) met its primary endpoint of progression-free survival at a planned interim analysis.

Virtual Event Details

Cullinan Therapeutics will host a virtual event for analysts and institutional investors on Monday, September 14, 2026, at 8:00 a.m. ET, following the Presidential Symposium presentation. Participants from Cullinan Therapeutics include Nadim Ahmed, Chief Executive Officer, Jeffrey Jones, MD, MBA, Chief Medical Officer.

A live webcast will be available via the events page of Cullinan Therapeutics’ investor relations website at View Source A replay will be archived on the website following the event.

(Press release, Cullinan Oncology, SEP 10, 2026, View Source [SID1234670740])

One Biosciences Receives €3,3 Million Funding Under i-Démo 5 From France 2030 to Accelerate Development of First Single-Cell Diagnostic for Triple-Negative Breast Cancer, in Collaboration With Institut Curie

On September 10, 2026 One Biosciences, a techbio company spun off from Institut Curie pioneering clinical-grade single-cell tumor profiling, and Institut Curie, the leading French center for the fight against cancer, reported support from Bpifrance through the France 2030 i-Démo1 program for the CAST project (Cancer Single-cell Analysis for Therapy), securing €3,3 Million in funding. This milestone marks a major step forward in the development of single-cell tumor profiling technology for routine cancer care.

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Triple-negative breast cancer (TNBC) represents approximately 15–20% of breast cancer cases. Patients face high relapse rates, rapid disease progression and limited treatment options, while clinicians still lack reliable biomarkers to predict which patients will respond to immunotherapy or chemotherapy combinations. Current diagnostic approaches average signals across millions of cells, masking the tumor heterogeneity that drives resistance and treatment failure.

The CAST project, led by One Biosciences in partnership with Institut Curie, aims to overcome these limitations. This four-year program seeks to bring OneMap, One Biosciences’ cutting-edge solution, to market as the first single-cell diagnostic platform designed to guide treatment decisions for patients with TNBC, commercialized as an in vitro diagnostic test.

OneMap combines single-cell transcriptomics and AI to analyze tumors at the resolution of individual cells and deliver clinically actionable reports within two weeks directly from standard hospital biopsies. By deciphering tumor heterogeneity at single-cell resolution and identifying the specific cell populations that may drive treatment resistance, this platform could enable clinicians to make more informed treatment decisions for each patient.

Initial studies conducted jointly by One Biosciences and Institut Curie have already demonstrated the ability to generate high-quality single-cell data from routine TNBC biopsies and identify cellular signatures associated with response to immunotherapy. CAST will further build on Institut Curie’s unique clinical expertise and its Institute of Women’s Cancers, co-founded with PSL university and INSERM, providing access to a cohort of more than 300 TNBC patients. This project is expected to become the world’s largest clinically annotated single-cell dataset in triple-negative breast cancer.

Supported by €3.3 million in funding under the fifth 2026 i-Démo call for projects as part of the France 2030 initiative, the CAST program will focus on four key areas: industrializing the OneMap platform, validating predictive biomarkers in TNBC, preparing for regulatory approval, and scaling One Biosciences’ centralized clinical laboratory infrastructure in the Paris region to enable future commercial deployment.

"This funding is a defining milestone for One Biosciences and the progression of single cell technology into the clinic," said Hedi Ben Brahim, CEO of One Biosciences. "CAST accelerates the path from breakthrough science to a scalable commercial product that can help oncologists make better treatment decisions for patients. We are very grateful to France 2030 for their transforming support."

"CAST perfectly reflects Institut Curie’s mission: transforming cutting-edge research into tangible benefits for patients," said Dr. Céline Vallot, Co-founder & Chief Scientific Officer of One Biosciences, CNRS Research Director, and head of the Dynamics of Epigenetic Plasticity in Cancer team2 at Institut Curie. "By bringing single-cell technologies into clinical practice, we have the opportunity to fundamentally improve the treatment of aggressive cancers. This approach helps ensure that every patient receives the treatment best suited to the unique biology of their disease, ultimately improving outcome and quality of life."

"Triple-negative breast cancer remains one of the hardest breast cancers to treat because we still lack robust tools to predict response and resistance," added Dr. Luc Cabel, medical oncologist at Institut Curie and Principal Investigator of the CAST project. "The medical need is to deescalate treatment for good responders to limit the side effects and to better chose a salvage treatment for bad responders. By combining clinical expertise with single-cell and AI technologies, CAST has the potential to give oncologists a much more precise understanding of each patient’s tumor and ultimately improve treatment decisions and outcomes."

By bridging the gap between research and clinical deployment, the CAST project represents a major step toward making single-cell precision oncology a reality for patients.

(Press release, One Biosciences, SEP 10, 2026, View Source [SID1234670739])

OncoHost to Present New PROphetNSCLC® Data at WCLC 2026 Demonstrating Predictive Performance Beyond Baseline Sampling

On September 10, 2026 OncoHost, a technology company transforming precision oncology through proteomics-based biomarker development, reported its acceptance to present a scientific poster at the 2026 World Conference on Lung Cancer (WCLC), taking place September 12–15, 2026, in Seoul, South Korea.

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The poster, titled "PROphetNSCLC Maintains Predictive Performance in Longitudinal Sampling Beyond Baseline in Metastatic NSCLC," evaluates whether PROphetNSCLC maintains its predictive performance when blood samples are collected beyond the traditional pre-treatment time point.

PROphetNSCLC is a plasma proteomics-based test designed to guide immune checkpoint inhibitor (ICI) treatment decision-making in advanced non-small cell lung cancer (NSCLC). While PROphetNSCLC was developed using samples collected prior to initiation of ICI treatment, real-world clinical workflows may not always allow for baseline blood collection. The study therefore assessed the stability of the plasma proteome and the concordance of PROphetNSCLC result in different sampling time points.

"The PROphet plasma proteomic assay has proven clinical utility as a baseline in treatment naïve patients, but in practice some patients don’t have pre-treatment samples" said Dr. David Gandara, Medical Oncologist & clinical-translational researcher in lung cancer, Co-Director-Center for Experimental Therapeutics, UC Davis Comprehensive Cancer Center, Clinical Advisor at OncoHost and co-author of the study. "These new data that PROphet results remain stable even after a patient begins chemotherapy or immunotherapy reinforce the reliability and clinical applicability of the assay".

"Immunotherapy is today the cornerstone of treatment for NSCLC patients without an oncogenic driving abnormality", added Fred Hirsch, MD, PhD, FASCO, Professor of Medicine & Pathology, Medical Oncologist, Clinical Advisor at OncoHost and co-author of the study. "The PROphet blood-based assay has demonstrated in several studies it can predict which patients who will benefit from immunotherapy with or without chemotherapy or not. The presented study shows the predictive stability of the test even if it is sampled during treatment, which makes the test very usable in the real-world setting".

The analysis included plasma samples collected from patients with advanced NSCLC receiving ICI-based therapies at three time points: prior to treatment; following one cycle of chemotherapy but before initiation of ICI therapy; and following one cycle of ICI-based treatment. Proteomic profiling measured 7,289 proteins, while investigators evaluated changes across the plasma proteome, preservation of Resistance Associated Protein (RAP; the PROphetNSCLC model proteins) expression, and the consistency of PROphet classification.

Results demonstrated substantial preservation of the biological signal underlying PROphetNSCLC despite treatment initiation. Among matched samples collected at baseline and following one cycle of chemotherapy, only 20 of the 7,289 measured proteins were differentially expressed, with none belonging to the 388 RAPs used by PROphet. Greater proteomic changes were observed following one cycle of ICI-based treatment, with 888 differentially expressed proteins, including 81 RAPs. Despite these changes, more than 73% of RAPs remained strongly correlated between matched samples across both longitudinal comparisons.

Comparison between the plasma proteome at baseline and after 1 chemotherapy or ICI-based cycle showed that more than 73% of the RAPs remained strongly correlated between matched samples. In concordance with the RAP preservation, PROphet classification demonstrated high consistency between matched samples, reaching 80% following chemotherapy and 69% following one cycle of ICI-based treatment, with no significant systematic bias compared with baseline classification. Importantly, PROphet maintained significant separation in overall survival between PROphet-POSITIVE and PROphet-NEGATIVE patients following one cycle of ICI-based treatment (HR=0.54, p=0.009).

"These findings represent an important step in expanding the real-world clinical utility of PROphetNSCLC," said Ofer Sharon, M.D., CEO of OncoHost. "Our goal is to ensure that more patients can benefit from precision treatment guidance, even when the realities of clinical care may require treatment to begin before all biomarker results are available. Demonstrating that PROphet maintains its predictive performance following one cycle of chemotherapy broadens the patient population for whom the test may be relevant and reinforces our commitment to delivering precision oncology solutions that integrate seamlessly into real-world clinical practice."

Poster Presentation Details
Title: PROphetNSCLC Maintains Predictive Performance in Longitudinal Sampling Beyond Baseline in Metastatic NSCLC
Poster Board #: P2.188
Presenters: David R. Gandara, M.D. & Fred Hirsch, M.D., co-authors of the study
Date & Time: 14/09/26 10:30-12:00 PM KST.

(Press release, OncoHost, SEP 10, 2026, View Source [SID1234670738])

Volition Presents Early Stage I Solid Cancer Detection at the ESMO MAP Conference

On September 10, 2026 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, reported the presentation of an abstract1 at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Molecular Analysis for Precision Oncology Conference (ESMO MAP) in London this week. The presentation entitled "Early stage I solid cancer detection by direct ChIP-seq of short CTCF-protected plasma ctDNA" and given by Dr. Andrew Retter, highlights the use of its Capture-Seq technology in the detection of early-stage I solid cancer.

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Dr Andrew Retter, Medical Consultant, Volition, said:

"We were delighted to be selected to present in the main auditorium at this prestigious conference.

"From a clinical perspective, the proof of concept and early blinded validation results reported are extremely encouraging. In two independent cohorts we reported no false positives and detected 49/49 cancers in the first cohort (including 23 early stage I/II and 21 healthy controls) and validated it in a second blinded cohort with 13/14 later stage cancers detected with 10 additional healthy controls2.

"We also subsequently reported data from a blinded validation cohort of 81 subjects (colorectal and lung cancer patients = 59, healthy controls = 22) and the results are likewise very promising; the early-stage cancer detection of 95% of stage I and II cancers is particularly noteworthy3.

"For patients, the potential significance is huge. If validated in larger cohorts, CTCF Capture-Seq could contribute to Multi-Cancer Early Detection (MCED) fulfilling a significant unmet clinical need.

"We also believe that Capture-Seq has the potential to play a role in cancer management, including but not limited to, Minimal Residual Disease detection and treatment monitoring, either alone or potentially in combination with other technologies too."

Dr Jake Micallef, Chief Scientific Officer, Volition added:

"This new method isolated CTCF-protected plasma ctDNA from background cell free DNA bound to nucleosomes2. Analysis of the isolated CTCF-protected ctDNA produced sequencing data sets for blood samples from early stage cancer patients that were absent from blood samples of healthy control subjects.

"These methodological and technological breakthroughs represent a novel liquid biopsy method for a novel class of potentially thousands of liquid biopsy sequence biomarkers. Capture-Seq shows potential for both a multi-cancer early detection (MCED) approach, either alone or in combination with other tests, and the detection of Minimal Residual Disease (MRD).

"We are fast-tracking the development of Capture-Seq: conducting further studies, including competing conditions and working with oncology Key Opinion Leaders.

"Volition is, I believe, the first liquid biopsy company to focus on circulating cell free nucleoproteins and we have filed a number of new patents to protect this technology."

Details:

ESMO MAP brings together leading experts in oncology, molecular diagnostics, and precision medicine for two days of high-level exchange, collaboration, and innovation.

10th September, 14:55pm, Main Auditorium, London Business Design Centre

Conference abstract
Pamart, D., et al. Direct analysis of transcription factor protected cfDNA in plasma by ChIP-seq: measurement of altered CTCF binding in cancer is a novel biomarker for liquid biopsy. Clin Epigenet (2026). View Source
Data on File : Volition TAM Model

(Press release, VolitionRX, SEP 10, 2026, View Source [SID1234670737])

Lunit Announces Collaboration with 10x Genomics to Integrate AI-Enabled Pathology Analysis with Spatial Molecular Data for Oncology Clinical Research

On September 10, 2026 Lunit (KRX: 328130), a leading provider of AI for cancer diagnostics and precision oncology, reported that 10x Genomics, Inc. (Nasdaq: TXG) will incorporate Lunit’s AI-powered pathology platform, Lunit SCOPE IO, into its oncology biomarker discovery workflow. Lunit SCOPE IO will be used to analyze Hematoxylin and Eosin (H&E) pathology images alongside spatial molecular data generated from 10x’s oncology-focused clinical research studies.

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10x Genomics is a leader in single cell and spatial biology, with its technologies cited in more than 10,000 research publications and enabling discoveries across oncology, immunology, neuroscience and other fields.

The work brings together molecular insights generated using 10x’s Xenium and Atera spatial platforms with tissue characterization from Lunit SCOPE IO. By analyzing pathology images alongside spatial molecular data, 10x aims to better understand how tissue morphology relates to the underlying biology of tumors and identify biomarkers associated with treatment response and resistance.

"10x Genomics has built powerful tools for understanding the molecular organization of tissue," said Brandon Suh, CEO of Lunit. "Lunit SCOPE IO adds the ability to analyze the full H&E landscape at scale. Together, we believe these technologies can help researchers connect deep molecular insight with the tissue patterns that pathologists recognize every day."

"Spatial technologies provide a fundamentally richer view of the biology within tumors and their microenvironment," said Roman Yelensky, Vice President, Clinical Applications of 10x Genomics. "By combining that molecular depth with Lunit’s AI-based analysis of the same H&E images pathologists work with every day, we can give researchers a more complete view of the tumor to accelerate the discovery of biomarkers that could inform treatment strategies and enable potential future diagnostic development."

The work will initially support oncology clinical research studies focused on antibody-drug conjugates and immunotherapy response prediction. These studies are part of 10x’s broader effort to explore potential future diagnostic applications of spatial technologies in oncology.

Lunit SCOPE IO uses deep learning to analyze whole-slide H&E pathology images and characterize tissue features including tumor and stromal regions, immune-cell distribution, tertiary lymphoid structures and other features of the tumor microenvironment. Used alongside 10x’s spatial technologies, these analyses provide additional tissue context that complements molecular profiling in oncology clinical research.

(Press release, Lunit, SEP 10, 2026, View Source [SID1234670736])