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Lunit AI Predicts Immunotherapy Outcome in Colorectal, Kidney, and Lung Cancer at ESMO 2025

On October 14, 2025 Lunit (KRX:328130.KQ), a leading provider of AI for cancer diagnostics and therapeutics, reported the presentation of three studies at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, taking place October 17–21 in Berlin, Germany. All three studies highlight how Lunit’s AI pathology solution, Lunit SCOPE IO, can identify biomarkers that predict response to immune checkpoint inhibitors (ICIs), offering new potential to guide more effective and personalized cancer treatment.

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Among these, the first study, selected for oral presentation, was conducted in collaboration with Chiara Cremolini, MD, PhD, Professor of Medical Oncology at the University of Pisa, Italy. Researchers applied Lunit SCOPE IO to pre-treatment H&E slides from patients with proficient mismatch repair (pMMR) metastatic colorectal cancer (mCRC) enrolled in the AtezoTRIBE and AVETRIC trials. The AI quantified multiple cell types within the tumor microenvironment, generating a biomarker that stratified patients into "biomarker-high" and "biomarker-low" groups.

In the AtezoTRIBE trial, biomarker-high patients treated with atezolizumab plus FOLFOXIRI/bevacizumab showed significantly improved progression-free survival (PFS) and overall survival (OS) compared to biomarker-low patients, while no such benefit was observed in the control arm. Validation in the AVETRIC cohort confirmed improved survival outcomes for biomarker-high patients receiving ICI-based therapy, with better PFS and OS compared to biomarker-low patients. These results suggest that an AI-derived tumor microenvironment biomarker could help identify patients with pMMR mCRC who are most likely to benefit from immunotherapy combinations—an urgent unmet need in this population.

A collaborative study with Yonsei University College of Medicine, Korea, evaluated whether AI-defined immune phenotypes (IP) could predict outcomes in patients with advanced clear cell renal cell carcinoma (ccRCC) treated with either nivolumab plus ipilimumab (NIVO+IPI) or sunitinib (SUN). Using Lunit SCOPE IO, tumors were classified as inflamed or non-inflamed, based on the density and spatial distribution of tumor-infiltrating lymphocytes.

Patients with inflamed tumors treated with NIVO+IPI demonstrated significantly longer PFS, OS, and higher response rates (60.5% vs. 23.2%) compared to those with non-inflamed tumors. No such benefit was observed in the SUN arm. Findings were validated in an independent ccRCC cohort and aligned with inflamed gene expression signatures from The Cancer Genome Atlas, supporting AI-based immune phenotyping as a promising biomarker to guide treatment selection between immunotherapy combinations and targeted therapies in first-line treatment for ccRCC.

The third study, conducted in collaboration with the National Cancer Center Hospital East (NCCHE) Japan, further validated the predictive power of Lunit SCOPE IO for ICI treatment response in non-small cell lung cancer (NSCLC) patients. In this multicenter prospective study, tumors classified as inflamed showed significantly better responses and longer survival with ICI therapy compared to non-inflamed tumors, a difference not observed among patients treated with cytotoxic chemotherapy. This result strengthens the evidence supporting Lunit SCOPE IO as a predictive biomarker for immunotherapy benefit in NSCLC.

"At ESMO (Free ESMO Whitepaper) 2025, we are demonstrating how AI can unlock predictive biomarkers directly from routine pathology slides," said Brandon Suh, CEO of Lunit. "These findings show the potential of Lunit SCOPE IO to help identify patients who will truly benefit from immunotherapy—whether in colorectal or kidney cancer—and to guide treatment strategies that can make cancer care more precise and effective."

Lunit’s Featured Presentations at ESMO (Free ESMO Whitepaper) 2025

Oral Presentation [#725O/Berlin Auditorium – Hub 27, Oct.20, 09:10-20 AM]: Leveraging Artificial Intelligence to predict immune checkpoint inhibitor (ICI) efficacy in proficient MMR mCRC: translational analyses of AtezoTRIBE and AVETRIC trials — Chiara Cremolini, University of Pisa, Italy
Poster Presentation [#1912P]: Inflamed immune phenotype as a novel predictive marker of immune checkpoint inhibitors for non-small cell lung cancer — Yoshitaka Zenke, National Cancer Center Hospital East, Japan
Poster Presentation [#2624P]: Artificial intelligence (AI)-powered immune phenotype predicts differential benefit from nivolumab plus ipilimumab versus sunitinib in advanced clear cell renal cell carcinoma — Chang Gon Kim, Yonsei University College of Medicine, Korea
Visit Lunit at booth #3017 to learn more about its latest AI-powered cancer research and innovations in digital pathology.

(Press release, Lunit, OCT 14, 2025, View Source [SID1234656654])

iOnctura debuts cambritaxestat (IOA-289) clinical data in patients with pancreatic cancer at ESMO

On October 14, 2025 iOnctura, a clinical-stage precision oncology company focused on neglected and hard-to-treat cancers, reported the Phase Ib study investigating oral autotaxin (ATX) inhibitor, cambritaxestat (IOA-289), has met the primary endpoint: demonstrating safety, tolerability and anti-tumor responses, in combination with standard-of-care chemotherapy, in patients with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC). These data are being presented as a poster at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Berlin, Germany.1

Lead investigator, Davide Melisi, M.D., Ph.D, Associate Professor of Medical Oncology, and Director of the Digestive Molecular and Clinical Oncology Research Unit, University of Verona, and Investigational Cancer Therapeutics Clinical Unit at the University Hospital of Verona, Verona, Italy said, "These early findings with cambritaxestat are encouraging. Clinical activity alongside a manageable safety profile is particularly meaningful in a disease as aggressive and fibrotic as metastatic pancreatic cancer. These findings warrant continued scientific exploration in autotaxin inhibition."

The Phase Ib dose escalation study, AION-02 (NCT05586516) evaluated cambritaxestat in combination with standard-of-care chemotherapy GnP in patients with previously untreated mPDAC. Sixteen patients received cambritaxestat orally, twice daily at doses of 100 mg (n=4), 200 mg (n=4), 400 mg (n=5) and 800 mg (n=3). GnP was administered by IV infusion, weekly for three weeks of a four-week cycle.

The results show no dose-limiting toxicities, and no treatment-emergent adverse events (TEAE) leading to drug discontinuation or dose modification. Pharmacodynamic analysis showed a dose dependent reduction in the ATX-dependent plasma lipid LPA C18:2 over 24 hours supporting cambritaxestat’s on-target effects. Patients in the higher-dose cohorts had consistent and durable reductions of the tumor marker CA19-9. These changes were associated with radiographic responses and survival.

Dr. Michael Lahn, Chief Medical Officer at iOnctura said, "These data reinforce the therapeutic promise of targeting the autotaxin pathway to address the complex biology of pancreatic cancer, and potentially other tumors with high expression of autotaxin and its associated signaling. As we advance development, we remain focused on unlocking the potential of cambritaxestat to improve outcomes for patients facing some of the most challenging and hard-to-treat cancers."

Cambritaxestat is the first autotaxin inhibitor to be investigated in cancer patients and is being developed as a first-in-class therapy across multiple cancer indications.

This study was co-funded by the European Union and recruited patients in Italy and the United Kingdom.

(Press release, iOnctura, OCT 14, 2025, View Source [SID1234656653])

Mabwell Announces Latest Clinical Results of Novel B7-H3-Targeting ADC 7MW3711 to Be Presented at 2025 ESMO Congress

On October 14, 2025 Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, reported that clinical research results of its novel B7-H3-targeting ADC (R&D code: 7MW3711) for multiple advanced solid tumors, will be presented as a poster at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025.

As of Sep. 15, 2025, 74 patients with advanced solid tumor were enrolled and treated with 7MW3711 in the phase I/II study. Among 54 patients treated at 4.0 mg/kg or above and reaching tumor assessment, 19 partial responses (PRs) or complete responses (CRs) were observed. 7 patients with esophageal cancer (EC) were enrolled at 4.0 mg/kg or above and achieved an objective response rate (ORR) of 42.9% and a disease control rate (DCR) of 100%. Among lung cancer patients treated at the 4.0 mg/kg Q2W and reaching tumor assessment, the ORR for small cell lung cancer (SCLC) and squamous non-small cell lung cancer (Sq-NSCLC) were 50.0% and 38.5% respectively, with DCR of 90.0% and 92.3% respectively.

No dose-limiting toxicities (DLTs) were observed in the dose escalation phase, and the maximum tolerated dose (MTD) has not yet been reached. The most common Grade ≥3 TEAEs were white blood cell (WBC) count decreased, neutrophil count decreased, anemia, lymphocyte count decreased, platelet count decreased.

The study results suggest encouraging efficacy of 7MW3711 in advanced solid tumors, especially in esophageal and lung cancer.

About 7MW3711

7MW3711 is a novel B7-H3-targeting ADC independently developed by Mabwell. Given the expression profile and distribution of B7-H3, ADCs targeting B7-H3 hold promising therapeutic potential for cancers with significant unmet medical needs, including lung cancer, sarcoma, prostate cancer, head and neck cancer, and esophageal carcinoma, indicating broad market prospects.

7MW3711 is pharmaceutical characterized as stable structure, homogeneous composition, high purity, and it is suitable for industrial scale-up. Compared with ADCs in the same class worldwide, 7MW3711 has shown better tumor killing effects in multiple animal tumor models. 7MW3711 utilizes a novel camptothecin payload, which demonstrates stronger antitumor activity than DXd payloads in preclinical studies. Developed with site-specific conjugation technology, 7MW3711 is a homogeneous ADC with a drug-antibody ratio of 4, ensuring optimal stability and batch-to-batch consistency. Its payload is released through tumor tissue protease hydrolysis, further enhancing systemic stability in humans. In the safety evaluation model of animals including cynomolgus monkeys, 7MW3711 demonstrated good safety profile and pharmacokinetic properties.

(Press release, Mabwell Biotech, OCT 14, 2025, View Source [SID1234656651])

Merus Announces Publication of an Abstract on Petosemtamab in Metastatic Colorectal Cancer at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

On October 14, 2025 Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), an oncology company developing innovative, full-length multispecific antibodies and antibody drug conjugates (Biclonics, Triclonics and ADClonics), reported initial interim clinical data as of an April 28, 2025 data cutoff from the ongoing phase 2 trial of the bispecific antibody petosemtamab in combination with standard of care FOLFOX/FOLFIRI in 1L, 2L metastatic CRC (mCRC) and petosemtamab monotherapy in 3L+ mCRC. Updated data will be presented in a plenary session oral presentation by Dr. Moh’d Khushman M.D., Washington University School of Medicine, St. Louis, MO at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) on Friday, October 24 at 10:20 a.m. ET.

"We are encouraged by these early data indicating the promise of petosemtamab to combine safely with chemotherapy, and its potential to benefit a wide range of cancer patients that have metastatic colorectal cancer," said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. "We look forward to providing a more mature clinical update of a larger cohort of patients from a later cutoff date in our plenary session oral presentation."

Petosemtamab (MCLA-158: EGFR x LGR5 Biclonics):

Presentation title: Petosemtamab (MCLA-158) monotherapy or with chemotherapy in metastatic colorectal cancer: Preliminary antitumor activity and safety data from a phase 2 trial

Observations in the abstract include:

As of an April 28, 2025 data cutoff date:

36 patients (pts) with left- and/or right-sided, KRAS, NRAS, and BRAF wildtype microsatellite stable mCRC received petosemtamab 1500 mg Q2W, in combination with FOLFOX/FOLFIRI or as monotherapy
Pts treated in 1L or 2L had no prior anti-EGFR therapy
Pts treated in 2L received 1 prior chemotherapy regimen in the metastatic setting
Pts treated in 3L+ received at least 2 prior regimens in the metastatic setting, including a prior anti-EGFR therapy
1L petosemtamab with FOLFOX/FOLFIRI
7 pts were treated in 1L (6 FOLFOX and 1 FOLFIRI), with 6 ongoing
3 pts were efficacy evaluable, with median follow up of 2.6 months
1 unconfirmed complete response and 2 partial responses (PR; 1 unconfirmed) observed
2L petosemtamab with FOLFOX/FOLFIRI
10 pts were treated in 2L (1 FOLFOX and 9 FOLFIRI), with 8 ongoing
8 were efficacy evaluable, with median follow up of 3.4 months
4 PRs (2 unconfirmed), 3 stable diseases (SD; all ongoing) and 1 clinical deterioration prior to first scan
All unconfirmed responses in 1L and 2L were continuing on therapy without disease progression
3L+ petosemtamab monotherapy:
19 pts were treated, with 12 pts ongoing
14 were efficacy evaluable, with median follow up 2.5 months,
1 unconfirmed PR ongoing without disease progression, 6 SDs (all ongoing), 6 progressive diseases and 1 death unrelated to treatment prior to first scan observed
Petosemtamab safety:
No fatal treatment-related TEAEs observed in each cohort
Petosemtamab plus FOLFOX:
Most frequent treatment-emergent adverse events (TEAEs) regardless of causality (all Grades [G]/G3) were dermatitis acneiform (71%/0%), constipation (43%/0%), fatigue (43%/0%), and peripheral neuropathy (43%/0%)
Petosemtamab plus FOLFIRI:
Most frequent TEAEs regardless of causality (all G/G3) were diarrhea (70%/0%), mucosal inflammation (50%/10%), and fatigue (40%/0%)
Petosemtamab monotherapy:
Most frequent TEAEs regardless of causality (all G/G3) were rash (58%/0%), and nausea (26%/0%)
Presentations:
Title: Petosemtamab (MCLA-158) monotherapy or with chemotherapy in metastatic colorectal cancer: Preliminary antitumor activity and safety data from a phase 2 trial
Session Title: Plenary Session 4: Clinical Trials Plenary Session
Date and Time: Friday, October 24, 10:20 a.m. ET
The same data will also be available in a poster:
Session Title: Poster Session B
Session Date and Time: Friday, October 24, 12:30-4:00 p.m. ET The full presentations are planned to be available on the Merus website at the start of each session.

(Press release, Merus, OCT 14, 2025, View Source [SID1234656650])

Candel Therapeutics Announces Positive Interim Data After Repeated Administration of CAN-3110 in Recurrent Glioblastoma and Announces Publication in Science Translational Medicine

On October 14, 2025 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, reported encouraging interim data from its ongoing phase 1b clinical trial of CAN-3110 (linoserpaturev) in recurrent glioblastoma, and a publication in the high-impact scientific journal Science Translational Medicine.

The research detailed in the publication "Serial Multiomics Uncovers Anti-Glioblastoma Responses Not Evident by Routine Clinical Analyses," published on October 8, 2025 (link to abstract), was led by E. Antonio Chiocca, M.D., Ph.D., Executive Director of the Center for Tumors of the Nervous System at the Mass General Brigham Cancer Institute, as part of the multi-institutional Break Through Cancer Accelerating GBM Therapies Through Serial Biopsies TeamLab.

The publication presents findings from the comprehensive analysis of 97 serial tumor biopsies collected from two patients treated with repeated administrations of CAN-3110 in Cohort C of the ongoing phase 1b clinical trial (NCT03152318). By integrating multi-omic datasets with conventional histology and standard-of-care brain magnetic resonance imaging (MRI), the study revealed a discordance between immune biomarkers and histologic evidence of response on the one hand and imaging results on the other. Biopsy analyses demonstrated that CAN-3110 induced dynamic spatial and temporal remodeling of the tumor microenvironment, where tumor cells are replaced by immune cells. In one of the two patients, this process resulted in a complete pathological response. Interestingly, immune infiltration leads to an apparent increase in tumor size on MRI, which may be mistakenly interpreted as disease progression. These results underscore the limitations of conventional imaging in evaluating the response to viral immunotherapy and highlight the importance of overall survival (OS) data, supported by histology.

Among the key discoveries, the investigators reported the expansion of novel tissue-resident effector memory T cell clonotypes specifically targeting CAN-3110 epitopes, together with the expression of HLA-presented immunopeptides, including cancer-associated antigens. These findings provide evidence for both viral- and tumor-specific immune activation after intra-tumoral injection of CAN-3110.

"These data unveil a critical limitation in glioblastoma clinical trials, demonstrating our inability to accurately assess efficacy of immunotherapies using conventional imaging," said Dr. Chiocca, the principal investigator of the clinical trial. "Through sophisticated analysis of serial biopsy samples, we showed that CAN-3110 can transform the tumor microenvironment. For the first time, we identified T cell clonotypes, specifically reactive against oncolytic HSV viral epitopes, alongside evidence for an antitumoral response, providing support for the dual mechanism of action of CAN-3110."

The Company today also reported updated survival data for all patients enrolled in the phase 1b clinical trial of CAN-3110 in rHGG. Updated median OS (mOS) was 11.8 months (CI: 8.3–14.9) for arm A (n = 41) and 12.0 months (CI: 10.0–NA) for arm B (n = 9), respectively, after a single injection of CAN-3110, consistent with previously reported data for arms A and B. At the time of data cutoff (8/15/2025), one patient from arm A and one patient from arm B were still alive after prolonged follow-up (59.2 and 42.4 months, respectively, after CAN-3110 administration).

At the time of data cutoff, 9 patients in arm C had received multiple administrations of CAN-3110. At the 1×10⁸ PFU dose, 3 patients received 4 injections, 1 patient received 5 injections, and 2 patients received 6 injections. At the 1×10⁷ PFU dose, 1 patient received 4 injections, and 2 patients received 5 injections. Median follow-up was 8.9 months. Four out of 9 patients were alive at time of data cutoff (range 3.1-28.2 months after initiation of CAN-3110 treatment). Five patients had died, of which 3 died more than one year after initiation of CAN-3110 treatment (range 5.5-21.8 months). With a short follow up time for the most recently dosed patients and 2 additional patients still to be enrolled in arm C, we expect to present mature mOS data and an update on long-term survivors in Q4 2026. Of importance for the study design of a potential pivotal trial, there was no clear-cut evidence that > 4 injections resulted in better clinical outcomes than 4 injections, suggesting that a larger number of CAN-3110 administrations may not be required to achieve optimal efficacy.

"Glioblastoma is among the most difficult cancers to treat, with an expected median overall survival of less than 6 to 9 months in recurrent glioblastoma. The promising data presented today highlight the transformational potential of CAN-3110 in this indication, with OS in individual patients substantially exceeding historical benchmarks," said Francesca Barone, M.D., Ph.D., Chief Scientific Officer of Candel. "These results support the notion that CAN-3110 could uniquely reprogram the cold, immunosuppressive tumor microenvironment, associated with extended survival."

"The encouraging results with CAN-3110 in recurrent glioblastoma strengthen our confidence in the potential of our viral immunotherapy platform to address one of the most devastating cancers," said Paul Peter Tak, M.D., Ph.D., FMedSci, President and Chief Executive Officer of Candel. "The observed clinical benefit, together with evidence of immune activation in the tumor microenvironment, supports our plans to design a small phase 2 clinical trial of CAN-3110 in recurrent glioblastoma, working closely with investigators, the glioblastoma community, and regulators; CAN-3110 has previously received FDA Fast Track Designation and Orphan Drug Designation for the treatment of recurrent high-grade glioma."

About CAN-3110

CAN-3110 (linoserpaturev) is a first-in-class, replication-competent herpes simplex virus-1 (HSV-1) next-generation oncolytic viral immunotherapy candidate designed for dual activity for oncolysis and immune activation in a single therapeutic. CAN-3110 is being evaluated in a phase 1b clinical trial in patients with rHGG. In October 2023, the Company announced that Nature published results from this ongoing clinical trial. CAN-3110 was generally well tolerated with no dose-limiting toxicity reported. In the clinical trial, the investigators observed improved mOS compared to historical controls after a single CAN-3110 injection in this therapy-resistant condition.1 The Company and academic collaborators are currently evaluating the effects of repeat CAN-3110 injections in rHGG, supported by the Break Through Cancer foundation.

(Press release, Candel Therapeutics, OCT 14, 2025, View Source [SID1234656577])