On October 14, 2025 GNTbm (stock code: 7427, Taiwan) reported the preclinical data on GNTbm-TKI, a novel multi-receptor tyrosine kinase inhibitor for cancer immunotherapy. GNTbm-TKI will be presented as posters at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting, which is held in Berlin, Germany, from Oct 17 to 21, 2025.

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Abstract: 2242
Title:Preclinical development of GNTbm-TKI, a novel multi-receptor tyrosine kinase inhibitor, while combined with GNTbm-38 showing potent induced tumor microenvironment remodeling activity in cancer immunotherapy
Session Date/Time: 10/19/2025, 12:00-12:45 CEST
Poster Board Number: 1577P

Currently, although there are many options for cancer immunotherapy, they still cannot meet the needs of clinical treatment, especially for advanced solid tumors defined as ‘cold tumors’. Genetic alterations of certain receptor tyrosine kinases (TKs), including TAM (TYRO3, AXL, and c-MER), are critical in creating environment conducive to tumor development in several cancers such as HNSCC, CRC, HCC, and RCC. GNTbm-TKI is a novel multi-targeted TKI, showing induction of immune activation in the tumor microenvironment (TME), that indicates the potential application in cancer immunotherapy for unmet medical needs.

The results of the study show that GNTbm-TKI strongly inhibited the activities of TYRO3, AXL, c-MER, BTK, ROS1, NTRK2, MET, and VEGFR2 at nanomolar level. GNTbm-TKI showed anti-proliferation activity in NCI-60 human cancer cell lines with low GI50 values. GNTbm-TKI showed a superior in vivo efficacy in WT mice compared to immune-deficient mice in CT-26 model, indicating anti-cancer immune activation induced by the treatment. Furthermore, treatment with GNTbm TKI + GNTbm-38 (an immune activator of class ⅠHDACi) combined with ICI significantly improved tumor response rate and boosted survival rate through synergistic effect by normalizing tumor vessels, increasing activated CD8+ T cell infiltration into tumors, inducing memory T cell persistence, and strongly inhibiting mobilization of immunosuppressive cells into tumors. On the other hand, GNTbm-TKI + GNTbm-38 combined with anti-PD-1/VEGF bispecific antibodies in a humanized B-PD-1/PD-L1/VEGFA mouse model also greatly improved anti-cancer with a strong synergistic effect.

GNTbm-TKI is a potent immune-activating multi-tyrosine kinase inhibitor, and it is surprisingly found capable of significantly reshaping the tumor microenvironment when combined with GNTbm-38. When further combined with ICI or anti-PD-1/VEGF bispecific antibodies, it can greatly enhance anti-cancer efficacy, providing a scientific basis for future clinical trials.

About GNTbm-TKI
GNTbm-TKI is a new chemical entity independently developed by GNTbm. It is a drug candidate selected by an immuno-competent tumor-bearing animal testing platform, and has undergone many preclinical research studies to be demonstrated that it has very outstanding anti-cancer activity in tumor microenvironment. GNTbm-TKI is an oral drug with dual effects of strong immune activation and multi-tyrosine kinase, which is unique when compared to the mechanism of other TKI drugs. GNTbm-TKI can remodel the tumor microenvironment (TME) through a unique multiple regulatory mechanism based on its kinase targets which it selectively inhibits. GNTbm-TKI strongly inhibits tumor growth and development, suppresses tumor invasion and metastasis, inhibits tumor angiogenesis, and most importantly, possesses potent tumor immune regulatory activity. When GNTbm-TKI is combined with GNTbm-38, based on their respective unique mechanisms, they have a complementary and powerful tumor microenvironment remodeling function, capable of converting ‘cold tumors’ into ‘hot tumors.’ When further combined with ICI or anti-PD-1/VEGF bispecific antibodies, they exhibit exceptionally superior anti-tumor immuno-oncology activity, which can attract CTL to infiltrate into the TME, and activate CTLs and reduce CTL exhaustion. At the same time, it can also reduce the attraction of immunosuppressive cells (such as: TAM, Treg, and MDSCs) into the TME, so as to achieve the remodeling of the TME, which is more conducive to obtaining the therapeutic benefits of cancer immunotherapy. GNTbm-TKI monotherapy can be used in the treatment of advanced neuroendocrine tumor, and GNTbm-TKI can also be combined with GNTbm-38 or/and ICI/anti-PD-1/VEGF bispecific antibodies for treatment of a variety of solid tumors, mainly through a unique anti-cancer immune-regulating and multiple-tyrosine kinase inhibition mechanism to achieve anti-cancer treatment goals.

(Press release, GNT Biotech & Medicals, OCT 14, 2025, View Source;medicals-corporation-gntbm-presented-preclinical-data-on-gntbm-tki-a-novel-multi-tyrosine-kinase-inhibitor-with-potent-immune-activation-at-the-2025-esmo-annual-meeting-302583015.html [SID1234656657])

On October 14, 2025 Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, reported that its self-developed CDH17-targeting ADC (R&D code: 7MW4911) received IND clearance from the National Medical Products Administration (NMPA) in China to initiate clinical study in patients with advanced solid tumors.

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7MW4911 is an investigational CDH17-targeting ADC developed using Mabwell’s proprietary IDDC platform. Its highly optimized structure integrates three key elements:

– Mab0727: A highly specific CDH17 monoclonal antibody with rapid internalization properties, cross-species (human/monkey) moderate affinity, and minimal off-target binding.

– Novel cleavable linker: Ensures precise payload release in tumor tissues.

– MF-6 payload: A proprietary DNA topoisomerase I inhibitor designed to overcome multidrug resistance (MDR), exhibiting superior plasma stability, controlled drug release, and potent bystander effects.

In July 2025, Mabwell published preclinical data in Cell Reports Medicine ("Overcoming multidrug resistance in gastrointestinal cancers with a CDH17-targeted ADC conjugated to a DNA topoisomerase inhibitor"), demonstrating 7MW4911’s tumor-selective cytotoxicity via CDH17-mediated internalization. Key advantages include:

– Optimized molecular design: Homogeneous drug-to-antibody ratio (DAR=4, >95%) and stable linker confer exceptional plasma stability, while membrane-permeable MF-6 drives potent bystander killing.

– Broad Antitumor Efficacy: Demonstrates robust tumor regression in colorectal, gastric, and pancreatic cancer PDX/CDX models, including tumors with RAS/BRAF mutations and diverse Consensus Molecular Subtypes (CMS).

– MDR resistance: Outperforms MMAE/DXd-based ADCs in ABC transporter-mediated MDR models and reverses tumor progression post-ADC treatment.

– Target versatility: Active even in tumors with low-to-moderate CDH17 expression, expanding potential patient eligibility.

– Favorable safety profile: Limited tissue distribution in mice, controllable pharmacokinetics (moderate half-life, no accumulation), and a wide therapeutic window in cynomolgus monkeys, with no significant toxicity signals.

With this profile, 7MW4911 emerges as a promising therapeutic candidate for advanced gastrointestinal cancers. 7MW4911 has also received IND clearance from US FDA to initiate clinical study in patients with advanced colorectal cancer and other advanced gastrointestinal tumors.

About CDH17

CDH17 is a pan-cancer validated target with restricted expression in normal intestinal epithelium but marked overexpression in gastrointestinal cancers (e.g., colorectal, gastric, pancreatic). Its aberrant expression correlates with tumor metastasis and poor prognosis, positioning it as an ideal therapeutic target.

(Press release, Mabwell Biotech, OCT 14, 2025, View Source [SID1234656656])

On October 14, 2025 Caris Life Sciences (NASDAQ: CAI), a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, reported it will unveil six studies at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, in Berlin, Germany from October 17-21, 2025. These presentations highlight the transformative power of multiomics, a scientific approach that integrates data from multiple biological layers to achieve a comprehensive understanding of biological systems and disease. The research spans nine tumor types, and results showcase how integrated profiling, subtyping, and biomarker discovery are driving more informed treatment decisions and improving patient outcomes.

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The six studies were conducted in collaboration with more than 25 leading cancer centers across the U.S., Europe, and Japan, including members of the Caris Precision Oncology Alliance. The research will be featured across multiple formats, including one oral "Proffered Paper," one mini-oral and four poster presentations. The studies highlight Caris’ continued leadership in applying next-generation sequencing (WES and WTS), immunohistochemistry (IHC) and real-world clinico-genomic data to uncover actionable insights. Tumor types represented include colorectal, gastric, breast, pancreatic, head & neck, prostate, urothelial, renal, and biliary tract cancers.

"By integrating real-world data, advanced sequencing and biomarker discovery, we’re refining cancer subtyping and treatment decisions to improve patient outcomes across numerous cancer types,’ said Milan Radovich, PhD, Senior Vice President and Chief Scientific Officer at Caris. "ESMO provides an international stage to share these insights and accelerate the future of personalized cancer care."

Oral ‘Proffered Paper’ includes:

The Mechanism of Mismatch Repair Deficiency (MMRd) Informs Survival Outcomes Derived from Immune Checkpoint Blockade (ICB) Across MMRd Solid Tumors (Presentation Number: 1110)
Saturday, Oct 18, 2025
Mini-oral includes:

Comprehensive Multi-Omics Analysis of Early-Onset Cancer: Insights from the MONSTAR-SCREEN-2 Experience (Presentation Number: 115MO)
Saturday, Oct 18, 2025
Posters include:

Impact of Androgen Deprivation Therapy (ADT) on KLK2 mRNA Expression and Immunologic Correlates Across Prostate Cancer Disease States (Presentation Number: 2437P)
Saturday, Oct 18, 2025
Optimizing Immunotherapy in Mismatch Repair-Deficient Colorectal Cancer Through Tailored, Subtype-Specific Treatment Approaches (Presentation Number: 795P)
Sunday, Oct 19, 2025
Transcriptomic-Based Prediction of Therapeutic Response in Metastatic RAS-Mutant Colorectal Cancer (Presentation Number: 829P)
Sunday, Oct 19, 2025
NOTCH: A Dynamic Pathway in Head and Neck Squamous Cell Carcinoma (Presentation Number: 1409P)
Monday, Oct 20, 2025
The full abstracts will be available on the Caris website at the event’s conclusion.

The Caris Precision Oncology Alliance (POA) consists of 97 cancer centers, academic institutions, research consortia and healthcare systems, including 45 NCI-designated cancer centers, all collaborating to advance precision oncology and biomarker-driven research. Caris and POA members collaborate to establish and optimize standards of care for molecular testing through innovative research focused on predictive and prognostic markers, aiming to improve clinical outcomes for cancer patients.

(Press release, Caris Life Sciences, OCT 14, 2025, View Source [SID1234656655])

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])

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

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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])