ZM008 / Zumutor - LARVOL DELTA

A phase 1 first-in-human study of the novel anti-LLT1 antibody (ZM008) alone and in combination with anti-PD1 antibody in patients with advanced solid tumors. (ASCO 2025) - P1 | "Synergistic anti tumor effects were observed with ZM008 in combination with pembrolizumab...Clinical trial information: NCT06451497. Research Sponsor: Zumutor Biologics Inc."

Clinical • Combination therapy • IO biomarker • Metastases • P1 data • Bladder Cancer • Genito-urinary Cancer • Immunology • Infectious Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Solid Tumor • Triple Negative Breast Cancer • KLRB1

Phase 1 clinical trial of the anti-LLT1 antibody ZM008 as monotherapy and in combination with pembrolizumab in advanced solid tumor patients (EORTC-NCI-AACR 2024) - P1 | "Patients with high LLT1 expressing tumors could possibly benefit with ZM008 treatment post standard of care with anti PD1 or PDL1 therapies. Updated results will be presented."

Clinical • Combination therapy • IO biomarker • Metastases • Monotherapy • P1 data • Oncology • Ovarian Cancer • Solid Tumor • KLRB1

Phase 1 Trial of ZM008 as Single Agent and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=33 | Recruiting | Sponsor: Zumutor Biologics Inc.

Combination therapy • Metastases • New P1 trial • Biliary Cancer • Breast Cancer • Colorectal Cancer • Diffuse Large B Cell Lymphoma • Esophageal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hematological Malignancies • Hepatology • Lung Cancer • Lymphoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Pancreatic Cancer • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer

Zumutor Biologics Announces Dosing of First Patient with ZM008, a First-in-Class Anti LLT1 Antibody (PRNewswire) - "Zumutor Biologics...announced that the first patient was dosed in its Phase 1 clinical trial, with ZM008. The dose escalation trial is evaluating ZM008 in patients with advanced solid tumors, as a single agent and in combination with pembrolizumab....The ZM008-001 trial is an open-label, first-in-human, multicenter, Phase 1 dose escalation trial of ZM008 administered alone or combined with Pembrolizumab. The trial will assess the safety, pharmacokinetics, establish the maximum tolerated dose, pharmacodynamic biomarkers, and initial antitumour activity of ZM008. The study will recommend the Phase 2 dose."

Trial status • Solid Tumor

First-in-human phase 1 clinical trial of ZM008, a monoclonal IgG1 targeting LLT1, monotherapy and in combination with pembrolizumab in advanced solid tumors (AACR 2024) - "ZM008 treatment will release the immune break, activate the infiltrated immune cells and provide anti tumor effects in solid cancers either as a standalone treatment or combination therapy. Retrospective analysis of patient samples pre and post ZM008 treatment will identify relevant biomarkers for patient recruitment and better prediction of prognosis."

Clinical • Combination therapy • IO biomarker • Metastases • Monotherapy • P1 data • Tumor mutational burden • Bladder Cancer • Genito-urinary Cancer • Kidney Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • BRCA • CD276 • CD33 • CD69 • HAVCR2 • ICOS • IDO1 • IFNG • IL10 • IL2 • IL4 • KLRB1 • LAG3 • LAMP1 • NKG2D • PD-L1 • TIGIT • TMB

Phase 1 clinical trial design of ZM008, a first-in-class anti LLT1 antibody is a promising therapy for multiple solid cancers (SITC 2023) - "Background Lectin-like transcript 1 (LLT1) interaction with CD161 on NK cells facilitates tumor immune escape. In addition, to avoid adverse reactions with Pembrolizumab combination arm we have designed a staggered parallel approach with detailed safety data discussion with the agency at the BED dosing. This unique design allows maximum patient safety while evaluation of novel standalone I/O therapy or combination therapies."

Clinical • IO biomarker • P1 data • Tumor mutational burden • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • Urothelial Cancer • CD33 • HAVCR2 • ICOS • IL6 • KLRB1 • LAG3 • LAMP1 • PD-1 • TIGIT • TMB

Biomarkers for novel NK checkpoint inhibitor anti LLT1 antibody, ZM008: Patient transcriptome analysis (ESMO 2023) - "Multiple anti-inflammatory gene signatures could be useful in stratifying patients for ZM008 treatment. In addition, TMB & MSI scores and MMR gene expression could be monitored as potential biomarkers in phase I clinical trials with ZM008."

Biomarker • Checkpoint inhibition • Clinical • IO biomarker • Tumor mutational burden • Oncology • BRCA • CD33 • CD8 • HAVCR2 • ICOS • IL2 • IL6 • KLRB1 • LAG3 • LAMP1 • PD-1 • TIGIT • TMB

Zumutor Biologics Inc announces FDA clearance of IND application of ZM008, a novel monoclonal antibody drug against multiple solid cancers (PRNewswire) - "Zumutor Biologics Inc...announces that the US Food and Drug Administration (FDA) has granted the company's Investigational New Drug (IND) application for the novel drug ZM008 to initiate a Phase 1, first-in-human, clinical study for the treatment of multiple solid cancers. ZM008 is a human IgG1 monoclonal antibody against LLT1 (CLEC2D), which disrupts the interaction of LLT1-CD161 between human immune cells and Tumor cells resulting in antitumor effects of ZM008 in monotherapy....FDA also accepted the 'safety first' staggered parallel clinical design of ZM008 combination arm with Pembrolizumab to benefit a wider range of patients whose immune response could be boosted with ZM008 followed by Pembrolizumab treatment to obtain favourable disease responses."

IND • New P1 trial • Oncology • Solid Tumor

"#Zumutor receives the US patent for its novel biologic #ZM008 https://t.co/EldfGsSaTP" (@1stOncology)

ZM008, a first in class monoclonal anti LLT1 antibody demonstrated clinical potential in multiple solid cancers (SITC 2022) - "GLP safety and toxicity studies in Cynomolgus monkey support future clinical application of ZM008. Overall, the data suggests ZM008 drug product is poised to initiate phase 1 trial (monotherapy and combination with Pembrolizumab) in multiple solid cancers."

Clinical • Bladder Cancer • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer • CASP3 • CD69 • CD8 • GZMB • IFNG • KLRB1 • NCAM1 • NKG2D • PRF1 • TNFA

Abrogation of natural killer cell check point pathway LLT1/CD161 by novel anti LLT1 antibody ZM008 and its therapeutic applications in solid cancers. (ASCO 2022) - "A Phase 1 open label, multicenter dose escalation clinical trial is planned in patients with advanced solid tumors to evaluate the safety and tolerability of ZM008, as monotherapy and in combination with Pembrolizumab. This study for the first time revealed intense staining of LLT1 protein in high Gleason score prostate cancer, demonstrating therapeutic potential of ZM008 in solid cancers not responsive to current I/O checkpoint therapies. Invitro and in vivo experiments have shown human NK cells activation resulting in significant tumor growth reduction. CD56+ NK and CD8+ T cells infiltrations indicate transformation of “Cold tumors” to “Hot tumors”."

IO biomarker • Genito-urinary Cancer • Head and Neck Cancer • Immune Modulation • Inflammation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer • CD69 • CD8 • IFNG • KLRB1 • NCAM1 • NKG2D