CJRB-101 / CJ Biosci - LARVOL DELTA

First-in-human study of CJRB-101, a live biotherapeutic product in combination with pembrolizumab in selected types of advanced or metastatic cancer. (ASCO 2025) - P1/2 | "CJRB-101 plus pembrolizumab was well tolerated with manageable safety profile. Preliminary efficacy data show anti-tumor activity in metastatic NSCLC, and early biomarker data support the role of immune activation of CJRB-101. Exploratory analysis of PBMCs, multiplex IHC, PD biomarker, and fecal microbiota metagenomics analysis are ongoing."

Combination therapy • IO biomarker • Metastases • P1 data • Anemia • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD4 • CD8 • GZMB • HAVCR2 • PD-1

Phase I trial of CJRB-101 plus pembrolizumab in patients with metastatic non-small cell lung cancer, head and neck squamous cell carcinoma and melanoma. (PubMed, J Immunother Cancer) - P1/2 | "Early clinical data show encouraging antitumor response of CJRB-101 plus pembrolizumab in ICI-naïve metastatic NSCLC with PD-L1 >50%."

First-in-human • IO biomarker • Journal • P1 data • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Identification of potential biomarkers and immune characteristics in patients with non-small cell lung cancer treated with CJRB-101 plus pembrolizumab (AACR 2025) - "We demonstrated that clinical response to CJRB-101 plus pembrolizumab and its association with enhanced macrophage function, increased GZMB+ T cell, and reduced Treg. Further analysis is in progress with additional clinical samples."

Biomarker • Clinical • IO biomarker • Late-breaking abstract • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD4 • CD8 • GZMB • HAVCR2 • IFNG • PD-1 • PRF1 • PYCARD • TLR8

CJRB-101 induces immune responses through the GUT-TME axis in immune cell-driven mechanism in lung cancer models (AACR 2024) - "TLR4-mediated mechanism was evaluated using ex vivo and in vivo assay treated with CJRB-101 or cell membrane of CJRB-101.Results CJRB-101 combined with pembrolizumab effectively suppressed tumor growth in anti-PD-1 resistant PDX models. In vivo results indicated that anti-cancer efficacy of CJRB-101 is immune-cell driven by TLR4-dependent stimulation of key immune cell populations (macrophages, CD8+ T cells, neutrophils) modulated by the cell membrane of CJRB-101. CJRB-101 is currently undergoing clinical investigation for treatment of patients with advanced NSCLC."

Immune cell • IO biomarker • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD34 • CD8 • GZMB • IFNG • IL1B • IL6 • TLR4

Unveils CJRB-101 phase 1/2 interim analysis, demonstrating safety and partial efficacy (Korea Biomedical Review) - P1/2 | N=160 | NCT05877430 | Sponsor: CJ Bioscience, Inc. | "In a poster presented at ASCO 2025, the company reported no grade 3 or higher adverse events, serious adverse events (SAEs), or treatment discontinuations....A poster presented at ASCO showed that CJRB-101 increases the expression of genes related to T-cell function and activation (GZMB and PRF1) and prevents the expression of immunosuppressive genes (CTLA4 and IDO1)....In addition, a disease control rate (DCR) of 41 percent was reported in 22 patients with ICI-refractory NSCLC. The interim analysis concluded that the CJRB-101 combination may have contributed to some disease stabilization."

P1/2 data • Non Small Cell Lung Cancer

CJ Bioscience to Present Preclinical Data on Microbiome New Drug at 'ECCO 2025' [Google translation] (HIT News) - "The company explained that it is developing CJRB-201 as a follow-up pipeline to its main pipeline, ‘CJRB-101,’ and that it plans to disclose its anti-inflammatory effects and mechanism of action through immune analysis and animal testing at this conference...According to the company, the research team discovered that among 60 strains of the Faecalibacterium genus, CJRB-201 most effectively induced regulatory T cells (Treg) with immune-regulating functions. In addition, in a mouse experimental model, it confirmed the effects of improving major disease indicators, such as suppressing weight loss, improving disease activity index, alleviating tissue pathology, suppressing inflammatory cytokine secretion, and improving colon length....'Based on the results of this study, we plan to begin full-scale clinical development in 2026.'"

Preclinical • Inflammatory Bowel Disease

Safety, Tolerability, and Preliminary Efficacy of CJRB-101 With Pembrolizumab in Subjects With Selected Types of Advanced or Metastatic Cancer (clinicaltrials.gov) - P1/2 | N=160 | Recruiting | Sponsor: CJ Bioscience, Inc. | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • BRAF

Safety, Tolerability, and Preliminary Efficacy of CJRB-101 With Pembrolizumab in Subjects With Selected Types of Advanced or Metastatic Cancer (clinicaltrials.gov) - P1/2 | N=160 | Not yet recruiting | Sponsor: CJ Bioscience, Inc.

Combination therapy • Metastases • New P1/2 trial • Head and Neck Cancer • Immune Modulation • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • BRAF