OM-RCA-01 / OncoMax, Bureau for Cancer Research - LARVOL DELTA

Preclinical rationale for FGFR1 blockade in colorectal cancer. (ASCO-GI 2026) - "When tumors reached ~150 mm³, animals were randomized to receive: 1) OM-RCA-01 (30 mg/kg, i.p., twice weekly for 3 weeks); 2) bevacizumab (5 mg/kg, i.p., twice weekly for 3 weeks); 3) OM-RCA-01 + bevacizumab combination; 4) 5-fluorouracil (30 mg/kg, i.p., on Days 1–3 of each week for 3 weeks); 5) triple combination, or 6) saline control. Targeting FGFR1 effectively inhibited CRC cell proliferation and tumor progression in preclinical models. While dual FGFR1/VEGF antibody therapy did not enhance antitumor efficacy compared with single agents, the addition of chemotherapy produced a marked improvement in therapeutic activity. Tumor growth inhibition."

Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • FGF2 • FGFR1

TAGNOT: A Phase 1b/2 Study of the Safety and Efficacy of the Monoclonal Antibody OM-RCA-01 in Patients With Metastatic Tumors Expressing Fibroblast Growth Factor Receptor 1 (clinicaltrials.gov) - P1/2 | N=58 | Recruiting | Sponsor: Kidney Cancer Research Bureau | Active, not recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Adenocarcinoma • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor • ALK • ER • HER-2 • PGR

Conceptualization of fibroblast growth factor receptor 1 targeting nanomedicines. (PubMed, Explor Target Antitumor Ther) - "FGFR1 plays a role in the resistance to immune checkpoint inhibitors (ICIs) such as pembrolizumab and nivolumab...Based on the FGFR1-related research and the active targeting strategy, we believe that modifying the surface of nanomedicines with anti-FGFR1 antibodies (such as OM-RCA-01) is an effective targeted treatment method for tumors with high expression of FGFR1. Although there have been relevant studies confirming the feasibility of this approach, there are challenges in clinical application, especially in terms of maintaining uniform quality during large-scale production. Therefore, we suggest conducting further optimization studies in the future to accelerate the clinical application of such drug delivery systems and provide more efficient and cost-effective options for tumor treatment."

IO biomarker • Journal • Oncology • FGFR1

TAGNOT: A Phase 1b/2 Study of the Safety and Efficacy of the Monoclonal Antibody OM-RCA-01 in Patients With Metastatic Tumors Expressing Fibroblast Growth Factor Receptor 1 (clinicaltrials.gov) - P1/2 | N=58 | Active, not recruiting | Sponsor: Kidney Cancer Research Bureau

New P1/2 trial • Breast Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor

Extracellular FGFR1 inhibition with OM-RCA-01 humanized antibody suppresses tumor growth in FGFR1-expressing colorectal cancer models (AACR-NCI-EORTC 2025) - "Selective inhibition of the FGFR1 extracellular domain with OM-RCA-01 effectively suppressed FGF2-driven proliferation in vitro, blocked patient-derived CRC spheroid growth, and significantly reduced tumor growth in vivo. These findings support OM-RCA-01 as a promising targeted therapy for FGFR1-expressing CRC."

Preclinical • Colorectal Cancer • Oncology • Solid Tumor • FGF2

Future perspectives: targeting fibroblast growth factor receptor 1 to enhance the efficacy of immunotherapy. (PubMed, Explor Target Antitumor Ther) - "More recently, FGFR1 has been implicated in the mechanisms of immune evasion, particularly its role in resistance to immune checkpoint inhibitors (ICIs) such as pembrolizumab and nivolumab. Preclinical studies demonstrate that combining FGFR1 inhibitors, such as the novel monoclonal antibody OM-RCA-01, with ICIs significantly improves antitumor activity, enhancing T cell responses and cytokine production. This article explores the role of FGFR1 in cancer biology, its contribution to immunotherapy resistance, and the therapeutic potential of targeting FGFR1 to enhance the efficacy of ICIs."

Journal • Review • Oncology • FGFR1

A novel anti-FGFR1 monoclonal antibody OM-RCA-01 exhibits potent antitumor activity and enhances the efficacy of immune checkpoint inhibitors in lung cancer models. (PubMed, Immunooncol Technol) - "In vitro, the combination of nivolumab and OM-RCA-01 resulted in higher levels of interferon gamma and interleukin-2 release compared with nivolumab alone. In vivo, pembrolizumab in combination with OM-RCA-01 produced a greater inhibitory effect on tumor growth compared with vehicle and pembrolizumab alone...Combining an anti-FGFR1 antibody with a checkpoint inhibitor may enhance the efficacy of both drugs. However, further studies are needed to elucidate the mechanism of this interaction."

Checkpoint inhibition • IO biomarker • Journal • Preclinical • Infectious Disease • Lung Cancer • Oncology • Solid Tumor • FGFR1 • IFNG • IL2 • PD-L1

Overcoming resistance to immunotherapy with FGFR inhibition in GU cancer models (ESMO 2023) - "OM-RCA-01, a anti-FGFR1 humanized antibody, and alofanib, a FGFR2 allosteric inhibitor showed promising results in previous studies...Treatment with ipilimumab (ipi, 200 mcl on days 7, 10, and 13) was initiated in both cohorts when tumor volumes reached 70 mm3...The table summarizes the results of in vivo studies. Table: 1073P Conclusions Inhibition of FGFR1 and FGFR2 following immunotherapy resulted in a twofold suppression of tumor growth, especially in the CAFs+ cohort."

Preclinical • Genito-urinary Cancer • Kidney Cancer • Oncology • Prostate Cancer • Renal Cell Carcinoma • CAFs • FGFR2 • IFNG • VIM

Neutralizing anti-FGFR1 antibody as a combined partner of anti-PD-1 antibodies in tumor models (ESMO 2022) - "Methods In vitro assays using human T cells were performed to evaluate lymphocyte responses to stimulation with nivolumab alone (1-100 nmol/l) or with OM-RCA-01 (1-10 nmol/l)...Treatment with OM-RCA-01 (30 mg/kg) and pembrolizumab (10 mg/kg) or pembrolizumab alone or saline (vehicle) every 3 days was started when the tumors reached 70 mm3...No group mean body weight losses or clinical manifestations of toxicity were observed. Conclusions Co-inhibition of FGFR1 and PD-1 drives activation of T-cell clones to support enhanced antitumor activity."

Preclinical • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • FGFR1 • IFNG • PD-L1

Combined FGFR1 and PD-1 inhibition could enhance antitumor activity in lung cancer models (AACR 2022) - "Treatment with intravenous OM-RCA-01 (30 mg/kg) with pembrolizumab (10 mg/kg) or pembrolizumab alone (10 mg/kg) or saline (vehicle) every 3 days was started when the tumors reached 70 mm3 in volume. In conclusion, OM-RCA-01 antibody has potent antitumor activity against lung cancer in vitro and in vivo. Our findings also support that the co-inhibition of FGFR1 and immune checkpoints can enhance antitumor activity compared to anti-PD-1 antibody monotherapy."

IO biomarker • Preclinical • Lung Cancer • Oncology • Solid Tumor • FGF2 • FGFR1 • PD-L1