ON203 / OncoOne - LARVOL DELTA

Targeting the oxidized form of macrophage migration inhibitory factor (oxMIF) with antibody ON203 activates the tumor microenvironment (AACR 2023) - "Taken together, the anti-oxMIF antibody ON203 demonstrated antitumorigenic effects by reducing tumor cell proliferation and by modulating the TME towards immunosupportive functions. In the upcoming clinical Phase 1 trial ON203’s safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with solid tumors will be analyzed to evaluate its potential as a standalone or combinatorial therapy with immune checkpoint inhibitors."

Biomarker • IO biomarker • Tumor microenvironment • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • GZMB • IL10 • LAMP1 • MIF • TGFB1

Preclinical Evaluation of ON203, A Novel Bioengineered mAb Targeting Oxidized Macrophage Migration Inhibitory Factor as an Anticancer Therapeutic. (PubMed, Mol Cancer Ther) - "In vivo, ON203 mAb demonstrated superior efficacy over imalumab in both prophylactic and established prostate cancer (PC3) mouse xenograft models. In summary, our data highlight the potential of the second-generation anti-oxMIF mAb ON203 as a promising immunotherapy for patients with solid tumors, warranting clinical evaluation."

IO biomarker • Journal • Preclinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • MIF

ON203: A new antibody targeting the oxidized form of macrophage migration inhibitory factor (oxMIF) exerts antitumorigenic activity and modulates the tumor microenvironment. (SITC 2022) - "Conclusions The anti-oxMIF antibody ON203 demonstrated antitumorigenic effects by (i) reducing tumor cell proliferation, (ii) reducing angiogenesis and intravasation and (iii) by modulating the TME towards immunosupportive functions. In the upcoming clinical Phase 1 trial ON203’s safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with solid tumors will be analyzed to evaluate its potential as a standalone or combinatorial therapy with immune checkpoint inhibitors, kinase inhibitors or antiangiogenic agents."

Biomarker • IO biomarker • Tumor microenvironment • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CD31 • GZMB • IL10 • LAMP1 • MIF • PECAM1

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Anti-oxMIF Antibody ON203 in Malignant Solid Tumors (IASLC-WCLC 2022) - "Treatment will continue until progressive disease (as defined by the RECIST criteria), unacceptable toxicity, DLT, or withdrawal of patient’s consent, with an estimated study duration of 10 months. A dose expansion phase will follow to further substantiate the safety profile, gain additional signals of efficacy, as well as to correlate outcomes with biomarkers."

Clinical • PK/PD data • Brain Cancer • Cardiovascular • CNS Tumor • Hypertension • Infectious Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MIF

ON203: A new antibody targeting the oxidized form of macrophage migration inhibitory factor demonstrates antitumorigenic activity and TME modulation in patient-derived CRC tumoroids (ESMO-GI 2022) - "Tissue penetration and target occupancy analyses demonstrated specific binding of imalumab to oxMIF in CRC liver metastases. These findings are in line with in vivo efficacy models. Therefore, ON203 has a high potential to become a new treatment option for patients with colorectal cancers as a standalone therapy or in combination with checkpoint inhibitors, chemotherapeutics, anti-angiogenic drugs, or kinase inhibitors."

Clinical • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • CD8 • FCGR2A • FCGR2B • GZMB • IL10 • LAMP1 • MIF • TNFA

ON203: A new antibody targeting the oxidized form of macrophage migration inhibitory factor demonstrates antitumorigenic activity in preclinical models (EACR 2022) - "Our results substantiate a Ph 1 trial evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with solid tumors. Conclusion ON203 has a high potential to become a new treatment option for patients with solid tumors as a standalone therapy or in combination with checkpoint inhibitors, chemotherapeutics, anti-angiogenic drugs, or kinase inhibitors."

Preclinical • Oncology • Solid Tumor • MIF

OncoOne (BIO 2022) - "OncoOne is r advancing their lead asset ON203, an optimized oxMIF mAb, to clinic in early 2023...ON104 has great potential to improve upon the current standards of care in rheumatoid arthritis, ulcerative colitis, Crohn’s disease, refractory asthma, and other autoimmune disorders. OncoOne initiated investor discussions this year to secure Series B fund"

Asthma • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Arthritis • Inflammatory Bowel Disease • Oncology • Pulmonary Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Solid Tumor • Ulcerative Colitis • MIF

Novel bioengineered monoclonal antibodies targeting oxidized macrophage migration inhibitory factor as anti-cancer therapeutics and companion diagnostics (AACR 2022) - "ON203 has a high potential to significantly improve efficacy compared to the 1st generation anti-oxMIF mAb, with Zr89-ON102 as companion diagnostic for patient stratification. We aim to develop these anti-oxMIF mAbs together for clinical use to create new treatment options for patients with solid tumors, with a clear rationale to combine ON203 with other immunotherapies or checkpoint inhibitors (Noe and Mitchell, 2020)."

Companion diagnostic • IO Companion diagnostic • Colon Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • IL6 • MIF • TNFA

OncoOne Presents Preclinical Proof of Concept Data for its Next-Generation oxMIF-targeted Monoclonal Antibody ON203 at the AACR Annual Meeting (Businesswire) - "OncoOne...announced today the presentation of preclinical proof-of-concept data on its lead candidate ON203, a therapeutic monoclonal antibody targeting oxMIF, and the radiodiagnostic 89Zr-ON102, at the American Association for Cancer Research (AACR) Annual Meeting 2022, held from April 8-13, in New Orleans, Louisiana. ON203 demonstrated tumor growth suppression in two cancer mouse models and superior tumor cell killing effects in vitro as compared to a first generation anti-oxMIF antibody which had reached clinical evaluation."

Preclinical • Oncology • Solid Tumor

OncoOne and GenScript ProBio Enter Agreement for the Manufacturing of Monoclonal Antibody Drugs Targeting oxMIF (PRNewswire-Asia) - "OncoOne...and GenScript ProBio...announced that the companies have entered into an agreement for the cell line development, drug substance and drug product manufacturing of therapeutic and diagnostic monoclonal antibodies (mAbs) directed against the promising immuno-oncology target, oxidized macrophage migration inhibitory factor (oxMIF)....By partnering with GenScript ProBio's high-end manufacturing practices, OncoOne aims to have its first two oxMIF candidates, the therapeutic program ON203 as well as the companion radio-labeled diagnostic, ON102, enter phase I clinical trials in 2023."

Licensing / partnership • New P1 trial • Oncology